Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019

GOVERNMENT OF ZAMBIA STATUTORY INSTRUMENT NO. 79 OF 2019 The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 ARRANGEMENT OF REGULATIONS PART I PRELIMINARY PROVISIONS Regulation 1. Title 2. Interpretation PART II MARKETINGAUTHORISATION OF MEDICINES 3. Application for marketing authorisation 4. Request for additional information 5. Grant of marketing authorisation 6. Rejection of application 7. Validity of marketing authorisation 8. Annual retention fee 9. Amendment of marketing authorisation 10. Surrender of marketing authorisation 11. Transfer of marketing authorisation 12. Suspension of marketing authorisation 13. Restoration of marketing authorisation 14. Revocation of marketing authorisation 15. Application for duplicate marketing authorisation 16. Renewal of marketing authorisation 17. Local responsible person 18. Register of marketing authorisations Copies of this Statutory Instrument can be obtained from the Government Printer, P.O. Box 30136, 10101 Lusaka. Price K64.00 each. 22ndNovember, 2019 Statutory Instruments 405 406 Statutory Instruments 22nd November, 2019 PART III CATEGORY OF DISTRIBUTION OF MEDICINE 19. Category of distribution of medicine 20. Re categorisation of Medicine PART IV LABELLING AND PACKAGING 21. Labelling and packaging requirements for medicine 22. Package insert for medicine 23. Revocation of statutory instrument No. 47 of 1993 SCHEDULE IN EXERCISE of the powers contained in sections 39 and 69 of the Medicines and Allied Substances Act, 2013, the following Regulations are made: PART I PRELIMINARY PROVISIONS 1. TheseRegulationsmay be cited as theMedicines andAllied Substances (MarketingAuthorisation of Medicines) Regulations, 2019. 2. In these Regulations, unless the context otherwise requires— “ active pharmaceutical ingredient ” means a substance intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body, and may be used as is or in the manufacture of a pharmaceutical dosage form; “ batch ” means a defined quantity of a starting material, packaging or medicinal product processed in a single process or series of processes and expected to be homogeneous; “ bio-availability ”means the rate and extent of availability of an active pharmaceutical ingredient from a dosage form as determined by its concentration time curve in the systemic circulation or by its excretion in urine; “ bio-equivalence data ” means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical alternatives becomes available at the site of drug action administered; “ commercial pack ” means the presentation of a finished medicinal product as it will be placed on market; “ composition ” means a tabulation of ingredients represented in formof proportion, degree of strength, quality and purity in which the ingredients are contained in a medicinal product; “ container ” means a bottle, jar, box, packet, sachet or other receptacle, not being a capsule or other article, in which the product is or is to be administered or consumed, and where the receptacle is or is to be contained in another receptacle, includes the former receptacle but not the latter receptacle; “ description of the product ” means a full visual description of themedicinal product, including colour, size, shape and other relevant features; 22ndNovember, 2019 Statutory Instruments 407 Title Interpretation “ dosage form ”means the form inwhich a medicinal product is presented, such as solution, suspension, elixir, eye drop, emulsion, ointment, suppository, tablet or capsule; “ excipient ” means a substance intended to be used as is or in the manufacture of a medicinal product for a specific function, but does not exert pharmacological activity; “ expiry date ” means the date given by the manufacturer and placed on the container of a medicinal product up to which the product is expected to remain within the given specifications if stored according to manufacturer’s instructions; “ finished pharmaceutical product ” means a product that has undergone all the stages of production, including packaging in its final container and labelling; “ formulation ” means the composition of a dosage form, including the characteristics of its raw materials and the operations required to process it; “ general sale medicine (GS) ” means a medicine which is intended to be supplied or sold without a prescription with or without the supervision of a registered pharmacist in a pharmacy or in any other licensed premises; “ general sale medicines veterinary (GSV) ” means veterinary medicine which is intended to be supplied by any retailer approved by theAuthority; “ herbal medicine ” includes a herb, herbal material, herbal preparation and finished herbal product that contains as an active ingredient, a part of a plant or other plant material or combination; “ holder ofmarketing authorisation ”means a person towhom amedicinal product has been issued a market authorisation and is responsible for all aspects of the medicinal product including quality, safety, efficacy and compliance with conditions of marketing authorisation; “ international non proprietary name ” means a unique name of a medicine that is globally recognised and is public property; “ labelling ”means affixing to or displaying on a container or package, the product information, ingredients and content of the product; “ local responsible person ” means a person residing in Zambia and appointed in accordance with regulation 17; “ marketing authorisation number ” means an identification number issued to a medicinal product granted marketing authorisation; 408 Statutory Instruments 22nd November, 2019 “ pharmacy medicine (P) ” means a medicine which is intended to be supplied or sold without a prescription but under the supervision of a registered pharmacist; “ pharmacy medicines veterinary (PV) ” means veterinary medicine which is intended to be supplied by a registered veterinary surgeon, pharmacist or veterinary para professional with or without a prescription; “ prescription onlymedicine (POM) ”means amedicinewhich is intended to be supplied, sold or dispensed only under a prescription issued by an authorised prescriber; “ prescription only medicine veterinary (POM V) ” means veterinary medicines which is intended to be supplied on prescription by a veterinary surgeon; “ proprietary name ” means the trade or brand name that is unique to a particular medicine and bywhich it is generally identified; “ quality standard ” means the specifications used to control the nature, strength, purity, composition, quantity or other characteristics of an ingredient or finished pharmaceutical product to ensure that it is fit for its purpose; “ shelf life ” means the period of time duringwhich an active pharmaceutical ingredient or medicinal product, if stored correctly, is expected to comply with the approved specification as determined by stability studies on a number of batches of the active pharmaceutical ingredient or medicinal product; “ stability ” means the ability of a medicine to retain its properties within approved specifications throughout its shelf life; “WHO type certificate of a pharmaceutical product ” means a certificate of the type defined in the World Health Organisation certification scheme on the quality of pharmaceutical products in international commerce; and “ veterinary medicine ” means a substance or mixture of substances manufactured, sold or presented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in an animal; (b) restoring, correcting or beneficial modification of organic or mental functions in an animal; and (c) an article intended for use as a component of any article specified in paragraphs (a) or (b), but does not include a medical device or its component, part or accessory 22ndNovember, 2019 Statutory Instruments 409 3. (1) A person who intends to place a medicine on the market shall apply to theAuthority for amarketing authorisation in Form I set out in the Schedule on payment of the fee set out in theMedicines andAllied Substances (Fees) Regulations, 2016. (2) The application referred to in sub-regulation (1) shall be accompanied by (a) at least two samples of the product in the smallest proposed commercial pack size; (b) a dossier which shall contain— (i) a summary and overview of quality, non clinical and clinical data; (ii) chemical, pharmaceutical and biological data relevant to the application; (iii) non clinical data, where applicable; and (iv) clinical or bio-equivalence data; (c) in the case of a herbal medicine, documentation relating to the quality assessment, safety assessment and efficacy assessment of the herbal medicine; and (d) any other information relating to the safety, quality and efficacy of the medicine in respect of which the application is made. (3) The Authority shall, on receipt of an application for a marketing authorisation, conduct an assessment to evaluate the safety, quality and efficacy of the medicine in respect of which the application is made. 4. TheAuthoritymay request an applicant to submit additional information or samples in relation to an application in Form II set out in the Schedule on payment of a prescribed fee. 5. TheAuthority shall grant amarketing authorisation in Form III set out in the Schedule, if the Authority is satisfied— (a)with the information submitted on the safety, quality and efficacy of the medicine; (b)with the labeling and packaging of the medicine; (c) with the indications, dosage form, dosage and route of administration of the medicine; and (d) that the medicine is manufactured in compliance with the requirements of current good manufacturing practices as recommended by the World Health Organisation or any other recognisedentity. 410 Statutory Instruments 22nd November, 2019 Application for marketing authorisation S.I. No. 38 of 2016 Request for additional information Grant of marketing authorisation 6. (1) The Authority shall reject an applicationfor marketing authorisation if— (a) the applicant fails to meet the requirements for the issue of the marketing authorisation; (b) there is insufficient data to support the safety, quality and efficacy of the product; (c) in the case of a local manufacturer, the pharmaceutical licence to manufacture is suspended or revoked; (d) an ingredient contained in the medicine is banned or not recommended for any other reason as determined by theAuthority; (e) the medicine in respect of which the application is made is considered unregistrable based on treatment guidelines or disease patterns in the Republic; and (f) the applicant provides false information in the application. (2) The Authority shall, where it refuses a marketing authorisation under sub regulation (1), inform the applicant in Form IV set out in the Schedule. 7. Amarketing authorisation is valid for five years, subject to the terms and conditions of the market authorisation. 