Medicines and Related Substances Regulations (SI.No.163 2019)

REPUBLIC OF BOTSWANA GOVERNMENT GAZETTE EXTRAORDINARY Vol. LV, No. 102 GABORONE 27th December, 2019 CONTENTS Page Supplement C — Medicines and Related Substances Regulations, 2019 — SI.No.1630£2019... C.1029-1179 The Botswana Govemment Gazette is printed by Department of Government Printing and Publishing Services, Private Bag 0081, GABORONE, Republic of Botswana. Annual subscription rates are P600,00 post free surface mail, SADC Countries airmail P1,357,00, Rest of Africa airmail P1,357,00, Europe and USA atial P1.73500. The price for this issue of the Extraordinary Gazerre is P5.00. Supplement C — Botswana Government Extraordinary Gazette dated 27th December, 2019 Statutory Instrument No. 163 of 2019 MEDICINES AND RELATED SUBSTANCES ACT (Cap. 63:04) MEDICINES AND RELATED SUBSTANCES REGULATIONS, 2019 (Published on 27th December, 2019) ! ARRANGEMENT OF REGULATIONS REGULATION 1. 2. Part I — Preliminary Citation Interpretation Part II — Medicines - Registration of medicine - Validity period of registration of medicine - Renewal of registration - Exemption from registration of medicines for individual patient . Import of unregistered medicines for personal use - Exemption from registration of medicines for wholesale . Exemption of donated unregistered medicines . Variations . Notifications - Recall of medicines by other institutions outside Botswana - Recall of medicines by Authority - Withdrawal of marketing authorisation - Suspension or revocation of marketing authorisation Part Il — Licensing . Licensing of pharmaceutical operations - Licensing of manufacturing facility - Licensing of pharmacy - Licensing of pharmaceutical wholesaler . Licensing of pharmacies within a group practice - Licensing of dispensaries in surgeries and institutional dispensaries - Variation of licence - Suspension or withdrawal of licence - Renewal of licence Part IV — Record keeping and import of medicines . Record keeping . Import of medicines 27. 28. Parallel import of medicines Import of samples for registration C.1029 C.1030 29. Post-market surveillance 30. Adverse medicine reactions 31. Counterfeit medicines 32. Medicines in transit 33. Designation of ports 34. Disposal of unwanted medicines 35. Classification and description of medicines 36. Prescription of medicines 37. Contents of prescriptions 38. Emergency administration 39. General dispensing 40. Dispensing of Schedules 1A, 1B and 1C medicines 41. Emergency dispensing of Schedules 1A, 1B and 1C medicines 42. Dispensing of Schedule 2 medicines 43. Dispensing of Schedules 1D and 3 medicines 44, Emergency supply of medicines by pharmacist 45. Storage of medicines by prescribers 46. Dispensing of medicines by healthcare providers other than pharmacists 47. Sale and use of precursor chemicals 48. Storage of medicines 49. Product information 50. Import and export of narcotics, psychotropics and precursor chemicals 51. Records for narcotics, psychotropics and precursor chemicals 52. Correction of records 53. Advertising and promotion 54. Inspection of premises Part V — Control of clinical trials 55. Application for use of medicines for clinical trials 56. Monitoring of clinical trial 57. Inspection and audit of clinical trials 58. Suspension or termination of approval to conduct clinical trials 59. Disposal of unused medicines in clinical trials Part VI — Cosmetics 60. Registration of cosmetics 61. Exemption for registration of cosmetics 62. Publication of list of prohibited ingredients 63. Labelling of cosmetics 64. Licensing of manufacturing cosmetics 65. Import of cosmetics Part VII — Complementary medicines 66. Registration of complementary medicines 67. Validity period of registration of complementary medicines Part VIII — General 68. Harmonisation and collaborative activities of Authority 69. Appeals Committee 70. Banned medicines 71. Offences and penalties 72. Revocation of Cap. 63:04 (Sub. Leg.) SCHEDULES C.1031 IN EXERCISE of the powers conferred on the Minister of Health and ‘Wellness by section 69 of the Medicines and Related Substances Act, the following Regulations are hereby made — Part I — Preliminary 1. These Regulations may be cited as the Medicines and Related Substances Citation Regulations, 2019. 2. In these Regulations, unless the context otherwise requires — “Active Pharmaceutical Ingredients (APIs)” means any substance or combination of substances used in a finished pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings; “authorised person” means any person given the responsibility for ensuring the medicines’ requirements are in compliance with the laws and regulations in force in Botswana; “bonded warehouse” means a warehouse where goods are stored and held before being cleared to enter the country and these may also be used to store goods in transit; “complementary medicines” means a labelled substance or mixture of substances manufactured, sold or Tepresented for use as adjuvants to conventional therapy in — (a) the mitigation or prevention of an abnormal physical state; or (b) restoring, correcting or modifying physical, mental or organic functions in humans, and originate from plant, mineral, animal including microorganisms, homeo pathic preparations, nutritional substances in accepted pharmaceutical dosage forms, a combination of the above or any other such preparations as may be approved by the Authority; “guidelines” means documents outlining regulatory requirements applied by the Authority in line with these Regulations as listed in Schedule 6; “notification” means changes that could have minimal or no adverse effects on the overall safety, efficacy and quality of the Finished Pharmaceutical Product (FPP); “parallel importation” means cross-border importation of a medicine or a product registered by the Authority, without the consent of the Ppatentee, where the medicine has been put on the market by the patentee or by another acting with the patentee’s consent, or having an economic tie to the patentee; Tnterpretation C.1032 Registration of medicine Validity period of registration of medicine Renewal of registration Exemption from registration of medicines for individual patient “qualified person” means a person registered with the relevant professional body to undertake work or practise within a specific technical field or area meeting the minimum requirements in the guidelines; and “variations” means — (@) major variations which are changes that could have major effects on the overall safety, efficacy and quality of the FPP; or (b) minor variations which are changes that may ‘Thave minor effects on the overall safety, efficacy and quality of the FPP. Part Il — Medicines 3.(1) An application for registration of medicine shall be in Form 1 set out in Schedule 4 and shall be accompanied by — (@) an application fee set out in Schedule 5; (b) the Common Technical Document in Form 2 set out in Schedule 4; and (c) asample as described in the guidelines. (2) The Authority shall specify conditions for registration for a particular medicine or group of medicines and may — (a) amend any conditions for registration; (b) specify product labelling requirements; or (¢) determine what s to be described in the label or packages of medicines. (3) Where an application to register medicines is successful, the Authority shall issue the registration certificate to the applicant in Form 3 set out in Schedule 4. (4) Where an application to register medicines is unsuccessful, the Authority shall inform the applicant in writing, stating the reasons for the decision not to register the medicine. (5) A summary of technical assessment reports for approved and rejected registration may be published and made available to the public. (6) A marketing authorisation holder shall be responsible for the importa- tion, advertising and promotion of his or her medicine. 4. Aregistration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set out in Schedule 5. 5.(1) A person may apply to the Authority for the renewal of registration of medicines. (2) An application under subregulation (1) shall be — (a) in Form 1 set out in Schedule 4; (b) accompanied by a renewal fee set out in Schedule 5; and (c) submitted to the Authority not Jater than six months before the expiry date of registration. 6. (1) A medical practioner may apply in Form 4, upon payment of an application fee set out in Schedule 5 to the Authority to exempt the registration of medicines from outside Botswana, for his or her patient’s personal use. (2) Subject to subregulation (1), the application shall comply with the guidelines and shall be signed by an importing pharmacist residing in Botswana. (3) The Authority may, after having considered the application and the supporting documents, grant the exemption. (4) The validity period of the exemption from registration shall be six months. 7. (1) A person who imports medicine from outside Botswana for personal use shall not import more than one month’s supply of medicine. (2) Subject to subregulation (1), where a person brings more than one month’s supply, but less than three months’ supply, he or she shall produce, upon request by a competent authority, a certified copy of the prescription from a medical practitioner. (3) Subject to regulation 6, a person shall apply to the Authority in writing for an exemption from registration for any subsequent supplies of the imported medicine. 8.(1) An applicant may apply to the Authority to exempt the registration of medicines for wholesale from outside Botswana under special circumstances as determined by the Authority. (2) The application shall — (@) comply with the guidelines; and (b) be accompanied by the application fee in Form 5 set out in Schedule 5. (3) The applicant may be required to pay for the inspection of the manufacturing site prior to authorisation. 9. A person may apply to the Authority for exemption from registration of donated medicines in Form 6 as set out in Schedule 4 and he or she shall meet the requirements of the guidelines on donation. 10. (1) A marketing authorisation holder shall not make a variation in the particulars of a registered medicine without the prior approval of the Authority, except where the change is a notification. (2) A variation application shall be submitted to the Authority and shall be — (a) in terms of Form 7 set out in Schedule 4; (b) accompanied by a variation fee set out in Schedule 5; and (¢) accompanied by the supporting documents as specified in the conditions laid down for each type of variation. (3) The marketing authorisation holder shall ensure that all the necessary validation has been conducted to demonstrate that the change does not reduce the quality, safety or efficacy of the medicine. (4) The Authority may cancel the registration of a medicine where variations are made without prior approval of the Authority. 11. (1) A marketing authorisation holder shall apply to the Authority for a notification of a variation in the particulars of a registered medicine in Form 7 set out in Schedule 4. (2) Subject to subregulation (1), the applicant shall pay to the Authority a notification fee set out in Schedule 5. (3) An application for immediate notification shall be submitted soon after implementing the variation. (4) An application for annual notification shall be submitted within 12 months after implementing the variation. (5) The Authority shall ensure that quality, safety and efficacy of a medicine is still maintained. 12. Where an institution outside Botswana recalls some medicines, a marketing authorisation holder shall provide the Authority with the following — (a) information on the batches of medicine involved; (b) recall plan and procedure, including the disposal of the recalled medicines; (c) distribution list; and (d) areport of the investigation, before and after the recall. C.1033 Import of unregistered medicines for personal use Exemption from registration of ‘medicines for wholesale Exemption of donated unregistered medicines Variations Notifications Recall of ‘medicines by other institutions outside. Botswana C.1034 Recall of medicines by Authority Withdrawal of marketing authorisation Suspension or revocation of marketing authorisation Licensing of pharmaceutical operations Licensing of ‘manufacturing facility 13.(1) Where the Authority recalls medicines, the Authority shall inform the — (a) public of the procedure to be followed through all possible communication media; and (b) marketing authorisation holder in writing, of its decision, stating the Teasons. (2) The marketing authorisation holder shall be responsible for the disposal of the medicines. 14.(1) A marketing authorisation holder who wishes to withdraw his or her medicines from the market shall provide the Authority with — (a) information on the decision to withdraw: (b) the effective date of withdrawal; (c) reasons for withdrawal; and (d) the plan of communication to prescribers and dispensers. (2) The Authority shall update the register to indicate the withdrawal. 15. (1). Where the Authority suspends or revokes marketing authorisation for reasons including — (a) failure to report adverse reactions to the Authority; (b) failure to meet safety, quality, efficacy requirements; or (c) implementing variations without approval of the Authority, the Authority shall communicate to the marketing authorisation holder in writing, the decision to suspend or revoke the market authorisation. (2) In the case of a suspension or revocation, the Authority shall, within seven days of taking the decision, communicate to the marketing authorisation holder, conditions of the suspension, the duration and the action the marketing authorisation holder has to take. (3) In the case of a revocation, the marketing authorisation holder shall be required to recall his or her medicines from the market in line with the guidelines. (4) The Authority shall notify the public of the decision to suspend or revoke the market authorisation. Part III — Licensing 16. (1) An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5. (2) The Authority may, having considered the application, grant the applicant a licence in Form 9 set out in Schedule 4 and the Authority may attach conditions thereto as it may consider necessary. (3) The Authority shall inform an unsuccessful applicant in writing, of the decision not to licence the premises and the reasons, in line with the guidelines. (4) Where premises are licensed, the premises shall be under the supervision of a qualified person in line with the guidelines. (5) Subject to subregulation (4), any change in the person who supervises the premises shall be communicated to the Authority within 30 days. (6) The Authority shall keep a database of all licenced manufacturing facilities, pharmacies and pharmaceutical wholesalers. 17.(1) An applicant may apply to the Authority for a licence to ‘manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5. (2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines. 18.(1) An application for a licence to operate a pharmacy shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines. 19.(1) An application for a licence to operate a pharmaceutical wholesaler shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of all the required documents according to the guidelines. 20. (1) An applicant may apply to the Authority for a licence to operate a pharmacy within a group practice in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) Subject to subregulation (1), the licence may be under that of a hospital or a pharmacy where the pharmacy services are outsourced. (3) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of a licence or provisional licence of a hospital or a group practice. 21. (1) An applicant shall apply to the Authority for a licence to operate dispensaries in surgeries and institutional dispensaries in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) Where the institutions are required to be licensed by other authorities, the Authority shall issue a licence in Form 9 set out in Schedule 4 subject to submission of a licence or provisional licence of a surgery or an institution. (3) Inits assessment of the application, the Authority shall take into account the scope of practice of the institution in granting the licence. (4) The Authority shall issue a licence, subject to submission of a licence or provisional licence of a surgery or institution. 22.(1) Alicence holder shall apply to the Authority for variation of his or her licence. (2) The application for variation shall be in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5. (3) The Authority may approve the amendments and where the Authority does not approve, it shall inform the unsuccessful applicant in writing, stating the reasons for the decision. 23. (1) Where the licence holder does not meet the required standards and guidelines, the Authority may suspend or withdraw the licence. (2) The Authority shall notify the licence holder of the decision and may indicate the actions to be taken by the licence holder and give the licence holder seven days to respond. (3) The facility shall be closed for the duration of the suspension. (4) Where a licence is withdrawn the facility shall cease to operate. 24.(1) Anapplication for renewal of a licence made under these Regulations shall be made at least three months before expiry of the licence. (2) The application shall be in Form 8 set out in Schedule 4 and shall be in accordance with the guidelines. C.1035 Licensing of pharmacy Licensing of pharmaceutical wholesaler Licensing of pharmacies within a group practice Licensing of dispensaries in surgeries and institutional dispensaries Variation of licence Suspension or withdrawal of licence Renewal of licence C.1036 Record keeping Import of medicines Pazallel import of medicines Tmport of samples for registration Post-market surveillance (3) The application shall be accompanied by a fee set out in Schedule 5. Part IV — Record keeping and import of medicines 25. (1) A person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines shall, according to his or her scope of operation, keep a record as outlined in the guidelines. (2) The Authority may at any time in writing, order a person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines to produce the record for inspection. (3) An inspector may at all reasonable times inspect the records. 26. (1) A person shall apply to the Authority for 2 permit to import medicines, medical products or cosmetics other than narcotics, psychotropics and precursor chemicals in Form 10 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) An application for an import permit shall be accompanied by authorisa- tion from a market authorisation holder to import medicines to Botswana in line with the guidelines. (3) Subject to subsection (1), the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines. (4) Upon assessment the Authority may authorise an entity not licensed as a wholesaler to import medicines, medical products or cosmetics upon payment of a fee set out in Schedule 5. (5) Subject to subregulation (1), a person may apply for a permit to import medicines, medical products or cosmetics that have been exempted from registration in line with the guidelines. (6) All purchasing orders shall be vetted and authorised by the Authority. (7) A person authorised to import medicine shall pay a fee as set out in Schedule 5 for each consignment in line with the guidelines. (8) A wholesaler shall notify the Authority and submit an acknowledgement in line with the guidelines, upon receipt of medicines. 27. An applicant shall apply to the Authority in Form 11 set out in Schedule 4 for parallel import of medicines — (@) in the manner outlined in the guidelines; (b) accompanied by a fee set out in Schedule 5; and (¢) the importer shall provide the authorisation from the Ministry responsible for trade. 28. A person shall apply to the Authority for approval to import samples in Form 10 set out in Schedule 4. 29. (1) A prescriber, pharmacist and a health care professional shall report any safety, quality and efficacy issues to the Authority and to the marketing authorisation holder in line with the guidelines. (2) The Authority shall from time to time conduct risk based inspections of pharmaceutical operations and take samples of medicines, medical products or cosmetics on the market for testing and investigation to establish the quality, safety and efficacy in Form 12 set out in Schedule 4. (3) The Authority shall, where a sample fails to meet the relevant specifications — (a) issue the marketing authorisation holder or importer with a written warning and up to a maximum of 30 days to identify the source or cause of the quality defect and any action to be taken to improve quality; or (b) where the failure warrants a recall of the medicines, medical products or cosmetics as set out in the guidelines, the Authority shall order the marketing authorisation holder or importer to recall the medicine, medical product or cosmetic. (4) The marketing authorisation holder shall remove from the market and dispose at his or her cost, medicines, medical products or cosmetics that do not meet the required standards which disposals shall be in accordance with regulation 34. (5) The marketing authorisation holder shall keep records of the recall and disposal of the medicines, medical products or cosmetic and he or she shall submit a copy of the records to the Authority. (6) A person licensed to operate a pharmaceutical operation shall report any suspected problems, regarding the quality, safety or efficacy of the medicines to the Authority. (7) Amarketing authorisation holder or importer shall carry out investigation to identify the root cause of the problem and develop a risk management plan to prevent recurrence including a comprehensive review of the manufacturing process. (8) The Authority shall assess the report of the investigation and risk management plan where a marketing authorisation was earlier suspended, before it can lift the suspension. (9) The Authority may investigate and decide on an appropriate action to be taken by either the Authority or the marketing authorisation holder, where any problem is suspected. (10) The Authority, the marketing authorisation holder or importer and the manufacturer shall keep the public informed about the findings and any relevant information about the medicines, medical products and cosmetics within a specified time according to the guidelines. (11) The marketing authorisation holder or importer shall in accordance with the guidelines, provide a post market surveillance plan for his or her medicine and report to the Authority, any findings from an accredited quality control laboratory. (12) All testing shall be done in accredited quality control laboratories. 30.(1) The Board shall appoint a committee to deal with adverse medicines, medical products or cosmetics reactions and to review reports of suspected medicine reactions. (2) A marketing authorisation holder of medicines, medical products or cosmetics shall report to the Authority any adverse reactions in line with the suidelines. (3) The marketing authorisation holder shall ensure all labels and package inserts are amended to include any new adverse reactions, ‘warning, including precautions within such period as may be determined by the Authority. (4) A prescriber, pharmacist or a health care professional shall report to the Authority any adverse reactions in accordance with the guidelines. 31.