Dangerous Drugs Regulations, 1975

RGN 1111 of 1975 [CAP.15:02 Dangerous Drugs Regulations, 1975 Rhodesia Government Notice No. 1111 of 1975 ARRANGEMENT OF REGULATIONS PRELIMINARY 1. Title 2. Interpretation of terms. Part I PART II DRUGS 3. Interpretation of terms in this Part. 4. Offences by persons not authorized or licensed 5. Offences by authorized or licensed persons. 6. Cultivation of plants 7. Duties of owners and occupiers of land. 8. Authorized persons. 9. Keeping of registers by authorized or licensed persons. Part II PART IV DRUGS 10. Prohibited manufacture 11. Manufacture by authorized or licensed persons. 12. Unlawful supply 13. Supply by authorized or licensed persons 14. Unlawful possession. 15. Possession by authorized or licensed persons. 16. Position of patients 17. Acquisition, administration, possession and supply by authorized persons. 18. Licensed chemist. 19. Midwives. 20. Aircraft. 21. Government officers, missionaries, police officers and mining companies. 21A. Application for the issue of a licence to a person to acquire, possess and administer Part IV drugs for the capture of game. 21B. Requirements for the issue of a licence to a person to acquire, possess and administer Part IV drugs for the capture of game. 21C. Secretary to refer applications to the Minister 21D. Minister to issue licences. 21E. Refusal of licences by the Minister. 21F. Duration of licences. 21G. Form of licences. 21H. Variation, amendment and cancellation of licences 21I. Production and return of licences 21J. Renewal of licences 22. Prescriptions. 23. Supply of prescription. 24. Procuring by authorized or licensed person. 25. Prescription for more than four months. 26. Addicts. 27. Packaging and labelling 28. Keeping of registers by suppliers 28A. Destruction of Part IV drugs 29. Issue of certain licences prohibited. Part III PARTIALLY CONTROLLED DRUGS 30. Offences by unlicensed persons. 31. Wholesalers to be licensed. 32. Offences by wholesalers and manufacturers 33. Keeping of registers by wholesalers and manufacturers 34. Persons not affected by this Part. Part IV GENERAL 35. Meaning of ‘possession’ 36. Effect of authority or licence 37. Revocation of licence or permit. 38. Withdrawal of authority. 39. Delivery of drugs to recipient’s messenger. 40. Drugs in transit 41. Position of carrier 42. Manner of keeping of registers. 43. Preservation of registers, records etc. 44. Applications for licences or permits. 44A. Appeals 44B. Certain details to be stated in import and export licences. 45. Provisions applicable to importers and exporters 45A. Secretary to send copy of export licence to Government of importing country 45B. Endorsement of export licence or similar authorization 45C. Forms of certificates and licences 45D. Alteration of drugs in bonded warehouses prohibited. 45E. Alteration of packaging 46. Duties of authorized or licensed person who ceases to practise etc. 47. Repeals and savings. First Schedule: Midwife’s supply order. Second Schedule: Preparations which are not Part IV preparations. Third Schedule: Form of Register. Fourth Schedule: Part IV drugs and Part IV preparations with respect to which entries shall be made separately. Fifth Schedule: Fees. Sixth Schedule: Forms IT is hereby notified that the Minister of Health has, in terms of the Dangerous Drugs Act [Chapter 15:02] , made the following regulations:– [amended by the Editor to cross-refer to the Health Professions Act Chapter 27:19 which replaced Chapter 27:08, and amended Chapters 15:03 and 15:05 - all with effect from the 2nd April, 2001.] PRELIMINARY Title and date of operation 1. (1) These regulations may be cited as the Dangerous Drugs Regulations,1975. (2) These regulations shall come into operation on the 1st January 1976. Interpretation of terms 2. (1) In these regulations – “appropriate fee” means the fee prescribed in the Fifth Schedule. [inserted by S.I. 409 with effect from 10 December, 1999.] “authorized person” means a person authorized or treated as authorized in terms of section 8, 16 (1) , 17 ,18 ,19 , 20 or 39 (2) , as the context in each case requires, to supply, administer, distribute, procure, advertise for sale, acquire, possess, carry on any process in the manufacture of, or manufacture, any drug by virtue of being a person or a member of a class of persons specified in that section and ‘authorized’ shall be construed accordingly. “dangerous drug register” – means the register required to be kept in terms of section 9, 28 or 33. “dental surgeon” –means a person registered or exempted from registration as a dental surgeon under the Health Professions Act [Chapter 27:19] “drug” means any Part II drug, any Part IV drug, any Part IV preparation or any partially controlled drug; [amended by S.I. 409 with effect from 10 December, 1999.] “Form” means the appropriate form set out in the Sixth Schedule; [inserted by S.I. 409 with effect from 10 December, 1999.] “licensed chemist” means a person who is practising as, or carrying on the business of a pharmaceutical chemist on premises licensed in terms of Part VI of the Medicines and Allied Substances Control Act [Chapter 15:03]; “licensed person” means a person authorised to supply, distribute, procure, advertise for sale, acquire, possess or, as the case may be, carry on the process in the manufacture of, or manufacture, any drug or cultivate any plant from which a drug is derived by virtue of the terms of and conditions of a licence issued to him for that purpose, and ‘licence’ , ‘license’ and ‘licensed’ shall be construed accordingly; “medical practitioner” means a person registered or exempted from registration as a medical practitioner under the Health Professions Act. [Chapter 27:19]; “midwife” means a fully trained, practising midwife who is in possession of a valid midwife’s supply order; “midwife’s supply order” means an order in the form prescribed in the First Schedule for the supply of tincture of opium and any preparation containing pethidine; “Part I and Part III drug” definitions - [ repealed by S.I. 409 with effect from 10 December,1999.] “Part II drug” means any drug to which Part II of the Act applies other than an extract to tincture of Indian hemp; [inserted by S.I. 409 with effect from 10 December, 1999.] “Part IV drug” means any drug to which Part IV of the Act applies and which is not– a) a partially controlled drug; or b) a Part IV preparation. [inserted by S.I. 409 with effect from 10 December, 1999.] “Part III preparation” . . . . . . [repealed by S.I. 409 with effect from 10 December, 1999.] “Part IV preparation” means a preparation containing such proportion of any drug to which Part IV of the Act applies, other than a partially controlled drug, as is sufficient to make the preparation a drug to which Part IV of the Act applies, but does not include a) any preparation with respect to which the Minister has, in terms of subsection (4) of section 10 of the Act, declared that the provisions of Part IV of the Act shall not or shall cease to apply; or b) any preparation specified in the Second Schedule; [inserted by S.I. 409 with effect from 10 December, 1999.] “partially controlled drug” means any drug or product to which the Minister has, in terms of subsection (3) of section 10 or, as the case may be, section 14 of the Act, applied Part IV of the Act with modification that the said drug or product shall not be treated as a drug to which Part IV of the Act applies for the purposes of Part II of these regulations; [amended by S.I. 409 with effect from 10 December, 1999.] “pharmacist” means a pharmaceutical chemist registered or exempted from registration in terms of the Health Professions Act [Chapter 27:19] “prescription” means a prescription given for an individual by– a) a medical practitioner for the purpose of medical treatment; b) a dental surgeon for the purpose of dental treatment. c) a veterinary surgeon for the purpose of animal treatment. “qualified nurse” means a nurse registered as a general nurse, midwife, sick children’s nurse or psychiatric nurse in terms of the Health Professions Act. [Chapter 27:19]; “register” means a bound book, but does not include any form of loose-leaf register or card-index; “registered premises” means premises licensed in terms of Part III of the Medicines and Allied Substances Control Act. [Chapter 15:03]; “retail business” means the business of retailing, dispensing or compounding drugs carried on at a shop; “veterinary surgeon” means a person registered under the Veterinary Surgeons Act [Chapter 27:15] “wholesale dealer” means any person who carries on the business of selling drugs to persons who buy to sell again. (2) Any reference in the Fourth Schedule to the percentage of a drug contained in any substance or preparation shall, unless it is otherwise expressly provided, be construed in the following manner, that is to say a reference to a substance or preparation containing on per centum of any drug means– a) in the case of a solid, that one gram of the drug is contained in every hundred grams of the substance or preparation; b) in the case of a liquid, that one millilitre of the drug, or if the drug itself is a solid, one gram of the drug is contained in every hundred millilitres of the substance or preparation; and so, in proportion, for any greater or lesser percentage. PART I PART II DRUGS Interpretation of terms in this Part 3. In this part– ‘owner or occupier’ in relation to land, means– a) the occupier of land or, in the case of unoccupied land, the registered owner thereof; b) in the case of a mining location, the person carrying on mining operations on the mining location; c) in the case of State land over which grazing or other rights have been granted, the holder of such rights; d) in the case of tribal trust land, the occupier or the person who has the use of such land or the chief or headman who has immediate jurisdiction thereover, or all or any of the inhabitants of the nearest kraal; e) in the case of commonage or town lands or roads or other like areas, the local authority or other authority under whose control or within whose jurisdiction such land, road or other area is situate. Offences by persons not authorized or licensed 4. No person who is not an authorized or licensed person shall– a) acquire or possess a Part II drug; or b) supply to or procure for any person, including himself, a Part II drug or advertise for sale a Part II drug. [amended by S.I. 409 with effect from 10 December, 1999.] Offences by authorized or licensed persons 5. No authorized or licensed person shall – a) acquire or possess a Part II drug otherwise than in accordance with the provisions of this Part and, in the case of a licensed person, otherwise than in accordance with the terms and conditions of his licence; or b) supply to or procure for, or offer to supply to or procure for an person who is not authorised or licensed person a Part II drug. [amended by S.I. 409 with effect from 10 December, 1999.] Cultivation of plants. 6. (1) No person who is not a licensed person shall cultivate any plant form which a Part II drug is derived. (2) No licensed person shall cultivate any plant from which a Part II drug is derived otherwise than in accordance with the terms and conditions of his licence. [amended by S.I. 409 with effect from 10 December, 1999.] Duties of owners and occupiers of land. 7. (1) Every owner or occupier of land shall clear or cause to be cleared from his land any plant from which a Part II drug is derived which is found to be growing wild or which is being cultivated in contravention of the provisions of these regulations. (2) The owner or occupier of land who has cleared or caused to be cleared from his land any plant from which a Part II drug is derived shall destroy by fire the plant so cleared. [amended by S.I. 409 with effect from 10 December, 1999.] Authorized persons. 8. (1) Subject to the provisions of these regulations, any person who is – (a) a medical practitioner; (b) a veterinary surgeon; (c) a pharmacist or licensed chemist; (d) a pharmacist– (i) employed by a licensed chemist; or (ii) employed in a hospital, clinic, dispensary or like institution administered by the State or by a local authority, or in any other hospital, clinic, dispensary or like institution approved by the Minister, or (iii) employed in any medical store of the State; (e) a person in charge of a laboratory used for the purposes of research or instruction and attached to– (i) a university, university college or other educational institution approved by the Minister; or (ii) any hospital referred to in subparagraph (ii) of paragraph (d); ( f ) an analyst employed by the State; (g) an inspector appointed under the Act of the Hazardous Substances and Articles (Group III : General) Regulations, 1981 or the Medicines and Allied Substances Control Act [Chapter 15 :03] [amended by S.I. 409 with effect from 10 December, 1999.] is authorized, in that capacity and so far as is necessary for the practice or exercise of his profession, function or employment, to acquire possess and supply Part I drugs. (2) Every person authorized in terms of subsection (1) to possess a Part I drug shall, unless the exigencies of the practice or exercise of his profession, function or employment otherwise require, keep every Part I drug in his custody in a locked receptacle which can be opened only by him or another authorized person. Keeping of registers by authorized or licensed persons. 