8. (1) The holder of a marketing authorisation shall pay an annual retention fee to the Authority in respect of the following year at the end of every year during which the authorisation is valid, except the year when the authorisation is granted. (2) The annual retention fee for the following year shall be— (a) effective from 1st January of the year following the grant of the marketing authorisation; and (b) paid to the Authority by 31st December of each year. (3) Where a marketing authorisation is granted during the last quarter of a calendar year, the holder of themarketing authorisation shall be exempted from paying the annual retention fee for the following year. (4) Where the holder of a marketing authorisation fails to pay the annual retention fee by 31st December for a particular product (a) themarketing authorisation issued in respect of that product shall be suspended; (b) the Authority shall not authorise the importation of the product; 22ndNovember, 2019 Statutory Instruments 411 Rejection of application Validity of marketing authorisation Annual retention fee (c) in case of locally manufactured products, the Authority shall not authorise the continued manufacture of the product; and (d) themarketing authorisation in respect of the product may be revoked by the Authority. 9. (1) A personwhowishes to amend amarketing authorisation shall apply to the Authority in Form V set out in the Schedule on payment of a prescribed fee. (2) The Authority shall, within ninety days from the date of receipt of an application for the amendment of a marketing authorisation, consider the application and notify the holder of the marketing authorisation of its decision. 10. Where the holder of a marketing authorisation decides not to continue with the business to which the marketing authorisation relates, the holder shall notify the Authority and surrender the marketing authorisation. 11. (1) Amarketing authorisation is solely for use by the holder of the marketing authorisation and is not transferable to any other person without the prior approval of theAuthority. (2) A person who wishes to transfer a marketing authorisation shall apply to the Authority in FormVI set out in the Schedule on payment of a prescribed fee. (3) TheAuthority shall,within sixtydays fromthedate of receipt of the application for the transfer of the marketing authorisation, notify the applicant of the decision of the Authority in respect of the application. (4) Where the Authority approves the transfer of a marketing authorisation, it shall issue a new marketing authorisation to the transferee. 12. (1) The Authority may suspend a marketing authorisation if— (a) there are concerns regarding the safety, quality or efficacy of the medicine to which it relates; (b) the holder of the marketing authorisation fails to pay the annual retention fee; (c) the holder of the marketing authorisation fails to comply with any termor conditionof themarketing authorisation; or (d) the medicine in respect of which the marketing authorisation was issued poses a risk or threat to public health. 412 Statutory Instruments 22nd November, 2019 Amendment of marketing authorisation Surrender of marketing authorisation Transfer of marketing authorisation Suspension of marketing authorisation (2) The Authority shall, before suspending a marketing authorisation, give notice to the holder of amarketing authorisation of the intention to suspend the marketing authorisation in FormVII set out in the Schedule. (3) The Authority shall, if the holder of a marketing authorisation fails to remedy the defects within the period specified by theAuthority in the notice issued in sub-regulation (2), suspend the marketing authorisation and notify the holder of the marketing authorisation in FormVIII set out in the Schedule. (4) The holder of a marketing authorisation shall, during the period of suspension of a marketing authorisation, quarantine the affected medicine as directed by theAuthority at the holder of the marketing authorisation’s cost. 13. (1) The Authority may restore a suspended marketing authorisation if theAuthority is satisfied that corrective measures have been taken by the holder of the marketing authorisation as directed by theAuthority. (2) The Authority shall issue the notice of restoration of a suspended marketing authorisation in Form IX set out in the Schedule. 14. (1) The Authority may revoke a marketing authorisation if the holder— (a) contravenes the terms and conditions of the marketing authorisation; (b) manufactures medicine that does not comply with the quality standard for that medicine; (c) fails to complywith current goodmanufacturing practices; (d) fails to comply with the terms and conditions for the suspension under regulation 12; or (e) obtained the authorisation on the basis of fraud, negligence or misrepresentation. (2) The Authority shall, before revoking a marketing authorisation, give notice to the holder of themarketing authorisation of the intention to revoke the marketing authorisation in Form X set out in the Schedule. (3) The Authority shall, where the holder of a marketing authorisation fails to remedy the breaches specified in the notice within the period specified by theAuthority, revoke the marketing authorisation andnotify the holder inFormXI set out in theSchedule. 22ndNovember, 2019 Statutory Instruments 413 Restoration of marketing authorisation Revocation of marketing authorisation (4) The holder of a marketing authorisation shall, on the revocation of the marketing authorisation, recall and quarantine or dispose of the medicine to which the revocation relates as directed by theAuthority at the holder of themarketing authorisation’s cost. 15. (1) A holder of amarketing authorisation whosemarketing authorisation is lost, defaced or damagedmay apply for a duplicate marketing authorisation in Form XII set out in the Schedule on payment of a prescribed fee. (2) TheAuthority shall, within fourteen days of receipt of an application under subregulation (1), issue a duplicate marketing authorisation to the applicant. 