(1) Animporter, exporter, marketing authorisation holder, manufacturer, distributor, dispenser, and promoter of medicines, medical products or cosmetics shall have in place, risk management plans to prevent circulation of counterfeit medicines. C.1037 Adverse medicine reactions Counterfeit medicines C.1038 Medicines in ansit Designation of ports Disposal of unwanted medicines Classification and description of medicines Prescription of medicines (2) The plans under subregulation (1) shall include the following measures — (a) 1o prevent counterfeit medicines, medical products or cosmetics from entering Botswana; (b) to prevent the sale and use of counterfeit medicines, medical products or cosmetics; (¢) to address counterfeit medicines, medical products or cosmetics once detected on the market; and (d) to regularly review risk management plans. (3) The Authority shall publish the information on circulating counterfeit medicines, medical products or cosmetics as and when the need arises. 32. (1) Any person transiting medicines, medical products or cosmetics through Botswana shall apply to the Authority for a transit permit in line with the guidelines by completing Form 13 set out in Schedule 4 and accompanied by a fee set out in Schedule 5. (2) The Authority shall issue a transit permit in Form 14 set out in Schedule 4. (3) The importer of medicines shall ensure that medicines, medical products or cosmetics in a bonded warehouse comply with requirements for transit as set out in the guidelines. (4) The importer of medicines shall keep records for the medicines, medical products or cosmetics at the bonded warehouse which records shall be open for inspection by the Authority and other relevant authorities. 33. (1) The Authority shall recommend designation of ports of import and export to the Minister. (2) The Authority shall review the list of designated ports from time to time. 34.(1) A person who disposes of medicines shall follow the guidelines and keep disposal certificates issued by the relevant authorities, for the Authority’s inspection. (2) The destruction of any Schedule 1A, Schedule 1B Schedule 1C medicines or precursors, in part or whole, shall be reported to the Authority in accordance with the guidelines and, except where the destruction is accidental, the destruction shall be supervised by a pharmacist and witnessed by a police officer. (3) Aperson shall dispose of unused medicines in a clinical trial in line with the guidelines. (4) The Authority may in special circumstances authorise the export of medicines, medical products or cosmetics that do not meet specifications for disposal in line with the guidelines. 35.(1) The Authority shall carry out a risk based review of the classification of medicines in consultation with the relevant stakeholders. (2) For purposes of the Act and these Regulations, medicines shall be classified in accordance with the lists set out in Schedule 1 and the lists shall be published in the Gazerte. 36. (1) Prescriptions of medicines shall be written in generic or approved international non-proprietary names (INN) except when a particular brand of medicine is preferred and clinically acceptable reasons for such preference are communicated to the dispenser. (2) The Minister shall draw guidelines on dispensing and prescription of medicines in terms of section 38 (3) and section 39 (2) of the Act. (3) In granting limited powers of prescription of Schedules 1, 2, 3 and 4 medicines under section 39 (2) of the Act, the Minister may grant to — (@) registered nurses in hospitals or Government clinics specialising in medical fields such as ophthalmology, psychiatry, midwifery, or as a registered family nurse practitioner, power to prescribe only those medicines specific to their speciality or training and, where applicable, ‘which are specified for them in the Botswana National Medicines Formulary; () registered nurses in Government clinics and health posts, power to prescribe only those medicines which are specified for them in the Botswana National Medicines Formulary; (c) dental therapists, power to prescribe only those medicines specified for them in the Botswana National Medicines Formulary; (@) registered pharmacists, power to prescribe Schedules 1 and 2 medicines only in the circumstances referred to in regulations 38,40 and 41; (e) optometrists and chiropractors limited prescribing powers according to their scope of practice; (f) pharmacists to prescribe Schedule 3 medicines; and () nurses to give repeat prescriptions for Schedules 1,2 and 3 medicines for palliative care at hospitals, hospices and at home-based care. 37.(1) A valid prescription shall contain the following information — (a) particulars of the patient including name, age and gender; (b) name of the medicine, dosage form, dosage strength, directions for use, duration of treatment or quantity; (c) name, signature and address of prescriber; (d) date of prescription; and (e) the facility stamp. (2) For Schedules 1A, 1B and 1C medicines the quantity shall be written in words and figures. (3) A prescriber shall keep a copy of each prescription issued by him or her for a period of one year. 38. (1) An emergency medical services provider may under emergency situations administer Schedules 1 » 2 and 3 medicines without a written prescription. (2) Subject to subregulation (1), in administering such medicines, the emergency medical services provider shall follow his or her scope of practice as determined by the Botswana Health Professions’ Council. (3) For medicines which are not within his or her scope, the emergency medical service provider may administer with medical direction and he or she shall keep registers and records of the medicine administered. 39. (1) A person shall not dispense medicine of a quantity greater than the amount and the stated duration of treatment in the prescription. (2) Aperson dispensing medicine shall endorse on the prescription the date when the medicine is dispensed, the quantity dispensed, and he or she shall append his or her signature thereto. (3) A repeat prescription may be dispensed for a maximum of six times from the date of issue. 40. (1) Schedules 1A, 1B and 1C medicines may only be dispensed by a pharmacist upon a written prescription by a medical practitioner or dentist, presented for dispensing within 30 days of the date of its issue, and for the supply of a quantity not greater than the quantity indicated on the prescription, which shall not exceed 30 days’ supply. C.1039 Contents of prescriptions Emergency administration General dispensing Dispensing of Schedules1A, 1Band IC medicines C.1040 Emergency dispensing of Schedules 14, 1Band 1C medicines Dispensing of Schedule 2 medicines Dispensing of Schedules 1D and 3 medicines Emergency supply of medicines by ‘pharmacist (2) The prescription shall be retained in the pharmacy for a period of five years after the date it was dispensed. (3) The dispenser of a Schedules 1A, 1B and 1C medicine shall enter a record of such dispensing and the register shall be kept for a period of five years after the last entry. (4) Separate registers shall be kept for Schedules 1A, 1B and 1C medicines. (5) Except when being administered to a patient, every Schedules 1A, 1B and 1C medicines shall be kept under safe custody in a lockable cabinet or in a safe securely fixed in terms of regulation 48 (2). 41.(1) Emergency dispensing of Schedules 1A, 1B and 1C medicines may be done where — (a) there is a repeat prescription for a patient known by both the prescriber and pharmacist; (b) the pharmacist has contacted the prescriber and the prescriber is confirmed as being a medical practitioner or dentist; and (c) the pharmacist is satisfied that it is impossible or impracticable to obtain a written prescription. (2) The prescription may be made by telephone, email or fascimile, in quantities not exceeding those stated in regulation 40 (1), on condition that a written prescription shall be provided within 48 hours. 42. Schedule 2 medicines may be dispensed in — (a) referral hospitals, district hospitals, primary hospitals, mission hospitals, mine hospitals or private hospitals by a pharmacist or an intern pharmacist, a pharmacy technician under the supervision of a pharmacist, or by any authorised dispenser upon a written prescription issued by a medical practitioner or a dentist; (b) aretail pharmacy, by a pharmacist, a pharmacy technician under the supervision of a pharmacist or by any authorised dispenser upon a written prescription issued by a medical practitioner or a dentist; (¢) a Government clinic, by a pharmacy technician under the supervision of a pharmacist upon a written prescription issued by an authorised prescriber; or (d) aprivate health facility by an authorised dispenser. 43. Schedules 1D and 3 medicines shall only be dispensed by a pharmacist or any authorised dispenser upon a prescription. 44. (1) Notwithstanding regulation 42, in an emergency Schedule 2 medicines may be supplied or dispensed without a prescription by a pharmacist, where — (a) there is an immediate need for the medicine requested to be supplied and it is impractical in the circumstances to obtain a prescription; or (b) the treatment with the medicine has on a previous occasion been prescribed for the person requesting it. 5 (2) The quantity of the medicine to be supplied in accordance with subregulation (1) shall not exceed five days’ treatment: Provided that — (a) where the medicine in question is an ointment, a cream or an aerosol for the relief of asthma, which has been made up for sale in a container elsewhere than at a place of supply, the dispenser may supply the smallest pack available; (b) where the medicine in question is an oral contraceptive, the dispenser may supply a sufficient quantity for a full cycle; or (¢) where the medicine required is in such a package that it is impractical to split the package, the whole Ppackage may be supplied. 45. (1) A prescriber may, in line with the guidelines store some medicines to administer to his or her patients. (2) Subject to subregulation (1), the type and quantities of the medicines administered shall be determined by the scope of the prescriber’s practice and the prescriber shall fulfill other requirements set out in the guidelines. 46. (1) A healthcare provider shall apply to the Director of Health Services for an approval to dispense medicines. (2) An approval shall be given to a medical practitioner, dentist, pharmacy technician and any other health personnel on condition that he or she has competency in dispensing medicines. (3) A dispensary, clinic, health post and mobile clinic shall meet the standards set out in the guidelines. 47.(1) Precursor chemicals at Schedule 2 of these Regulations shall be sold by authorised dealers. (2) The use of the precursor chemicals that require import permits shall be authorised by the Authority. (3) Registers of the sale and use of chemicals shall be maintained by the authorised dealers and the register shall capture information as determined by the Authority. 48. (1) Medicines shall be stored in secure, well ventilated rooms, with adequate lighting and controlled temperatures. (2) Schedule 1 medicines shall be kept in bolted locked steel cabinets or rooms with controlled access. (3) The storage facilities shall be protected from pests, harsh weather and shall meet building codes. (4) The guidelines relating to the storage of medicines shall be updated as the Authority determines. 49.(1) Any product information shall be provided inline with the guidelines. (2) The container of every medicine imported, manufactured, processed or packed in Botswana shall bear a label written in English, with the following information clearly indicated thereon — (@) either the approved name of the medicine as used in official pharmacopoeias or formularies, or the international non-proprietary name; (b) the brand name, if any; (c) the contents of the container; (d) the quantity of active ingredients per dosage unit; (e) the name of the manufacturer or applicant; (f) the batch identification; (g) the expiry date; (h) any special storage conditions that may be necessary or desirable; (i) any warnings or precautions that ‘may be necessary or desirable; () any directions for use if sold without prescription; and (k) any appropriate statutory or restrictive direction or label in terms of subregulation (6); () any conditions of registration stipulated by the Authority during registration; and (m) manufacture date. C.1041 Storage of medicines by prescribers Dispensing of medicines by ‘healthcare ‘providers other than pharmacists Sale and use of precursor chemicals Storage of medicines Product information C.1042 (3) In any special circumstances the Authority may exempt any particular consignment of medicines from the requirements of subregulation Q). (4) The container of every medicine dispensed to a patient shall have a label bearing the following information — (a) full name of the patient; (b) date of dispensing: (c) pack size; (d) name and signature of the dispenser; and (e) all information required for the purposes of subregulation (1). (5) The container of any medicine exempted from registration shall as far as possible bear the information required under subregulation (1). (6) The containers of pre-packed medicines shall bear the label with the following — (a) name, strength and quantity of the medicine; (b) batch number; (c) date of manufacture; (d) expiry date; and (e)’ manufacturer. (7) If the medicine contains any ingredient that is known to cause any allergic reaction, there shall be a warning to that effect. (8) For medicines which require caution, such medicine shall bear a label giving information and instructions in accordance with the following — Word Content (1) “Contains aspirin” (unless name of product includes word “aspirin”); plus “If symptoms persist, consult your doctor”; plus the recommended dosage: plus “Do not use on children under 12 years except on medical advice.” The label shall include name of the applicant, Botswana registration number and the Schedule. (2) “Contains an aspirin derivate™; plus “If symptoms persist, consult your doctor”; plus the recommended dosage. (3) “Contains paracetamol” (unless the name of the product includes the word “paracetamol™); plus “If the symptoms persist, consult your doctor”; plus “Do not exceed the stated dose™; plus the recommended dosage. (4) “Warning. Asthmatics shall consult their doctor before using this. product.” (5) “Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.” “Not to be used for babies” or “Not to be administered, except on medical advice, to a child under two years.” (7) “Oral Rehydration Therapy is recommended in all forms of diarrhoea.” (8) “For external use only.” This cautionary wording shall be used if a product is an embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel for external application. (9) “Warning. Do not exceed the stated dose.” This cautionary wording shall be used on pharmacy medicines (P) exempted from POD requirements by reason of the proportion or level in such product of any substance, and which are not for external use. (6, 50. (1) An application for import of narcotics, psychotropics and precursor chemicals shall be made to the Authority by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5. (2) Upon assessment the Authority shall issue an import permit in Form 16 set out in Schedule 4, to the applicant, which permit shall be valid for six months, (3) After receipt of the medicines the pharmacist shall notify the Authority and submit an acknowledgement in Form 17 set out in Schedule 4 and a copy of export permit from the relevant country, within seven days. (4) An application for export of narcotics, psychotropics and precursor chemicals shall be made by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5. (5) The Authority shall issue an export permit in Form 18 set out in Schedule 4, valid for six months prior to exportation of the medicines. (6) After dispatch of the medicines, the pharmacist shall notify the Authority and submit an acknowledgement in Form 17 set out in Schedule 4 within seven days. 51.(1) Separate registers shall be kept for Schedules 1A, 1B, 1C medicines and precursor chemicals. (2) Registers to be kept by the manufacturer, seller, importer, exporter or distributor of such medicines shall contain the following information, as appropriate, the — (@) quantities received, issued, spoiled, disposed of and the balance of the medicine concerned; (b) name and business address of the supplier; (c) date on which the medicine was received; (d) import permit number in the case of imports; (e) export permit number in the case of exports; (f) name and business address of the purchaser; (g) date of sale of the medicine; and (h) invoice or reference number of such sale. (3) Registers kept by the dispenser of medicines under subregulation (1) shall contain the following information where appropriate, the — (@) quantities received, issued, spoiled, disposed of and the balance of the medicines concerned; (b) name and business address of the supplier; (¢) date on which the medicine was received; (d) name and address of the patient to whom the medicine was dispensed; (e) prescription number or reference number upon which the medicine was dispensed; (f) date of such dispensing; and (2) name and address of the prescriber. (4) All invoices for the purchase or supply of Schedules 1A, 1B, 1C medicines or precursor chemicals shall be kept for a minimum of five years. (5) All registers or records required to be kept under this regulation shall be retained for a period of five years after the date of the last relevant entry, and shall be kept available for inspection by authorised officers. (6) All registers and records required to be kept under these Regulations shall be balanced within seven days. (7) Aregister shall be a bound book with serially numbered pages. C.1043 Import and export of narcotics, ‘psychotropics and precursor chemicals Records for narcotics, psychotropics and precursor chemicals C.1044 Correction of records Advertising and promotion Inspection of premises Application for use of medicines for clinical trials (8) A register shall not transferrable without the Authority’s approval. 52.(1) A person who keeps a register under the Act shall make corrections to the register by drawing a line through the entry being corrected and shall insert his or her initials on the corrected entry. (2) A correction to a register shall not be masked or done with correction fluid and there shall be no overwriting. 53. (1) A market authorisation holder shall submit advertising and promotional materials to the Authority for approval before use. (2) The Authority shall assess advertising and promotional materials according to set guidelines and issue a written approval to the market authorisation holder. (3) Schedules 1,2 and 3 medicines shall not be advertised directly to the public. (4) Subject to subregulation (3), only registered medicines may be advertised or promoted. ¢ (5) Medicines may be advertised to the professionals or in professional journals and publications. (6) Schedule 4 medicines may be advertised to the public. (7) Any advertising shall not mislead, compare medicines from other manufacturers and shall not include illustrations or pictures which may offend. (8) The adverts shall not contain promises that have not been scientifically proven and shall not make reference to symptoms in a manner likely to mislead the public. 54. (1) The Authority shall ensure all premises are inspected to assess compliance to set guidelines. (2) An inspector shall present proof of authorisation and identification to the pharmaceutical operator before the inspection under subregulation (1) is carried out. (3) The inspections shall be done at all reasonable times and where samples are collected during inspections, the inspectors shall provide the pharmaceuti- cal operator with a list of samples taken in Form 24 set out in Schedule 4. (4) The form under subregulation (3) shall be signed by both the inspector and the person in authority of the inspected premises. (5) Where an inspector seizes medicines in terms of section 47 (3) of the Act, he or she shall complete Form 24 set out in Schedule 4. Part V — Control of clinical trials 55. (1) The applicant shall apply to the Authority in Form 19 set out in Schedule 4 accompanied by a fee set out in Schedule 5. (2) The Authority shall issue an applicant a written approval for use of medicines regulated under the Act. (3) The Authority shall keep registers of — (a) medicines and sites approved for clinical trials; and (b) all authorised and rejected clinical trials. (4) The clinical trials shall be conducted according to the set standards and guidelines. (5) All applications for clinical trials shall be registered with a World Health Organization recognised clinical trials registry. (6) A detailed report on the results of the clinical trial shall be submitted to the Authority at the completion of the trial. 56. The reporting of adverse events in clinical trials shall be in line with set guidelines and shall meet international standards. 57. The Authority shall inspect clinical trial sites for readiness and compliance with good clinical practices. 58. (1) The Authority may suspend or terminate an approval to conduct clinical trials where the Authority determines that the use of the medicines under trial is not safe or the anticipated benefits cannot be realised. (2) The trials may also be suspended or terminated if the conduct is not according to the approval issued under these Regulations. 59. A person who disposes of unused medicines in a clinical trial shall notify the Authority in terms of regulation 34. Part VI — Cosmetics 60. (1) A person shall apply to the Authority for registration of cosmetics in Form 20 Part A set out in Schedule 4 and accompanied by a — (a) payment of a fee in Schedule 5; and (b) sample as described in the guidelines. (2) The registration procedure for cosmetics shall be as outlined in the guidelines. (3) The Authority shall, upon assessment issue an approval in Form 23 set out in Schedule 4 and in line with the guidelines. (4) The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of Tequirements and guidelines for efficient operations and prudent use of cosmetics. (5) An approval issued in terms of subregulation (3) shall be valid for five years subject to annual submission of information accompanied by the Annual fee in Schedule 5. (6) Any cosmetic product awarded marketing authorisation shall maintain information regarding safety, manufacturing and any other necessary information as detailed in the guidelines and shall be accessible to the. Authority. (7) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications. 61. (1) An applicant may apply in Form 20 Part B set out in Schedule 4 upon payment of a fee set out in Schedule 5 to the Authority to exempt the registration of cosmetics from outside Botswana under special circumstances. (2) The Authority may, after having considered the application and the supporting documents, grant the exemption in line with the guidelines. 62. The Authority shall determine and publish a list of prohibited ingredients according to the guidelines. 63. The container for cosmetics shall be labelled in English with the following information — (a) the name of the product; (b) list of ingredients; (c) manufacturer’s details; C.1045 Monitoring of clinical trial Inspection and audit of clinical trials Suspension or termination of approval to conduct clinical trials Disposal of unused medicines in clinical trials Registration of cosmetics Exemption for registration of cosmetics Publication of list of prohibited ingredients Labelling of cosmetics C.1046 Licensing of manufacturing cosmetics Import of cosmetics Registration of complementary medicines (d) shelf life, expiry date or period of use after opening; (e) batch identification; (f) storage conditions; (g) directions for use; and (h) any warnings or precautions. 64. A person shall apply to the Authority for a manufacturing licence of cosmetics in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5. 65.