9. Every person authorized or licensed to supply Part II drugs shall– (a) keep, in accordance with the provisions of this section and section 42, a register, and enter therein, in chronological sequence in the form specified in the Third Schedule, true particulars with respect to– (i) every quantity of a Part II drug acquired by him; (ii) every quantity of a Part II drug supplied by him; (iii) every quantity of a Part II drug used by him; (b) use a separate part of his register for entries relating to– (i) raw opium (ii) coca-leaves (iii) indian hemp and the resins obtained from Indian hemp, and all preparations, other than extract and tincture of Indian hemp, of which such resins form the base. [amended by S.I. 409 with effect from 10 December, 1999.] PART II PART IV DRUGS Prohibited Manufacture 10. No person who is not an authorized or licensed person shall manufacture or carry on any process in the manufacture of a Part IV drug. Manufacture by authorized or licensed persons. 11. No authorized or licensed person shall manufacture or carry on any process in the manufacture of a Part IV drug– (a) otherwise than in accordance with the provisions of this Part and in the case of licensed person, otherwise than in accordance with the terms and conditions of his licence; and (b) otherwise than on authorized or licensed premises. Unlawful supply 12. No person who is not an authorized or licensed person shall supply to or procure for, or offer to supply to or procure for, any person including himself, or advertise for sale a Part IV drug or Part IV preparation. [amended by S.I. 409 with effect from 10 December, 1999.] Supply by authorized or licensed persons 13. (1) Subject to the provisions of subsection (2), no authorized or licensed person shall supply to or procure for any person a Part IV drug or Part IV preparation otherwise than in accordance with the provisions of this Part and, in the case of licensed person, otherwise than in accordance with the terms and conditions of his licence. (2) The administration of a Part IV drug or Part IV preparation by or under the direct personal supervision of, and in the presence of, a medical practitioner, or by or under the direct personal supervision of, and in the presence of a dental surgeon, or by a midwife in accordance with the provisions of section 19, shall not be treated, for the purposes of subsection (1), as the supply to any person of a Part IV drug or Part IV preparation. [amended by S.I. 409 with effect from 10 December, 1999.] Unlawful possession 14. No person who is not an authorized or licensed person shall possess a Part IV drug or Part IV preparation. [amended by S.I. 409 with effect from 10 December, 1999.] Possession by authorized or licensed persons 15. No authorized or licensed person shall possess a Part IV drug or Part IV preparation otherwise in accordance with the provisions of this Part and, in the case of a licensed person, in accordance with the terms and conditions of his licence. [amended by S.I. 409 with effect from 10 December, 1999.] Position of patients 16. (1) Subject to the provisions of subsection (2), a person to whom a Part IV drug or Part IV preparation is lawfully supplied– (a) by a medical practitioner or veterinary surgeon; or (b) on a prescription lawfully given by a medical practitioner, a dental surgeon or a veterinary surgeon; shall be treated, for the purposes of this Part, as a person authorized to be in possession of that Part IV drug or Part IV preparation. (2) A person who is supplied by a medical practitioner, or on a prescription lawfully given by a medical practitioner, with a Part IV drug or a Part IV preparation shall not be treated, for the purposes of this Part, as a person authorized to be in possession of that Part IV drug or Part IV preparation if, at the time when he is so supplied, he is also being supplied with a Part IV drug or Part IV preparation by or on a prescription given by another medical practitioner in the course of treatment and did not disclose that fact to the first mentioned medical practitioner. [amended by S.I. 409 with effect from 10 December, 1999.] Acquisition, administration, possession and supply by authorized persons. 17 (1) Subject to the provisions of these regulations, any person who is– (a) a medical practitioner (b) a dental surgeon; (c) a veterinary surgeon; (d) a pharmacist– (i) employed by a licensed chemist; or (ii) employed in a hospital clinic, dispensary or like institution administered by the State or by a local authority, or in any other hospital, clinic, dispensary or like institution approved by the Minister; or (iii) employed in any medical store of the State. (e) a qualified nurse in charge of a ward, theatre or outpatient’s department in any hospital referred to in subparagraph (ii) of paragraph (d); (f) a qualified nurse who– (i) is employed in a supervisory capacity over two or more wards in any hospital referred to in subparagraph (ii) of paragraph (d); and (ii) has been appointed by the medical practitioner in charge of the hospital to be responsible at any time for the distribution of Part IV drugs or Part IV preparations within the hospital; (g) a person in charge of a laboratory used for the purpose of research of instruction and attached to (i) a university, university college or other educational institution approved by the Minister; or (ii) any hospital referred to in subparagraph (ii) of paragraph (d); (h) an analyst employed by the State; or (i) an inspector appointed under the Act or the Hazardous Substances and Articles (Group III: General) Regulations 1981, or the Medicines and Allied Substances Control Act [Chapter 15:03] is authorized in that capacity and so far as is necessary for the practice or exercise of his profession, function or employment to acquire, administer, possess and supply Part IV drugs and Part IV preparations. [amended by S.I. 409 with effect from 10 December, 1999.] (2) Nothing in subsection (1) contained shall authorise– (a) the supply by a dental surgeon of a Part IV drug or Part IV preparation which is not administered by him or under his direct supervision and in his presence to persons receiving treatment from him; ;or (b) any qualified nurse referred to in paragraph (e) or ( f ) of subsection (1) (i) to procure a Part IV drug or Part IV preparation otherwise than from a person employed or engaged in dispensing medicines at that hospital and except upon a written order signed by him; (ii) to supply a Part IV drug or Part IV preparation otherwise than in accordance with the directions of a medical practitioner in charge of any patient in the ward, theatre or, as the case may be , out-patients’ department concerned: Provided that in the case of the medical practitioner being absent, the qualified nurse may, in a case of emergency, supply a Part IV drug or Part IV preparation on condition that the said qualified nurse records the supply in the register and the register is countersigned by the medical practitioner at the earliest opportunity. (3) The matron of any hospital referred to in subparagraph (ii) of paragraph (d) of subsection (1) in which no pharmacist is employed or engaged in dispensing medicines is authorized, in her capacity as a matron and so far as is necessary for the purposes of that hospital and the exercise of her duties, to procure Part IV drugs or Part IV preparations on the order, in writing, of a medical practitioner employed or engaged in that hospital and to be in possession of and to supply Part IV drugs and Part IV preparations so procured. (4) A person who is authorized in terms of this section to acquire, administer, possess or supply a Part IV drug or Part IV preparation shall at all times keep that drug or preparation– (a) on his person or within sight or reach; or (b) in a fixed, locked receptacle, the key to which is kept only by himself or by another person authorized to be in possession of that Part IV drug or Part IV preparation : Provided that such a person may keep a Part IV drug or Part IV preparation in the luggage compartment of a motor vehicle if that luggage-compartment is kept locked and he keeps that key thereto on his person. (5) An order, in writing, signed by a qualified nurse to which subparagraph (I) of paragraph (b) of subsection (2) relates, shall be marked, in such a way as to show that it has been fulfilled, by the person employed or engaged in dispensing medicines who fulfils that order, and shall be kept in the dispensary, and a copy or note of the order shall be kept by the qualified nurse in charge of the ward, theatre or out-patients department of the hospital for use in which that Part IV drug or Part IV preparation was procured. [amended by S.I. 409 with effect from 10 December, 1999.] Licensed Chemist 18. (1) Any person who is a licensed chemist is authorized– (a) in the ordinary course of his retail business to manufacture at his registered premises– (i) any extract or tincture of Indian hemp; and (ii) any Part IV preparation; (b) to carry on, subject to the provisions of these regulations, at his registered premises the business of retailing, dispensing and compounding Part IV drugs and Part IV preparations. (2) Nothing in subsection (1) contained shall be construed as authorising any licensed chemist to possess a Part IV drug or Part IV preparation otherwise than on his registered premises. (3) Every licensed chemist authorized in terms of subsection (1) to manufacture and to carry on the business of retailing, dispensing and compounding Part IV drugs or Part IV preparations shall, unless the exigencies of the exercise of his profession, function or employment otherwise require, keep every Part IV drug or Part IV preparation in his possession in a locked receptacle which can be opened only by him or another authorized person. [amended by S.I. 409 with effect from 10 December, 1999.] Midwives 19. (1) In this section– “drug” means tincture of opium and any preparation containing pethidine. (2) An application for a midwife’s supply order shall be made in writing to the Secretary. (3) A midwife’s supply order shall be valid until the thirty-first day of December in the year during which it is issued. (4) Subject to the provisions of subsection (5), a midwife is authorized, so far as is necessary for the practice of his profession or employment, to procure, be in possession of and administer drugs. (5) The following provisions shall apply to the supply to a midwife and the possession and administration by a midwife of drugs– (a) on each occasion when a midwife procures drugs, he shall, in addition to a signed order referred to in section 24, produce his midwife’s supply order; (b) the supplier shall note on the midwife’s supply order the date on which drugs are supplied, the name and the quantity of the drugs supplied, and his name and registered address; (c) on each occasion when a midwife procures a drug, he shall enter in a drugs-book, to be kept by him and used solely for the purposes of this section, the name and amount of the drug and the form in which it is procured and the date and the name and the address of the supplier; (d) a midwife shall not, in any one year, procure a quantity of a drug greater than the total amount of that drug specified in his midwife’s supply order; (e) a midwife shall, when he administers a drug, as soon as practicable thereafter, enter in his drugs-book the name of the drug administered, the name and address of the woman to whom it was administered, the amount administered and the form in which it was administered; (f) a midwife shall, except when the exigencies of the practice or exercise of his profession or employment as a midwife otherwise require, keep every drug in his custody in a locked receptacle which can be opened only by him. Aircraft 20. (1) In this section– “aircraft” means any aircraft in which passengers are carried for hire or reward; “Air Navigation Regulations” means the Air Navigation Regulations 1988, published in Statutory Instrument 79 of 1988; [amended by S.I. 409 with effect from 10 December, 1999.] “operator” means a person or organization engaged in, or offering to engage in, an aircraft operation. (2) Subject to the provisions of