16. (1) A personwhowishes to renew amarketing authorisation shall apply to the Authority at least one hundred and eighty days before the expiry date of the marketing authorisation in FormXIII set out in the Schedule on payment of a prescribed fee. (2) An application for the renewal of amarketing authorisation shall be accompanied by— (a) a consolidated report of any amendments made to the marketing authorisation, including adverse drug reaction reports and safety updates; and (b) the product quality review report. (3) TheAuthority shall renew amarketing authorisation if the holder has compliedwith the terms and conditions of themarketing authorisation. (4) TheAuthority shall, where theAuthority refuses to renew amarketing authorisation, notify the applicant in Form IV set out in the Schedule. (5) A holder of a marketing authorisation whose application for renewal has been rejected may submit an application for a marketing authorisation in accordance with regulation 3. 17. (1) Subject to the Companies Act, 2017 and any other relevant written law, a foreign based applicant shall appoint a local responsible person to— (a) submit an application, document and sample of products to the Authority on behalf of the applicant or holder of the marketing authorisation; and (b) receive the decision of the Authority relating to the application on behalf of the applicant or holder of the marketing authorisation. 414 Statutory Instruments 22nd November, 2019 Application for duplicate marketing authorisation Renewal of marketing authorisation Local responsible person Act No. 10 of 2017 (2) Subject to sub regulation (1), where the application is granted, the holder of the marketing authorisation shall ensure that a local responsible person implements the pharmacovigilance plan on behalf of the foreign holder of the marketing authorisation. 18. (1) The Authority shall, where it grants a marketing authorisation, specify the appropriate category of distribution of the medicine which relates to the marketing authorisation. (2) A personmay sell or supplymedicine for human use under the following categories: (a) prescription onlymedicine; (b) pharmacy medicine; and (c) general sale medicine. (3) A personmay sell or supply veterinary medicine under the following categories: (a) prescription onlymedicine - veterinary; (b) pharmacy medicine veterinary; and (c) general sale medicine veterinary. 19. TheAuthority shall take into consideration the safety profile of the medicine when determining the category of distribution and may move certain medicines from one category to another. 20. (1) A holder of a marketing authorisation shall label the primary package or container of a medicine to show— (a) the name and dosage form of the medicine; (b) the name and quantity of active pharmaceutical ingredient or in case of a herbal medicine, a botanical, english or other name, and the quantity of each ingredient; (c) the quantity or volume of the medicine per unit pack; (d) the indications and directions for use, including the target species in case of veterinary medicine; (e) the storage instructions; (f) the expiry date; (g) the batch number; (h) the marketing authorisation number; (i) the name and address of the holder of the marketing authorisation; 22ndNovember, 2019 Statutory Instruments 415 Categories of distribution of medicines Re categorisation ofmedicine Labelling and packaging requirements for medicine (j)suitable coding; (k) the name of the manufacturer, if different from the holder of the marketing authorisation; (l) the category of distribution; (m) a precautionary statement “Keep away from the reach of children”; (n) in case of a veterinary medicine, a statement “For Veterinary Use Only”; and (o) any other information required by the Authority for purposes of the Act. (2) Where the space on a primary container of medicine is not adequate to accommodate the information specified in sub regulation (1), the holder of a marketing authorisation shall label the primary container to indicate the— (a) name and dosage form of the medicine; (b) quantity or volume of the medicine per unit pack; (c) expiry date; (d) name and quantity of active ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient; (e)marketing authorisation number; (f) storage instructions; and (g) batch number, except that all the particulars specified under sub regulation (1) shall be set out on the secondary package. (3) A holder of a marketing authorisation shall, where the container of medicine is unable to accommodate the information under sub-regulation (2), indicate the details of labelling requirements for each type of container as may be determined by the Authority. (4) This regulation does not apply to medicine that is re packaged for dispensing. (5) Despite the other provisions of this regulation, theAuthority may waive the labeling requirements, as appropriate, to ensure the safety, quality and efficacy of the medicine. 416 Statutory Instruments 22nd November, 2019 21. An original container of a medicine shall be accompanied by a package insert printed in legible letters in English stating the (a) name and dosage form of the medicine; (b) name and quantity of active pharmaceutical ingredient, or in case of a herbal medicine, a botanical, English or other name, and the quantity of each ingredient; (c) indications, in case of a veterinary medicine, specifying target species; (d) dosage and directions for use, in case of a veterinary medicine, specific to each target species; (e) contra-indications; (f) side effects; (g) drug interactions; (h) precautions and warnings, including withdrawal periods, in case of a veterinarymedicine used in food producing animals; (i) symptoms, signs, treatment andmanagement of overdose; (j) presentation of the medicine; (k) description of packaging and container closure system; (l) storage instructions; (m) shelf life; (n) name and address of the holder of the marketing authorisation; and (o) name of the manufacturer, if different from the holder of themarketing authorisation. 