(1) A person shall apply to the Authority to import cosmetics in Form 10 set out in Schedule 4 accompanied by a fee set out in Schedule 5. (2) Upon assessment the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines. (3) Only registered or exempted cosmetics may be imported. (4) The marketing authorisation holder shall submit advertising and promo- tional materials to the Authority for authorisation before use. (5) The Authority shall assess advertising and promotional materials ac- cording to set guidelines and issue a written authorisation to the marketing authorisation holder. (6) A person authorised to import cosmetics shall pay a fee set out in Sched- ule 5 for each consignment in line with the guidelines. Part VIL — Complementary medicines 66. (1) An application for registration of complementary medicines shall be submitted in Form 21 set out in Schedule 4 and accompanied by — (a) an application fee set out in Schedule 5; and (b) asample as described in the guidelines. (2) The Authority shall specify conditions for registration for a particular complementary medicine and may — (a) amend any conditions for registration; (b) specify product labelling requirement; or (c) determine what is to be described in the labels or packages of complementary medicines. (3) Scientific evidence of safety and efficacy data shall be required for the registration of any therapeutic claim. (4) Where anapplication to register a complementary medicine s successful, the Authority shall issue a written approval for registration to the applicant in Form 22 set out in Schedule 4. (5) Where an application to register complementary medicines is unsuccessful, the Authority shall inform the applicant in writing stating the reason for the decision not to register the medicine. (6) No application for a complementary medicine shall be made to the Authority for an injectable and eye preparations. (7) The container for complementary medicines shall be labelled in English with the following information — (@) the botanical or INN name of the product; (b) the brand name of the product; (c) list of ingredients; (d) the quantity of active ingredients per dosage unit; (¢) name and address of manufacturers; (f) shelf life, expiry date; (g) batch identification; (h) storage conditions; (i) directions for use; (/) any warnings or precautions; (k) any contraindications; () manufacturing date; and (m) the statement that “there are no approved therapeutic claims”, where applicable. (8) The Authority shall review allowable indication and functional claims from time to time and shall publish the claims in the Gazetre. (9) A person may apply to the Authority for the renewal of registration of complementary medicines in Form 4 set out in Schedule 4. (10) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications. 67. An approval issued in terms of regulation 66 shall be valid for five years subject to annual submission of information accompanied by the Annual fee in Schedule 5. PART VIII — General 68. The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of resources. 69. Any person aggrieved by the decision of the Authority may appeal to the Appeals Committee. 70. The Minister shall, in consultation with the Authority publish a list of banned medicines in Schedule 3. 71. A person who — (a) contravenes the provisions of these Regulations, for which no penalty is provided; (b) fails to comply with any direction given or Tequest made by the Authority or any competent authority under these Regulations; or (c) fails to comply with any condition of a licence, commits an offence and is liable to the penalties provided for under section 66 of the Act. 72. The Drugs and Related Substances Regulations are hereby revoked. C.1047 Validity period of registration of complementary medicines Harmonisation and collaborative activities of Authority Appeals Committee Banned medicines Offences and penalties Revocation of Cap. 63:04 (Sub. Leg.) C.1048 SCHEDULES SCHEDULE 1 (reg. 36, 37, 38,40, 41 and 43) SCHEDULE 1 MEDICINES NO. NAME OF THE MEDICINE 1-methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters and ethers; their salts 2-Methyl-3-morpholino-1,1-diphenyl-propanecarboxylic acid; its salts; its esters and ethers; their salts 4-cyano-1-methyl-4-phenylpiperidine; its salts 4-cyano-2-dimethylamino-4,4-diphenylbutane; its salts 4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts Acetorphine hydrochloride Acetorphine; its salts; its esters and ethers; their salts Acetyl-methadol see Methadyl acetate Alfentanil Allylprodine; its salt Alphacetylmethadol; its salts; its esters and ethers; their salt Alphameprodine; its salts ‘Alphamethadol; its salts, its esters and ethers; their salts alpha-methylphenethylamine see Amphetamine N-(2-(N-methylphenethylamino)propyl)propionanilide see Diampromide Methylphenidate; its salts Amidone see Methadone Amphetamine phosphate Amphetamine sulphat Amphetamine; its salts Anileridine; its salts Benzethidine; its salts Benzylmorphine hydrochloride Benzylmorphine; its salts; its esters and ethers; their salts Betacetylmethadol; its salts Betameprodine; its salts Betamethadol; its salts; its esters and ethers; their salts Betaminoisopropylbenzene see amphetamine Betaprodine; its salts Bezitramide; its salts Carfentanil; its stereoisomers its salts; its esters and ethers, their salts Clonitazene; its salts Codeine hydrochloride see Codeine Codeine phosphate see Codeine Codeine sulphate see Codeine Codoxime see Dihydrocodeinone O-carboxymethyloxime Delta-9-tetrahydrocannabinol see Dronabinol Desomorphine; its salts; its esters and ethers; their salts Desoxyephedrine see Methylamphetamine Desoxynorephedrine see Amphetamine CATEGORY 1A Dexamphetamine phosphate Dexamphetamine sulphate Dexamphetamine; its salts Dextrodiphenopyradine see Dextromoramide Dextromoramide tartrate Dextromoramide; its salts Dextropropoxyphene; its salt; its esters and ethers; their salts but in a preparation for oral use containing not more than 135mg of dextropropoxyphene (calculated as base, per dosage unit, or with a total concentration of not more than 2.5% calculated as base, in undivided preparations: Schedule 2) Diampromide; its salts Diethylthiambutene hydrochloride Diethylthiambutene; its salts Dihydrocodeine phosphate see dihydrocodeine Dihydrocodeine tartrate see dihydrocodeine Dihydrocodeinone enolacetate see Thebacon Dihydrocodeinone O-carboxymethyl-oxime; salts; esters and ethers; their salts Dihydrocodeinone see hydrocodone Dihydrodeoxymorphine see Desomorphine Dihydrohydroxycodeinone see Oxycodone Dihydrohydroxymorphinone see Oxymorphine Dihydromorphine; its salts; its esters and ethers; their salts Dihydromorphinone see Hydromorphone Dimenoxadole; its salts Dimepheptanol; its salts; its esters and ethers; their salts Dimethylthiambutene; its salts Dioxaphetyl butyrate; its salts Diphenoxylate hydrochloride see diphenoxylate Dipipanone hydrochloride Dipipanone; its salts Dronabinol Drotebanol; its salts; its esters and ethers; their salts Ethylmethylthiambutene; its salts Ethylmorphine hydrochloride see Ethyl morphine Etonitazine; its salts Etorphine hydrochloride Etorphine; its salts; its esters and ethers; their salts Etoxeridine; its salts; its esters and ethers; their salts Fenethylline; its salts; its stereoisomers; their salts Furethidine; its salts Glutethimide; its salts; its stereoisomers; their salts Hebaine; its salts Hexobarbitone sodium Hydrocodone bitartrate Hydrocodone; its salts Hydromorphinol; its salts; its esters and ethers; their salts Hydromorphone; its salts; its esters and ethers; their salts Hydroxypethidine; its salts; its esters and ethers; their salts C.1049 C.1050 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 929 100 101 102 103 104 105 Isomethadone Ketobemidone; its salts; its esters and ethers; their salts Levamfetamine Levomethamphetamine Levomethorphane; its salts Levomoramide; its salts Levophenacylmorphan; its salts; its esters and ethers; their salts Levorphanol tartrate Lofentanil; its stereoisomers; its salts; its esters and ethers; their salts Meclogqualone Mephentermine sulphate Metazocine; its salts; its esters and ethers; their salt Methadone hydrochloride Methadone; its salts Methady] acetate; its salts Methamphetamine see Methylamphetamine Methylamphetamine hydrochloride Methylamphetamine; its salts Methyldesorphine; its salts; its esters and ethers; their salts Methyldihydromorphine; its salts; its esters and ethers; their salts Methyldihydromorphinone see Metopon Methylphenidate hydrochloride Methylphenidate; its salts Metopon; its salts; its esters and ethers; their salts Morpheridine; its salts Morphine acetate see Morphine Morphine hydrochloride see Morphine Morphine methobromide; its esters and ethers Morphine sulphate see Morphine Morphine tartrate see Morphine Morphine; its salts; its esters and ethers; their salts; its pentavalent nitrogen derivatives; their esters and ethers Morphine-N-oxide; its esters and ethers Morpholinoethylnorpethidine see Morpheridine Myrophine; its salts Nicomorphine; its salts Noracymethadol; its salts Norlevorphanol; its salts; its esters and ethers; their salts Normethadone; its salts Normorphine; its salts; its esters and ethers; their salts Norpipanone; its salts Opium, medicinal Oxycodone; its salts; its esters and ethers; their salts Oxymorphone; its salts; its esters and ethers; their salts Papaveretum see Opium, medicinal Pethidine hydrochloride Pethidine; its salts Phenadone see Methadone Phenadoxone; its salts Phenampromide; its salts Phenazocine hydrobromide Phenazocine; its salts; its esters and ethers; their salts Phendimetrazine tartrate Phendimetrazine; its salts Phenmetrazine hydrochloride Phenmetrazine theoclate Phenmetrazine; its salts Phenomorphan; its salts; its esters and ethers; their salts Phenoperidine; its salts; its esters and ethers: their salts Pholcodine citrate see Pholcodine Pholcodine tartrate see Pholcodine Piritramide; its salts Potassium clorazepate Prazepam Proheptazine; its salts Properidine; its salts Quinalbarbitone Quinalbarbitone sodium Racemethorphan; its salts Racemoramide;, its salts Racemorphan; its salts; its esters and ethers; their salts Secobarbitone see Quinalbarbitone Temazepam Thebacon; its salts Tilidate; its salts; its esters and ethers; their salts Trimeperidine; its salts Amferpramone Amylobarbitone Amylobarbitone sodium Benzphetamine; its salts Bezphetamine hydrochloride Buprenorphine Buprenorphine hydrochloride Butalbital Cathine; its salts; its stereoisomers not being phenylpropanolamine; their salts Chlorphentamine hydrochloride Chlorphentamine; its salts Cyclobarbitone Diethylpropion hydrochloride Lefetamine(SPA) Mazindol Mefenorex; its salts; its stereoisomers; their salts Meperedine see Pethidine Mephentermine; its salts Pemoline Pentazocine hydrochloride Pentazocine lactate Pentobarbitone Pentobarbitone sodium C.1051 C.1052 182 183 184 185 186 187 188 Phentermine Phenylmethylbarbituric acid Pinazepam Pipradrol hydrochloride Pipradrol; its salts Allobarbital Barbitone Barbitone sodium Bromazepam Butobarbitone Butobarbitone sodium Camazepam Chlordiazepoxide Chlordiazepoxide hydrochloride Clobazam Clonazepam Clorazepate Clotiazepam Cloxazolam Delorazepam Diazepam Estozolam Ethchlorvyno Ethinimate Ethyl loflazepate Fencamfamin; its salts; its sterecisomers; their salts Fentanyl; its salts Fludiazepam Flunitrazepam Flurazepam hydrochloride; its salts Flurazepam monohydrochloride Halazepam Haloxazolam Heptabarbitone Hexobarbitone Ketazolam Loprazolam mesylate Lorazepam Lormetazepa Medazepam Meprobamate Methylphenobarbitone Methyprylone Midazolam N-Ethylamphetamine; its salts; its stereoisomers; their salts Nimetazepam Nitrazepam Nordazepam Oxazepam Oxazolam 232 233 234 235 236 237 238 239 245 246 247 248 Phenobarbitone Phenobarbitone sodium Piminodine; its salts Propylhexedrine; its salts; its stereoisomers; their salts Pyrovalerone; its salts; its stereoisomers; their salts Secbutobarbitone Secbutobarbitone sodium Sufentanil; its salts; its esters and ethers; their salts Triazolam Vinylbital Codeine; its salts 1(A) but if for non-parenteral use and in undivided preparations with ms 1.5% (calculated as base: and not more than 200ml: Schedule 3) Acetyldihydrocodeine; its salts 1(A) but if for non-parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) (b) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) Codeine; its salts 1(A) but if for non-parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) (b) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) (c)in single-dose preparations with ms per dosage unit 1.5% (calculated as base, and md 10mg: or calculated as base, and not more than 30 tablets: Schedule 3) Difenoxin (13-cyano-3 3-diphenyl-propyl)-4-phenylpiperidine4-carboxylic acid) 1A (but if in preparation containing, per dosage unit, not more than 0.5mg of difenoxin and a quantity of atropine sulphate equivalent to at least 5% of the dose of difenoxin: Schedule 2) Dihydrocodeine; its salts 1A but if for non-parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) *(b) in undivided preparations with ms 1.5% (calculated as base) and md 10mg (calculated as base: Schedule 3) (c) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) (d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 10mg (calculated as base: Schedule 3) Diphenoxylate; its salts but if in preparation with ms per dosage unit 2.5mg of diphenoxylate (calculated as base, and quantity of atropine sulphate equivalent to at least 1% of the dose of diphenoxylate: Schedule 2) Ethylmorphine; its salts but if for non-parenteral use and (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) (b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2 1D 1D 1D 1D 1D 1D C.1053 C.1054 249 250 251 252 Nicocodine; its salts but if for non parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) 1D (b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) 1D Nicodicodine; its saltsbut if for non-parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2) 1D (b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) 1D Norcodeine; its salts but if for non-parenteral use and: (a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2 (b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2) 1D Pholcodine; its salts 1A but if for non-parenteral use and: (a) in undivided preparations with ms 2.5%. (calculated as base: Schedule 2)(b) in undivided preparations with ms 1.5% (calculated as base) and md 20mg (calculated as base: Schedule 3)(c) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 20mg (calculated as base: Schedule 3) 1D Propiram; its salts 1A but if in preparations containing, per dosage unit, not more than 100mg propiram (calculated as base, and compounded with at least same amount of methylcellulose: Schedule 2) 1D (2) SCHEDULE 2 MEDICINES . NAME OF THE MEDICINE Alfacalcidol(1 alpha hydroxy calceferol) Roxarsone (4-hydroxy-3 nitrophenyl arsonic acid) Abacavir Acebutolol Acepromazine Acepromazine maleate Acetanilide Acetarsol Acetazolamide Acetazolamide sodium Acetohexamide Acetylcarbromal Acetylcholine chloride Acetylcysteine Acetyldigitoxin Acetylstrophanthidin Acetylsulphafurazole Acetylsulphamethoxypyridazine Aconite Acrosoxacin Actinomycin C Actinomycin D Acyclovir (except topical preparation Schedule 3) Adicillin Adiphenine hydrochloride Adrenaline Adrenaline acid tartrate Adrenaline hydrochloride Albumin human (immuno) Alclofenac Alclometasone diproprionate Alcuronium chloride Aldosterone Alendronate Alfacalcidol Alfuzosin Algestone acetonide Algestone acetophenide Alkomide Allyloestrenol Alphadolone acetate Alphaxalone Alprazolam Alprenolol Alprenolol hydrochloride Alprostadil Alseroxylon Altizide Amantadine ‘Ambenonium chloride Ambuside Ambutonium bromide Amcinonide Ametazole hydrochloride Amidopyridone Amikacin sulphate Amiloride Aminocaproic acid Aminodarone hydrochloride Aminoglutethemide Aminophylline Aminopterin sodium Aminosalicylic acid Amiodarone Amiphenazole hydrochloride Amitriptyline Anmitriptyline embonate Amitriptyline hydrochloride Amlodipine C.1055 C.1056 Ammonium bromide ‘Amodiaquine hydrochloride Amoxapine Amoxycillin Amoxycillin trihydrate Amphomycin Ampbhotericin Ampicillin Ampicillin sodium Ampicillin trihydrate Amsacrine Amylocaine hydrochloride Anagrelide Anastrozole Ancrod Androsterone Angiotensin amide Anterior pituitary extract Antimony barium tartrate Antimony dimercaptosuccinate Antimony lithium thiomalate Antimony pentasulphide Antimony potassium tartrate Antimony sodium tartrate Antimony sodium thioglycollate Antimony sulphate Antimony trichloride Antimony trioxide Antimony trisulphide Apiol Apomorphine Apomorphine hydrochloride Apramycin Apramycin sulphate Aprotinin Arecoline Arecoline hydrobromide Arecoline-acetarsol Arsanilic acid Arsphenamine Atazanavir Atenolol Atorvastatin Atracurium besylate Azacyclonol Azacyclonol hydrochloride Azaperone Azapropazone Azathioprine Azidocillin potassium Azithromycin Azothioprine Azothioprine sodium Bacampicillin hydrochloride Bacitracin Bacitracin methylene disalicylate Bacitracin zinc Baclofen Barium carbomate Barium chloride Barium sulphide Beclamide Beclomethasone Beclomethasone dipropionate Bemegride Benactyzine hydrochloride Benapryzine hydrochloride Bendrofiuazide Benethamine penicillin Benoxaprofen Benperidol Benserazide Benzathine penicillin Benzbromarone Benzhexol hydrochloride Benzilonium bromide Benzoclamine hydrochloride Benzquinamide Benzquinamide hydrochloride Benzthiazide Benztropine mesylate Benzyl penicillin Benzyl penicillin calcium Betahistine hydrochloride Betamethasone Betamethasone adamantoate Betamethasone benzoate Betamethasone dipropiomate Betamethasone sodium phosphate Betamethasone valerate Betaxolol hydrochloride Bethanecol chloride Bethanidine sulphate Bezafibrate Bicalutamide Biperidine hydrochloride Biperidine lactate Bismuth glucollylarsanilate Bisoprolol Bleomycin sulphate C.1057 C.1058 170 171 172 175 Boldenone undecylenate Bretylium tosylate Brimonidine Bromocriptine mesylate Bromperidol Bromvaletone Budesonide Bumetadine Bumetanide Buphenine hydrochloride Bupivacaine Bupivacaine hydrochloride Buspirone hydrochloride Busulphan Butacaine sulphate Butanilicaine phosphate Butriptyline hydrochloride Butylchloral hydrate Cabergoline Calcitonin Calcitriol Calcium aminosalicylate Calcium amphomycin Calcium benzamidosalicylate Calcium bromide Calcium bromidolactobionate Calcium carbimide Calcium folinate Calcium metrizoate Calcium sulphaloxate Candesartan Candicidin Canrenoic acid Cantharidin Capreomycin sulphate Captopril Caramiphen edisylate Caramiphen hydrochloride Carbachol Carbamazepine Carbenicillin sodium Carbenoxolone sodinm Carbidopa Carbidopa monohydrate Carbimazole Carbon tetrachloride Carboplatin Carboprostrometamol Carbromal Carbuterol hydrochloride C.1059 Carindacillin sodium Carisoprodol Carmustine Carvedilol Cefaclor Cefazedone sodium Cefazolin Cefepime Cefixime Cefotaxime Cefoxitin sodium Cefpodoxime Cefprozil Ceftazidime Ceftizoxine sodium Ceftriaxone Cefuroxime sodium Cephalexin Cephalexin sodium Cephaloridine Cephalosporin C Cephalosporin E Cephalosporin N Cephalothin sodium Cephamandole nafate Cephazolin sodium Cephradine Cerium oxalate Chenodeoxycholic acid Chloral antipyrine Chloral betaine Chloral formamide Chloral glycerolate Chiloral hydrate Chloralose Chloralurethene Chlorambucil Chloramphenicol Chlorisondamine chloride Chlormadinone acetate Chlormerodrin Chlormethiazole Chlormezanone Chloroquine and its salts (except for prophylaxis of malarial prophylaxis Schedule 3) Chlorothiazide Chlorotrianisene Chloroxazone Chlorphenoxamine hydrochloride Chlorpromazine Chlorpromazine embonate C.1060 270 Chlorpromazine hydrochloride 271 Chlorpropamide 272 Chlorprothixene 273 Chlorprothixene hydrochloride 274 Chlortetracycline 275 Chlortetracycline hydrochloride 276 Chlorthalidone 277 Cholestyramine 278 Chorionic gonadotrophin 279 Chormethiazole edisylate 280 Ciclacillin 281 Ciclobendazole 282 Cimetidine & its salts (except for short term relief of heartburn, dyspepsia and hyperacidity 200mg -400mg per single dose- maximum 4800mg Schedule 3) 283 Cinchocaine 284 Cinchocaine hydrochloride 285 Cinchophen 286 Cinoxacin 287 Ciprofioxacin 288 Ciprofloxacin hydrochloride 289 Cisplatin 290 Citalopram 291 Cladribine 292 Clarithromycin 293 Clavulanic acid 294 Clenbuterol hydrochloride 295 Clindamycin and its salts (except for topical preparation Schedule 3) 296 Clindamycin hydrochloride hydrate 297 Clindamycin palmitate hydrochloride 298 Clindamycin phosphate 299 Clindinium bromide 300 Clobetasol 301 Clobetasol 17-propionate 302 Clobetasone butyrate 303 Clofazimine 304 Clofibrate 305 Clomiphene citrate 306 Clomipramine 307 Clomipramine hydrochloride 308 Clomocycline 309 Clomocycline sodium 310 Clonidine 311 Clonidine hydrochloride 312 Clopenthixol decanoate 313 Clopenthixol hydrochloride 314 Clopidogrel 315 Cloprostenol sodium 316 Clorexolone 317 Clorprenaline hydrochloride 318 Clostebol acetate Cloxacillin benzathine Cloxacillin sodium Clozapine Cocculus indicus Co-dergocrine myselate Colchicine (except for acute gout attack maximum 6mg, 0.5-1mg per single dose Schedule 3) Colestipol hydrochloride Colistin sulphate Colistin sulphomethate Colistin sulphomethate sodium Conium leaf Corticotrophin Cortisone Cortisone acetate Cotarnine chloride Co-tetroxazine Co-trimoxazole Cropropamide Crotethamide Croton oil Croton seed Curare Cycloghosphamide Cyclopenthiazide Cyclopentolate hydrochloride Cyclophosmamide Cyclosporin Cyclothiazide Cyproterone acetate Cytarabine Cytarabine hydrochloride Dacarbazine Dactinomycin Danazol Dantrolene sodium Dapsone Dapsone ethane ortho sulphonate Darunavir Daunorubicin hydrochloride Deanol salts and esters Debrisoquine sulphate Dehydroemetine hydrochloride Delmadinone acetate Demecarium bromide Demeclocycline Demeclocycline calcium Demeclocycline hydrochloride Deoxycortone acetate Deoxycortone pivalate C.1062 368 369 370 371 372 373 374 375 376 371 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 Deptropine citrate Dequalinium chloride Deserpidine Desferroxamine mesylate Desfluorotriamcinolone Desipramine hydrochloride Deslanoside Desmopressin Desonide Desoxymethasone Dexamethasone Dexamethasone 21-isonicotinate Dexamethasone phenylpropionate Dexamethasone pivalate Dexamethasone sodium m-sulphobenzoate Dexamethasone sodium phosphate Dexamethasone trioxaundecanoate Dextromethorphan hydrobromide Dextrothyroxine sodium Diazoxide Dibenzepin hydrochloride Dichloralphenazone Dichlorophernasine hydrochloride Dichlorphenamide Diclofenac and its salts (topical preparation & oral 500mg maximum, 50-100mg per single dose Schedule 3) Dicyclomine hydrochloride (except in antacid preparation Schedule 3) Dienoestrol Diethanolamine fusidate Diethylamine acetarsol Diflucortolone valerate Diflunisal Digitalis leaf Digitoxin Digoxin Dihydrallazine sulphate Dihydroergotamine mesylate Dihydrostreptomycin sulphate Diltiazem hydrochloride Dimercaprol Dimethisoquin hydrochloride Dimethisterone Dimethothiazine mesylate Dimethyl sulphoxide Dimethyltubocurarine bromide Dimethyltubocurarine chloride Dimethyltubocurarine iodide Dinitrodiphenylsulphonylethylenediamine Dinoprost Dinoprostone Diphetarsone Dipivefrin hydrochloride Diprenorphine hydrochloride Dipyridamole Dipyrone Disodium etidronate Disopyramide Disopyramide phosphate Distigmine bromide Disulfiram Disulphamide Dithranol d-Norgestrel Dobutamine hydrochloride Docetaxel Dolutegravir Dompridone Donepezil Dopamine hydrochloride Dothiepin Dothiepin hydrochloride Doxapram hydrochloride Doxazosin Doxepin hydrochloride Doxorubicin Doxycycline Doxycycline calcium chelate Doxycycline hydrochloride Droperidol Drospirenone Drostanolone Drostanolone propionate Duloxetine Dyaxide Dydrogesterone Ecthiopate iodide Edrophonium Efavirenz Emepromium bromide Emetine Emetine bismuth iodide Emetine hydrochloride Emtricitabine Enalapril maleate Epicillin Epirubicin Epithiazide Epoprostenol sodium Ergometrine tartrate Ergotoxine esylate C.1064 467 Erythromycin & its salts (except topical preparation Schedule 3) 468 Erythropoietin 469 Escitalopram 470 Esomeprazole & its salts (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of esomeprazole Schedule 3) 471 Estramustine phosphate 472 Etafedrine hydrochloride 473 Ethacrynic acid 474 Ethamsylate 475 Ethchlorvynol 476 Ethebenecid 477 Ethiazide 478 Ethinyloestradiol 479 Ethionamide 480 Ethisterone 481 Ethoheptazine citrate 482 Ethopropazine hydrochloride 483 Ethosuximide 484 Ethotoin 485 Ethulose 486 Bthyl acetanilide 487 Ethyl biscoumacetate 488 Ethyloestrenol 489 Ethynodiol diacetate 490 Etidronate disodium 491 Etomidate 492 Etoposide 493 Factor IX concentrate 494 Factor XII concentrate 495 Factor XIII concentrate 496 Fazadinium bromide 497 Felodipine 498 Fenbufen 499 Fenfluramine hydrochloride 500 Fenoprofen 501 Fenoprofen calcium 502 Fenoterol hydrobromide 503 Fenpipramide hydrochloride 504 Fenpiprane hydrochloride 505 Filgrastin 506 Finasteride 507 Flavoxate hydrochloride 508 Flecainide 509 Fluanisone 510 Fluclorolone acetonide 511 Flucloxacillin sodium 512 Fluconazole 513 Flucytosine 514 Fludarabine Fludrocortisone acetate Flufenamic acid Flugestone Flugestone acetate Flumedroxone acetate Flumethasone Flumethasone pivalate Flunisolide Fluocinolone acetonide Fluocinonide Fluocortolone Fluocortolone hexanoate Fluocortolone pivalate Fluopromazine hydrochloride Fluorometholone Fluorouracil Fluorouracil trometamol Fluoxetine Fluoxymesterone Flupenthixol decanoate Flupenthixol dihydrochloride Fluperolone acetate Fluphenazine deconoate Fluphenazine enanthate Fluphenazine hydrochloride Fluprednidene acetate Fluprednisolone Fluprostenol sodium salt Flurandrenolone Flurbiprofen Fluspirilene Flutamide Fluticasone Fluvastatin Fluvoxamine Follicle stimulating hormone Formosulphathiazole Formoterol Fosfestrol tetrasodium Framycetin sulphate (except topical & ophthalmic preparation Schedule 3) Frusemide Fumagillin Fumagillin bicyclohexylamine Furazolidone Furosemide Fusidic acid Gabapentin Gallamine triethiodide Gelsemine Gelsemium C.1065 C.1066 565 Gemcitabine 566 Gemfibrozil 567 Gentamicin and its salts (except topical and ophthalmic use Schedule 3) 568 Gestodene 569 Gestronol 570 Gestronol hexanoate 571 Glibenclamide 572 Glibornuride 573 Gliclazide 574 Glimepiride 575 Glipizide 576 Glyceryl trinitrate 577 Glycopyrronium bromide 578 Glymide 579 Gonadorelin 580 Gramicidin 581 Granisetron 582 Growth hormone 583 Guanethidine monosulphate 584 Guanoclor sulphate 585 Guanoxan sulphate 586 Hachimycin 587 Halcinonide 588 Haloperidol 589 Heparin and its salts (except for topical use Schedule 3) 590 Heptaminol hydrochloride 591 Hexachlorophene 592 Hexamine phenylcinchoninate 593 Hexoestrol 594 Hexoestrol dipropionate 595 Homatropine 596 Homatropine hydrobromide 597 Homatropine methylbromide 598 Hydralazine hydrochloride 599 Hydrargaphen 600 Hydrobromic acid 601 Hydrochlorothiazide 602 Hydrocortamate hydrochloride 603 Hydrocortisone and its salts & derivatives (except in preparations for external use and ms 1% Schedule 3) 604 Hydroflumethiazide 605 Hydroguinone 606 Hydroxychloroquine sulphate 607 Hydroxymethylgramicidin 608 Hydroxyprogesterone 609 Hydroxyprogesterone enanthate 610 Hydroxyprogesterone hexanoate 611 Hydroxyurea 612 Hydroxyzine embonate 613 Hydroxyzine hydrochloride C.1067 Hyoscine Hyoscine and its salts (except oral use Schedule 3) Hyoscyamine and its salts (except oral use Schedule 3) Tbuprofen (except in preparation for topical and oral use maximum 9600mg, 400mg per single dose Schedule 3) Idoxuridine Ignatius bean Imipenem Imipramine Imipramine hydrochloride Imipramine ion exchange resin bound salt or complex Immunoglobulins Indapamide hemihydrates Indomethacin (except in preparation for topical, rectal and oral use maximum 750mg, 25mg per single dose Schedule 3) Indoramin hydrochloride Insulins Todamide Todamide meglumine Todamide sodium Ipratropium Iprindole hydrochloride Iproniazid phosphate Iptratropium bromide Irbesartan Irinotecan Isoaminile Isoaminile citrate Isocarboxazid Isoconazole nitrate (except topical & vaginal preparation Schedule 3) Isoetharine Isoetharine hydrochloride Isoetharine mesylate Isoniazid Isoprenaline hydrochloride Isoprenaline sulphate Isopropamide iodide Isosorbide dinitrate Isosorbide mononitrate Isotretinoin Ispaghula Ttraconazole Jaborondi Kanamycin sulphate Ketamine hydrochloride Ketoconazole (except topical & vaginal preparation Schedule 3) Ketoprofen Ketotifen (except cough preparation Schedule 3) Labetolol hydrochloride Lactogernic hormone C.1068 Lamivudine Lamotrigine Lanatoside C Lanatoside complex A, B and C Lansoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 30 mg and in package sizes of no more than 4200 mg of lansoprazole Schedule 3) Latamoxef disodium Latanoprost Lead arsenate Letrozole Levallorphan tartrate Levetiracetam Levocetrizine Levodopa Levofloxacin Levonorgestrel Levothyroxine L-Histidine hydrochloride Lidoflazine Lignocaine and its salts (except topical use 2% Schedule 3 and less than 2% Schedule 4) Lincomycin Lincomycin hydrochloride Liothyronine sodium Lisinopril Lithium carbonate Lithium sulphate Lobeline; its salts Lofepramine Lofepramine hydrochloride Lomustine Lopinavir Losartan Loxapine succinate L-Pyroglutamyl-L-histidyl-L-proline amide L-Tryptophan Luteinising hormone Lymecycline Lynoestrenol Mafenide acetate Mafenide hydrochloride Mafenite propionate Magnesium bromide Magnesium fluoride Magnesium metrizoate Mandragora autumnalis Mannomustine hydrochloride Maprotiline hydrochloride Mebeverine hydrochloride (except in preparation for oral use Schedule 3) Mebhydrolin napadisylate Mecamylamine hydrochloride Meclofenoxate hydrochloride Medrogestrone Medroxyprogesterone acetate Mefenamic acid (except for oral use in dysmenorrhoea Schedule 3) Mefruside Megestrol Megestrol acetate Meglumine iodoxamate Meglumine ioglycamate Meglumine iotraxate Meglumine ioxaglate Melarsonyl potassium Melengestrol Melengestrol acetate Meloxicam Melphalan Melphalan hydrochloride Mepenzolate bromide Mephenesin (except in preparation for oral use Schedule 3) Mepivacaine hydrochloride Meptazinol hydrochloride Mequitazine Mercaptopurine Mercuderamide Meropenem Mersalyl Mersalyl acid Mesna Mesterolone Metabutethamine hydrochloride Metaraminol tartrate Metformin hydrochloride Methacycline Methacycline calcium Methacycline hydrochloride Methallenoestril Methandienone Methandriol Methdilazine hydrochloride Methenolone acetate Methenolone enanthate Methicillin sodium Methimazole Methindizate hydrochloride Methixene Methixene hydrochloride Methohexitone sodium Methoserpidine Methotrexate Methotrexate sodium C.1069 C.1070 761 762 763 764 765 766 767 768 769 770 771 772 773 Methotrimeprazine Methotrimeprazine hydrochloride Methoxamine hydrochloride Methylclothiazide Methyldopa Methyldopate hydrochloride Methylephedrine hydrochloride Methylergotamine maleate Methylpentynol Methylpetynol carbamate Methylprednisolone Methylprednisolone acetate Methylprednisolone sodium succinate Methyltestosterone Methylyhiouracil Methysergide maleate Metoclopramide hydrochloride Metolazone Metomidate hydrochloride Metoprolol tartrate Metronidazole Metronidazole benzoate Mexiletine hydrochloride Mezlocillin sodium Mianserin hydrochloride Minocycline Minocycline hydrochloride Minoxidil (except in topical preparation Schedule 3) Mirtazapine Mithramycin Mitomycin C Mitopodozide Mitozantrone hydrochloride Molindone hydrochloride Mometasone Montelukast Moxifloxacin Moxonidine Mustine hydrochloride Mycophenolate Nadolol Naftidofuryl oxalate Nalbuphine hydrochloride Nalidixic acid Nalorphine hydrobromide Naloxone hydrochloride Nandrolone decanoate Nandrolone laurate Nandrolone phenylpropionate Naproxen Naproxen sodium Natamycin N-Benzoyl sulphanilamide Nebivolol Nedocromil sodium Nefopam hydrochloride Neoarsephenamine Neomycin and its salts (except topical Neostigmine bromide Neostigmine methylsulphate Netilmicin sulphate Nevirapine Nialamide Nicotinaldemyde thio-semicarbazone Nicoumalone Nifedipine Nikethamide Niridazole Nitrofurantoin Nitroxoline Nizatidine (except for short term releif of heartburn, d -300mg per single dose maximum dose 4200mg Sche: N-Methy] acetanilide Nomifensine hydrogen maleate Noradrenaline Noradrenaline acid tartrate Norethandrolone Norethisterone Norethynodrel Norfloxacin Norgestrel Northisterone acetate Northisterone heptanoate Nortriptyline hydrochloride Novobiocin calcium Novobiocin sodium Oestradiol Oestradiol benzanoate Oestradiol cypaionate Oestradiol dipropionate Oestradiol diundecanoate Oestradiol enanthate Qestradiol phenylpropionate Oestradiol undecanoate Oestradiol valerate Oestriol Oestriol di-hemisuccinate Oestrogenic substances, conjugated Oestrone Ofloxacin preparation, ophathalmic preparation Schedule 3) yspepsia and hyperacidity 150mg C.1072 860 Olanzapine 861 Oleandomycin phosphate 862 Omeprazole (except for 14-day treatment for frequent heartburn at a daily dose of 20 mg in package sizes of no more than 280 mg of omeprazole Schedule 3) 863 Ondansetron 864 Opipramol hydrochloride 865 Orciprenaline sulphate and its salts (except for use in cough preparation Schedule 3) 866 Orthocaine 867 Ouabain 868 Ovarin gland, dried 869 Oxaliplatin 870 Oxamniquine 871 Oxandrolone 872 Oxantel pamoate 873 Oxatomide 874 Oxbuprocaine hydrochloride 875 Oxcarbazepine 876 Oxedrine tartrate 877 Oxolinic acid 878 Oxophemasine hydrochloride 879 Oxophernasine tartrate 880 Oxpentifyline 881 Oxprenolol hydrochloride 882 Oxybutynin 883 Oxymeterone 884 Oxymetholone 885 Oxypertine 886 Oxypertine hydrochloride 887 Oxyphenbutazone 888 Oxyphencyclamine hydrochloride 889 Oxyphenonium bromide 890 Oxytetracycline and its salts (except for topical and ophthalmic preparation Schedule 3) 891 Oxytocins, natural and synthetic 892 Paclitaxel 893 Pancuronium bromide 894 Pantoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of pantoprazole Schedule 3) 895 Papaverine 896 Papaverine hydrochloride 897 Papaveroline 898 Papaveroline 2-sulphonic acid 899 Paraldehyde 900 Paramethadione 901 Paramethasone acetate 902 Parathyroid gland 903 Pargyline hydrochloride 904 Paromycin sulphate 905 Paroxetine 906 Pecilocin 907 Pempidine tartrate C.1073 Penbutolol sulphate Penethamate Penicillamine Penicillamine hydrochloride Penicillin V Pentamidine Pentolinium tartrate Pentoxifylline Perhexiline hydrogen maleate Pericyazine Perindopril Perphenazine Phebutrazate hydrochloride Phenacaine Phenacemide Phenbenicillin potassium Phenclzine sulphate Phenethicillin potassium Pheneturide Phenformine hydrochloride Phenglutarimide hydrochloride Phenindone Phenoxybenzamine hydrochloride Phenoxymethylpenicillin Phenoxymethylpenicillin calcium Phenoxymethylpenicillin potassium Phensuximide Phentolamine hydrochloride Phentolamine mesylate Phenyl aminosalicylate Phenylbutazone Phenylbutazone sodium Phenylephrine hydrochloride (except for nasal, flu & ophthalmic preparation Schedule 3) Phenytoin Phenytoin sodium Pheprocoumon Phernasone sulphoxylate Phthalylsulphacetamide Phthalylsulphathiazole Physostigmine Physostigmine aminoxide salicylate Physostigmine salicylate Physostigmine sulphate Pilocarpine Pilocarpine hydrochloride Pilocarpine nitrate Pimozide Pindolol Pioglitazone Pipenzolate bromide C.1074 958 Piperacillin sodium 959 Piperidolate hydrochloride 960 Pipothiazine palmitate 961 Piracetam 962 Pirbuterol acetate 963 Pirbuterol hydrochloride 964 Pirentanide 965 Pirenzepine hydrochloride 966 Piroxicam (except topical preparation and oral for use in acute gout attack maximum 100mg, per single dose 20mg Schedule 3) 967 Pituitary powdered (posterior globe) 968 Pituitatry gland (whole dried) 969 Pivampicillin hydrochloride 970 Pivmecillinam 971 Pivmecillinam hydrochloride 972 Pizotifen and its salts (except cough preparation Schedule 3) 973 Plicamycin 974 Poldine methylsulphate 975 Polidexide 976 Polidexide hydrochloride 977 Polidexide sulphate 978 Polymyxin B sulphate (except topical & ophthalmic preparation Schedule 3) 979 Polyoestradiol phosphate 980 Polythiazide 981 Potassium aminosalicylate 982 Potassium arsenite 983 Potassium bromide 984 Potassium cancrenoate 985 Potassium clavulanate 986 Potassium perchlorate 987 Pralidoxime chloride 988 Pralidoxime iodide 989 Pralidoxime mesylate 990 Pramipexole 991 Pravastatin 992 Prazosin hydrochloride 993 Prednisolone 994 Prednisolone 21-steaglate 995 Prednisolone acetate 996 Prednisolone butylacetate 997 Prednisolone hexanoate 998 Prednisolone m-sulphobenzoate 999 Prednisolone pivalate 1000 Prednisolone sodium m-sulphobenzoate 1001 Prednisolone sodium phosphate 1002 Prednisone 1003 Prednisone acetate 1004 Prenalterol hydrochloride 1005 Prenylamine lactate 1006 Prilocaine hydrochloride 1007 Primaquine phosphate 1008 Primodine 1009 Probenecid 1010 Probucol 1011 Procainamide hydrochloride 1012 Procaine hydrochloride 1013 Procaine penicillin 1014 Procarbazine hydrochloride 1015 Prochlorperazine edisylate 1016 Prochlorperazine maleate 1017 Prochlorperazine mesylate 1018 Procyclidine hydrochloride 1019 Progesterone 1020 Proguanil hydrochloride 1021 Prolintane hydrochloride 1022 Promazine embonate 1023 Promazine hydrochloride 1024 Promethazine and its salts (except topical and oral use Schedule 3) 1025 Propanidid 1026 Propantheline bromide 1027 Propicillin potassium 1028 Propiomazine hydrogen maleate 1029 Propofol 1030 Propranolol hydrochloride 1031 Propylphenazone 1032 Propylthiouracil 1033 Proquamezine fumarate 1034 Proquazone 1035 Prostaglandin F2 alpha tromethamine 1036 Protamine sulphate 1037 Prothionamide 1038 Prothipendyl hydrochloride 1039 Protriptyline hydrochloride 1040 Proxymetacaine hydrochloride 1041 Pseudoephrine hydrochloride 1042 Pseudoephrine sulphate 1043 Pyrazinamide 1044 Pyridostigmine bromide 1045 Pyrimethamine 1046 Quetiapine 1047 Quinapril 1048 Quinestradiol 1049 Quinestrol 1050 Quinethazone 1051 Quingestanol 1052 Quinidine 1053 Quinidine bisulphate 1054 Quinidine phenylethylbarbiturate 1055 Quinidine polygalacturonate 1056 Quinuronium sulphate C.1075 C.1076 1057 Rabeprazole 1058 Racephedrine hydrochloride 1059 Raltegravir 1060 Ramipril 1061 Ranitidine and its salts (except in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4500 mg of ranitidine Schedule 3) 1062 Rauwolfia (serpetina and vomitoria) 1063 Reproterol hydrochloride 1064 Rescinnamide 1065 Reserpine 1066 Rfamide 1067 Rifampicin 1068 Rifamycin 1069 Rimiterol hydrobromide 1070 Risedronic acid 1071 Risperidone 1072 Ritodrine hydrochloride 1073 Ritonavir 1074 Rolitetracycline nitrate 1075 Ropinirole 1076 Rosuvastatin 1077 Rosuvastatin 1078 Roxithromycin 1079 Salazosulphadimidine 1080 Salbutamol 1081 Salbutamol and its salts (except inhaler, autohaler and oral use Schedule 3) 1082 Salbutamol sulphate 1083 Salmetrol 1084 Saquinavir 1085 Saxagliptin 1086 Selegiline hydrochloride 1087 Sera and antisera 1088 Sertraline 1089 Serum gonadotrophin 1090 Sibutramine 1091 Simvastatin 1092 Sissomycin sulphate 1093 Sodium aminosalicylate 1094 Sodium antimonylgluconate 1095 Sodium apolate 1096 Sodium arsanilate 1097 Sodium arsenite 1098 Sodium bromated 1099 Sodium bromide 1100 Sodium cacodylate 1101 Sodium cromoglycate (except for use in ophthalmic & inhalation preparation Schedule 3) 1102 Sodium ethacrynate 1103 Sodium fluoride 1104 Sodium fucidate (except topical prepation Schedule 3) 1105 Sodium methylarsinate 1106 Sodium metrizoate 1107 Sodium monofiuorophosphate 1108 Sodium stibogluconate 1109 Sodium valproate 1110 Sotalol hydrochloride 1111 Spectinomycin 1112 Spiramycin 1113 Spiramycin adipate 1114 Spirinolactone 1115 Stannous fluoride 1116 Stanolone 1117 Stanozolol 1118 Stilboestrol 1119 Stilboestrol dipropionate 1120 Streptodornase 1121 Streptokinase 1122 Streptomycin 1123 Streptomycin sulphate 1124 Strychnine 1125 Strychnine arsenate 1126 Strychnine hydrochloride 1127 Succinylsulphathiozole 1128 Sucralfate 1129 Sulbactam sodium 1130 Sulconazole nitrate 1131 Sulfabromethazine 1132 Sulfacytine 1133 Sulfadicramide 1134 Sulfadoxine 1135 Sulfametopyrazine 1136 Sulfamonomethoxine 1137 Sulfapyrazole 1138 Sulphacetamide 1139 Sulphacetamide and its salts (except topical and ophthalmic use Schedule 3) 1140 Sulphacetamide sodium 1141 Sulphachlorpyridazine 1142 Sulphadiazine 1143 Sulphadiazine sodium 1144 Sulphadimethoxine 1145 Sulphadimidine 1146 Sulphadimidine sodium 1147 Sulphafurazole 1148 Sulphafurazole diethanolamine 1149 Sulphaguanidine 1150 Sulphaloxic acid 1151 Sulphamerazine 1152 Sulphamerazine sodium 1153 Sulphamethizole 1154 Sulphamethoxazole C.1077 C.1078 1155 Sulphamethoxydiazine 1156 Sulphamethoxypyridazine 1157 Sulphamethoxypyridazine sodium 1158 Sulphamethylphenazole 1159 Sulphamoxole 1160 Sulphanilamide 1161 Sulphaphenazole 1162 Sulphapyridine 1163 Sulphapyridine sodium 1164 Sulphaquinoxaline 1165 Sulphaquinoxaline sodium 1166 Sulpharsphenamine 1167 Sulphasalazine 1168 Sulphasomidine 1169 Sulphasomidine sodium 1170 Sulphathiourea 1171 Sulphathiozole 1172 Sulphathiozole sodium 1173 Sulphatolamide 1174 Sulphaurea 1175 Sulphinpyrazone 1176 Sulphomyxin 1177 Sulpiride 1178 Sulthiame 1179 Sumatriptan 1180 Suxamethonium bromide 1181 Suxamethonium chloride 1182 Suxethonium bromide 1183 Tacrine hydrochloride 1184 Talampicillin 1185 Talampicillin hydrochloride 1186 Talampicillin napsylate 1187 Tamoxifen 1188 Tamoxifen citrate 1189 Tamsulosin 1190 Teclothiazide potassium 1191 Teicoplanin 1192 Telmisartan 1193 Temozolomide 1194 Tenofovir 1195 Terbutaline 1196 Terbutaline sulphate 1197 Testosterone 1198 Testosterone 17B chloral hemiacetal 1199 Testosterone acetate 1200 Testosterone cyclohexylpropionate 1201 Testosterone cypionate 1202 Testosterone decanoate 1203 Testosterone enanthate 1204 Testosterone isocaproate 1205 Testosterone phenylpropionate 1206 Testosterone propionate 1207 Testosterone undecanoate 1208 Tetrabenazine 1209 Tetracaine 1210 Tetracosatrin 1211 Tetracosatrin acetate 1212 Tetracycline and its salts (except for topical and ophthalmic use Schedule 3) 1213 Thallium acetate 1214 Theophylline 1215 Thiethylperazine 1216 Thiethylperazine di-(hydrogen malate) 1217 Thiocarlide 1218 Thioguinine 1219 Thiopentone sodium 1220 Thiopropazate hydrochloride 1221 Thioproperazine mesylate 1222 Thioridazine 1223 Thioridazine hydrochloride 1224 Thiotepa 1225 Thiothexene 1226 Thiouracil 1227 Thymoxamine hydrochloride 1228 Thyroid 1229 Thyrotrophin 1230 Thyrotrophin releasing hormone 1231 Thyroxine sodium 1232 Tianulin hydrogen fumarate 1233 Tiaprofenic acid 1234 Ticarcillin sodium 1235 Tigloidine hydrobromide 1236 Timolol maleate 1237 Tioconazole (except topical & vaginal use Schedule 3) 1238 Tiotropium bromide 1239 Tobramycin 1240 Tobramycin sulphate 1241 Tocainide hydrochloride 1242 Tofenacin hydrochloride 1243 Tolazamide 1244 Tolazoline hydrochloride 1245 Tolbutamide 1246 Tolbutamide sodium 1247 Tolmetin sodium dehydrate 1248 Tolperisone 1249 Topiramate 1250 Torasemide 1251 Totaquine 1252 Tranexamic acid 1253 Tranylcypromine sulphate 1254 Trazadone C.1079 C.1080 1255 Treosulfan 1256 Treotinon 1257 Tretamine 1258 Tretinoin 1259 Triacetyloleandomycin 1260 Triamcinolone 1261 Triamcinolone acetonide 1262 Triamcinolone diacetate 1263 Triamcinolone hexacetonide 1264 Triamterene 1265 Tribromoethyl alcohol 1266 Triclofos sodium 1267 Tricyclamol chloride 1268 Trienbolone acetate 1269 Trientine dihydrochloride 1270 Trifluoperazine 1271 Trifluoperazine hydrochloride 1272 Trifluoperidol 1273 Trifluoperidol hydrochloride 1274 Trilostane 1275 Trimepramine mesylate 1276 Trimeprazine 1277 Trimeprazine tartrate 1278 Trimetaphan camsylate 1279 Trimetazidine 1280 Trimetazidine hydrochloride 1281 Trimethoprim 1282 Trimipramine maleate 1283 Trimustine hydrochloride 1284 Tripolidine 1285 Tropicamide 1286 Tubocurarine chloride 1287 Tybamate 1288 Tylosin 1289 Tylosin phosphate 1290 Tylosin tartrate 1291 Tyrothricin 1292 Uramustine 1293 Urea stibamine 1294 Uridine-5-triphosphoric acid 1295 Urifollitrophin 1296 Urokinase 1297 Ursodeoxycholic acid 1298 Vaccines 1299 Valaciclovir 1300 Valproic acid 1301 Valsartan 1302 Vancomycin hydrochloride 1303 Vasopressin tannate 1304 Vecuronium bromide C.1081 1305 Venlafaxine 1306 Verapamil hydrochloride 1307 Vidagliptin 1308 Viloxazine hydrochloride 1309 Vinblastine sulphate 1310 Vincristine sulphate 1311 Vindesin sulphate 1312 Vinorelbine 1313 Viomycin pantothenate 1314 Viomycin sulphate 1315 Vitamin A 1316 Vitamin A acetate 1317 Vitamin A palmitate 1318 Vitamin D 1319 Vitamins 1320 Warfarin 1321 Warfarin sodium 1322 Xylazine hydrochloride 1323 Yohimbine hydrochloride 1324 Zidovudine 1325 Zimeldine hydrochloride 1326 Zoledronic acid 1327 Zomepirec sodium 1328 Zopiclone 1329 Zuclopenthixol hydrochloride (3) SCHEDULE 3 MEDICINES NO. NAME OF THE MEDICINE Acetylsalicylic acid label (1) Acetylsalicylic acid label (1) Aconite in preparations and mixtures of ms 0.02% Acyclovir Adrenaline, if — Adrenaline, if —(a) in inhalers Adrenaline, if —(b) in preparations for external use Aescin and its salts Aesculin Albendazole Allopurinol Amethocaine Amethocaine and its salts in preparations for non-parenteral use (except those intended for local ophthalmic use: Schedule 2). Amethocaine gentisate Amethocaine hydrochloride Astemizole Atropine & its salts in preparations for external use and antidiarrhoeal preparations, (except those intended for local opthalmic & parenteral use: Schedule 2) Atropine sulphate Azatadine maleate label (5) C.1082 23 25 26 27 28 29 52 53 54 55 56 57 58 59 60 61 62 Belladonna alkaloid Benzocaine Benzocaine in preparations for external use and ms 4% (except preparations for local ophthalmic use: Schedule 2)) Benzoyl peroxide Benzoyl peroxide in preparations for external use with ms 10% Bromhexine hydrochloride Brompheniramine maleate Bupivacaine hydrochloride in preparations for non-parenteral use, (except those intend- ed for local opthalmic use: Schedule 2) Bupivacaine in preparations for non-parenteral use, (except those intended for local opthalmic use: Schedule 2) Butacaine sulphate in preparations for non-parenteral use, (except those intended for local opthalmic use: Schedule 2) Butalbital Butanilicaine phosphate in preparations for non-parenteral use, (except preparations in- tended for local ophthalmic use: Schedule 2) Butylscopolamine Cantharidin in preparations for external use and ms 0.01 % Caramiphen edisylate in: Caramiphen edisylate in:(a) tablet preparations and ms 7.5mg (calculated as base) Caramiphen edisylate in:(b) liquid preparations and ms 0.1% (calculated as base) Carbenoxolone sodium in preparations for external use ms 2% Carbocisteine Cetirizine Cetirizine and its salts Chloramphenicol Chloramphenicol cinnamate Chloramphenicol palmitate Chloramphenicol sodium succinate Chlorhexidine Chloroquine phosphate Chloroquine sulphate Chlorpherinamine maleate, label (5) (But in preparations for parenteral use: Schedule 2) Cimetidine Cimetidine hydrochloride Cinchocaine hydrochloride in preparations for non-parenteral use ms 3%, (except preparations for local ophthalmic use: Schedule 2) Cinchocaine in preparations for non-parenteral use and ms 3%, (except preparations for local ophthalmic use: Schedule 2) Cinnarizine Clemastine, label (5) Clioquinol Clioquinol in preparations for external use Clotrimazole Colchicine Cromoglycate Sodium Cromolyn Sodium Cyanocobalamin (except parenteral use Schedule 2) Cyclizine hydrochloride in preparations for non-parenteral use 63 64 66 67 68 69 70 72 73 74 75 76 77 79 80 81 82 100 101 102 103 C.1083 Cyproheptadine Dequalinium chloride in: Dequalinium chloride in:(a) throat lozenges or throat pastilles and ms 0.25mg Dequalinium chloride in:(b) external paint preparations and ms 1% Desloratadine Dextromethorphan hydrobromide Dextromethorphan hydrobromide in preparations for internal use with md 15mg (calculated as base) Diclofenac and its salts Dicyclomine hydrochloride Diethylamine Salicylate Di-Iodohydroxyquinoline Dimenhydrinate in preparations for non-parenteral use label (5) Dimethindine maleate, label (5) Dimethisoquin hydrochloride in preparations for non-parenteral use, (except preparations for local ophthalmic use: Schedule 2) Diphenhydramine hydrochloride in preparations for non-parenteral use, label (5) Diphenylpyraline hydrochioride, label (5) Econazole Econazole and its salts Econazole nitrate Emetine hydrochloride in preparations for internal or external use and ms 1% (calculated as base) Emetine in preparations for internal or external use and ms 1% Ephedrine & its salts in: (a) preparations for internal use (except nasal sprays and nasal drops) with md 30mg (calculated as base) and mdd 60mg (calculated as base) label (4) Ephedrine & its salts: (b) nasal sprays or nasal drops and ms 2% (calculated as base), label (4) Ergotamine tartrate Etofylline Ferrous & its salts (except Iron in preparations for internal use and mdd 100mg (calculated as iron) Schedule 4 and Iron preparation for parenteral use Schedule 2) Ferrous arsenate Fexofenadine Hydrochloride Folic acid Folic acid (Schedule 2) in preparations for internal use and mdd 500 micrograms, Glucagon Gramicidin in preparations for external use and ms 0.02% Griseofulvin Heparin Heparin calcium Hexachlorophene in preparations for external use and: Hexachlorophene in preparations for external use and:(a) in soaps with ms more than 0.1 % but not more than 2% label (6) Hexachlorophene in preparations for external use and:(b) in medicines other than soaps or aerosols with ms more than 0.1% but not more than 0.75% label ©) Homatropine in preparations for external use (except preparations for local ophthalmic use: Schedule 2)) Hydrocortisone Hydrocortisone 17-butyrate C.1084 104 105 106 107 108 109 110 111 112 113 114 115 116 17 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 141 142 143 144 145 Hydrocortisone acetate Hydrocortisone caprylate Hydrocortisone hydrogen succinate Hydrocortisone sodium phosphate Hydrocortisone sodium succinate Hydroxychloroquine sulphate for the prophylaxis of malaria Labelling for malaria prophylaxis Hydroxymethylgramicidin in throat lozenges or throat pastilles Hyoscine Hyoscine butylbromide Hyoscine hydrobromide Hyoscine methobromide Hyoscine methonitrate Touprofen Idoxuridine in preparations for external use (except preparations for local ophthalmic use:Schedule 2) Indomethacin Ipecacuanha see emetine Iron; its salts Isoconazole nitrate Ketoconazole Ketotifen L-Histidine hydrochloride used as an ingredient in dietary or nutritional medicines as an amino acid Lignocaine Lignocaine hydrochloride Loperamide hydrochloride Loratadine Mebendazole Mebeverine hydrochloride Mefenamic acid Mefloquine Hydrochloride Mephenesin Mepivacaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) Mepyramine Maleate Metabutethamine hydrochloridein preparations for non-parenteral use, (except preparations for local ophthalmic use) Methylephedrine hydrochloride in preparations for internal use with md 30mg and mdd 60mg Miconazole Miconazole and its salts Miconazole nitrate Mupirocin N-acetylcysteine Naphazoline and its salts in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05% Naphazoline and its salts: (a) in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05% Naphazoline and its salts: (b) in eye drops and ms 0.015% 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 C.1085 Naphazoline hydrochloride Naphazoline nitrate Neomycin Neomycin palmitate Neomycin sulphate Neomycin undecanoate Niclosamide Nitrofurazone Nitrofurazone in preparations for external use Nystatin Orphenadrine and its salts Orphenadrine citrate Orphenadrine hydrochloride Orthocaine in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) Oxybuprocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) Oxymetazoline Oxytetracycline Oxytetracycline calcium Oxytetracycline dihydrate Oxytetracycline hydrochloride Paracetamol label (3) Phenacaine in preparations for non-parenteral use, (except those intended for local ophthalmic use) Phenazone Phenazone and derivatives Phenazone salicylate Phenindamine tartrate Pheniramine maleate Phenylephrine hydrochloride Piperazine & its salts Piroxicam Pizotifen Pizotifen hydrogen maleate Podophyllum resin in ointments or impregnated plasters for external use with ms 20% Polymyxin B sulphate Polyvinyl Alcohol Potassium chloride Potassium chloride (except injectable Schedule 2) Potassium citrate Prilocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2) Proguanil hydrochloride for prophylaxis of malaria Labelling for malaria prophylaxis Proxymetacaine hydrochloride in preparations for non-parenteral use (except those intended forlocal ophthalmic use: Schedule 2) Pseodophedrine sulphate in preparations for internal use with md 60mg and mdd 180mg Pseudoephedrine and its salts (except in preparations for internal use with md 60mg and mdd 180mg Schedule 3) Pseudoephrine hydrochloride C.1086 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 207 218 219 220 221 222 223 224 225 226 [C F R S Pseudoephrine sulphate Pyrantel and its salts Pyrantel embonate Pyrantel tartrate Quinine and its salts (except in preparations for internal use md 100mg (calculated as base) and mdd 300mg (calculated as base) Schedule 3) Ranitidine hydrochloride Salbutamol Salbutamol sulphate Sildenafil Siver sulphadiazine Sodium apolate in preparations for external use Sodium arsenite in preparations for internal and external use and ms 0.013% Sodium cromoglycate Sodium fiuoride: Sodium fluoride:(a) in preparations for use in the prevention of dental caries, other than dentifrices, in the form of: (i) tablets or drops and mdd 2.2mg Sodium fluori i) mouth rinses other than those for daily use and ms 0.2% Sodium fluoride:(iii) mouth rinses for daily use and ms 0.05% Streptodornase in preparations for external use Streptokinase in preparations for external use Sulconazole in preparations for external use, (except vaginal use Schedule 2) Sulphacetamide Sulphacetamide sodium Terbinafine Terfenadine Tetracycline Tetracycline hydrochloride Tetracycline phosphate complex Tetrahydrozoline Tetryzoline Hydrochloride Theophylline Thiabendazole Tildenafil Tinidazole Tioconazole Tyrothricin in throat lozenges or throat pastilles Vardenafil Zinc Bacitracin (4) SCHEDULE 4 MEDICINES . NAME OF THE MEDICINE 8-Hydroxyquinoline Aluminium and its salts Alverine Citrate Amino Acids Ammonium Chloride 41 42 43 45 46 47 48 49 50 51 C.1087 Amyl-M-Cresol Aniseed Oil Arachis Oil Ascorbic acid in preparations for non-parenteral use Benzoic Acid Benzydamine Hydrochloride Benzyl Benzoate Bisacodyl Boric acid Caffeine Calcium and its salts Camphor Carbon tetrachloride N.B. if the unlicenced product is sold for non-medical purposes e.g. cleaning, there are no restrictions on its sale Carboxymethylcellulose Sodium Castor Oil Cetalkonium Chloride Cetrimide Cetylpyridinium Chioride Chlorbutol Chlorhexidine: Chlorhexidine:(a) for external use (except vaginal use: Schedule 3) Chlorhexidine:(b) in preparations for mouth wash and for use in the prevention of dental caries Cinnamon Oil Coal Tar Crotamiton Dimethicone Docusate Sodium Eucalyptus Oil Folic acid in preparations for internal use and mdd 200 micrograms Gentian Violet Glycerol Guaifenesin Hexachlorophene: in preparations for external use and: Hexachlorophene: in preparations for external use and:(a) in soaps with ms 0.1% label (6) Hexachlorophene: in preparations for external use and:(b) in aerosols with ms 0.1% label (6) Hexachlorophene: in preparations for external use and:(c- in medicines other than soaps or aerosols with ms 0.1% label (6) Hydroxyquinoline sulfate Ichthammol Kaolin Lactulose Liquid Paraffin Magaldrate Magnesium and its salts Magnesium trisilicate Menthol Methyl Salicylate C.1088 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 7 78 79 80 81 82 83 84 85 86 87 88 Monosulfiram Oral Rehydration Salts Paracetamol in tablet preparations with ms 500mg and not more than 30 tablets label (3) Pectin Phenol Phenolphthalein Podophyllum Indian Podophyllum resin Potassium hydroxy quinoline sulfate Povidone-Iodine Pyridoxine Salicylic Acid Selenium Sulphide Sennosides A - B Simethicone Sodium Bicarbonate Sodium Chloride Sodium fluoride in dentifrices and ms 0.33% Sodium monofiuorophosphate in dentifrices and ms 1.14% Stannous fluoride in dentifrices and ms 0.62% Tartaric Acid Trace Elements (except for parenteral use Schedule 2) Turpentine Oil ‘Undecenoic Acid Urea Vitamin A in: :(a) preparations for internal use with mdd 7500 iu Vitamin A (2250 mcg Retinol equivalent) Vitamin A in:(b) preparations for external use Vitamin A acetate in:(a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) Vitamin A acetate in:(b) preparations for external use Vitamin A palmitate in:(a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent) Vitamin A palmitate in:(b) preparations for external use Vitamin D in:(a) preparations for internal use with mdd 10 mcg Vitamin D in:(b) preparations for external use Vitamins, mixed in non-parenteral preparations Zinc Chloride Zinc Oxide Zinc sulphate in non-parenteral preparations (except in preparations for local ophthalmic use:Schedule 2) NOTES Explanation of abbreviations and other phrases used in lists of medicines md: (maximum dose) i.e. the maximum quantity of the drug or substance that is contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. C.1089 mdd: (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. ms: (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w or /v, as appropriate. external use: means for application to the skin, teeth, mucosa of the mouth, throat, nose, eye, ear, vagina or anal canal when a local action only is necessary and extensive systemic absorption is unlikely to occur. N.B. The following are not regarded as for external use: throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething Ppreparations. oral use: means administration through the mouth. parenteral administration: means administration by breach of the skin or mucous membrane. SCHEDULE 2 (reg.47) PRECURSOR CHEMICALS Precursor chemicals in Tables I and II of the 1988 Convention Table I Acetic anhydride N-Acetylanthranilic acid Ephedrine Ergometrine Ergotamine Isosafrole Lysergic acid 3.4-Methylenedioxyphenyl-2-propanone Norephedrine Phenylacetic acid alpha-Phenylacetoacetonitrile 1-Phenyl-2-propanone Piperonal Potassium permanganate Pseudoephedrine Safrole C.1090 Note: The salts of the substances are listed in the table whenever the existence of such salts is possible. Table IT Acetone Anthranilic acid Ethyl ether Hydrochloric acid Methyl ethyl ketone Piperidine Sulphuric acid Toluene Note: The salts of the substances listed in the table whenever the existence of such salts is possible. SCHEDULE 3 (reg. 69) BANNED MEDICINES Amphetamine Brolamphetamine (DOB, Bromo-STP) Bufotenine (N,N-Dimethylserotonin) Cannabis Cocaine Coca Leaf Cathinone DET or 3-[2-(diethylamino) ethyl] indole Dexamphetamine DMA or (+ or -)-2,5-dimethoxy-alpha-methylphenethylamine DMT or 3-[2-(dimethylamino) ethyl] indole DOET or (+ or -)-4-ethyl-2,5-dimethoxy-alpha-phenethylamine Ecgonine Eticyclidine (PCE) Fentanyl analogues (unless listed in another Schedule): acetyl-alpha-methyl-fentany! alpha- methyl-fentanyl alpha-methyl-fentanyl-acetanilide alpha-methyl-thiofentanyl beta-hydroxy- fentanyl 3-methyl-thiofentanyl 3-methyl-fentanyl and its cis- and trans- isomeric forms thiofentanyl para-flurofentanyl Harmaline Harmine Heroin (diacetylmorphine) (+)-lysergide (LSD, LSD-25) MDMA or (+ or -)-N, alpha-dimethyl-3 4-(methylenedioxy)-phenethylamine Mecloqualone Mescaline C.1091 Methaqualone 4-methylaminorex MMDA or 2-methoxy-alpha-methyl-4,5(methylenedioxy) phenethylamine N-ethyl MDA or (+ or -)-N-ethyl-alpha-methyl-3 4-(methylenedioxy) phenethylamine N-hydroxy MDA or (+or -)-N-[alpha-methyl-3 4 (methylene-dioxy) phenethyl)hydroxylamine Opium Parahexyl Pethidine analogues: 1-methyl-4-phenyl-4-propionoxy-piperidine (MPPP) 1-methyl-4-phenyl-2,5 6-tetrahydropieridine (MPTP) 1-phenylethyl-4-phenyl-4-acetyloxy-piperidine (PEPAP) PMA Poppy straw concentrate Psilocine or psilotsin Psilocybine Rolicyclidine (PHP, PCPY) STP, DOM or 2.5-dimethoxy-alpha 4-dimethylphenelhylamine Tenamfetamine (MDA) Tenocyclidine (TCP) Tetrahydrocannabinol TMA or (+ or -)-3 4 5-trimethoxy-alpha-methylphenethylamine All preparations and mixtures of the following unless specifically excluded or unless listed in another Schedule: (i) the isomers of substances above, where existence of such isomers is possible: (il) the esters and ethers of such substances and of the isomers referred to above or isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible; (iii) the salts of such substances and of the isomers referred to in (i), and the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible; (iv) the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible. C.1092 SCHEDULE 4 (reg.3,5,9,11,16,17, 18, 19, 20, 21, 22, 24, 26, 27, 28, 32, 50, 54, 55, 60, 61, 64 and 66) FORMS FORM 1 APPLICATION FOR REGISTRATION OF MEDICINE Module 1: Administrative Information Application Form This application form shall be included in the Botswana Common Technical Document — Module 1 Administrative Information. The application form is to be used for an application for registration of a medicinal product, B-listed medicines and renewal of registration submitted to the Authority. A separate application form for each strength and pharmaceutical dosage form is required. However, different strengths may be submitted in one dossier. New application: Renewal application: (Tick whichever applicable) (a) Particulars of the Applicant/Prospective holder of the certificate of registration (PHCR) Name: Business address: Postal address: Telephone No: Fax No: E-mail address: Site/Applicant Master File Number: Pharmacist responsiblelauthorised to communicate with the Authority Name: Business address: Telephone No: C.1093 Fax No: E-mail address: (Attach a letter of authorisation signed by the person responsible for the overall management and control of the business— Annex 1.2.2.2) ‘ (b) Particulars of the medicine Product Category#: Proprietary name: Pharmacological classification: Dosage form: Approved name(s): Strength(s) per dosage unit: Descriptive name of Biological medicine: Route of administration: Country of origin (country in which the original development was carried out): Manufacturing, packaging, testing sites Manufacturer(s): Physical address of site(s): Site master file reference number(s): Date of submission Licence number: Date of issue: Primary Packer(s): Physical address of site(s): Site Master File reference number(s): Date of submission Licence number: Date of issue: Secondary Packer(s): C.1094 Physical address of site(s): Site Master File reference number(s): Date of submission: Licence number: Date of issue: Finished product release control (FPRC)(s): Physical address of site(s): Site master file reference number(s): Date of submission: Licence number: Date of issue: Finished product release responsibility (FPRR)(s): Physical address of site(s): Site Master File reference number(s): Date of submission Licence number: Date of issue: [ 1t is hereby confirmed that copies of the latest GMP certificate for manufacturer(s) and packer(s) and/or a copy of the appropriate manufacturing licence(s) and Site Master File(s) have been included in section 1.7. (c) Declaration and signature The undersigned hereby declares that all the information herein, and in the Annexes and Modules hereto, are correct and true and are relevant to this particular medicine, and that all existing data which are relevant to the quality, safety and efficacy of the product have been supplied in the dossier, as appropriate. [ It is hereby confirmed that fees have been paid according to current legislation, and proof is attached in Annex 1.2.2.1 Szgnalure of Pharmacist [Section (a) above] Date of application , C.1095 Name in block letters Designation Date of current amendment (d) Type of application NEW APPLICATION Indicate the type of medicine, the type of data included as proof of efficacy, and the review procedure using a check mark (°) or a cross (X) — Human Medicine: NCE Data as proof of efficacy: Pharmaceutical Multisource Pre-clinical Biological Biosimilar Clinical Review Procedure: Routine | Tamrr | [Expedited (Fast rack) For multiple/duplicate applications of the same medicinal product Proposed Proprietary Name(s) of the other product(s): Date of application(s) (yyyy-mm-dd): AMENDMENT/VARIATION Indicate the type of amendment/variation using a check mark (¢) or a cross (X): Inspection Response to pre-registration recommendation: Pharmaceutical and Analytical Pharmaceutical & Analytical Clinical Clinical Proprietary Name Proprietary Name C.109 (€) Qualified person for Pharmacovigilance Name: Business address: 24 Hour Telephone No: Fax No: E-mail address: (Attach CV—Annex 122.5) (f) Amendment history Date of letter of amendment Summarised details of Date of application amendment (include Type Regulatory Authorizy and Category) response d The following is a description of the categories: 1. Category A: Low risk medicines These are medicines of low risk medicines mostly intended for self-medication as may be decided by the Authority. 2. Category B: Established medicines These are medicines with safety and efficacy record well documented in standard textbooks including Martindale, Goodman and Gilman, USP-DI. 3. Category C: Exempted medicines These are medicines exempted under section 23 (3) and (4) of the Medicines and Related Substances Act. The Authority may request additional information, as the medicine continues to be used. A completed application for registration exemption form shall be submitted to the Authority. 4. Category D: Medicine requiring selected areas of evaluation Medicines under this category may include: (@) new combination medicines; (b) first line generic medicine; (c) established medicine with new indication(s); (d) new formulation of an established medicine; or (e) any other medicine as the Authority may decide. C.1097 5. Category E: New medicines and biologicals These are new chemical entities, new formulation and all biological medicines. For these, detailed pharmaceutical, pharmacological and clinical documentation shall be submitted. Applicants may also be requested to submit evaluation reports or approvals from a Stringent Regulatory Authority (SRA) defined as a member of ICH prior to 23 October 2015, namely: the US Food and Drug Administration, the European Commission and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or an ICH observer prior to 23 October 2015, namely: the European Free Trade Association, as represented by Swiss medic and Health Canada; or a regulatory authority associated with an ICH member through a legally-binding, mutual Tecognition agreement prior to 23 October 2015, namely: Australia, Iceland, Liechtenstein and Norway. C.1098 FORM 2 (reg. 3,23 and 26) APPLICATION FOR REGISTRATION OF MEDICINE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE » Botswana Module 1 * CTD-Modules 2 - 5 Common Technical Document Modular format of applications for registration in CTD format Module 1 — Administrative information and prescribing information 1.0 Cover Letter. 1.1 Comprehensive table of content: 12 Application... 1.3 Labelling and packagin 1.4 Information about the experts 1.5 Specific requirements for different types of applications. 1.6 Environmental risk assessment.. 1.7 Good manufacturing practice. 1.8 Details of Screening.. 1.9 Individual patient data — statement of availability, if applicable 1.10 Foreign regulatory status. 1.11 Bioequivalence trial information 1.12 Paediatric development programm 1.13 Information relating to Pharmacovigilance. 1.14 Electronic review documents (e.g. product information, BTIF, QOS, QIS).... Module 2 — CTD Summaries 2.1 CTD Table of Contents (modules 2 to 5. 2.2 Introduction..... 2.3 Quality Overall Summary - Introductior 2.4 Non-clinical Overview. 2.5 Clinical Overview. 2.6 Non-clinical Written and Tabulated Summaries.. 2.7 Clinical Summary..... Module 3 — Quality 3.1 Table of contents of module 3..... 3.2 Body of data... 32.8 Drug Substance/Active Pharmaceutical Ingredient (name, manufacturer). 32P Drug Product/Pharmaceutical Product (name, dosage form 32.A Appendices... 32R Regional Information, 3.3 Literature references... C.1099 Module 4 — Non-clinical study reports 4.1 Table of contents of Module 42 Study reports..... 4.3 Literature references Module 5 — Clinical Study Reports 5.1 Table of contents of Module 5... 5.2 Tabular listing of all clinical studies. 5.3 Clinical study report: 5.4 Literature references. Modular format of applications for registration in CTD format Module 1 — Administrative information and prescribing information 13 13.1 132 133 134 141 142 143 15.1 152 153 16 Cover Letter Comprehensive table of contents Application Application form Annexes to application form 1.2.2.1 Proof of payment Letter of authorisation for communication on behalf of the applicant Electronic copy declaration Curriculum vitae of the person responsible for pharmacovigilance Drug Substance/API change control Copy of EMA certificate for a Vaccine Antigen Master File (VAMF) Copy of EMA certificate for a Plasma Master File (PMF) Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) Copy of confirmation of API prequalification document (CPQ) 1.2.2.10 Letter of access from APIMF, CEP or CPQ holder 1.2.2.11 Quality Information Summary (QIS) — To submit only at the time of registration and/or immediately after registration and after every variation approval. Labelling and packaging Package Insert /Summary of Product Characteristics (SmPC) Patient Information Leaflet (PIL) Labels (outer and inner labels) Braille Information about the experts Quality Non-clinical Clinical Specific requirements for different types of applications Studies and data for generic products Same/Separate Applications 152.1 Tablets/Capsules/Suppositories/Lozenges 1522 Syrups/Liquids/Solutions (non parenterals)/Creams/ointments 1523 Ampoules, Vials and Large Volume Parenterals 1524 Different applicants/proprietary names for the same formula Genetically modified organisms Environmental risk assessment C.1100 1.6.1 Non-GMO (genetically modified organisms) 162 GMO 1.7 Good manufacturing practice 1.7.1 Date of last inspection of each site 1.7.2 Inspection reports or equivalent document 1.7.3 Latest GMP certificate (not older than 3 years) for APT and FPP manufacturer/s and packer/s and a copy of the appropriate manufacturing licence 174 Registration of Responsible Pharmacist or Suitably Qualified Person for local manufacturers 1.7.5 Sample and Documents (e.g. FPP, device(s), certificates of analysis) 1.7.5.1 Confirmation of submission of sample 1.7.5.2 Certificate of analysis of the sample 1.7.6 Certified copy of a permit to manufacture specified controlled substances 1.7.7 Site Master File(s) 1.8 Details of Screening 1.9 Individual patient data - statement of availability, if applicable 1.10 Foreign regulatory status 1.10.1 List of SADC or other countries in which an application for the same product as being applied for has been submitted, registered, rejected or withdrawn. 