subsection (3), an operator is authorized to procure and possess Part IV drugs or Part IV preparations. [amended by S.I. 409 with effect from 10 December, 1999.] (3) The following provisions shall apply to the supply to and the possession by an operator of Part IV drugs and Part IV preparations– (a) and order referred to in section 24 for the supply of Part IV drugs or Part IV preparations shall be made in duplicate on the official notepaper of the operator or his authorized representative; (b) it shall be stated in the order whether the order is for the initial supply of Part IV drugs or Part IV preparations or for the replacement of any Part IV drugs or Part IV preparations previously supplied in terms of this section, and in the latter case, the reasons for the replacement; (c) the order shall be countersigned by the Director of Civil Aviation, who shall send the duplicate to the Secretary; (d) Part IV drugs or Part IV preparations shall be in a form approved by the Secretary, and shall be kept in a sealed container, adequately labelled to indicate the method of use and the quantity and nature of the contents, in the first-aid kit of the aircraft; (e) the quantity of Part IV drugs or Part IV preparations carried in any aircraft shall not amount to more than the equivalent of twenty milligrams of morphine for any person who may lawfully be on board that aircraft at any one time; (f) a responsible official appointed by the operator shall– (i) satisfy himself at intervals not exceeding one month that the Part IV drugs or Part IV preparations carried in each aircraft have not been removed from the first aid kit for any unauthorized purpose; (ii) inspect and check at intervals not exceeding six months the Part IV drugs or Part IV preparations carried in each aircraft; (g) the operator shall keep a permanent record at his principle place of business in Zimbabwe of the receipt, distribution and disposal of all Part IV drugs or Part IV preparations obtained in terms of this section; (h) Part IV drugs or Part IV preparations procured by an operator in terms of this section shall not be transferred, on the change of ownership of any of his aircraft, to another person without the permission of the Secretary. (4) Any person who ceases to be an operator shall – (a) notify the Secretary of that fact; and (b) dispose of the Part IV drugs or Part IV preparations in his possession in accordance with the directions of the Secretary. [amended by S.I. 409 with effect from 10 December, 1999.] Government officers, missionaries, police officers and mining companies 21. (1) The Minister may, at his discretion license– (a) any officer of the State in charge of a station at which no Government medical officer is stationed from which a Government medical officer is for the time being absent; (b) any officer of the State who undertakes a journey on duty during which he will be at a distance representing more than twenty-four hours travelling-time from any station of the State; (c) any person in charge of a mission station of a missionary society; (d) a police officer in charge of a police station; (e) a first aid worker in the employ of any mining company; (f) any person who is registered on a register maintained by the Health Professions Council and who is in charge of a hospital, clinic, dispensary or like institution administered by the State or by a mission, local authority, municipal council or rural council and at which no medical practitioner is stationed or from which the medical practitioner is for the time being absent; [inserted by R.G.N. 329 of 1978, with effect from 5 May, 1978] (g) any registered nurse who is a first aid worker; [inserted by R.G.N. 329 of 1978, with effect from 5 May, 1978] (h) any registered nurse who is employed by an hospice organisation which is primarily involved in the palliative care of terminally ill persons ; [inserted by S.I. 409 of 1999, with effect from 10 December, 1999.] to procure, possess and administer Part IV drugs or Part IV preparations, subject to the provisions of subsection (2) and such terms and conditions as he may fix. (1a) Any person referred to in subsection (1) who wishes to obtain a licence shall make an application in Form DD1. [inserted by S.I. 409 of 1999, with effect from 10 December, 1999.] (2) The following provisions shall apply to the supply to, and the possession and administration by, a person licensed in terms of subsection (1) of Part IV drugs and Part IV preparations– (a) on each occasion when he procures a Part IV drug or Part IV preparation, he shall, in addition to a signed order referred to in section 24, produce to the supplier his licence; (b) on each occasion when he procures a Part IV drug or Part IV preparation, he shall enter it in a drugs-book, to be kept by him and used solely for the purposes of this section, the name and the amount of the Part IV or Part IV Preparation and the form in which it is procured and the date and the name and address of the supplier; (c) he shall, when he administers a Part IV drug or Part IV preparation ,as soon as practicable thereafter, enter in his drugs-book the name of the Part IV drug or Part IV preparation administered, the name and address of the person to whom it was administered, the amount administered and the form in which it was administered; (d) he shall, except when a Part IV drug or Part IV preparation is to be administered, keep every Part IV drug or Part IV preparation in his custody in a locked receptacle which can be opened by him or another authorized person; (e) he shall not administer a Part IV drug or Part IV preparation procured in terms of this section otherwise than for strictly medical, surgical or dental purposes. [amended by S.I. 409 with effect from 10 December, 1999.] Application for the issue of a licence to a person to acquire, possess and administer Part IV drugs for the capture of game. 21A. Any person who wishes to obtain a licence to acquire, possess and administer a Part IV drug for the purpose of capturing game shall submit an application to the Secretary, in Form DD2 and such application shall be accompanied by the appropriate fee. [inserted by S.I. 409 of 1999, with effect from 10 December, 1999.] Requirements for the issue of a licence to a person to acquire, possess and administer Part IV drugs for the capture of game 21B.(1) Subject to subsection (2) , no person shall be issued with a licence unless such person (a) has passed and examination approved by the Secretary in the use of drugs for the capture of game; Provided that this shall not apply to a veterinary surgeon registered with the Council of Veterinary Surgeons of Zimbabwe; or (b) in the case of a veterinary surgeon, holds a certificate of attendance in a course in the use of drugs for the capture of game; (c) satisfies the Secretary that he is familiar with the regulations relating to safe custody, possession and administration of a Part IV drug and such other matters as the Secretary may determine from time to time. (2) The Secretary may exempt any person from any of the requirements referred to in subsection (1) if he is satisfied that such person has– (a) passed other examinations in the course of such person’s studies; or (b) had such other practical experience which the Secretary considers justifies the grant of such exemption. [inserted by S.I. 409 of 1999] Secretary to refer applications to the Minister 21C.(1) The Secretary shall, after assessing an application submitted to him in terms of s21A, refer the application to the Minister, with any recommendation he may have thereon. (2) A licence issued in terms of subsection (1) shall authorise the licensee to acquire, possess and administer a Part IV drug for the purpose of capturing game. [inserted by S.I. 409 of 1999] Minister to issue licences 21D.(1) The Minister may issue a licence to any person who makes an application in terms of section 21A, and in issuing such licence, the Minister may impose such conditions as he considers necessary or desirable. (2) A licence issued in terms of subsection (1) shall authorise the licensee to acquire, possess and administer a Part IV drug for the purpose of capturing game. [inserted by S.I. 409 of 1999] Refusal of licences by the Minister 21E.(1) The Minister may refuse to issue a licence to any person who makes an application in terms of section 21A. (2) Where a Minister intends to refuse to grant a licence in respect of an application submitted in terms of section 21A, the Secretary shall inform the applicant, in writing, of the Minister’s intention and the reasons therefor, and request the applicant to submit to the Minister within thirty days, any representations he may wish to make on the matter. (3) If– (a) no representations are submitted in terms of the subsection (2); or (b) after considering any representations submitted in terms of subsection (2), the Minister is of the opinion that a licence should not be issued; the Secretary shall notify the applicant of the Minister’s refusal. [inserted by S.I. 409 of 1999] Duration of licences 21F. Any licence which is issued in terms of section 21C shall be valid for a period of twelve months, commencing on the 1st of January, in each year, and may be renewed annually thereafter before its expiry. [inserted by S.I. 409 of 1999] Form of licences 21G. A licence issued in terms of section 21C shall be in form DD3. [inserted by S.I. 409 of 1999 ] Variation, amendment and cancellation of licences 21H. The Minister may, in his discretion, vary or amend the conditions of , or cancel any licence issued in terms of section 21C at any time: Provided that the Secretary shall, before the Minister acts in terms of this section, notify the licensee of the Minister’s intention, together with the reasons and thereupon section 21D shall mutatis mutandis, apply. [inserted by S.I. 409 of 1999] Production and return of licences 21I.(1) Whenever the Minister– (a) cancels any licence; or (b) varies or amends the conditions of any licence; or (c) imposes new conditions on the renewal of any licence; the Secretary shall request the holder of the licence to produce such licence within such period as he may specify, and the holder thereof shall produce such licence within the specified period. (2) Any person who fails to comply with a request in terms of subsection (1) shall be guilty of an offence. (3) Whenever the Minister varies, amends or imposes any new conditions on any licence, the Secretary shall return such licence duly endorsed to the holder thereof within a reasonable time. [inserted by S.I. 409 of 1999] Renewal of licences 21J. (1) A licence issued in terms of section 21D may be renewed before its expiry. (2) No licence shall be renewed in every five-year period, unless the applicant holds a certificate of attendance in a course in the use of drugs for the capture of game. (3) An application for the renewal of a licence shall be lodged with the Secretary in form DD2, and such application shall be accompanied by the appropriate fee. (4) Upon receipt of an application to renew a licence the Secretary shall, after assessing the application, refer the application to the Minister with any recommendation he may have thereon. (5) The Minister may renew such licence if he is satisfied that the applicant has observed the conditions subject to which the licence was issued. [inserted by S.I. 409 of 1999] Prescriptions. 