22. Aholder of amarketing authorisation shall provide a patient information leaflet for general sale medicine and medicine used in chronic conditions. 23. The Pharmacy and Poisons (Medicines) (Importation, Manufacture and Sale) Order, 1993, is revoked. 22ndNovember, 2019 Statutory Instruments 417 Package insert for medicine Patient information leaflet Revocation of S.I. No. 47 of 1993 418 Statutory Instruments 22nd November, 2019 SCHEDULE (Regulations 3, 4, 5, 6, 9, 11, 12, 13, 14, 15, 16 and 18) PRESCRIBED FORMS FORM I (Regulations 3 (1) and 14(5)) (To be completed in triplicate) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 APPLICATION FOR A MARKETING AUTHORISATION Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PART I PARTICULARS OF APPLICANT A. PARTICULARS OF COMPANY 1. (a) Name of business entity (b) Tax Payer Identification Number (where applicable) 2. Type of business entity 3. Business premises (a) Plot No: (b) Street: (c) Telephone No: (d) Fax No: (e)Mobile No: (f) Email address (g) Postal address (h) Town (i) District (j) Province (k) Country B CONTACT PERSON (a) Name (b) Designation (c) Physical address (d) Postal address (e) Phone (f) fax (g) Email address C LOCAL RESPONSIBLE PERSON (Applicable to foreign based applicants) (a) Name (b) Designation (c) Physical address (d) Postal address 22ndNovember, 2019 Statutory Instruments 419 ( ) (e) Phone (f) fax (g) Email address 7. Container, closure and administration system 8. Proposed indication (specify target species in case of veterinary medicine) 9. Package size 10. Shelf life (months) 11. Storage conditions/instructions 12. Proposed category of distribution 13. Marketing authorisation status in other countries PART III PARTICULARS OF MANUFACTURER Name, address and responsibility (e.g. fabrication, packaging, labelling, testing etc.) of each manufacturer, including contractors and each proposed production site or facility involved in manufacturing and testing of the product: 1. Name: 2. Physical address (include block(s)/unit(s) if applicable 3 Responsibility: If more than one site is involved (e.g. manufacturing of dosage form, primary packaging, release etc.), clearly identify the site for each stage. include copies of the latest GMP certificate for manufacturer and packers or a copy of the appropriate manufacturing licence PART II PARTICULARS OF THE PRODUCT 1. Name of the medicine: 2. International non-proprietary names of the active pharmaceutical ingredient, including form (salt, hydrate, polymorph) and strength (in case of a herbal medicine, specify the botanical, English or any other name and the quantities of each ingredient) 3. ATC code 4. Dosage form 5. Route of administration 6. Name and site address of source of the active raw material (in case of herbal medicine) 420 Statutory Instruments 22nd November, 2019 PART IV COMPOSITION List of all components of the finished pharmaceutical product and their amounts on a per unit, batch and percentage basis including individual components of mixtures prepared in-house (e.g. coatings) and overages, if any Ingredients and quality standard (in case of a herbal medicine, specify the botanical, english or any other name Function (reason for inclusion) Strength (label claim) Quantity per unit dosage form (e.g. mg/tablet) % per unit dosage form Quantity per batch % per batch <complete with appropriate title e.g. core tablet, contents of capsule, powder for injection> Subtotal 1 <complete with appropriate title e.g. film-coating> Subtotal 2 Total 8. PART V: TYPE OF APPLICATION Indicate the type of medicine, the type of data included as proof of efficacy, and the review procedure Human Medicine NCE Data as proof of efficacy: Chemical Multisource Pre-clinical Biological Biosimilar Clinical Veterinary Medicine: Biostudy Chemical BCS biowaiver Biological Bibliography Herbal: Review Procedure Routine Abridged Fast Track (Expedited) DECLARATION AND SIGNATURE: I declare that all the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I understand that submission of false information shall render the application void and that if approval is granted, the market authorisation may be revoked. Particulars of the Person signing on behalf of the Applicant …………………………………………………… ………………………………………………………….. Name Designation ……………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: ………………………………………………………………………………………………..….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………………………………….…….….…………... Application complete (Proceed for evaluation): ………………………………………………………..…………..….. Application incomplete (refer to applicant for additional information): ………………………………………………….…………..…………………………………………………………… OFFICIAL STAMP 22ndNovember, 2019 Statutory Instruments 421 FORM II (Regulations 4 (1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 REQUESTFORADDITIONALINFORMATION Application No:…………………………………… To: ……………………………………………………………………………………….....…. Address: ………………………………………………………………….…………….....…….. You are requested to furnish, within…………………….. days of this Notice, the following information or documents in respect of your application for………………………………………. (a) ………………………………………………………………………………...…….. (b) ……………………………………………………………………………………….. (c) …………………………………………………………………………………………. (d) ……………………………………………………………………………………….. If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. Dated this………………………… day of …………………………….., 20……………. ……………….