1.10.2 WHO type Certificate of Pharmaceutical Product (COPP) 1.10.3 Registration certificate or marketing authorisation 1.10.4 Foreign prescribing and patient information 1.10.5 Data set similarities 1.11 Bioequivalence trial information 1.11.1 Study Title(s) (or brief description giving design, duration, dose and subject population of each study) 1.11.2 Protocol and study numbers 1.11.3 Investigational products (test and reference) details 1.11.4 Confirmation that the test product formulation and ‘manufacturing process is the one being applied for 1.11.5 Proof of procurement of the biostudy reference product 1.11.6Name and address of the Research Organisation(s)/Contract Research! Organisation(s) where the bioequivalence studies were conducted 1.11.7 Sponsor and responsible sponsor representative: name and address, contact details 1.11.8 Duration of Clinical phase: dates of dosing and last clinical procedure 1.11.9 Date of final report 1.12 Paediatric development programme 1.13 Information relating to Pharmacovigilance 1.13.1 Pharmacovigilance system 1.13.2 Risk management system 1.14 Electronic review documents (e.g. product information, BTTF, QOS and QIS) Module 2 — CTD Summaries 2.1 CTD Table of Contents (modules 2 to 5) 2.2 Introduction 2.3 QualityOverall Summary — Introduction 2.3. S Quality Overall Summary — Drug Substance/Active Pharmaceutical Ingredient (name, manufacturer) 2.3.5.1 General Information (name, manufacturer) 2.3.8.2 Manufacture (name, manufacturer) Cca101 2.3.8.3 Characterisation (name, manufacturer) 2.3.8.4 Control of Drug Substance/Active Pharmaceutical Ingredient (name, manufacturer) 2.3.8.5 Reference Standards or Materials (name, manufacturer) 2.3.8.6 Container Closure System (name, manufacturer) 2.3.8.7 Stability (name, manufacturer) 2.3.P Quality Overall Summary — Drug Product/Finished Pharmaceutical Product (name, dosage form) 2.3.P.1 Description and Composition of the Drug Product/Pharmaceutical Product (name, dosage form) 2.3.P.2 Pharmaceutical Development (name, dosage form) 2.3.P.3 Manufacture (name, dosage form) 2.3 P4 Control of Excipients (name, dosage form) 2.3.P5 Control of Drug Product/Pharmaceutical Product (name, dosage form) 2.3.P.6 Reference Standards or Materials (name, dosage form) 2.3.P.7 Container Closure System (name, dosage form) 2.3.P.8 Stability (name, dosage form) 2.3.A Quality Overall Summary — Appendices 2.3.A.1 Facilities and equipment (name, manufacturer) 2.3.A.2 Adventitious agents safety evaluation (name, dosage form, manufacturer) 2.3.A.3 Excipients 2.4 Non-clinical Overview 2.5 Clinical Overview 2.5.1 Product Development Rationale 2.5.2 Overview of Bio pharmaceutics 2.5.3 Overview of Clinical Pharmacology 2.5.4 Overview of Efficacy 2.5.5 Overview of Safety 2.5.6 Benefits and Risks Conclusions 2.5.7 Literature References 2.6 Non-clinical Written and Tabulated Summaries 2.6.1 Introduction 262 Pharmacology Written Summary* 2.6.2.1 Brief Summary 2.6.2.2 Primary Pharmacodynamics 2.6.2.3 Secondary Pharmacodynamics 2.6.2 .4 Safety Pharmacology 2.6.2.5 Pharmacodynamic Medicine Interactions 2.6.2.6 Discussion and Conclusions 2.6.2.7 Tables and Figures (See Appendix A) 2.6.3 Pharmacology Tabulated Summary (See Appendix B) 2.6.4 Pharmacokinetics Written Summary? 2.6.4.1 Brief Summary 2.6.4.2 Methods of Analysis 2.6.4.3 Absorption 2.6.4.4 Distribution 2.6.4.5 Metabolism (interspecies comparison) 2.6.4.6 Excretion 2.6.4.7 Pharmacokinetic Medicine Interactions 2.6.4.8 Other Pharmacokinetic Studies 2.6.4.9 Discussion and Conclusions “The CTD defines these further heading levels and navigation should be provided within the document to these subheadings. C.1102 2.6.4.10 Tables and Figures (See Appendix A) 2.6.5 Pharmacokinetics Tabulated Summary (See Appendix B) 2.6.6 Toxicology Written Summary? 2.6.6.1 Brief Summary 2.6.6.2 Single-Dose Toxicity 2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluations) 2.6.6.4 Genotoxicity 2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations) 2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) 2.6.6.7 Local Tolerance 2.6.6.8 Other Toxicity Studies (if available) 2.6.6.9 Discussion and Conclusions 2.6.6.10 Tables and Figures (See Appendix A) 2.6.7 Toxicology Tabulated Summary (See Appendix B) 2.7 Clinical Summary 2.7.1 Summary of Biopharmaceutical Studies and Associated Analytical Methods® 2.7.1.1 Background and Overview 2.7.1.2 Summary of Results of Individual Studies 2.7.1.3 Comparison and Analyses of Results Across Studies 2.7.1.4 Appendix 2.7.2 Summary of Clinical Pharmacology Studies 2.7.2.1 Background and Overview 2.7.2.2 Summary of Results of Individual Studies 2.7.2.3 Comparison and Analyses of Results Across Studies 2.7.2.4 Special Studies 2.7.2.5 Appendix 2.73 Summary of Clinical Efficacy — Indication’ 2.7.3.1 Background and Overview of Clinical Efficacy 2.7.3.2 Summary of Results of Individual Studies 2.7.3.3 Comparison and Analyses of Results Across Studies 2.7.3.3.1 Study Populations 2.7.3.3.2 Comparison of Efficacy Results of All Studies 2.7.3.3.3 Comparison of Results in Sub-populations 2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations 2.7.3.5 Persistence of Efficacy and/or Tolerance Effects 2.7.3.6 Appendix 2.7.4 Summary of Clinical Safety® 2.7.4.1 Exposure to the Medicine 27.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies 2 7.4.1.2 Overall Extent of Exposure 2 7.4.1.3 Demographic and Other Characteristics of Study Population 2.7.42 Adverse Events 2.7.42.1 Analysis of Adverse Events 2.7.4.2.1.1 Common Adverse Events 2.7.42.1.2 Deaths 2.7.42.1.3 Other Serious Adverse Events 2.7.4.2.1.4 Other Significant Adverse Events 2.7.42.1.5 Analysis of Adverse Events by Organ System or Syndrome 2.7.4.2.2 Narratives *The CTD defines these further headings levels and navigation should be provided within the documents to these subheadings Thid Ca1103 2.7.4.3 Clinical Laboratory Evaluations 2.7.4.4 Vital Signs, Physical Findings and Other Observations related to Safety 2.7.4.5 Safety in Special Groups and Situations 2.7.4.5.1 Intrinsic Factors 2.7.4.5.2 Extrinsic Factors 2.7.45.3 Medicine Interactions 2.7.45.4 Use in Pregnancy and Lactation 2.745.5 Overdose 2.7.4.5.6 Medicine Abuse 2.7.4.5.7 Withdrawal and Rebound 2.7.4.5.8 Effects on Ability to Drive of Operate Machinery or Impairment of Mental Ability 2.7.4.6 Post-marketing Data 2.7.4.7 Appendix 2.7.5 Literature References 2.7.6 Synopses of Individual Studies Module 3 - Quality 3.1 Table of contents of module 3 3.2 Body of data 3.2.S Drug Substance/Active Pharmaceutical Ingredient (name, manufacturer) 3.2.8.1 General information (name, manufacturer) 3.2.8.1.1 Nomenclature (name, manufacturer) 3.2.5.1.2 Structure (name, manufacturer) 3.2.5.1.3 General Properties (name, manufacturer) 3.2.8.2 Manufacture (name, manufacturer) 3.2.8.2.1 Manufacturer(s) (name, manufacturer) 3.2.5.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 3.2.8.2.3 Control of Materials (name, manufacturer) 3.2.8.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 3.2.8.2.5 Process Validation and/or Evaluation (rame, manufacturer) 3.2.8.2.6 Manufacturing Process Development (name, manufacturer) 3.2.8.3 Characterisation (name, manufacturer) 3.2.8.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) 3.2.8.3.2 Impurities (name, manufacturer) 3.2.8.4 Control of active pharmaceutical ingredient (name, manufacturer) 3.2.8.4.1 Specifications (name, manufacturer) 3.2.8.4.2 Analytical Procedures (name, manufacturer) 3.2.8.4.3 Validation of Analytical Procedures (name, manufacturer) 3.2.8.4.4 Batch Analyses (name, manufacturer) 3.2.8.4.5 Justification of Specification (name, manufacturer) 3.2.8.5 Reference Standards or Materials (name, manufacturer) 3.2.8.6 Container Closure System (name, manufacturer) 3.2.8.7 Stability (name, manufacturer) 3.2.8.7.1 Stability summary and conclusions (name, manufacturer) 3.2.8.7.2 Post approval stability protocol and stability commitment (name, manufacturer) 3.2.8.7.3 Stability Data (name, manufacturer) 3.2.P Drug Product/Pharmaceutical Product (name, dosage form) 3.2.P.1 Description and Composition of the Drug Product/pharmaceutical product (name, dosage form) 3.2 P2 Pharmaceutical Development (name, dosage form) C.1104 3.2.P2.1 Components of the Drug Product/Pharmaceutical Product (name, dosage form) 3.2P2.1.1 Drug Substance/Active Pharmaceutical Ingredient(s) (name, dosage form) 3.2.P.2.1.2 Excipients (name, dosage form) 3.2.P2.2 Final Drug Product/pharmaceutical product (name, dosage form) 3.2.P2.2.1 Formulation development (name, dosage form) 32.P2.2.2 Overages (name, dosage form) 3.2.P2.2.3 Physicochemical and biological properties (name, dosage form) 3.2.P2.3 Manufacturing process development (name, dosage form) 3.2.P2.4 Container closure system (name, dosage form) 3.2.P2.5 Microbiological attributes (name, dosage form) 3.2.P2.6 Compatibility (name, dosage form) 3.2.P.3 Manufacture (name, dosage form) 3.2.P.3.1 Manufacturer(s) (name, dosage form) 3.2.P3.2 Batch formula (name, dosage form) 3.2.P3.3 Description of manufacturing process and process controls (name, dosage form) 3.2.P3.4 Controls of critical steps and intermediates (name, dosage form) 3.2.P3.5 Process validation and/or evaluation (name, dosage form) 3.2.P4 Control of Inactive Pharmaceutical Ingredients (name, dosage form) 3.2P4.1 Specifications (name, dosage form) 3.2.P4.2 Analytical procedures (name, dosage form) 3.2.P.4.3 Validation of analytical procedures (name, dosage form) 3.2.P4.4 Justification of specifications (name, dosage form) 3.2.P4.5 Excipients of human or animal origin (name, dosage form) 3.2.P4.6 Novel excipients (name, dosage form) 3.2.P5 Control of Drug Product/pharmaceutical product (name, dosage form) 3.2.P5.1 Specification(s) (name, dosage form) 3.2.P.5.2 Analytical procedures (name, dosage form) 3.2.P.5.3 Validation of analytical procedures (name, dosage form) 3.2.P5.4 Batch analyses (name, dosage form) 3.2.P.5.5 Characterisation of impurities (name, dosage form) 3.2.P.5.6 Justification of specifications (name, dosage form) 3.2.P.6 Reference standards or materials (name, dosage form) 3.2.P.7 Container closure system (name, dosage form) 3.2.P.8 Stability (name, dosage form) 3.2.P.8.1 Stability summary and conclusion (name, dosage form) 3.2.P.8.2 Post-approval stability protocol and stability commitment (name, dosage form) 3.2.P.8.3 Stability data (rame, dosage form) 3.2.A Appendices 3.2.A.1 Facilities and equipment (name, manufacturer) 3.2.A.2 Adventitious agents safety evaluation (name, dosage form, manufacturer) 3.2.A.3 Excipients 3.2.R Regional Information 3.2R.1 Production documentation 3.2.R.1.1 Executed production documents 3.2.R.1.2 Master production documents 3.2.R 2 Analytical procedures and validation information 3.2.R 3 Bioequivalence trial information 3.2 R.3.1 Bioequivalence trial information form (or BTIF) 3.2.R.3.2 Biowaiver requests in relation to conducting comparative bioavailability study 3.3 Literature references C.1105 Module 4 — Non-clinical study reports 4.1 Table of contents of Module 4 4.2 Study reports 4.2.1 Pharmacology 4.2.1.1 Primary pharmacodynamics 4.2.1.2 Secondary pharmacodynamics 4.2.1.3 Safety pharmacology 4.2.1.4 Pharmacodynamic medicine interactions 4.2.2 Pharmacokinetics 4.2.2.1 Analytical methods and validation reports 4.22.2 Absorption 4.2.2.3 Distribution 4.2.2 .4 Metabolism 4.2.2.5 Excretion 4.2.2.6 Pharmacokinetic medicine interactions (non clinical) 4.2.2.7 Other pharmacokinetic studies 4.2.3 Toxicology 4.2.3.1 Single-dose toxicity (in order by species, by route) 4.2.3.2 Repeat dose toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations) 4.2.3.3 Genotoxicity 4.23.3.1 Invitro 4.2332 In vivo (including supportive toxicokinetics evaluations) 4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations) -3.4.1 Long-term studies (in order by species, including range-finding studies that cannot be appropriately included under repeat-dose toxicity or pharmacokinetics) 4.2.3.4.2 Short or medium term studies (including range finding studies that cannot be appropriately included under repeat-dose) 4.2.3.4.3 Other studies 4.23.5 Reproductive and developmental toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following subheadings should be modified accordingly) 4.2.3.5.1 Fertility and early embryonic development 4.2.3.5.2 Embryo-foetal development 4.2.3.5.3 Prenatal and postnatal development, including maternal function 42354 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated 4.2.3.6 Local tolerance 4.2.3.7 Other toxicity studies (if available) 4.2.3.7.1 Antigenicity 4.2.3.7.2 Immunotoxicity 4.2.3.7.3 Mechanistic studies (if not included elsewhere) 4.2.3.7.4 Dependence 4.2.3.7.5 Metabolites 423.7.6 Impurities 4.2.3.7.7 Other 4.3 Literature references Module 5 — Clinical Study Reports 5.1 Table of contents of Module 5 C.1106 5.2 Tabular listing of all clinical studies 5.3 Clinical study reports 53.1 Reports of biopharmaceutic studies 5.3.1.1 Bioavailability (BA) Study Reports 5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports 5.3.1.3 In vitro-in vivo correlation study reports 5.3.1.4 Reports of bioanalytical and analytical methods for human studies. 5.3.2 Reports of studies pertinent to pharmacokinetics using human biomaterials 5.3.2.1 Plasma Protein Binding Study Reports 5.3.2.2 Reports of Hepatic Metabolism and Medicine Interaction Studies 5.3.2.3 Reports of Studies Using Other Human Biomaterials 5.3.3 Reports of human pharmacokinetic (PK) Studies 5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports 5.3.3.2 Patient PK and Initial Tolerability Study Reports 5.3.3.3 Intrinsic Factor PK Study Reports 5.3.3.4 Extrinsic Factor PK Study Reports 5.3.3.5 Population PK Study Reports 5.3.4 Reports of human pharmacodynamic (PD) studies 5.3.4.1 Healthy Subject PD and PK/PD Study Reports 5.3.4.2 Patient PD and PK/PD Study Reports 5.3.5 Reports of efficacy and safety studies 5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication 5.3.5.2 Study Reports of Uncontrolled Clinical Studies 5.3.5.3 Reports of Analyses of Data from More than One Study 5.3.5.4 Other Study Reports 5.3.6 Reports of Post-marketing experience 5.3.7 Case report forms and individual patient listings 5.4 Literature references Cca107 FORM 3 (reg.3(3)) APPROVAL FOR REGISTRATION OF A MEDICINE Subject to due compliance with the requirement of the Medicines and Related Substances Act and Regulations thereto, the following medicine is approved by the Authority to be marketed in Botswana and entered into the Medicine Register as follows: Registration Number: Name of Medicine: Active ingredient(s), approved name or volume of the medicine: i and quantity per dosage unit or per suitable mass Dosage Form: Strength: Manufacturer: Manufacturing country: Package size(s): Packaging material: Approved Indication(s): Schedule: Special conditions: Date granted: Valid until: Authorisation: Signature: (Name and stamp): C.1108 FORM 4 (reg. 6 and 66 (9)) APPLICATION FOR REGISTRATION EXEMPTION — PATIENT O Single Patient O Multiple Patients *Separate Forms to be filled for each patient Application Number: 1. Patient’s 2. Address: Age and Sex 3. Approved/generic name of medicine: 4. Brand name of medicine: 5. Name and address of Manufacturer: 6. Registration number in other countries and registered indications: 7. Dosage: 8. Pack size 9. Strength and formulation 10. Duration of treatment: 11. Medical history (a) Clinical condition (b) Medicines previously used: (c) Outcome of treatment (in brief) with medicines mentioned in (b) above C.1109 (d) Any additional information 12. Progress report (including adverse drug reactions if any) and request for continuation: 13. Name and physical address of Medical Practitioner: 14. Qualifications and Practice Number 15. Signature 16. Date: 17. Pharmacy (name and address): a. Name of Practitioner: b. Botswana Health Professions Council Registration Number: 18. Importer: c. Name of practitioner: d. Botswana Health Professions Council Registration Number: This form to be submitted to the patient’s pharmacy with the relevant prescription. To be completed for any subsequent applications after the initial 6 months approval. C.a1110 For Official Use: Date request received: Drug category: Investigational New Old Registration Appl. Submitted: Yes No Registration Appl. Number Registration Application Evaluated: Yes No If Yes, state the outcome: Pending Rejected If Rejected, give reasons: Decision: Exemption Granted: Conditions, if any: Valid Until: Exemption Refused Reasons Caiin FORM 5 (reg.8) APPLICATION FOR REGISTRATION EXEMPTION — WHOLESALER MEDICINE OR RELATED SUBSTANCE Name of the medicine or related substance: Approved name(s) of active ingredient(s): Dosage form: Strength(s): Quantity Name and address of manufacturer: cai2 Motivation Attach the following documents to this form 2) Copies of Certificate of analysis from two latest batches, (to attach CoA of sample batch). b) Registration Certificate of the product in the country of origin. c) GMP Certificate from country of origin. d) Certificate of Pharmaceutical Product. e) For Sterile products a valid cGMP Certificate for the Finished Pharmaceutical Products (FPP) manufacturing site, issued by either ICH member countries, regulatory authorities that participate in the Pharmaceutical Inspection Cooperation Scheme (PIC/s), WHO or National Medicines Regulatory Authorities in Zambia (ZAMRA), Zimbabwe (MCAZ), Tanzania (TFDA) and Uganda (NDA). f) For Biosimilars a valid Registration Certificate for the product must be issued by ICH member countries prior to 23 October, 2013. g) The applicant or pharmacist must submit a package insert. SUPPLIER APPLICANT Name, address and qualifications of the Applicant: Signature of Applicant Date: For Official Use: Date request received: Medicine category: Investigational New Old Registration Application Registration Application Submitted: Evaluated: Yes NO Yes No Registration Application Number: If Yes, state the outcome: Pending Rejected If Rejected, give reasons: cau3 Decision: Exemption Granted: Exemption Refused Conditions, if any: Reasons Valid until: ca1i4 FORM 6 (reg. 9) APPLICATION FOR REGISTRATION EXEMPTION — DONATION Name of the medicine or related substance: Approved name(s) of active ingredient(s): Dosage form: Strength(s): Quantity: C.a115 Name and address of Manufacturer: Name of Donor Intended recipient of donation Motivation a) b) ©) d) h) €) Attach the following documents to this form Copies of Certificate of analysis from two latest batches, (to attach CoA of sample batch) Registration Certificate of the product in the country of origin. c¢GMP Certificate from country of origin. Certificate of Pharmaceutical Product. For Sterile products a valid cGMP Certificate for the Finished Pharmaceutical Products (FPP) manufacturing site, issued by either ICH member countries, regulatory authorities that participate in the Pharmaceutical Inspection Cooperation Scheme (PIC/s), WHO or National Medicines Regulatory Authorities in Zambia (ZAMRA), Zimbabwe (MCAZ), Tanzania (TFDA) and Uganda (NDA). For Biosimilars a valid Registration Certificate for the product must be issued by ICH member countries prior to 23 October, 2013 The applicant or pharmacist must submit a package insert SUPPLIER C.1116 APPLICANT Name, address and qualifications of the applicant: Signature of Applicant Date: For Official Use: Date request received: Medicine category: Investigational New ol Registration Application Registration Application Submitted: Evaluated: Yes No Yes No Registration Application Number: If Yes, state the outcome: Pending Rejected If Rejected give reasons: Decision: Exemption Granted: Exemption Refused Conditions, if any: Reasons Valid Until: can7 FORM 7 (reg. 10 and 66) 'VARIATION APPLICATION FORM Registration No: Product Name: Applicant’s Full Name Postal Address Contact Person’s Name Title: Telephone & Fax: Email: Website: Type of variation being sought (please indicate as applicable) Countries where variation is approved: Description of proposed variation Reasons for proposed variation I hereby submit an application for the concerned product to be varied in accordance with the proposal given above. I declare that — e there are no other changes than those identified; « all conditions for the change(s) concerned are fulfilled; and « the required documents as specified for the change(s) have been submitted. Name: Position: Signature: Date: Variation Response: cans FORM 8 (reg. 16,17, 18,19, 21, 22, 24 and 64) APPLICATION FOR PREMISES LICENCE: O Dispensary [ Standalone Pharmacy [[] Wholesaler [] Group Practice Pharmacy [] Trader [[] Manufacture medicines and cosmetics* (see also reverse page) [] Variation of Licence [] Renewal of License [J Re-submission Reasons for variation Medicines Schedules: [JWholesaler Schedule 1] 2] 30 4[] [JPharmacy Schedule 17] 2] 3] 4[] [Manufacturer Schedule 1] 2[] 30 4[J [ Trader Schedule 4 only Name of applicant (of person representing the company) Address of applicant My qualifications are (profession/education) The premises are located (address) Date: Signature: C.1119 ADDITIONAL INFORMATION NEEDED FOR APPLICATION TO MANUFACTURE MEDICINES 1. The following shall be the key personnel in the manufacturing plant: Name Qualification Experience Quality Control Pharmacist Production Pharmacist Quality Assurance Pharmacist Other 2. The following are products intended to be manufactured (attached list showing name of product, active ingredient, strength and dosage form, include formulations and manufacturing process): 3. The following are the equipment to be used (attach list showing the name, type and capacity of equipment): C.a120 FORM 9 (Reg. 16,17 18, 19, 20, 21, 22 and 64) PHARMACEUTICAL PREMISES LICENCE (specify type of licence) Pharmacy, Wholesaler, Manufacturer 1. Licencee 2. Type of premises licenced 5. Name of Business 6. Conditions of issue/renewal 8.The.... (specify type) should operate in compliance with the requirements of the Medicines and Related Substances Act, Regulations and applicable guidelines. For/Chief Executive Officer Date and Stamp.......coeeesseeeesaossnsosensense FORM 10 (reg. 26, 27, 28 and 65) APPLICATION FOR IMPORT PERMIT 1. Full name and address of importing company: Cai21 2. Licence number: Authorised Person: 3.Tel: Fax: Email: Type of business: (Specify Wholesale/Pharmaceutical Manufacturer/Other) hereby apply for permit to import medicines/cosmetics products into Botswana. 