22. (1) In this section– “recognised preparation” means a preparation contained in the British Pharmacopoeia or the British Pharmaceutical Codex. (2) The following provisions shall apply to the prescriptions prescribing Part IV drugs or Part IV preparations– (a) a prescription shall be in writing, and shall be signed and dated by the person giving it; (b) a prescription shall specify the address of the person giving it; (c) a prescription shall specify the name and address of the person for whose treatment it is given or, if it is given by a veterinary surgeon, the name and address of the person to whom the Part IV drug or Part IV preparation is to be delivered; (d) a prescription shall be endorsed thereon, if given by a dental surgeon, the words ‘for dental treatment only’ or, if given by a veterinary surgeon ‘for animal treatment only’; (e) if one or more recognized preparations are prescribed, the prescription shall specify the total amount of the preparation or, as the case may be, of each preparation, or, in the case of a preparation packed in ampoules, specify the total amount of the preparation or, as the case may be of each preparation which is intended to be administered; (f) if the preparation prescribed is not a recognized preparation, the prescription shall specify the total amount of the Part IV drug prescribed or , if the preparation is packed in ampoules , either the total amount to be supplied or the total amount intended to be administered. [amended by S.I. 409 with effect from 10 December, 1999.] (3) For the purposes of this Part, a prescription to be dispensed in a hospital and given for the treatment of a patient in that hospital and given for the treatment of a patient in that hospital which is written on the patient’s bed-card or case-sheet and signed by the person giving it shall be treated as a prescription which complies with the provisions of subsection (2). Supply on prescription 23. (1) No person shall supply a Part IV drug or Part IV preparation on a prescription unless (a) the prescription complies with the provisions of this Part; and (b) he is acquainted with the signature of the person by whom the prescription purports to be given, and has no reason to suppose that it not genuine. (2) Save as is provided in subsection (3), no prescription shall authorize the supply of a Part IV drug or Part IV preparation more than once. (3) If a prescription prescribing a Part IV drug or Part IV preparation states that it may, subject to the lapse of an interval or intervals specified in the prescription, be dispensed a second, third or fourth time, the Part IV drug or Part IV preparation thereby prescribed may be supplied a second, third or fourth time after specified interval or intervals. (4) A person dispensing a prescription prescribing a Part IV drug or Part IV preparation shall– (a) at the time when he dispenses it, mark thereon the date on which it is dispensed a second, third or fourth time, the date of each occasion on which it is dispensed; and (b) retain and keep the prescription on the premises where it is dispensed, so as to be at all times available for inspection. (5) No person shall make or supply a copy of any prescription prescribing a Part IV drug or Part IV preparation, other than a copy of a prescription for submission to the State or a medical aid society for the purpose of receiving payment for Part IV drugs or Part IV preparations supplied thereon, unless he is requested to do so by the Secretary, an inspector, a commissioned police officer or any other member of a police force authorized, in writing, by a magistrate or by a commissioned police officer. (6) A copy of a prescription made in terms of subsection (5) shall be clearly and indelibly marked ‘Copy only. Not to be dispensed.’ (7) Notwithstanding anything contained in these regulations, where a licensed chemist is reasonably satisfied that a person ordering any Part IV drug or Part IV preparation is a medical practitioner who is, by reason of some emergency, unable to furnish a prescription immediately, he may, notwithstanding that no prescription has been given, if the said person undertakes to furnish him within the seven days next following with a prescription, deliver the Part IV drug or Part IV preparation ordered in accordance with the directions of the said person, so, however, that, notwithstanding anything in any such directions, the supply shall not be repealed unless such a prescription has been given: Provided that, if any person by whom such undertaking has been given fails to deliver to the seller a prescription in accordance with the undertaking, or if any person for the purpose of obtaining delivery of any Part IV drug or Part IV preparation under the provisions of this subsection, makes a statement which is, to his knowledge, false, he shall be deemed to have contravened the provisions of this section. [amended by S.I. 409 with effect from 10 December, 1999.] Procuring by authorized or licensed person 24. An authorized or licensed person shall not procure a Part IV drug or Part IV preparation unless he produced to the supplier an order, in writing, signed, and dated by him in which is stated– (a) the name and address of the person by whom the Part IV drug or Part IV preparation is required or the institution for which it is ordered; and (b) the name and quantity of the Part IV drug or Part IV preparation required; and (c) the use to which Part IV drug or Part IV preparation is to be put; and (d) the name and address and profession or qualification of the person signing the order. [amended by S.I. 409 with effect from 10 December, 1999.] Prescription for more than four months 25. (1) Any medical practitioner who considers it necessary for the purpose of treatment of any patient continuously to prescribe for him a Part IV drug or Part IV preparation for a period greater than four months shall report the case to the Secretary. [amended by S.I. 409 with effect from 10 December, 1999.] (2) When a case is reported in terms of subsection (1), the Secretary may, by notice in writing to the medical practitioner– (a) on such conditions as he may specify, authorise the continued prescribing of the drug or preparation for the patient concerned; or (b) prohibit the continued prescribing of the drug or preparation for the patient concerned, and the medical practitioner shall not thereafter so prescribe the drug or preparation. Addicts. 26. (1) Save as is otherwise provided in this section, no medical practitioner shall supply or administer to or prescribe for any person a Part IV drug or Part IV preparation merely for the purposes of addiction. (2) A medical practitioner who considers it necessary for the purposes of treatment or care of a patient who is a drug addict that he should receive rational supplies of a Part IV drug or Part IV preparation shall report the case to the Secretary. (3) When a case is reported in terms of subsection (2), the Secretary may, at his discretion, permit in writing a medical practitioner to supply and, additionally or alternatively, administer and, additionally or alternatively, prescribe such quantities of the Part IV drug or Part IV preparation to which the patient is addicted as the Secretary may in the circumstances consider necessary. (4) No medical practitioner shall supply or prescribe for the treatment of a drug addict a Part IV drug or Part IV preparation in excess of the quantity permitted by the Secretary. (5) No person authorized or licensed to have in his possession a Part IV drug or Part IV preparation and who is not a person referred to in subsection (1) of section 16, shall use or prescribe that Part IV drug or Part IV preparation for the purposes of self-administration. [amended by S.I. 409 with effect from 10 December, 1999.] Packaging and labelling 27. (1) Subject to the provisions of these regulations, no person shall– (a) supply a Part IV drug unless the package or bottle in which it is contained is plainly marked with the amount of the Part IV drug contained therein; or (b) supply a Part IV preparation unless the package or bottle in which it is contained is plainly marked– (i) in the case of a powder, solution or ointment, with the total amount of the powder, solution or ointment in the package or bottle and the percentage of the Part IV drug contained in the powder, solution or ointment; (ii) in the case of tablets or other similar articles with the amount of the Part IV drug in each article and the number of articles in the package or bottle. (2) Nothing in this section contained shall apply to a Part IV preparation lawfully supplied in accordance with the provisions of this Part by, or on a prescription lawfully given by, a medical practitioner, a dental surgeon or a veterinary surgeon. [amended by S.I. 409 with effect from 10 December, 1999.] Keeping of registers by suppliers 28. (1) Every person authorized or licensed to supply Part IV drugs or Part IV preparations shall– (a) keep, in accordance with the provisions of this section and section 42, a register and shall enter therein, in chronological sequence, in the form specified in the Third Schedule, true particulars with respect to– (i) every quantity of a Part IV drug or Part IV preparation acquired by him; and (ii) every quantity of a Part IV drug or Part IV preparation supplied by him and (iii) every quantity of a Part IV drug or Part IV preparation used by him; (iv) every quantity of a Part IV drug or Part IV preparation manufactured by him. [inserted by S.I. 409 of 1999] (b) use a separate page in the register for each Part IV drug or Part IV preparation specified in the Fourth Schedule. [amended by S.I. 409 with effect from 10 December, 1999.] (2) For the purposes of paragraph (b) of subsection (1)– (a) any ester, ether or derivative specified in item 41 of the Fourth Schedule shall be treated as including its salts and any preparation containing any such ester, ether or derivative or its salts; (b) any substance specified in items 46 to 72 of the Fourth Schedule shall be treated as including its salts and any preparation, admixture, extract or other substances containing any proportion of the substance or its salts. (3) Tablets and other similar articles shall be recorded in the register by number, and not by number of packages, and liquids, extracts and powders shall be recorded by volume or mass according to their nature. (4) Notwithstanding the provisions of subsection (1), a licensed chemist may transfer to his dispensary small quantities of Part IV drugs or Part IV preparations as is sufficient to make the medicine a drug to which Part IV of the Act applies, but only if the transfer and the date of the transfer are recorded in his register and a copy of each original prescription and a record of each repeat prescription is made in the prescription- book. [amended by S.I. 409 with effect from 10 December, 1999.] Destruction of Part IV drugs 28A. No person shall destroy any Part IV drug or Part IV preparation without the approval of the Secretary. [inserted by S.I. 409 with effect from 10 December, 1999.] Issue of certain licences prohibited 29. No licence shall be issued to any person for the manufacture of diacetylmorphine or the import or export of diacetylmorphine or its preparations. PART III PARTIALLY CONTROLLED DRUGS Offences by unlicensed persons 30. No person who is not a licensed person shall– (a) possess a partially controlled drug in a quantity exceeding five hundred grams; or (b) manufacture, or carry on any process in the manufacture of, a partially controlled drug. Wholesalers to be licensed 31. (1) A wholesaler dealer shall not possess, sell, supply or distribute a partially controlled drug unless he is licensed and otherwise than in accordance with the provisions of this Part and terms and conditions of his licence. (2) Nothing in subsection (1) contained shall apply to any wholesale dealer who is a person who carries on business from premises licensed in terms of Part VI of the Medicines and Allied Substances Control Act [Chapter 15:03] for the purposes of the manufacture of the drug. [amended by S.I. 409 with effect from 10 December, 1999.] Offences by wholesalers and manufacturers 32. No wholesale dealer in , or manufacturer of, partially controlled drugs shall– (a) supply a partially controlled drug unless the package or bottle in which it is contained is plainly marked with the amount of the partially controlled drug contained therein; (b) supply a partially controlled drug in a quantity exceeding five-hundred grams unless the person to whom it is supplied is a licensed person. Keeping of registers by wholesalers and manufactures 33. Every wholesale dealer in, and every manufacturer of, partially controlled drugs shall (a) keep, in accordance with the provisions of this section and section 42, a register, and shall enter therein, in chronological sequence, in the form specified in the Third Schedule, true particulars with respect to– (i) every quantity of a partially controlled drug manufactured or, as the case may be, acquired by him and (ii) every quantity of a partially controlled drug supplied by him; and (iii) every quantity of a partially controlled drug used by him; and (b) use a separate part of his register for entries relating to each partially controlled drug. Persons not affected by this Part 34. For the removal of doubt, nothing in section 31 to 33 contained shall apply to– (a) the sale, supply or distribution of a partially controlled drug by any person who is not a wholesale dealer in, or a manufacturer or, a partially controlled drug; or (b) the carrying on, at his registered premises, by a licensed chemist who is not a wholesale dealer, of the business of retailing, dispensing or compounding a partially controlled drug. PART IV GENERAL Meaning of ‘possession’ 35. A person shall be treated as in possession of a drug for the purposes of these regulations if that drug is in his actual custody or is held by some other person subject to his control or for him or on his behalf. Effect of authority or licence 36. Save as is otherwise expressly provided in these regulations, and in the case of a licensed person, subject to the terms and conditions of his licence– (a) a person authorized or licensed to manufacture