……………………. Director-General OFFICIAL STAMP 422 Statutory Instruments 22nd November, 2019 FORM III (Regulations 5 (1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 MARKETINGAUTHORISATION Marketing Authorisation No. MA ……/…… Name ofMedicine:………………………………………………………………………………… Dosage form:…………………………………………………………………………………… Pack size Shelf life (Months) Category of distribution ……………………...…. ……………………………. ……………………....….. ……………………....… …………………………… …………………..……… ……………………...…. …………………………… …………………….......... Name of active ingredient Quality standards Strength ………………………… ………………………….... ………………………….. ………………………… ……………………………. ………………………….. …………………..…….. ………………………...….. ………………………….. Name and address of holder of marketing authorisation: ………………………………………………………….....................................................……… ……………………………………………………………………................................................ ……………………………………………………………………………………………………………………………………………………………………… Valid until ………………………………………………………………………….………………. The terms and conditions of the marketing authorisation are attached herewith. ……………….………………… …………………....…… Director-General Date of issue SEAL 22ndNovember, 2019 Statutory Instruments 423 TERMS AND CONDITIONS OF THE MARKETING AUTHORISATION The holder of a marketing authorisation shall— (a) ensure that the medicine— (i) is manufactured in compliance with the current GoodManufacturing Practices (cGMP) as recommended by the World Health Organisation (WHO) or any other recognised entity; (ii) conforms with the quality standards, safety and efficacy and is suitable for the purpose for which it is intended; (iii) conforms to the summary of product characteristics; (b) ensure compliance with good distribution practices and that the medicine is supplied in accordance with the requirements applicable to the categories of distribution specified on thismarketing authorisation andwith regulations on labeling ofmedicine; (c) maintain an appropriate pharmacovigilance system for monitoring, detecting and reporting adverse drug reactions and the performance of products granted marketing authorisation; (d) pay to the Authority the annual retention fees, sample analysis fees and other fees as prescribed; (e) ensure that the marketing authorisation is not transferred without the written approval of the Authority; (f) for a foreign-based holder ofmarketing authorisation, appoint a local responsible person; (g) notify the Authority of any change that requires an amendment to a marketing authorisation; (h) when necessary or as directed by the Authority, withdraw any product from the market that is injurious to, or is likely to be injurious to public health; and (i) provide additional information or product samplewhen required to do so by theAuthority for purposes of the Act. NOTE: Non-compliance with any of the terms or conditions of a marketing authorisation will result in suspension or revocation of the marketing authorisation. 424 Statutory Instruments 22nd November, 2019 NOTICEOFREJECTIONOFAPPLICATIONFORAMARKETING AUTHORISATION/ RENEWALOFMARKETINGAUTHORISATION Application No.:……………………………… To (1)……………………………...............…………………............................. ……………………………………………………………………………………………………………… IN THE MATTER OF (2) ……………………………….................... you are notified that your application for (3) a marketing authorisation/renewal of a marketing authorisation has been rejected by the Authority on the following grounds: (a)……………...........................……………………………………….......…… (b)……………………………………………….....................………..…………… (c)………………………………………………………....................…..………………… (d)………………………………………………………………….....................……… . Dated this ……………………day of ………............……… 20……………... .......................................................... Director-General FORM IV (Regulations 6 (2) and 16 (4 ) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 OFFICIAL STAMP (1) Here insert the full names and address of the applicant (2) Here insert the reference No. of the application and the product name (3) Here insert the applicable application 22ndNovember, 2019 Statutory Instruments 425 FORMV (Regulation 9(1)) (To be completed in triplicate) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 APPLICATION FOR AMENDMENT OFMARKETING AUTHORISATION Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PART 1 PARTICULARS OF APPLICANT A BUSINESS APPLICANT 1. (a)Name of applicant (b) Tax Payer Identification Number (where applicable) 2. Type of entity 3. Business premises (a) Plot No: (b) Street: (c) Postal address (d) Telephone No: (e) Fax No: (f) Mobile No: (g) Email address (h) Town (i) District (j) Province (k) Country B CONTACT PERSON (a) Name (b) Physical address (c) Postal address (d) Phone (e) fax (f) Email address C LOCAL RESPONSIBLE PERSON (a) Name (b) Designation (c) Phone (d) Fax (e) Email address 426 Statutory Instruments 22nd November, 2019 PART II PARTICULARS OF PRODUCT (a) name of the product (b) marketing authorization No. (c) strength(s) (d) pack size(s) (a) dosage form PART III TYPE OF AMENDMENT 4. PARTICULARS OF AMENDMENT DESCRIPTION OF AMENDMENT(S) 1. 2. 3. 5. EXISTING PROPOSED AMENDMENT REASONS FOR AMENDMENT 6. Attachment Relevant documents relating to proposed amendment as required by the Authority DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person signing on behalf of the Applicant ……………………………………………………… ………………………………………………………….. Name Designation ……………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: ……………………………………………………………………………………...………………….. Application Number: …………………………………………………………………….……………………………….