4. Full name and address of supplier in exporting country Tel: Fax: Email: 5. Authorised person: Tel: 6. Purpose for which the medicines/cosmetics are required: (Tick whichever is applicable) [1 Registration samples [] Patient exemption [] Bulk exemption [] Clinical trials [] Wholesaling and distribution; Other, (Specify) 7. Attached herewith the Proforma Invoice No Date 8. Method of transportation: road [ )/rail [ )/ airfreight [ ] 9. Port of entry 10. Expected date 11. Details of medicines to be imported as quoted in the PO: ca22 Item | Trade International | Strength | Total Name Name and Product No. | Name Non- Quantity | and Address of Registration of Proprietary Address | Manufacturer | Number Medicine | Name of (INN) of Supplier Medicine Declaration: I certify that the information provided in the application form and proforma invoice is true and correct. Date of application, Signature of Applicant. Stamp FOR OFFICIAL USE ONLY: C.a123 Received by: Signature: APPLICATION APPROVED [ ] /REJECTED [ ] If rejected issue Rejection Form RECOMMENDED, APPROVED, PERMIT No. ISSUED ON. (DATE) SIGNED For/Chief Excecutive Officer Botswana Medicines Regulatory Authority C.1124 FORM 11 (reg. 26, 28 and 65) IMPORT PERMIT FOR MEDICINES MEDICAL PRODUCTS OR COSMETICS (Issued in accordance with section 28 of the Medicines and Related Substances Act) Permit No: /, In accordance with the Medicines and Related Substances Act, the Medicines and Related Substances Regulations and applicable guidelines authority is hereby granted for importation of product(s) listed on the table. Name of registered importer. Tel No Address Purchase Order No Exporting Country. Tel No Exporter. Address Atrival expected by ship/air/motor vehicle, via Port of Entry Products to be imported: Cosmetics [] ~ Medicines [ Item | Trade International | Strength | Total Name | Name and Product No. |Name of | Non- Quantity | and Address of Registration Medicine | Proprietary Address | Manufacturer | Number Name (INN) of of medicine Supplier Estimated value of consignment (BOTSWANA Pula) Issue Date Expiry date. Name. Signature. For/ Chief Executive Officer Stamp FORM 12 (reg.29) SAMPLE SUBMISSION FORM A. Customer Details C.a12s Full Name of the Customer Physical address Postal address Telephone Number Fax Number Contact Person Designation E-mail address L Full Name of the Person submitting the sample Designation Signature Signature Date Method of submission of the sample ( tick [ ] mark where applicable) Hand delivery by client’s representative Courier Post Delivery Document details C. Sample Details Brand name Generic name Dosage form Composition (International Non-proprietary Name) Concentration/strength of each labelled ingredient C.1126 Batch number Manufacturing date Expiry date Name and address of the manufacturer Type of primary container and closure Sample size Source of the sample Size of the consignment/lot/batch from which the item is sampled Storage conditions required to be maintained Date of sampling Sampled by: Full Name Designation Reason for requesting analysis Other items submitted with the sample e.g. CRS (Certified reference materials, etc) D. Tick (¥/) on the table below: Test ) *Method 1. Physical characteristics 2. Uniformity of Mass / Weight variation 3. Identification 4. Assay 5. Dissolution 6. Content of uniformity 7. Related substances / Impurities C.a127 8. Optical rotation 9. Limit test 10. Disintegration 11. Friability 12. Hardness 13. Average weight 14. Moisture Content 15. Loss on Drying 16. Melting point 17.pH 18. Deliverable volume 19. Weight/ml 20. Fill volume Liquid 21. Fill volume injectability 22. Microbial enumeration tests 23. Tests for Specified Microorganisms 24. Antibiotic Assay 25. Antimicrobial Effectiveness test (Preservative Efficacy) 26. Sterility 27. Bacterial Endotoxin (LAL) 28. Burst Volume and Pressure for latex condoms caizs 29. Freedom From Holes 30. Package Integrity test 31. Lubricant quantity test 32. Width 33. Length 34. Thickness 35. Other Tests (please specify) *Method: Specify method to be used USP, BP, Ph Eur, Ph Int., Manufacturer’s Method or other Validated Methods, International Standard ISO 4074 Natural Latex Rubber Condoms — Requirements and Test Methods, WHO Male Latex Condom specifications. Where no precise instructions are given then the monograph used is from officially recognised current versions of Pharmacopoeias, United States Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (Ph.Eur) and International Pharmacopoeia (Ph.Int.), International standards by International Organization for Standardization (ISO), World Health Organization (WHO) Male Latex Condom specifications. E. Authorisation Full Name of the Authorising Officer Designation Email address Phone number Signature Date FOR LABORATORY USE ONLY Sample Identification Number Quantity of sample Integrity of Package C.a129 Label Storage /handling conditions at the arrival/submission of the sample Documents accompanying the sample Registration number of the sample Sample received by: Designation Signature Date Authorised by: Designation Signature Date Payment details: Receipt Amount No. paid Accountant Signature Date C.1130 FORM 13 (reg.32) APPLICATION FOR TRANSIT PERMIT (An application in terms of section 34 of the Medicines and Related Substances Act) Name of Importing Company: Tel No: Address: Purchase Order No: Country of final Destination: Exporting Country: Name of Supplier: Address of Supplier: Arrival expected by ship/air/motor vehicle, via Port of Entry and depart through Expected time of arrival Expected time of Departure. Details of medicines to be imported for transit: Item | Trade International | Strength | Total Name Name and Product No. |Name of | Non- Quantity | and Address of Registration Medicine | Proprietary Address | Manufacturer | Number Name (INN) of (Country of medicine Supplier of Final Dest.) Estimated value of consignment (BOTSWANA Pula) Cai31 Declaration: I certify that the information provided in the application form is true and correct. Date of application. Signature of Applicant. FOR OFFICIAL USE ONLY: Received by: — Signature: APPLICATION APPROVED [ J/REJECTED [ ] If rejected issue Rejection Form RECOMMENDED. APPROVED. PERMITNo. ISSUED ON. (DATE) SIGNED For/Chief Executive Officer C.132 FORM 14 (Reg. 32) TRANSIT PERMIT FOR MEDICINES AND COSMETICS (Issued in accordance with section 34 of the Medicines and Related Substances Act) Permit No: / In accordance with the Medicines and Related Substances Act, the Medicines and Related Substances Regulations and applicable guidelines authority is hereby granted for transit of the attached product(s) to: Name of Importer: Tel No: Address: Purchase Order No: Country of final Destination: Exporting Country:. Tel No: Exporter: Address: Arrival expected by ship/air/motor vehicle, via Port of Entry and depart via, Issue Date Expiry Date, Name Signature. For/ Chief Executive Officer Stamp C.a1133 Item | Trade International | Strength | Total Name Name and Product No. | Name of | Non- Quantity | and Address of | Registration Medicine | Proprietary Address | Manufacturer | Number Name (INN) of (Country of Medicine Supplier of Final Destination) C.a134 FORM 15 (reg. 50) APPLICATION FOR PERMIT TO IMPORT OR EXPORT HABIT FORMING MEDICINES AND/OR PSYCHOTROPIC SUBSTANCES (An application in terms of section 43 of the Medicines and Related Substances Act). In accordance with the Medicine and Related Substances Act, the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971. I (Name of Applicant) registered as (Qualification and Registration Number) of (Company and Address) hereby apply for permit to import or export the following habit-forming medicines and/ or (Tick where appropriate) psychotropic substances: Item | Approved name of | Quantityand | Purpose: Stock will last | No. | medicine/substance presentation of | medicinal, (number of days if | and strength medicine or manufacture, applicable) k substance Tesearch, scientific, other (specify) Total number of Items From (name and address of exporting firm): Route of supply (by): Port of entry (at): C.1135 Signature of applicant: Date: NOTES: To be accompanied by a completed purchase order from the importing company specifying the exporting company. C.1136 FORM 16 (reg. 50) IMPORT PERMIT FOR HABIT FORMING MEDICINES AND/OR PSYCHOTROPIC SUBSTANCES In accordance with Section 43 of the Medicines and Related Substances Act, the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971, authority is hereby granted to: Name of importing Company: Location: Postal address: to import or acquire the Habit-Forming Medicine and/or Psychotropic substances specified hereunder from: Name of exporting firm: Location: Postal address: Item | Approved name of Quantity and Approved name | Purpose: No medicine/substance presentation of | and quantity of strength Preparation controlled medicine/ substances as base in kilograms C.1137 Total number of items. It is a condition of this permit that medicines or substances imported or acquired hereunder shall not be used by the person to whom this permit is issued, otherwise than for or in accordance with the Medicines and Related Substances Act. Medicines/substances ordered on this authority must be consigned by registered mail/road/air/ sea* (Delete the inapplicable) Port of Entry. Permit Expiry Date. Director. Licensing and Inspection Signature Date and stamp C.1138 FORM 17 (reg. 50) ACKNOWLEDGEMENT RECEIPT OR DISPATCH (An acknowledgement in terms of section 43 of the Medicines and Related Substances Act) Receipt of Habit-Forming Medicines, importation of which was authorised under the following permit/s is acknowledged Importing Company Import Permit No, Date of issue Date Medicine | Quantity | Quantity of | Export | Exported | Discrepancy Received | Name Received |Substance | Permit | from as base in No grams Authorised Importer: Signature: Date: C.1139 FORM 18 (reg. 50) EXPORT PERMIT FOR HABIT FORMING MEDICINES AND/OR PSYCHOTROPIC SUBSTANCES In accordance with the Medicines and Related Substances Act, 2013, the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971, authority is hereby granted to: (name, location and postal address of exporting firm) Item | Approved name of Quantity and [ Approved name | Purpose: medicinal, No. | medicine/substance presentation of | and quantity of | manufacture, and strength medicine or controlled research, scientific substance medicine/ and others (specify) substance as base in kilograms Total Number of Items: It is a condition of this permit that medicines/substances exported hereunder shall not be used by the person to whom the permit is issued or to whom the medicines/substances are exported to otherwise than in accordance with the provisions of the Medicines and Related Substances Act or the Single Convention on Narcotic Drugs 1961 or the Convention of Psychotropic Substances, 1971. This authority expires on ...........ccccooveriiiiiiivieinn Medicines/Substances ordered on this authority must be consigned by Registered Mail/Road/ Air/Sea* (*Delete the inapplicable). The importation of these Medicines/Substances into the country of destination has been authorised by: Import Permit No. Route of supply (by) -—- Port of entry (at) - SR Signature and stamp C.1140 To be completed in quintuplicate 1. 2. Original to accompany consignment Duplicate to be endorsed in accordance with the requirements of the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971, and returned to the Authority, Gaborone. Triplicate to be certified by the exporter and returned to the Authority, as soon as possible after the date of despatch. Quadruplicate to be retained by the exporter for their records. Quintuplicate to be retained by the export authorising office. C.a141 FORM 19 APPLICATION FOR USE OF MEDICINES FOR CLINICAL TRIALS (reg. 55) [ APPLICATION TO CONDUCT A CLINICAL TRIAL CHECKLIST FOR APPLICATION TO CONDUCT A CLINICAL TRIAL The following are the requirements when submitting an application to conduct a clinical trial: Covering letter Cover sheet Checklist Completed Application form All documents and electronic copies to be submitted in duplicate Final version of the Clinical Trial Protocol Patient Information leaflet and Informed Consent form Investigators Brochure and/or Package Insert Signed investigator(s) CV(s) in required format Signed declaration by Principal investigator(s) Signed joint declaration by Sponsor/National Principal investigator Signed declaration by Co- or Sub-investigators Signed declaration by regional monitor and/or study coordinator Indemnity and Insurance Certificate and/or Proof of Malpractice insurance of trialist(s) Ethics Committee(s) approval or Copy of letter submitted to Ethics Committee(s) Disks to be submitted in Microsoft Word format iii. Financial declaration by Sponsor and Principal investigator c142 CLINICAL TRIAL APPLICATION SECTION 1 = CHECKLIST OF REQUIRED DOCUMENTATION To be completed by Applicants for all Clinical Trials APPLICATION TO CONDUCT A CLINICAL TRIAL COVER SHEET Study Title: Protocol No: Version No: Date of Protocol: Study Medicine: Ref number (if applicable): Ref number(s) of comparator medicine(s) (if applicable): Ref number(s) of concomitant medicine(s) (if applicable): Date(s) Regulatory approval of previous protocol(s): Sponsor: Applicant: Contact Person: Address: Telephone Number: Fax Number: Cell Number: E-mail address: FOR OFFICIAL USE Date original application received: Tracking No: Application fee paid: Signature: Date: C.1143 ACKNOWLEDGEMENT OF RECEIPT OF APPLICATION (Contact details to be completed by the applicant). Whole cover sheet to be faxed to applicant once details in block above are completed. Contact Details: Name: Fax No.: Receipt of new application is hereby acknowledged. Date: Signature (of recipient): Name: CHECKLIST [J COVERING LETTER [0 FULLY COMPLETED APPLICATION (SECTIONS 1-3) 0 PROTOCOL (INCLUDING RELEVANT QUESTIONNAIRES, ETC.) ] PATIENT INFORMATION LEAFLET(S) AND INFORMED CONSENT(S) 0 INVESTIGATORS BROCHURE AND / OR ALL PACKAGE INSERTEy™——~ [0 INVESTIGATOR’S CV(S) IN REQUIRED FORMAT [J SIGNED DECLARATION(S) BY INVESTIGATOR(S) ] CV(S) AND SIGNED DECLARATION(S) BY STUDY CO-ORDINATOR AND/OR MONITOR [0 CERTIFICATE(S) OF ANALYSIS [J INSURANCE CERTIFICATE AND IF NECESSARY: [J LETTER ENDORSING GENERIC INSURANCE CERTIFICATE [J ETHICS APPROVAL OR [J COPY OF LETTER APPLYING FOR ETHICS COMMITTEE APPROVAL [0 COPY/IES OF RECRUITMENT ADVERTISMENT(S) (IF APPLICABLE) O FINANCIAL DECLARATION (SPONSOR AND NATIONAL PT) C.1144 Electronic versions of the application form (Sections 1-3), the protocol, the investigator’s brochure and/or other relevant documents: [J LABELLED CD-ROM (MSWORD OR RICH TEXT FORMAT) List of files submitted on CD-ROM: NB: INCOMPLETE APPLICATIONS WILL NOT BE PROCESSED Declaration by applicant: ‘We, the undersigned have submitted all requested and required documentation, and have dis- closed all information which may influence the approval of this application. ‘We, the undersigned, hereby declare that all information contained in, or referenced by, this application is complete and accurate and is not false or misleading. ‘We, the undersigned, agree to ensure that if the above-said clinical trial is approved, it will be conducted according to the submitted protocol and all applicable legal, ethical and regulatory requirements. Applicant (local contact) Date National Principal Investigator/ Date National Co-coordinator/ Other (state designation) C.1145 SECTION 2 — ADMINISTRATIVE AND SUPPLEMENTARY DETAILS Part 1: CONTACT DETAILS (NAME/ADDRESS/TEL/CELL/FAX/E-MAIL) 11 12 13 14 15 16 17 18 Applicant: (as in Section 1) Sponsor: (as in Section 1) If no sponsor, person or organisation initiating, managing, and / or funding the clinical trial: Local Contact Person for correspondence: National Principal Investigator/Coordinator: (or equivalent person) International Principal Investigator: (if applicable) Regional Monitor: Study Coordinator: Part 2: DETAILS OF INVESTIGATIONAL PRODUCT(S) 2.1 22 23 24 25 26 27 28 Name(s) and details of investigational product(s) to be used in trial: [A summary of the chemistry and manufacturing data, formulation, composition, excipients and strength should be provided. Complete chemistry and manufacturing data should be included in the investigator’s brochure. Product(s) registration number(s) and date(s) of registration, if applicable, should be included] Name(s) and details (as above) of comparator product(s) and product registration number(s) and date(s) of registration if applicable: [As in 2.1, where applicable. Package inserts for registered comparator products should be included) . Name(s) and details (as above) of concomitant medication(s) including rescue medications which are required in the protocol, and product registration number(s) if applicable: [Asin 2.1, where applicable. Package inserts for registered products should be included) Estimated Quantity of Trial Material (each medicine detailed separately) for which exemption will be required: If any of the above nedicines are marketed locally, explain whether locally-sourced products will be used in the trial: Details of receipt of medicines from supplier, packaging, storage and shelf-life and dispensing: Date (or envisaged date) of application for registration of trial medication: [Provide an explanation if registration is not envisaged] Registration status of trial medication, for the indication to be tested in this trial, in other countries: C.1146 [i.e. Country: date registered/date applied for / date registration refused / date registration withdrawn by applicant / date registration cancelled by regulatory authority) [Attach as an appendix if necessary) Part 3: DETAILS OF TRIALIST(S) AND TRIAL SITE(S) 3.1 Details of Investigator(s): [Designation and title of principal investigators [ investigators) Include Name/Address/ Tel/Cell/Fax/E-Mail] 3.2 Current work-load of Investigator(s): [Number of studies currently undertaken by trialist(s) as principal and/or co- or sub-investigator, and the total number of patients represented by these studies. Time- commitments of researcher(s) in relation to clinical trial work and non-trial work] Recommended format for Investigator work-load: Investigator (Name and designation): Total number of current | Number Date studies (all stages) on specified date kY Total number of Number Date patients / participants for which responsible on specified date ESTIMATED TIME PER WEEK [168 hours denominator] | Hours % Clinical trials Clinical work (patient contact) Administrative work Organisation (Practice/ Clinical work university/employer) Administrative work Teaching Preparation /evaluation Lectures/tutorials ‘Writing up work for publication/presentation Reading/sourcing information (e.g. internet searches) Other (specify) C.1147 3.3 Details of Trial Site(s): [Name of site, physical address, contact details, contact person, etc] 3.4 Capacity of Trial Site(s): [Number of staff, names, qualifications, experience - including study coordinators, site facilities, emergency facilities, other relevant infrastructure) Part 4: PARTICIPANTS (TRIAL SUBJECTS) 4.1 Number of local participants: 4.2 Total number of participants worldwide: 4.2 Total enrollment in each local site/centre: [If competitive enrollment, state minimum and maximum number per site.] 4.3 Volunteer base from which local participants will be drawn: 44 Retrospective data indicating potential of each site to recruit required number of participants within envisaged duration of trial: [Attach as an appendix if necessary] Part 5: OTHER DETAILS 5.1 Provide an explanation if the trial is to be conducted locally only and not in the host country of the applicant / sponsor: 5.2 Estimated duration of trial: 5.3 Details of other Regulatory Authorities to which applications to conduct this trial have been submitted, but approval has not yet been granted. Include date(s) of application: 54 Details of other Regulatory Authorities which have approved this trial. Include date(s) of approval and number of sites per country: 5.5 Details of other Regulatory Authorities or Research Ethics Committees which have rejected this trial, if applicable, and provide reasons for the rejection: 56 Details of and reasons for this trial having been suspended at any stage by other Regulatory Authorities, if applicable: 5.7 Details if this trial is being undertaken in other SADC countries, any other country in Africa, or any country where there is no regulatory control of clinical trials: 58 Previous studies using this agent which have been approved by the Regulatory Authority: Approval number: Study title: Protocol number: Date of approval: Principal Investigator: Date(s) of progress report(s): Date of final report: 5.9 If any sub-studies are proposed as part of this protocol, indicate whether these will also ‘be conducted locally. If not, please explain: C.1148 Part 6: ETHICS 6.1 62 6.3 64 6.5 6.6 6.7 6.8 Research Ethics Committee responsible for each site, date of approval or date of application: [Attach copy of response(s) made by, andlor conditions required by Research ethics Committee(s) if available] State which Good Clinical Practice (GCP) guidelines are being followed: Details of capacity building component of the trial, if any: Details of GCP training of investigators, monitors, study co-coordinators in terms of conducting this trial: Detailed safety and monitoring plan for each site: [Attach as an appendix if necessary] Details of trial insurance: [e.g. insurer, policy holder, policy number, insurance cover, period of validity] Details of possible conflict of interest of any person(s)/organisation(s) who/which will be involved in the trial: Remuneration to be received by investigators, trial participants or others: [Indicate breakdown of costs to be covered, if applicable. Indicate compensation to be received by participants for travel and incidental expenses.] SECTION 3 — APPLICANT’S REPORT / PRESENTATION [Please use Black 12 point Arial Font, using MS Word for the electronic version] [The following section should be fully completed] 1. 2. Title: Protocol Number/Identification: Summary of the Rationale for study: [Provide a brief description of the rationale and relevance of the study, e.g. why should this trial be undertaken at all?] Summary of the Background Information: [Provide a brief statement on each of the following:] Disease/problem Local relevance (e.g. local epidemiology) Properties of trial medicine (e.g. pharmacological/chemical/pharmaceutical) Pre-clinical findings: (e.g. laboratory/animal /toxicity/mutagenicity, etc) Clinical findings (e.g. pharmacokinetics, safety, tolerability, efficacy) Objectives of study: [These should be clearly listed and justified) Study design: [These should be clearly described, and each component justified. Include study phase, use of placebo, dosages, randomisation, blinding, duration of treatment, etc.] Trial Participants: [Number of participants; ability to enroll required number within stated time, etc] 10. 11. 12 13. C.1149 Criteria for selection, eligibility and enrollment: [Inclusion and exclusion criteria listed and justified) Treatment modalities and regimens, medicine accountability: [These should be clearly explained and justified for all participant groupslarms, e.g. route of administration, dose, etc. Clearly describe medicine accountability] Outcome measurements/variables: [These should be clearly stated and justified] Adverse events: [Measures to monitor assess and report all adverse events should be clearly stated and Justified] Statistical measures: [Provide a clear and justified description of the following:] Determination of sample size Statistical method(s) and analysis of quantitative measures Statistical method(s) and analysis of qualitative measures Data processing (e.g. how, where, when, who) Interim analysis and stopping rules if applicable Ethical Issues: (The following additional information, in respect of the proposed trial, is required:) « Comment on which GCP guidelines are being followed = Comment on choice of investigators = Comment on need for, appropriateness of, and relevance of GCP training / updating / for staff involved in this trial Comment on capacity building element of trial Comment on resources of sites and sponsor Comment on monitors and monitoring plan Indicate how additional staff (monitors, pharmacists, nursing staff, etc.) will maintain patient confidentiality, follow the protocol, and abide by ethical and regulatory requirements * Comment on insurance and indemnity measures ¢ Comment on appropriateness of Patient Information Leaflet and Informed Consent * Comment on availability and completeness of separate Patient Information leaflets and Informed Consent forms for any proposed archiving of biological specimens for later research or for genetics research. = Comment on ethics of the publication policy * Comment on treatment and/or management of participants and their disease condition(s) after completion of trial « Comment on ethics committee capacity to monitor site and conduct of trial © Provide an explanation if minimum recommended compensation for participants is not being provided. C.1150 14. Other relevant information not included above: * Are references adequate and dates of references current? * Are there discrepancies between the protocol and investigator’s brochure or package inserts? Are there specific explanation(s) for these discrepancies? * Other comments on this trial. For office use: Reviewer's questions and concerns to be considered and/or forwarded to applicant: Reviewer’s recommendation: Declaration of conflict of interests by reviewer (if applicable): Signature of reviewer: Date: C.1151 FORM 20 (reg. 60) PART A: APPLICATION FOR REGISTRATION OF COSMETICS SECTION 1 ADMINISTRATIVE: 1.1 Product and Applicant details Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TOBEALLOCATED BY ATHORITY Pack size(s): Uses of the final product: Shelf Life/Expiry Date/Date of Minimum Durability/Period After Opening Name and physical address of Manufacturer (s): (Attach GMP certificates/Manufacturing licence/ISO certificate for manufacturing sites) Countries where product is marketed (artach authorisation letters) DECLARATION FORM DECLARATION BY THE APPLICANT 1. All information submitted in the application form for Registration of Cosmetic is accurate. 2. All uses for this product have been declared on the application form. 3. There are no hidden side effects, cautions, contra indications etc not declared in the application. 