a drug shall be treated, for the purposes of these regulations, as authorized or, as the case may be, licensed to supply that drug; (b) a person authorized or licensed to supply a Part II drug, Part IV drug or Part IV preparation shall be treated, for the purposes of these regulations, as authorized or, as the case may be, licensed to be in possession of, to procure, to offer to supply or to procure and to advertise for sale that Part II drug, Part IV drug or Part IV preparation; [amended by S.I. 409 with effect from 10 December, 1999.] (c) a wholesale dealer licensed to supply a partially controlled drug shall be treated, for the purposes of these regulations, as licensed to be in possession of more than five hundred grams of that drug. Revocation of licence or permit 37. The Secretary may revoke a licence or permit at any time. [amended by S.I. 409 with effect from 10 December, 1999.] Withdrawal of authority 38. (1) If any authorized person is– (a) convicted of an offence against the Act or these regulations; or (b) adjudged or certified or otherwise lawfully proved to be mentally disordered or defective under any law relating to mental disorders; or (c) undergoing treatment as a temporary or voluntary patient in terms of any law referred to in paragraph (b); or (d) proved, to the satisfaction of the Secretary, to have become a drug-addict; the Secretary may, if he is of the opinion that that person cannot properly be allowed to remain an authorized person, by notice in the Gazette, withdraw the authority of that person. [amended by S.I. 409 with effect from 10 December, 1999.] (2) If a person whose authority is withdrawn by the Secretary in terms of subsection (1) is a medical practitioner, a dental surgeon or a veterinary surgeon, the Secretary may, by notice in the Gazette, direct that it shall not be lawful for that person to give any prescription prescribing a drug. (3) The Secretary may at any time– (a) restore any authority withdrawn in terms of subsection (1) ; or (b) suspend the withdrawal of any such authority; or (c) cancel the suspension of the withdrawal of any such authority. (4) If the withdrawal of the authority of a person is suspended by the Secretary as in paragraph (b) of subsection (3) is provided, that person shall continue to be an authorized person as if the authority had not been withdrawn. [amended by S.I. 409 with effect from 10 December, 1999.] Delivery of drug to recipient’s messenger 39. (1) If a Part II drug, Part IV drug or Part IV preparation is lawfully supplied to a person (hereinafter in this section called the recipient) otherwise than by or on a prescription given by a medical practitioner, a dental surgeon or a veterinary surgeon, the person supplying that Part II drug, Part IV drug or Part IV preparation (hereinafter in this section called the supplier) shall not deliver it to any person who purports to be sent by or on behalf of the recipient unless– (a) that person is authorized or licensed to be in possession of that Part II drug , Part IV drug or Part IV preparation; or (b) that person produces to the supplier a statement, in writing, signed by the recipient to receive that Part II drug, Part IV drug or Part IV preparation on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document. (2) A person to whom a Part II drug, Part IV drug or Part IV preparation is lawfully delivered as in subsection (1) is provided shall be treated, for the purposes of these regulations, as authorized to be in possession of that Part II drug, Part IV drug or Part IV preparation for such period as in the circumstances is reasonably sufficient to enable delivery to be made to the recipient. [amended by S.I. 409 with effect from 10 December, 1999.] Drugs in transit 40. (1) If a Part II drug, Part IV drug or Part IV preparation permitted under the law of any country outside Zimbabwe to be exported therefrom to any destination outside Zimbabwe is brought into Zimbabwe, no person shall cause or procure that Part II drug, Part IV drug or Part IV preparation to be diverted to any other destination unless he has been issued with a permit by the Secretary and otherwise than in accordance with the terms and conditions of that permit. [amended by S.I. 409 with effect from 10 December, 1999.] (2) For the purposes of this section, the destination to which a Part II drug, Part IV drug or Part IV preparation is permitted to be exported shall be the destination stated in the permission for the export thereof from the country of export. [amended by S.I. 409 with effect from 10 December, 1999.] (3) No drugs, which are in transit through Zimbabwe, being exported from a destination outside Zimbabwe to another destination, shall be permitted to pass through Zimbabwe unless a copy of the export authorization is presented to the Secretary. [inserted by S.I. 409 with effect from 10 December, 1999.] Position of carrier 41. No provision of these regulations relating to the possession of any drug shall apply to a carrier, his agent or servant who is in possession of a drug in the ordinary course of his business or as the case may be, the business of his principal or employer. Manner of keeping of registers 42. Any person required to keep a register in terms of section 9, 28 or 33 shall– (a) specify the type of drug to which the entries on any page of his register relate at the head of that page; (b) make every entry required to be made in terms of section 9, 28 or 33, as the case may be, in his register on the day on which the drug is received or, as the case may be, on which the transaction with respect to the supply of the drug by him takes place or, if that is not reasonably practicable, on the day next following that day; (c) not make any cancellation, obliteration or alteration of any entry; (d) make any correction to an entry only by way of a marginal note or footnote which shall specify the date on which the correction is made; (e) make all entries and corrections in ink or otherwise so as to be indelible; (f) not use his register for any purpose other than the purpose of these regulations; (g) on the demand of the Secretary or of any person empowered, in writing , by the Secretary in that behalf or of an inspector– (i) furnish such particulars as may be required with respect to the procuring or supplying by him of any drug or with respect to any stock of drugs in his possession; and (ii) for the purpose of confirming any such particulars, produce any stock of drugs in his possession; and (iii) produce his register and such other books or documents in his possession relating to any dealings in drugs as may be required; (h) keep a separate register in respect of each set of premises at which he carries on business; (i) keep each register at the premises to which it relates and so as to be at all times available for inspection; ( j) save as in paragraph (h) is provided, not keep more than one register for each class of drug with respect to which he is required to keep a separate register or a separate part of a register unless the Secretary has approved the keeping of a separate register for each department of the business carried on by him; (k) if he is a wholesale dealer, submit to the Secretary by the seventh day of each month details of all entries made in his register during the preceding month. Preservation of registers, records etcetera 43. (1) All registers, records, books, prescriptions, signed orders and other documents issued, made or kept in pursuance of the provisions of these regulations or for the purposes of these regulations shall be preserved– (a) in the case of a register, book or other like record, for a period of five years from the date on which the last entry is made; (b) in the case of any other document, for a period of five years from the date on which the document is issued or made. [amended by S.I. 409 with effect from 10 December, 1999.] (2) Every person required by the Act or by these regulations to be in possession of any permit, licence, order or prescription shall be deemed to be without such permit, licence, order or prescription unless he produces or gives satisfactory proof of possessing it. Applications for licences or permits 44. (1) An application for a licence under section 4 or 11 of the Act or for a licence or permit under these regulations shall be– (a) made in the case of an application– (i) to import drugs, Form DD4 ; (ii) to export or move drugs, Form DD5; which shall be obtained from the Secretary; [amended by S.I. 409 with effect from 10 December, 1999.] (b) accompanied, if the application is for a licence to export any drug from Zimbabwe, by the original copy of the certificate of the country of importation officially approving the import of that drug; (c) accompanied by the appropriate fee, if any, prescribed in the Fifth Schedule. (2) - . . . . . . [repealed by S.I. 409 with effect from 10 December, 1999.] Appeals 44A. Any person who is refused a licence by the Secretary may, within thirty days of such refusal, appeal to the Minister. [inserted by S.I. 409 of 1999] Certain details to be stated in import and export licences 44B.(1) Every import and export licence granted by the Secretary shall state– (a) the name and address of the importer and exporter; and (b) the international non-proprietary name of the drug, if any, and (c) the quantity to be imported or exported, as the case may be ; and (d) the period within which the importation or exportation shall be effected. (2) Every export licence shall state– (a) the number and date of the import certificate; and (b) the authority by whom such certificate is issued. [inserted by S.I. 409 of 1999.] Provisions applicable to importers and exporters 45. In addition to such terms and conditions as may be fixed in his licence to import or export any drug, the importer or, as the case may be, the exporter shall comply with the following provisions– (a) he shall not import or export any drug– (i) by ordinary or registered letter post ; (ii) to a bank to the account of any person; [amended by S.I. 409 with effect from 10 December, 1999.] (al) he shall ,for every import or export, as the case may be, whether such import or export consists of one or more drugs, obtain a separate licence from the Secretary for such importation or exportation; [inserted by S.I. 409 of 1999] (b) he shall, if he is an exporter of a drug– (i) which is to be exported in one package, place the duplicate licence to export that drug inside the outer wrapper of that package; (ii) which is to be exported in more than one package– A. place the duplicate licence to export that drug inside the outer wrapper of one package; and B. consecutively number on the outer wrapper all the packages in which the drug is contained ; and C. indicate on each package the number of the package in which the duplicate licence is to be found; (iii) not mislabel any drug. [inserted by S.I. 409 of 1999] (c) he shall advise the Secretary within seven days of the import or export of any drug imported or exported by him. Secretary to send copy of export licence to Government of importing country. 45A. Where the Secretary grants the issue of a export licence the Secretary shall send a copy of such licence to the Government of the importing country or territory. [inserted by S.I. 409 of 1999] Endorsement of export licence or similar authorization 45B.(1) Where the Secretary receives a copy of an export licence or similar authorization for the import of any Part IV drugs into Zimbabwe the Secretary shall– (a) after the importation has been effected; or (b) when the period fixed for the importation has expired; endorse the export licence or similar authorisation stating whether the exportation has been effected either under paragraph (a) or (b) and further stating– (i) the amount that has been imported; or (ii) where a lesser amount has been imported than that stated on the export licence or similar authorisation, the quantity so imported. (2) Upon endorsing the export licence or similar authorisation in terms of subsection (1), the Secretary shall forthwith return such export licence or similar authorisation to the Government of the exporting country. [inserted by S.I. 409 of 1999] Forms of certificates and licences 45C.