….. Payments Receipt Number: ………………………………………………………….….……………………………..……. Application accepted (Proceed for inspection): ………………………………….……………………………………….…. Application rejected (Notify applicant) ………………………………………….………………………………………….. ………………………………………………………………….…………………………………………………….……… OFFICIAL STAMP 22ndNovember, 2019 Statutory Instruments 427 FORM VI (Regulation 11(2)) (To be completed in triplicate) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 APPLICATION FOR TRANSFER OF MARKETING AUTHORISATION Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided PART I PARTICULARS OF APPLICANT A DETAILS OF CURRENT HOLDER OF MARKETING AUTHORISATION 1. (a) Name of applicant (b) TPIN 2. Type of entity 3. Business premises (a) Plot No: (b) Street: (c) Telephone No: (d) Fax No: (e)Mobile No: (f) Email address (g) Postal address (h) Town (i) District (j) Province (k) Country B CONTACT PERSON (a) Name (b) Physical address (c) Postal address (d) Phone (e) fax (f) Email address C LOCAL RESPONSIBLE PERSON (a) Name (b) Designation (c) Phone (d) Fax (e) Email address 428 Statutory Instruments 22nd November, 2019 PART II PARTICULARS OF TRANSFEREE 1. (a) Name of applicant (b) TPIN 2. Type of entity 3. Business premises (a) Plot No: (b) Street: (c) Postal address (d) Telephone No: (e) Fax No: (f) Mobile No: (g) Email address (h) Town (i) District (j) Province B INDIVIDUAL TRANSFEREE (a) Name (b) Physical address (c) Postal address (d) Phone (e) fax (f) Email address C LOCAL RESPONSIBLE PERSON OF TRANSFEREE (a) Name (b) Designation (c) Phone (d) Fax (e) Email address PART III PARTICULARS OF THEMEDICINE 1. Name of medicine 2. Marketing authorisation number 3. Strength 4. Pack size(s) 5. Dosage form 6. Proprietary name 4. ATTACHMENTS Contract of sale or acquisition of business between the holder of market authorisation and the proposed transferee Copy of original market authorisation DECLARATION AND SIGNATURE I declare that all the information I have stated in this application is correct and truthful to the best of my knowledge and belief. I understand that submission of false information shall render the application void and that if the market authorisation is granted, it shall be revoked. Particulars of the Person signing on behalf of the Applicant …………………………………………………… …………………………………….…………………… Name Designation ……………………………………………..….….. ……………………………………………………….… Signature Date FOR OFFICIAL USE ONLY Date of Submission: ……………………………………………………………………..………………….………….. Application Number: ……………………………………………………………………………………….……….….. Payments Receipt Number: ……………………………………………….…….….…………………………..………. Application accepted (Proceed for inspection): ……………………………………………………..……..……..…….. Application rejected (Notify applicant): ………………………….……………………..………………………….…… ………………………………………………………………….……………………………………………….……… OFFICIAL STAMP 22ndNovember, 2019 Statutory Instruments 429 FORMVII (Regulation 12(2)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 NOTICE OF INTENTION TO SUSPENDAMARKETING AUTHORISATION To (1)…………………………...............…………………............................. ……………………………………………………………………………………………………………… IN THE MATTER OF (2)..................................................you are hereby notified that the Authority intends to suspend your marketing authorisation on the following grounds: (a)……………...........................……………………………………….......…… (b)……………………………………………….....................………..…………… (c)………………………………………………………....................…..………………… (d)………………………………………………………………….....................……… Accordingly, you are requested to show causewhy your marketing authorisation should not be suspended and to take action to remedy the breaches set out in paragraphs ................... (above) within (3)................days of receiving this notice. Failure to remedy the said breaches shall result in the suspension of your marketing authorisation. Dated this …………………day of ………............……… 20……………... .......................................................... Director-General OFFICIAL STAMP (1) Here insert name of holder of marketing authorisation (2) Here insert of medicine and marketing authorisation number (3) Here insert number of days 430 Statutory Instruments 22nd November, 2019 FORMVIII (Regulation 12(3)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 NOTICE OF SUSPENSION OFMARKETINGAUTHORISATION To (1)…………………………...............…………………............................. ……………………………………………………………………………………………………………… IN THE MATTER OF (2) ........................................................ you are hereby notified that your marketing authorisation has been suspended for (3) ……………………..…….. on the following grounds: (a)……………...........................……………………………………….......…… (b)……………………………………………….....................………..…………… (c)………………………………………………………....................…..………………… Accordingly, you are requested to take action to remedy the breaches set out in paragraphs ................................................................ (above) within (4) ................................ days of receiving this Notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. Dated this …………………day of ………............……… 20……………... .......................................................... Director-General OFFICIAL STAMP (1) Here insert name of holder of marketing authorisation (2) Here insert name of medicine and marketing authorisation number (3) Here insert period of suspension (3) Here insert period of days 22ndNovember, 2019 Statutory Instruments 431 FORM IX (Regulation 13(2)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 NOTICEOFRESTORATIONOFMARKETINGAUTHORISATION To (1)…………………………...............