4. All promotional material shall be submitted to the Authority for approval before such material is used. 5. Any unwanted/harmful effects shall be reported to the Authority in writing with immediate effect. Name: Position: Signature: Date: Qualification: c1s2 COMPANY STAMP DECLARATION BY MANUFACTURER 1, the undersigned certify that all the information supplied in this form and all accompanying documentation is correct. 1. This product is not toxic to humans. 2. Anyunwanted/harmful effects shall be reported to the Authority in writing with immediate effect. 3. All promotional material shall be submitted to Authority for approval before such material is used. 4. There are no hidden side effects, cautions, contra indications etc not declared in the package insert/package label. Name: Position: Signature: Date: Qualification: Composition Tabulate the following Scheduleof: Active ingredients: Give approved name (if known), specify if active and give the usefulness in the final product. Inactive ingredients: Give reason for inclusion (if known), quantity per unit dose, specify if inactive and give the usefulness in the final product. Any other raw marterial used in manufacturing even if not present in final product e.g. water, alcohol. C.a1153 Ingredients Purpose for inclusion | Source of Ingredient | Uses for ingredient (Natural, Plant, Synthetic, e.g Ingredient A e.g. active e.g. helps with colds and flu e.g. Ingredient B e.g. inactive e.g. diluent Hazards Identification Route of Entry (Tick) Skin contact Skin absorption Eye contact Inhalation Ingestion First Aid Measures Skin Contact Eye Contact Inhalation Ingestion Safety and Toxicological Information Effects of acute exposure Effects of chronic exposure Irritability of the product Skin sensitisation Real-life Safety evaluation In-vitro testing Animal testing Human Testing Other C.1154 Provide sample of Label as per the guidelines Provide Certificate of analysis Provide Manufacturer’s flow chart PART B: APPLICATION FOR EXEMPTION FROM REGISTRATION OF COSMETICS SECTION 1 ADMINISTRATIVE: 1.2 Product and Applicant details Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TO BE ALLOCATED BY ATHORITY Pack size(s): | Total quantities: | Uses of the final product: Shelf Life/Expiry Date/Date of Minimum Durability/Period After Opening Name and physical address of Manufacturer (s): (Attach GMP certificates/ Manufacturing licence/ IO certificate for manufacturing sites) Countries where product is marketed (attach authorisation letters) SECTION 2: DECLARATION FORM DECLARATION BY THE APPLICANT 6. All information submitted in the application form for Registration of Cosmetic is accurate. 7. All uses for this product have been declared on the application form. 8. There are no hidden side effects, cautions, contra indications etc not declared in the application. 9. All promotional material shall be submitted to the Authority for approval before such material is used. 10. Any unwanted/harmful effects shall be reported to the Authority in writing with immediate effect. C.1155 Name: Position: Signature: Date: Qualification: COMPANY STAMP SECTION III: SUPPORTING DOCUMENTATION You are required to provide the following: 1. Sample of Label 2. Cetificate of analysis of one batch 3.180 22716/cGMP of manufacturer or equivalent C.1156 FORM 21 (reg. 66) APPLICATION FOR REGISTRATION OF COMPLEMENTARY MEDICINES SECTION 1: ADMINISTRATIVE: 1.1 Product and Applicant details Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TO BE ALLOCATED BY AUTHORITY Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TO BE ALLOCATED BY ATHORITY INN or Botanical Name (e.g. Vitamin D, Gingko Biloba etc): Presentation, Strength and dosage form: Pack size(s): Uses of the final product: Source (plant, chemical, animal etc) Countries where product is marketed (uttach‘ authorisation letters) Name and physical address of Manufacturer (s): (Attach GMP certificates/ Manufacturing licence/ IS0 certificate for manufacturing sites) Countries where product is marketed (artach authorisation letters) Type of application: New or Renewal C.1156 FORM 21 (reg. 66) APPLICATION FOR REGISTRATION OF COMPLEMENTARY MEDICINES SECTION 1: ADMINISTRATIVE: 1.1 Product and Applicant details Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TO BE ALLOCATED BY AUTHORITY Name, Address, Telephone and Fax numbers, and email address of Applicant: Proprietary name of product: Authority Application Number: TO BE ALLOCATED BY ATHORITY INN or Botanical Name (e.g. Vitamin D, Gingko Biloba etc): Presentation, Strength and dosage form: Pack size(s): Uses of the final product: Source (plant, chemical, animal etc) Countries where product is marketed (uttach‘ authorisation letters) Name and physical address of Manufacturer (s): (Attach GMP certificates/ Manufacturing licence/ IS0 certificate for manufacturing sites) Countries where product is marketed (artach authorisation letters) Type of application: New or Renewal C.1157 12 Declaration form DECLARATION BY THE APPLICANT 1. All information submitted in the application form for registration of complementary medicines is accurate. 2. All uses for this product have been declared on the application form. 3. There are no hidden side effects, cautions, contra indications etc not declared in the application. 4. All promotional material shall be submitted to the Authority for approval before such material is used. 5. Any unwanted/harmful effects shall be reported to the Auhority in writing with immediate effect. Name: Position: Signature: Date: Qualification: COMPANY STAMP C.1158 DECLARATION BY MANUFACTURER I, the undersigned certify that all the information supplied in this form and all accompanying documentation is correct. 1. This product is not toxic to humans. 2. Any unwanted/harmful effects shall be reported to the Authority in writing with immediate effect. 3. All promotional material shall be submitted to the Authority for approval before such material is used. 4. There are no hidden side effects, cautions, contra indications etc not declared in the package insert/package label. Name: Position: Signature: Date: Qualification: COMPANY STAMP PLEASE REFER TO THE COMPLEMENTARY MEDICINE GUIDELINE AS YOU FILL IN THIS FORM SECTION 2: COMPOSITION Tabulate the following Schedule of: * Active ingredients: Give approved name (if known); quantity per unit, specify if active and give the usefulness in the final product. + Inactive ingredients: Give reason for inclusion (if known), quantity per unit dose, specify if inactive and give the usefulness in the final product. * Any other raw marterial used in manufacturing even if not present in final product e.g. water, alcohol. Ingredients Unit (mg/ unit) | Purpose for inclusion | Uses for ingredient c.g Ingredient A e.g. active e.g. helps with colds and flu e.g. Ingredient B e.g. inactive e.g. diluent 8T 4 ca159 SECTION 3 PACKAGE INSERT Package insert shall bear the following: Approved name (as it appears on the label) Local or common name by which easily known Composition ‘What it is used for Direction of use Presentation (powder, mixture, cake etc) Contra-indications/Warning /Known symptoms of over-dosage Storage information and shelf life Manufacturer and or Applicant The actual copy of the package insert must be attached to the application form. SECTION 4: PHARMACEUTICAL DOCUMENTATION Give the listed details as part of your pharmaceutical documentation: 4.1 Comments on Specifications for Excipients For excipients obtained from sources that are at risk of transmitting Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE) agents (e.g., ruminant origin), a letter of attestation with supporting documentation shall be provided confirming that the material is not from a BSE/TSE affected country/area. 42 Specifications of the finished product e.g colour expected, consistencies in case of liquid medicines etc. Attach Certificates of Analysis for Final product. The CoA must include Control for Heavy Metals. 43 Stability Testing Data — Finished product Results of stability studies done on product must be submitted and the table of summary of the stability studies must be completed in the template below. Description of stability study details: Parameters Monitored: Container Closure system: Storage Conditions | Batch Number | Batch Size | Completed Time (°C, % RH) (in months) Summary and discussion of stability study results: Proposed storage conditions and shelf life: 44 Manufacturing procedures. To be presented in a flow diagram. 4.5 Container closure system Description of the material of container closure systems, including unit size or volume. C.1160 SECTION 5: SAFETY AND QUALITY ASSURANCE of Active Ingredients Provide information on the following where applicable 10.1 Botanical Authentication of Herbal Components 10.2 Safety and Toxicological information on the product 10.3 General qualitative and quantitative tests of Active Ingredients 104 Purity tests of the Active Ingredients SECTION 6: Evidence of Claim Provide proof of claim supported by: a. Clinical data (ie. including medical indications which are well-established in some countries and which have been validated by clinical trials, the results of which are recorded in the scientific literature); b. For uses described in pharmacopoeias and other well-recognized documents (i.e. medicinal uses that have been well-established in many countries and are included in official pharmacopoeias or official government monographs c. For uses described in traditional medicine (i.e. indications described in non-official pharmacopoeias and other forms of literature or purely traditional uses). SECTION 7: POST-MARKET SURVEILLANCE PLAN A satisfactory post-market surveillance plan must be provided in the application for registration of a complementary medicine. The plan must include but not limited to: adverse drug reaction form, product defect form. This requirement is applicable to herbal-based substances. Cai61 FORM 22 (reg. 66) APPLICATION FOR REGISTRATION OF COMPLEMENTARY MEDICINE [] Single Patient [[] Multiple Patients *Separate Forms to be filled for each patient Application Number: 1. Patient’s 2. Address: Age and Sex 3. Approved/generic name of medicine: 4. Brand name of medicine: 5. Name and address of Manufacturer: 6. Registration number in other countries and registered indications: 7. Dosage: 8. Pack size 9. Strength and formulation 10. Duration of treatment: 11. Medical history (a) Clinical condition C.1162 (b) Medicines previously used: (c) Outcome of treatment (in brief) with medicines mentioned in (b) above (d) Any additional information 12. Progress report (including adverse drug reactions if any) and request for continuation: 13. Name and physical address of medical practitioner: 14. Qualifications and Practice number C.1163 15. Signature 16. Date: 17. Pharmacy (name and address): a. Name of practitioner: b. Botswana Health Professions Council Registration Number: 18. Importer: a. Name of practitioner: b. Botswana Health Professions Council Registration Number: This form to be submitted to the patient’s pharmacy with the relevant prescription. To be completed for any subsequent applications after the initial 6 months approval. For Official Use: Date request received: Drug category: Investigational New Old Registration Appl. Submitted: Yes No Registration Appl. Number Registration Application Evaluated: Yes No If Yes, state the outcome: Pending Rejected If Rejected give reasons: Decision: Conditions, if any: Valid Until: Refusal Reasons C.1164 APPROVAL FOR REGISTRATION OF A COMPLEMENTARY MEDICINE Subject to due compliance with the requirement of the Medicines and Related Substances Act and Regulations thereto, the following complementary medicine is approved by the Authority to be marketed in Botswana and entered into the Complementary Medicine Register as follows: Registration Number: Name of Medicine: Active ingredient(s) approved name or volume of the complementary medicine: and quantity per dosage unit or per suitable mass Dosage Form: Strength: Name and address of Manufacturer(s): Package size(s): Indication(s): Special conditions: Date granted: Valid until: Authorisation: Signature: (Name and stamp): L C.1165 FORM 23 (reg. 60 and 61) APPROVAL FOR REGISTRATION OF A COSMETIC Subject to due compliance with the requirement of the Medicines and Related Substances Act and Regulations thereto, the following cosmetic is approved by the Authority to be marketed in Botswana and entered into the Cosmetics Register as follows: Registration Number: Name of Cosmetic: Name, Address, Telephone and Fax numbers, and email address of Applicant: Name and address of Manufacturer (s): Package size(s): Use of the final product: Shelf Life/Expiry Date/Date of Minimum Durability/Period After Opening Special conditions: Date granted: Valid until: Authorisation: Signature: (Name and stamp): C.1166 FORM 24 (reg.54) INSPECTION/ SEIZURE FORM Medicine found at the premises or ports of entry contrary to the law and confiscated/seized / quarantined in accordance with section 47(3) of the Medicines and Related Substances Act. Name of Premises/Port of entry: Date of inspections: Physical Address: Name of Person in Charge: Reg. No. Name of Persons found working in premises or accompanying consignment: 1. ID: 2. 1D: 35 ID:, List of Medicines/Cosmetics/Medical devices confiscated by inspectors Item Description (trade and proprietary | Batch no. Quantity | Expiry name where applicable) date C.1167 PARTICULARS I, the owner/in-charge of the above-named premises/ consignment, confirm that the drugs listed above have been confiscated/seized by inspectors. as indicated above. Signature of the Owner/In-charge. Name of Inspector. Signature of Inspector. Designation, Name of Inspector. Signature of Inspector. Designation Name of Witness Signature of Witness, Designation Name of Witness. Signature of Witness, Designation **Original copy for BOMRA *Duplicate by owner or person in charge C.1168 SCHEDULE 5 FEES HUMAN MEDICINES DESCRIPTION (BOTSWANA PULA) Screening (all products) 11600 Application for registration (New Chemical Entity) | = Without delivery system manufactured in country + With a delivery system 12000 * Biological & biosimilar 15000 e 15000 vaccine 15000 Application for registration (generic) 12 500 Generic with clinical data Evaluation of additional submitted clinical | 5000 data (pre-registration) Evaluation of request to re-schedule 1000 Package insert amendment 2000 Application for registration of B listed 10 000 product Registration of medicine partly manufactured | 7 500 in BOTSWANA Registration of medicine fully manufactured | 5 000 in BOTSWANA Expedited application (New Chemical 50 000 Entity) Expedited application (generic) 40 000 Expedited application of line extension 15000 Line extension (New Chemical Entity) 7500 Line extension(generic) 7 500 | Generic with clinical data Registration of an orphan medicine 1000 Renewal of registration 5000 Annual Fee (NEC) medicines fully 1000 C.1169 Annual Fee (NEC) imported 1000 Annual Fee (generic) medicines fully 500 manufactured in country Annual Fee(generic) imported 1000 Application for Variation (NEC & generic) * major 1500 * minor 1000 ° notification 500 Re-issue of certificates 100 Certificate of Pharmaceutical Product (all | 250 products) Registration of complementary medicines- a) Inthe case of a complementary medicine imported into Botswana as a finished product for— [ BOTSWANA PULA) Screening fee 500 Re-Screening fee 500 Complementary medicine 5000 Aline extension of complementary medicine | 1 000 Renewal of registration 4000 Annual fee 400 Variations 500 b) In the case of a complementary medicine imported into Botswana for packaging, relabelling or repackaging before being sold as— [ Complementary medicine [1750 | ¢) Full manufacturing in Botswana | Complementary medicine [ 1000 d) In the case of expedited review of — ‘ Complementary medicine ‘ 10 000 1 ca170 = GMP COMPLIANCE FEES (USD) SADC 3 500 REST OF AFRICA 5000 ASIA 6 500 REST OF THE WORLD 7 000 Desk review 3500 LICENSING FEES (reg. 17,18, 19, 20, 21 and 23) * MANUFACTURING * LOCAL MANUFACTURER (BOTSWANA | PULA) Application for licensing fee [Licensing fees — Non Sterile Full manufacturing 4250 Part Manufacturing 7500 ‘ Licensing fees — Sterile Full manufacturing 7500 Part Manufacturing 15 000 Clinical Trial site 7500 Re-inspection 2500 * OTHER PHARMACEUTICAL OPERATIONS (BOTSWANA PULA) DISTRIBUTOR/WHOLESALER 1250 PHARMACY/DISPENSARY/AGRIC SHOP /VET CLINIC 750 AUTHORISED PREMISES 750 RE-INSPECTION 750 EXPEDITED LICENCE APPLICATION 10 000 ¢ LICENSING RENEWAL can (BOTSWANA PULA) DISTRIBUTOR/WHOLESALER 1250 PHARMACY/DISPENSARY/AGRIC SHOP/VET CLINIC 750 AUTHORISED PREMISES » 750 RE -INSPECTION 750 * PERMITS (BOTSWANA 1 PULA) Application to import / export Narcotics, psychotropics & precursor | 100 per permit chemicals Application to vary the import or export permit of Narcotics, | 100 per permit psychotropics & precursor chemicals Application to import / export for all products excluding Narcotics, | 50 per permit psychotropics & precursor chemicals Importation fee for wholesale exempted products 0.25% of the value of the consignment Importation fee for all other products 0.15% of the value of the consignment Application for Transit Permit 100 per permit * IMPORTATION OF UNREGISTERED MEDICINES (BOTSWANA PULA) Individual prescription 00 ‘Wholesale dealers per medicine 350 Hospitals/vet clinic per medicine 50 Clinical trials per medicine 150 ca7n2 * APPLICATION TO CONDUCT A CLINICAL TRIAL OF A MEDICINE FUNDED (BOTSWANA PULA) BY LOCAL SPONSOR Application to conduct a clinical trial 15000 Application to conduct a Sub study 7500 Application to conduct an Operational 7500 research ; (BOTSWANA PULA) BY FOREIGN SPONSOR Phase I study 50 000 Phase 2 study 40 000 Phase 3/4 study 30 000 Bioequivalence/Bioavailability 5000 AMENDMENT APPLICATION Local sponsor 500 Foreign sponsor 2 000 ¢ APPLICATION FOR APPROVAL OF ADVERTISEMENT OR PROMOTIONAL MATERIAL (BOTSWANA PULA) Application for approval of advertisement or | Print media — 500 promotional material per product Electronic media — 1 000 Cc1173 * Cosmetics a) In the case of cosmetics imported into Botswana as finished product for— (BOTSWANA PULA) Screening fee 250 Re- Screening fee 250 Cosmetics (registration) 800 A line extension of cosmetics 100 Renewal of registration 200 Annual fee 100 Variations 200 Exemption 175 b) Inthe case of cosmetics imported into Botswana for packaging, relabelling or repackaging before being sold as — ’ Cosmetics ’ 400 ‘ ¢) Full manufacturing in Botswana | Cosmetics [250 ] d) In the case of expedited review of — [ Cosmetics [5000 ] C1174 LABORATORY ANALYSIS FEES NO. | TEST PARAMETERS (BOTSWANA PULA) 1 Physical characteristics 150 Uniformity of mass 2 . tablets 200 3 ° capsules 250 Identification 4 . UV VIS 650 5 + HPLC 4350 6 * FTRR 1050 7 . TLC 1750 8 . Colour reaction 800 Assay 9 B UV/VIS 1 800 10 |- HPLC 6250 1 Titration 2250 Dissolution 12 |- UV/VIS 1300 3 |e HPLC 7 200 Uniformity of dosage unit 14 | Content of uniformity (cu) by UV/VIS 3200 15 | Content of uniformity (cu) by HPLC 9000 Uniformity of dosage unit 16 | Weight variation 250 Related Substances / Impurities 17 |HPLC 12 100 18 |TLC 5550 19 | Optical rotation 300 20 | Limit test 3000 21 | Moisture Content 700 22 | Loss on drying 700 23 | Disintegration 500 24 | Friability 250 ca7s 25 | Hardness 150 26 | Average weight 150 27 | Melting point 500 28 |Ph 150 29 | Deliverable volume 250 30 | Weight/ml 250 31 | Fill volume liquid 250 32 | Fill volume injectability 250 Microbiological tests 33 | Microbial enumeration tests 2500 34 | Tests for Specified Microorganisms 3500 35 | Antibiotic Assay 2000 36 | Antimicrobial Effectiveness test (Preservative | 3 000 Efficacy) 37 | Sterility 2500 38 | Bacterial Endotoxin (LAL) 4 500 39 | Microbial enumeration tests 2500 40 | Tests for Specified Microorganisms 2 000 Male Latex Condom tests Freedom From Holes 41 |- Batch Size 35 001-150 000 1250 42 | Batch Size 150 001-500 000 1500 43 e Batch Size 500 000 and over 1750 Burst Volume and Pressure 44 | Batch Size 35 001-150 000 1750 45 | Bartch Size 150 001-500 000 2000 46 | Batch Size 500 000 and over 2250 47 | Lubricant quantity 1000 48 | Package Integrity test 250 49 | Width 200 50 |Length 200 51 | Thickness 250 52 | Certificate of Analysis 250 C.1176 NOTES - UV/VIS-means Ultraviolet Visible HPLC means High Performance Liquid Chromatography TLC means Thin Layer Chromatography FTIR means Fourier Transform Infrared LAL means Limulus Amebocyte Lysate . Registration of Veterinary medicines (BOTSWANA PULA) Screening (all products) 870 New Chemical Entity 4530 Vaccine 10 000 Generic 2360 Generic with clinical data 4530 Additional submitted data (pre-reg) 2400 Rescheduling 5400 Package insert amendment 3500 Premix 1000 Medicated feed 800 Line extension of New Chemical Entity 2360 Line extension of a generic 1275 Registration of vaccine fully manufactured in | 4 080 BOTSWANA Registration of veterinary medicine partly | 5 000 manufactured in BOTSWANA Registration of veterinary medicine fully | 2 000 manufactured in BOTSWANA Renewal of registration 50% of registration amount Annual Fee of vaccine fully manufactured in BOTSWANA 275 Annual Fee (NCE) medicine fully manufactured | 275 in BOTSWANA Annual Fee (NCE) imported 915 Annual Fee (generic) medicines fully manufac- | 130 tured in BOTSWANA Annual Fee (generic) imported 435 Expedited application (New Chemical Entity) 17060 Expedited application (Vaccine) 16 000 Expedited application (generic) 15 190 Expedited application of line extension 7 690 Application for Variation (NCE & generic) . major 1300 . minor 375 . notification 190 c.1177 C.1178 SCHEDULE 6 LIST OF GUIDELINES (As published in the Authority’s Website) Human: Botswana Quality Registration Guidelines (reg. 3, reg 67) Botswana Bioequivalence/Interchangeability Guidelines (reg. 3) Botswana Variation Guideline (reg. I and reg. 12) Botswana Renewal Guideline (reg. 5) SADC Registration Guidelines for Human Medicines (reg. 3) ‘WHO Prequalification Guidelines (reg. 3) WHO Biosimilars Guidelines (reg. 3) WHO Variation Guidelines (reg. 11 and reg. 12) EMA Variation Guidelines (reg. 11, reg. 12) . ICH Guidelines (reg. 3, reg. 11 and reg. 12) . US FDA Guidelines (reg. 3, reg. 11 and reg. 12) . EMA Scientific Guidelines for Human Medicines (reg. 3, reg. 11 and reg. 12) . EMA Scientific Guidelines on Biological Human Medicines (reg. 3 and reg. 11) . Guidelines for donation of unregistered medicines (reg. 10) . SADC Product Information Guidelines . Minister’s Guidelines on Dispensing and Prescribing of Medicines O o t W i l =] [ E R T R E R S ] Veterinary: 1. Veterinary Medicines Registration Guidelines Complementary Medicines 1. Botswana Complementary Medicines Registration guidelines (reg. 66) 2. Botswana Complementary Medicines Variation guidelines (reg. 66) 3. Botswana Complementary Medicines Renewal guidelines (reg. 66) Cosmetics 1. Botswana Cosmetics Registration guidelines (reg. 60, reg. 61 , 62, 63, 64and reg 65) Inspections and Licensing Guidelines 1. Guidelines for licensing Pharmacy operations (reg. 16,17, 18,19, 20, 24, 25,26, 54 and 55) 2. Guidelines for dispensaries in Surgeries and Institutional dispensaries (reg. 21, 22, 23, 24,54 and 55) 3. Guidelines for licensing medicines wholesale operation (reg. 19, 20, 24 25, 26, 54 and 55) WHO GMP Guidelines (reg. 17, 18, 24, 25, 26, 54 and 55) 'WHO GCP Inspections Guideline (reg. 55 and 57) Guideline for licensing Veterinary Medicinal Products Retailing (Veterinary Regulations) N cu” Import and export 1. Import and Export Guidelines (reg. 26, 27, 28, 29,50, 51, 52 and 53) Clinical Trials 1. Botswana Guidelines for Clinical Trials (reg. 55, 56, 57, 58 and 59) Pharmacovigilance 1. Pharmacovigilance Guidelines Advertising and Promotion 1. Advertising and Promotion Guidelines MADE this 6th day of December, 2019. DR. LEMOGANG KWAPE, Minister of Health and Weliness. @ ISSN 2311 — 956X O