(1) The forms for certificates and licences granted by the Secretary in terms of paragraph (al) of section 45 shall– (a) in the case of a certificate of official approval of import of drugs, be in Form DD6; (b) in the case of a licence to import drugs, be in Form DD7; (c) in the case of a licence to export or move drugs, be in Form DD8. [inserted by S.I. 409 of 1999] Alteration of drugs in bonded warehouses prohibited 45D. No drug which is stored in a bonded warehouse or whilst in transit shall be subjected to any process which would change the nature of such drug. [inserted by S.I. 409 of 1999 ] Alteration of packaging 45E. No packaging of a drug which is stored in a bonded warehouse or whilst in transit shall be altered without the approval of the Secretary. [inserted by S.I. 409 of 1999] Duties of authorized or licensed person who ceases to practise 46. (1) Any authorized or licensed person in possession of drugs shall, before ceasing to practise or exercise his profession, function or employment at any place– (a) if he is being succeeded by an authorized or licensed person– (i) physically check with, and hand over to, his successor all drugs in his possession; and (ii) submit to the Secretary a statement, signed by himself and his successor ,certifying that the said drugs have been physically checked and handed over in accordance with subparagraph (I) and (iii) after handing over the drugs, rule off each page of the dangerous drugs register on which an entry has been made, and both he and his successor shall, when satisfied that it is a true record of the drugs on hand, sign each such page: Provided that , if either person is not satisfied that it is a true record, he shall immediately inform the Secretary of the reasons for his refusal; (b) if he is not being succeeded by an authorized or licensed person, inform the Secretary of the arrangements which he has made for the disposal of the drugs in his possession. (2) If arrangements in terms of paragraph (b) of subsection (1) have not been made, or are not to the satisfaction of the Secretary, the drugs shall be disposed of in such a manner as the Secretary shall order, and, immediately after disposing of the drugs in accordance with the arrangements or order, as the case may be, previously made, such authorized or licensed person shall notify the Secretary that he has done so, and shall at the same time, forward the dangerous drugs register and the supporting subscriptions and written orders to the Secretary, who shall retain them for a period of two years from the latest date of entry. (3) Where a medical practitioner, dental surgeon, veterinary surgeon or pharmacist is solely responsible for a Part IV drug or Part IV preparation, and is absent from the premises where such drug or preparation is normally stored, for a continuous period of seven days or more, in circumstances in which another medical practitioner, dental surgeon, veterinary surgeon or pharmacist becomes solely responsible for that drug or preparation, then, both before and after the period of absence, both persons shall– (a) physically check the stock of drugs; and (b) sign each page of the dangerous drugs register on which an entry has been made, when satisfied that it is a true record: Provided that, if either person is not satisfied that it is a true record, he shall refuse to sign such page, and shall immediately inform the Secretary of the reasons for his refusal. [inserted by R.G.N. 543 of 1976, with effect from 25 June,1976, and amended by S.I. 409 with effect from 10 December, 1999.] Repeals and savings 47. (1) The regulations specified in the Seventh Schedule are repealed. [amended by S.I. 409 with effect from 10 December, 1999.] (2) Notwithstanding the provisions of subsection (1) these regulations shall not be held to operate as new regulations but shall be construed as a consolidation and continuation without interruption of the regulations repealed by subsection (1). FIRST SCHEDULE (SECTION 2). MIDWIFE’S SUPPLY ORDER I hereby certify that…………………………………………………………………………… of………………………………………………………………………………………….. is a fully trained practising midwife and is authorized, in pursuance of subsection (4) of section 19 of the Dangerous Drugs Regulations 1975, to procure, during the period of validity of this supply order and for the purpose of his profession, tincture of opium and pethidine preparations not exceeding the quantities stated below. …………………………………………………………………………………………..……… …………………………………………………………………………………..……………… …………………………………………………………………………………………………. This supply order shall remain valid until the 31st December of the year in which it is issued, and shall be returned to me immediately on becoming invalid. Place……………………………… Signed………………………………….. Secretary for Health Date of issue……………………. (The following is to be printed on the reverse side of the form.) (1) This supply order shall be produced to the person from whom the drugs are procured. (2) The supplier shall, at the time when the transaction takes place, note under the appropriate heading in this order the date on which the drugs are supplied, the name and quantity of the drugs supplied, and his name and registered address. PETHIDINE PREPARATIONS Date supplied Details of preparation Quantity (strength of tablets, ampoules, etc.) supplied Total supplied to date Name and address of supplier TINCTURE OF OPIUM Date supplied Quantity supplied Total supplied to date Name and address of supplier SECOND SCHEDULE (SECTION 2) PREPARATIONS WHICH ARE NOT PART IV PREPARATIONS [amended by S.I. 409 with effect from 10 December, 1999.] Ipecacuanha pills with squill B.P.C.1934 Pills of mercury with chalk and opium B.P.C.1949 Aromatic powder of chalk with opium B.P.1953. Powder of ipecacuanha and opium B.P.1953. Suppository of lead with opium, B.P.C.1949 Eye drops of cocaine and mercuric chloride, oily B.P.C 1954 Mixtures of powder of ipecacuanha and opium, B.P.1953 with any of the following– mercury with chalk B.P. 1914 and B.P.1948; acetylsalicylic acid; phenacetin; quinine and its salts; sodium bicarbonate. Note: - Only those provisions of the Act and regulations, which relate to the import or export of drugs and the movement of drugs by road or rail beyond the borders of Zimbabwe apply to the preparations specified in this Schedule. THIRD SCHEDULE (SECTIONS 9, 28 AND 33) REGISTER OF DANGEROUS DRUGS Name of drug or preparation …………………………………………………………………… Date on which acquired or supplied Name and address of person from whom acquired or to whom supplied Reference Amount acquired Amount supplied Amount on hand FOURTH SCHEDULE (SECTIONS 2 AND 28) PART IV DRUGS AND PART IV PREPARATIONS WITH RESPECT TO WHICH ENTRIES SHALL BE MADE SEPARATELY 1. Medicinal opium. 2. Any extract or tincture of Indian hemp, and any preparation, not being a preparation capable of external use only, made from extract of tincture of Indian hemp. 3. Morphine and its salts, and any solution of dilution of morphine or its salts in an inert substance, whether liquid or solid, containing any proportion of morphine, and any preparation, admixture, extract or other substance (not being such a solution or dilution as aforesaid) containing not less than one-fifth of one percent of morphine (calculated in respect of anhydrous morphine). 4. Diacetylmorphine (also known as diamorphine or heroin) and its salts, and any solution or dilution of cocaine or its salts, and any preparation, admixture, extract or other substance containing any proportion of diacetylmorphine. 5. Cocaine (including synthetic cocaine) and ecgonine and their respective salts, and any solution or dilution of cocaine or its salts in an inert substance, whether liquid or solid, containing any proportion of cocaine, and any preparation, admixture, extract or other substance (not being such a solution or dilution as afore said) containing not less than one-tenth of one per cent of cocaine or any proportion of ecgonine. 6. Dihydrohydroxycodeinone (also known as eucodal) and its salts, and any preparation, admixture, extract or other substance containing any proportion of dihydrohydroxycodeinone or its salts. 7. Dihydrocodeinone (also known as dicodide) and its salts, and any preparation, admixture, extract or other substance containing any proportion of dihydrocodeinone or its salts. 8. Dihydromorphinone (also known as dilaudide) and its salts and any preparation, admixture, extract or other substance containing any proportion of dihydromorphinone or its salts. 9. 6-methyldihydromorphine and its salts, and any preparation, admixture, extract or other substance containing any proportion of 6-methyldihydromorphine or its salts. 10. Acetyldihyrocodeinone and its salts and any preparation, admixture, extract or other substance containing any proportion of acetyldihyrocodeinone or its salts. 11. Dihydromorphine and its salts, and any preparation, admixture, extract or other substance containing any proportion of dihydromorphine or its salts. 12. Morphine-N-oxide (also known as genomorphine) and any preparation, admixture, extract or other substance containing any proportion of morphine N-oxide. 13. Thebaine and its salts, and any preparation, admixture, extract or other substance containing any proportion of thebaine or its salts. 14. Benzylmorphine and its salts, and any preparation, admixture, extract or other substance containing any proportion of benzylmorphine or its salts. 15. Dihydrodesoxymorphine (also known as desomorphine) and its salts, and any preparation, admixture, extract or other substance containing any proportion of dihydrodesoxymorphine or its salts. 16. Pethidine and its salts and any preparation, admixture, extract or other substance containing any proportion of pethidine or its salts. 17. The isopropyl and other esters of 1-methyl-4-phenylpiperidine-4-carbolxylic acid (other than pethidine) and their salts and any preparation, admixture, extract or other substance containing any proportion of isopropyl or other esters of 1-methyl-4 phenylpiperidine-4-carboxylic acid or their salts. 18. Methyldihydromorphinone (also known as metopon) and its salts and any preparation, admixture, extract or other substance containing any proportion of methyldihydromorphinone or its salts.. 19. Alphaprodine and its salts, and any preparation, admixture, extract or other substance containing any proportion of alphaprodine or its salts. 20. Methadone (also known as amidone) and its salts, and any preparation, admixture, extract or other substance containing any proportion of methadone or its salts. 21. Betaprodine and its salts, and any preparation, admixture, extract or other substance containing any proportion of betaprodine or its salts. 22. Hydroxypethidine and its salts, and any preparation, admixture, extract or other substance containing any proportion of hydroxypethidine or its salts. 23. Isomethadone (also known as isoamidone) and its salts, and any preparation, admixture, extract or other substance containing any proportion of isomethadone or its salts. 24. Ketobemidone and its salts, and any preparation, admixture, extract or other substance containing any proportion of ketobemidone or its salts. 25. Methadol and its salts and any preparation, admixture, extract or other substance containing any proportion of methadol or its salts. 26. a-methadol and its salts, and any preparation, admixture, extract or other substance containing any proportion of a-methadol or its salts. 27. b-methadol and its salts, and any preparation, admixture ,extract or other substance containing any proportion of b-methadol or its salts. 28. Methadyl acetate and its salts, and any preparation, admixture, extract or other substance containing any proportion of methadyl acetate or its salts. 29. a-acetylmethadol and its salts, and any preparation, admixture, extract or other substance containing any proportion of a-acetylmethadol or its salts. 30. b-acetylmethadol and its salts, and any preparation, admixture, extract or other substance containing any proportion of b-acetylmethadol or its salts. 31. Phenadoxone and its salts, and any preparation, admixture, extract or other substance containing any proportion of phenadoxone or its salts. 32. Betameprodine and its salts, and any preparation, admixture, extract or other substance containing any proportion of betameprodine or its salts. 33. Methorphinan, other than dextrorphan (that is to say levorphan and reacemorphan) and its salts, and any preparation, admixture, extract or other substance containing any proportion of methorphinan or its salts. 34. 3-methoxy-N-methylmorphinan, other than dextromethorphan,(that is to say, levomethorphan and racemethorphan), and its salts and any preparation, admixture, extract or other substance containing any proportion of 3-methyoxy-N methylmorphinan or its salts. 35. Methyldesomorphine (6-methyl- desoxymorphine) and its salts, and any preparation, admixture, extract or other substance containing any proportion of methyldesomorphine or its salts. 36. 3-dimethylamino-1,1-di (2’-thienyl)-1- butene and its salts, and any preparation, admixture, extract or other substance containing any proportion of 3-dimethylamino 1,1-di(2’thienyl)-1-butene or its salts. 37. 3-ethylmethylamino-1, 1-di(2’-thienyl)-1-butene and its salts, and any preparation, admixture, extract or other substance containing any proportion of 3-ethylmethylamino 1, 1-di(2’thienyl)-1-butene or its salts. 38. 