…………………............................. ……………………………………………………………………………………………………………… IN THE MATTER OF (2)....................................................you are hereby notified that your marketing authorisation has been restored. Note that you are required to comply with the terms and conditions attached to the marketing authorisation. Dated this …………………day of ………............……… 20……………... .......................................................... Director-General OFFICIAL STAMP (1) Here insert name of holder of marketing authorisation (2) Here insert name of medicine and marketing authorisation number 432 Statutory Instruments 22nd November, 2019 FORMX (Regulation 14(2)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 NOTICEOF INTENTION TOREVOKEMARKETING AUTHORISATION To (1)…………………………...............…………………................................. ……………………………………………………………………………………………………………… IINTHEMATTEROF (2)..................................................you are hereby notified that theAuthority intends to revoke yourmarketing authorisation on the following grounds: (a)……………...........................……………………………………….......…… (b)……………………………………………….....................………..…………… (c)………………………………………………………....................…..………………… (d)………………………………………………………....................…..………………… Accordingly, you are requested to show cause why your marketing authorisation should not be revoked for the breaches set out in paragraphs ....................................................................... (above) within (3) ....................... days of receiving this notice. Failure to remedy the said breaches shall result in the revocation of your marketing authorisation. Dated this …………………day of ………............……… 20……………... ......................................................... Director-General OFFICIAL STAMP (1) Here insert name of holder of marketing authorisation (3) Here insert number of days (2) Here insert name of medicine and marketing authorisation number 22ndNovember, 2019 Statutory Instruments 433 FORMXI (Regulation 14(3)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 NOTICEOFREVOCATIONOFMARKETINGAUTHORISATION To (1)…………………………...............…………………................................. ……………………………………………………………………………………………………………… INTHEMATTEROF (2).................................................. you are hereby notified that your marketing authorisation has been revoked on the following grounds: (a)……………...........................……………………………………….......…… (b)……………………………………………….....................………..…………… (c)………………………………………………………....................…..………………… (d)………………………………………………………....................…..………………… You are therefore required to surrender the marketing authorisation to the Authority within twenty one days from the date of revocation. You are also required to comply with the terms and conditions attached. Dated this …………………day of ………............……… 20……………... ......................................................... Director-General OFFICIAL STAMP (1) Here insert name of holder of marketing authorisation (2) Here insert name of medicine and marketing authorisation number 434 Statutory Instruments 22nd November, 2019 FORMXII (Regulation 15(1)) (To be completed in triplicate) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 APPLICATION FOR A DUPLICATE MARKETING AUTHORISATION Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided 1. Name of business entity/individual/local responsible person 2. Marketing Authorisation No. 3. Physical Address 4. Affidavit of loss or damage to marketing of authorisation DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person signing on behalf of the Applicant ……………………………………………………………… ………………………………………………………….. Name Designation ………………………………………………………………….. …………………………………………………………… Signature Date FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………………….…….. Application Number: ……………………………………………………………………………………….……….……………….... Payments Receipt Number: ……………………………………………………………………….…….….…………………………. Application Accepted : ………………………………………………………………..…………………..……………………….….. Application Rejected (Notify applicant): ……………………..…………………………………………………………………….… ………………………………………………………………….…………………………………………………………………….... OFFICIAL STAMP 22ndNovember, 2019 Statutory Instruments 435 FORMXIII (Regulation 16(1)) (To be completed in triplicate) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations, 2019 APPLICATION FOR RENEWAL OF MARKETING AUTHORISATION Please complete in block letters Shaded fields for official use only Application No. Date and Time Information Required Information Provided A PRODUCT DETAILS 1. Name of Product Marketing Authorisation Number 2. Name of holder of market authorisation (a) Tax Payer Identification Number (where applicable) (b) Plot No: (c) Street: (d) Telephone No: (e) Fax No: (f) Mobile No: (g) Email address (h) Postal address (i) Town (j) District (k) Province (l) Country B CONTACT PERSON (a) Name (b) Physical address (c) Postal address (d) Phone (e) fax (f) Email address C LOCAL RESPONSIBLE PERSON (a) Name (b) Designation (c) Phone (d) Fax (e) Email address 3. Attachment Relevant documentation and additional data as outlined in the guidelines on Renewal of Marketing Authorisation Name of Applicant (individual or authorised representative) Date: ……………………………………………… Signature: …………………………………………………………. DR C. CHILUFYA, LUSAKA Minister of Health 18th November, 2019 [MH/101/16/1] FOR OFFICIAL USE ONLY Received by: ……………………………………………… Receipt No: ………………………………………………….. Amount Received: ……………………………….……….……………………………………..…………………………. … Serial No. of application: …………………………………………………………………….……….….…………... ………. OFFICIAL STAMP 436 Statutory Instruments 22nd November, 2019