3-diethylyamino-1, 1-di-(2’-thienyl)-1-butene (diethylthiambutene) and its salts, and any preparation, admixture, extract or other substance containing any proportion of 3 diethylyamino-1, 1-di-(2’-thienyl)-1-butene or its Salts. 39. 4,4-diphenyl-6-dimethylamino-3-hexanone and its salts, and any preparation, admixture, extract or other substance containing any proportion of 4,4-diphenyl-6 dimethylamino-3-hexanone or its salts. 40. 4,4-diphenyl-6-piperidino-3-hepatanone and its salts, and any preparation, admixture, extract or other substance containing any proportion of 4,4-diphenyl-6-piperidino-3 hepatanone or its salts. 41. The esters of morphine (other than diacetylmorphine) ecgonine, dihydro hydroxycodeinone, dihydrocodeinone, dihydromorphinone, acetyldihydro-codeinone and dihydromorphine and their respective salts, the ethers of morphine (other than benzylmorphine, methylmorphine, ethylmorphine and morpholinylethylmorphine) and their salts, and their salts, and the morphine-N-oxide derivatives and any other pentavalent nitrogen morphine derivatives, and any preparation, admixture, extract or other substance containing any proportion of any drug included in this paragraph. 42. 1:3-dimethyl-4-phenyl-4-propionyloxyhexamethyleneimine, its salts and any preparation, admixture, extract or other substance containing any proportion of 1:3 diamethyl-4-phenyl-4-propionyloxyhexamethylenieimine. 43. 3-hydroxy-N-phenethylmorphinan, its salts and any preparation, admixture, extract or other substance containing any proportion of 3-hydroxy-N-phenethylmorphinan. 44. 4-morpholino-2:2-dipenyl ethyl butyrate, its salts and any preparation, admixture, extract or other substance containing any proportion of 4-morpholino-2:2-dipenyl ethyl butyrate. 45. 4-dimethylamino-1:2-diphenyl-3-methyl-2-propionyloxybutane, its salts and any preparation, admixture, extract or other substance containing any proportion of 4 dimethylamino-1:2-diphenyl-3-methyl-2-propionyloxybutane. 46. Anileridine (1-[2-(p-aminophenyl)-ethyl]-4-phenylpiperidine-4-carbolyxic acid ethyl ester). 47. Etoxeridine (1-2[2-(2-hydroxyethoxy)-ethyl]-4-phenylpiperidine-4-carboxylic acid ethyl ester). 48. Dextromoramide, levomoramide and racemoramide [1-(3 methyl-4-morpholino-2 : diphenylbutyryl)-pyrrolidine]. 49. Morpheridine[1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester]. 50. Myrophine (myristyl ester of benzylmorphine). 51. Oxymorphone (dihydro-14-hydroxymorphinone). 52. Trimeperidine (1:2:5 trimethyl-4-phenyl-4-propionyloxy piperidine). 53. Benzethdine [ethyl 1 (2-benzoyloxyethyl)-4-phenylpiperidine-4-carboxylate). 54. Dimenoxadole (2-dimethylaminoethyl)-2-ethoxy-2 : 2 diphenylacetate). 55. Furethidine [ethyl 1 (2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4-carboxylate). 56. Norcodeine. 57. Normorphine. 58. Phenazocine [2’-hydroxy-5:9 dimethyl-2- (2-phenylethyl)-6:7-benzomorphan]. 59. Allylprodine (3 allyl-1 methyl-4 phenyl-4 propionoxypiperidine). 60. Clonitazene (2-p-chlorobenzyl-1-1-(2-diethylamnoethyl)-5-nitrobenzimidazole). 61. Diphenoxylate [ethyl 1-(3-cyano-3:3 diphenylpropyl)-4-phenylpiperidine-4 carboxylate]. 62. Etonitazine [1-(2-diethylaminoethyl)-2-p-ethoxybenzyl-5-nitrobenzimidzole]. 63. Hydromorphinol (14-hydroxydihydromorphine). 64. Levophenacylmorphan [(-)-3 hydroxy-N-phenacylmorphinan]. 65. Metazocine (2’-hydroxy-2:5:9-trimethyl-6: 7-benzomorphan). 66. Diampromide (N-[2-(N-methylphenethylamino)-propyl] propionanilide). 67. Norlevorphanol [(-)]-3 hydroxymorphinan]. 68. Phenampromide [N-(1-methyl-2-piperidincethyl) propionanilide]. 69. Phenoperidine [ethyl 1–(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylate]. 70. Piminodine [ethyl-(3-anilinopropyl)-4-phenylpiperidine-4-carboxylate]. 71. Nicocodine. 72. Noracymethadol (oe-dl-3 acetoxy-6 methylamino-4:4 diphenylheptane). 73. Acetorphine. 74. Etorphine. 75. Fentanyl 76. Piritramide. Note: No entries are required to be made with respect to any preparation containing a drug specified in this Schedule which is a preparation specified in the Second Schedule or a preparation specified in any notice published in terms of subsection (4) of section 10 of the Act. FIFTH SCHEDULE (SECTIONS 2 AND 44) FEES Fees 1. Application for a licence to acquire, possess and administer Part IV drugs……………… 2 000 000 2. Application for renewal of licence to acquire, Possess and administer Part IV drugs……… 2 000 000 3. Application for a licence to import drugs…… 600 000 4. Application for a licence to export drugs…… 600 000 SIXTH SCHEDULE FORMS Form DD1 Application for issue of a licence to a person Form DD2 Application for a licence/renewal to acquire, possess and administer drugs for use in game and capture Form DD3 Licence Form DD4 Application for licence to import dangerous drugs and corresponding import certificate Form DD5 Application for export licence or movement licence Form DD6 Certificate of official approval of import of dangerous drugs Form DD7 Licence to import dangerous drugs Form DD8 Licence to export dangerous drugs – movement licence Form DD1 DANGEROUS DRUGS ACT [CHAPTER 15:02] APPLICATION FOR ISSUE OF A LICENCE TO A PERSON TO (To be submitted in duplicate) 1. Full Names ……………………………………………………………………………………… 2. Date and place of birth…………………………………………………………………… 3. Qualifications…………………………………………………………………………… 4. Registration number with the Health Professions Council, if applicable (A copy of the registration certificate and the current practising certificate must accompany this application)………………………………………………………………………………… (Number of Practising Certificate with the Health Professions Council, if applicable): ………………………………………………………………………………………….. 5. Address (Home) …………………………………………………………………………………………..… ……………………………………………………………………………………….. (Business) …………………………………………………………………………………………..… ……………………………………………………………………………………….. 6. Telephone number (Home) ………………………………………………………………………………………….. 7. Present pace of employment ………………………………………………………………………………………….. 8. Position of applicant at place of employment (e.g. owner,manager, etc): ………………………………………………………………………………………….. 9. Have you ever been convicted of any offence relating to drugs? YES/NO* If YES state details :…………………………………………………………………………………………..… ………………………………………………………………………………………..…… …………………………………………………………………………………….. Date ……………………………… ……………………………………….. Signature of applicant *Delete the inapplicable. Note– The appropriate fees, etc are required to be attached to the application. Copies of original documents must be properly certified. If any document or fee required to be attached is not attached, the application cannot be accepted. If an applicant’s Practising Certificate is not renewed by the Health Professions Council for any reason, any licence issued in terms of these regulations will immediately become invalid. Drugs you wish to have included on your licence: ………………………………………………………………………………………….. Form DD2 DANGEROUS DRUGS ACT [CHAPTER 15:02] APPLICATION FOR A LICENCE/RENEWAL TO ACQUIRE, POSSESS AND ADMINISTER DRUGS FOR USE IN GAME AND CAPTURE 1. General Surname……………………………. First Names………………………… Home Address …………………………………………………………………………………………..… ………………………………………………………………………………………..…… ……………………………………………………………………………………..……… ………………………………………………………………………………….. Occupation…………………………………………………………………………… Previous licence number, if applicable…………………………………………………… Last course attended…………………………………………………………………………. 2. Give reasons of why you should be granted a licence/licence renewal …………………………………………………………………………………………..… ………………………………………………………………………………………..…… ……………………………………………………………………………………..……… ………………………………………………………………………………….. 3. List the drugs for which a licence is required on the attached Schedule A …………………………………………………………………………………………..… ………………………………………………………………………………………..…… …………………………………………………………………………………….. I certify that I know and understand the relevant regulations, safe custody and the use of these drugs. Date ………………………………….. Signature………………………………….. Also noted: Licences will not be renewed unless this form is completed in detail together with Schedule B. In the event of NIL return, this should be indicated on the Schedule. The expiring licence must be returned with this application. Schedule A Drugs to be included on your licence Narcotics and their antagonists Maximum quantity you wish to hold …………………………………………………………………………………………..……… …………………………………………………………………………………..……………… …………………………………………………………………………..……………………… …………………………………………………………………..……………………………… …………………………………………………………………………………………………. Sedatives, tranquillizers, reversal agents, muscle relaxants …………………………………………………………………………………………..……… …………………………………………………………………………………..……………… …………………………………………………………………………..……………………… ……………………………………………………………………………………………….. Supportive drugs …………………………………………………………………………………………..……… …………………………………………………………………………………..……………… ………………………………………………………………………………………………. SCHEDULE B DRUG RETURN Enter, Capture Drugs Only Drug Quantity held at 30/11/...... plus purchases during …………. Quantity used Quantity in stock at 30/11/………. Species immobilised give number of approx. numbers for large operations Form DD3 Licence No. File No. DANGEROUS DRUGS ACT [CHAPTER 15:02] In pursuance of the Dangerous Drugs Act [Chapter 15:02], and in accordance with powers delegated to me in terms of section 27 of the Act, I hereby grant to ………………………………………………………………………………………….. (hereinafter called “the licensee”) A LICENCE To…………………………………………………………………………………………..…… …………………………………………………………………………………….. …………… Subject to the following conditions: …………………………………………………………………………………………..……… ………………………………………………………………………………………………….. The licence, unless sooner revoked, shall continue in force until …………………………and on expiry or revocation shall be surrendered to the Secretary for Health and Child Welfare. ……………………………………………… for Secretary for Health and Child Welfare Ministry of Health and Child Welfare, P.O. Box CY 1122, Causeway, Zimbabwe. Date Form DD4 For Official Use Only Licence No……… File No……………… DANGEROUS DRUGS ACT [CHAPTER 15:02] APPLICATION FOR LICENCE TO IMPORT DANGEROUS DRUGS AND CORRESPONDING IMPORT CERTIFICATE (Dangerous Drugs Regulations, 1975, section 44 ) Attention is drawn to the instructions appearing overleaf. Delay will be caused if these instructions are not followed, or if any of the questions below are not answered, or if the declaration is not signed. (see Instruction 7) SEPARATE APPLICATIONS MUST BE SUBMITTED IN RESPECT OF EACH CONSIGNMENT TO BE IMPORTED (a) Full name and address of importer (see Instruction 1) …………………………………………………………………………………………..… ………………………………………………………………………………………..…… …………………………………………………………………………………….. (b) Full name and address of Consignor in exporting country …………………………………………………………………………………………..… ……………………………………………………………………………………….. (c) The drugs are to be imported *by sea and/or rail via ……………………………. by parcel post via ……………………………………………………………………… *by air freight via…………………………………………………..and will be imported through………………………………Customs office (State port of entry) *Delete the inapplicable words (d) Approximate date of arrival ………………………………………………………………………………………….. (e) State the purpose for which the drugs are required (if vague reasons only are given, further inquiries may be necessary, see Instruction 5.) ………………………………………………………………………………………….. (f) Particulars of each item (see Instructions 6) to be imported. Item No Quantity Full description of each item Active principal content (in grammes) Stocks on hand I hereby declare that to the best of my knowledge and belief all the particulars in this application are correctly stated, and in particular that the drugs, if their importation is allowed, will not be used for any purpose other than that stated in paragraph (e) Signed (see Instruction 7)…………………………………………………………………… Status………………………………………………………………………………………….. If on behalf of a company, state position in company………………………………………… Date ………………………………………………………………………………………….. N.B. This form must be signed in accordance with Instruction 7 and your attention is particularly drawn to section 19 (1)(c) of the Dangerous Drugs Act [Chapter 15:02] ON REVERSE SIDE OF FORM Instructions for completing this form NON-COMPLIANCE WITH THESE INSTRUCTIONS WILL INVOLVE DELAY Note : An Import Licence is an authority solely for the importation of a particular consignment, and must be produced to the Customs Officer at the time of importation. An Importation Certificate is for transmission to the consignor in the exporting country, for submission to his Government in support of his application for authority to export the consignment. It is not authority for the admission of the consignment into Zimbabwe 1. Application will, in ordinary circumstances, be entertained only if made by a person or company resident in Zimbabwe. They must always be made by the actual importer and not by a forwarding agent. (i.e. shipping agent or other such person) on his behalf. 2. Import Licences under the Dangerous Drugs Act [Chapter 15:02], are required for all drugs to which the Act applies Copies of the Act and orders made thereunder may be obtained from the Publications Office, Department of Printing and Stationery, Cecil House, Jason Moyo Avenue, Harare, P O Box CY 341, Causeway, Harare Zimbabwe. 3. A separate licence is required in respect of each consignment 4. The application fee for an import licence is two hundred dollars ($ 200.00), and must be forwarded with the application. Cheques, postal orders and money orders must be made payable to the Secretary for Health and Child Welfare. 5. Paragraph (e) The applicants should state the exact use for which the importation is required. e.g. for medical, dental or veterinary use, or for the purpose of being sold or supplied to some other person in accordance with the provisions of the Act. 6. Paragraph (f The following should be carefully observed: (a) Not more than one item should appear on each line provided in this space. Preparations of the same drug should be grouped together. Where the details of the items exceed ten lines of typing, six copies of a schedule giving the requisite particulars should be furnished instead of including them in table. (b) Each item should be described fully. In the case of ampoules, the total quantity of drug and volume of liquid in each ampoule, and not the quantity intended to be administered, must be stated. (c) The official conversion factors must be used in determining the active principal content, the name of which must be stated. 7. Signature of form. The declaration on the front page must be signed by the actual importer, or in the case of a company, by a person authorized under the Act to procure drugs. In either case, the person signing must insert under “ status ” the class of authorized person to which he belongs. All applications must be addressed to: The Secretary for Health and Child Welfare, P O Box CY 1122 Causeway Form DD5 For Official Use Only Licence No…………. File No…………… DANGEROUS DRUGS ACT [CHAPTER 15:02] APPLICATION FOR EXPORT LICENCE OR MOVEMENT LICENCE (Dangerous Drugs Regulations, 1975, section 44 and 46 ) Attention is drawn to the Instructions appearing overleaf. It is requested that the form be filled in legibly, preferably typewritten (a) Full name and address of supplier …………………………………………………………………………………………..… ………………………………………………………………………………………..…… …………………………………………………………………………………….. (b) State method by which drugs are to be exported: Rail ………………………………………………………………………………………… Airfreight………………………………………………………………………………… Road…………………………………………………………………………………… (c) State Port or Customs office through which the goods are to be exported ………………………………………………………………………………………….. (d) Full name and address of person to whom the drugs are to be supplied (as stated on Import Certificate, if any) …………………………………………………………………………………………..… ………………………………………………………………………………………..…… …………………………………………………………………………………….. (e) State whether the drugs are to be dispatched alone, or form part of a miscellaneous order. …………………………………………………………………………………………..… ……………………………………………………………………………………….. (f) Particulars of each item to be supplied (see Instruction 3) Item No Quantity Full description of each item Active principal content (in grammes) Stocks on hand I hereby declare that to the best of my knowledge and belief all the particulars in this application are correctly stated, and I undertake that if this licence is granted to me, it shall be used solely for the supply of goods being my own property or the property of a person or company for whom I am authorized to act in this transaction as the sole responsible representative. Signed (see Instruction 7) ……………………………………………………………………… Status………………………………………………………………………………………….. Date ………………………………………………………………………………………….. If on behalf of a company, state position in company………………………………………… N B This form must be signed in accordance with Instruction 4 and your attention is particularly drawn to section 19 (1) (c ) of the Dangerous Drugs Act [Chapter 15:02] ON REVERSE SIDE OF FORM Instructions for completing this form NON-COMPLIANCE WITH THESE INSTRUCTIONS WILL INVOLVE DELAY 1. Export Licences and Movement Licences under the Dangerous Drugs Act [Chapter 15:02], are required for all drugs to which the act applies. 2. The application fee for an Export Licence is two hundred dollars ($200,00), which must accompany each application. Cheques, postal orders and money orders must be made payable to the Secretary for Health and Child Welfare. No fee is charged for Movement Licences. 3. Paragraph ( f ) The following should be carefully observed: (i) Not more than one item should appear on each line provided in this space. Preparations of the same drug should be grouped together. Where the details of the items exceed ten lines of typing, six copies of a Schedule giving the requisite particulars should be furnished instead of including them in the table. (ii) Each item should be described fully. In the case of ampoules the total quantity of drug and volume of liquid in each ampoule, and not the quantity intended to be administered, shall be stated. (iii) The official conversion factors must be used in determining the active principal content, the name of which must be stated. 4. Signing of form. The declaration on the front page must be signed by a person authorized under the Act to supply drugs and domiciled in Zimbabwe, otherwise the application cannot be accepted. The person signing must insert under “status” the class of authorized person to which he belongs. 5. The consignment must be addressed exactly as stated in the licence. All applications must be addressed to: The Secretary for Health and Child Welfare, P O Box CY 1122 Causeway Harare Zimbabwe Form DD6 DANGEROUS DRUGS ACT [CHAPTER 15:02] CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT OF DANGEROUS DRUGS 1. Name of importer ………………………………………………………………………………………….. 2. Address …………………………………………………………………………………………..… ……………………………………………………………………………………….. 3. Telephone and fax numbers ………………………………………………………………………………………….. 4. Name of drug to be imported ………………………………………………………………………………………….. 5. International non-proprietary name of drug ………………………………………………………………………………………….. 6. Quantity to be imported ………………………………………………………………………………………….. 7. Name of country from which drug is being imported ………………………………………………………………………………………….. 8. Name and address of person, company, organization, etc, from which drug is being obtained ………………………………………………………………………………………….. 9. Port of entry ………………………………………………………………………………………….. 10. The consignment shall be imported before the ………………………………………………………………………………………….. The consignment is required solely for medical or scientific purposes Secretary for Health and Child Welfare Ministry of Health and Child Welfare, P.O. Box CY 1122, Causeway, Harare, Zimbabwe. Form DD7 DANGEROUS DRUGS ACT [CHAPTER 15:02] LICENCE TO IMPORT DANGEROUS DRUGS 1. Name of importer ………………………………………………………………………………………….. 2. Address …………………………………………………………………………………………..… ……………………………………………………………………………………….. 3. Telephone and fax numbers ………………………………………………………………………………………….. 4. Name of drug to be imported ………………………………………………………………………………………….. 5. International non-proprietary name of drug ………………………………………………………………………………………….. 6. Quantity to be imported ………………………………………………………………………………………….. 7. Name of country from which drug is being imported ………………………………………………………………………………………….. 8. Name and address of person, company, organization, etc, from which drug is being obtained ………………………………………………………………………………………….. 9. Port of entry ………………………………………………………………………………………….. 10. Period within which importation must be effected ………………………………………………………………………………………….. 11. The drugs stated herein have been */ have not been* approved for importation to a bonded warehouse. ………………………………………………………………………………………….. 12. Date of issue of licence ………………………………………………………………………………………….. The consignment is required solely for medical or scientific purposes Secretary for Health and Child Welfare Ministry of Health and Child Welfare, P.O. Box CY 1122, Causeway, Harare, Zimbabwe. * Delete the inapplicable ON REVERSE SIDE OF FORM CONDITIONS 1. The licence does not in itself authorize the licensee to be in possession of or to supply the drug imported. 2. The licence does not relieve the licensee from compliance with any Customs regulations in force for the time being relating to the importation of goods into or transshipment of goods in Zimbabwe or any Post Office regulations for the time being in force in Zimbabwe. 3. The licence is valid only for the licensee and may be revoked at any time by the Secretary for Health and Child Welfare, in which event it shall be immediately surrendered. It shall be produced for inspection when required by any person duly authorized under the Act. 4. Unless the licence is sooner revoked, it shall be produced to the Customs Officer at the time of importation, or, if the importation is not effected before the date specified overleaf, the licence shall immediately after that date be surrendered to the Secretary for Health and Child Welfare. ENDORSEMENT BY CUSTOMS OFFICER AT TIME OF IMPORTATION I hereby certify that the person named overleaf has imported the consignment thereon specified* by ** sea or rail/parcel post/ air freight/ road transport ……………………………………… Signature of Customs Officer OFFICIAL STAMP ………………………………………… Rank Port ………………………………………………………………………………………….. Date………………………………………………………………………………………….. * If the whole consignment for which the licence has been granted is not imported the Customs Officer should suitably amend the certificate above, and insert below the actual amount or item imported ** Delete whichever is inapplicable Amount Description of items ………………………………………………………………………………………….. ………………………………………………………………………………………….. ………………………………………………………………………………………….. This licence, when completed, must be returned immediately by the Customs Officer to The Secretary for Health and Child Welfare, P O Box CY 1122 Causeway Harare Zimbabwe Form DD8 ZIMBABWE DANGEROUS DRUGS ACT [CHAPTER 15:02] LICENCE TO EXPORT DANGEROUS DRUGS – MOVEMENT LICENCE 1. Name of exporter …………………………………………………………………………………………..… ……………………………………………………………………………………………. 2. Address …………………………………………………………………………………………..… …………………………………………………………………………………………… 3. Telephone and fax numbers ………………………………………………………………………………………….. 4. Name of drug to be exported ………………………………………………………………………………………….. 5. International non-proprietary name of drug ………………………………………………………………………………………….. 6. Active principal content (in grammes) ………………………………………………………………………………………….. 7. Quantity and description of drug to be exported ………………………………………………………………………………………….. 8. Name of country to which drug is being exported ………………………………………………………………………………………….. 9. Name and address of person, company, organization, etc, to whom export is being made …………………………………………………………………………………………..… ……………………………………………………………………………………….. 10. The drugs will be exported through the Customs Office at (State port of exit) ………………………………………………………………………………………….. 11. The drugs stated herein have been * / have not been* approved for exportation to a bonded warehouse. ………………………………………………………………………………………….. 12. The drugs are: Item No Quantity and description Active principal content (in grammes) FOR OFFICIAL USE ONLY 13. Number of import certificate 14. Date of import certificate 15. Name of authority, which has issued import certificate 16. Date of issue of licence *Delete the inapplicable CONDITIONS OF LICENCE (a) The drugs must be exported within three months of the date of issue of this licence. (b) The licence is valid only for drugs of the exact quantity, kind and form specified. (c) The consignment shall be addressed exactly as stated in the licence (d) The duplicate copy sent to the exporter (or supplier) shall be placed inside the outer wrapper of the parcel containing the drugs. If the drugs are contained in more than one parcel, the duplicate copy shall be placed inside the outer wrapper of one of them, the parcels shall be consecutively numbered on the outer wrapper, and on each parcel there shall be legibly stated the number of the parcel in which the duplicate copy is to be found. (e) No drug, to which this licence refers, may be exported or supplied by ordinary or registered letter post. (f) The licence is not transferable. The consignment is required solely for medical or scientific purposes Secretary for Health and Child Welfare Ministry of Health and Child Welfare, P.O. Box CY 1122, Causeway, Harare, Zimbabwe. Note:— 1. If any alteration is desired in this licence it must be returned with a request for amendment and a statement of the reasons therefore. No unauthorized alteration is permissible. 2. Failure to comply with paragraph (d) may lead to delay or confiscations of the consignment in the country of destination.