Medicines And Allied Substances Control Act [Chapter 15:03]

Chapter 15:03

 

Medicines And Allied Substances Control Act

Acts 14/1969, 62/1971, 35/1974, 20/1978, 41/1978 (s. 35) 39/1979, 7/1987, 11/1988, 18/1989 (s. 27), 1/1996, 6/2000 (s. 151), 22/2001 (s. 4), 23/2004 (s. 282). R.G.N. 899/1978.

ARRANGEMENT OF SECTIONS

PART I

PRELIMINARY Section

1. Short title.

PART II

MEDICINESCONTROL AUTHORITY

3. Establishment of Medicines Control Authority of Zimbabwe.

3A   Succession to former Council.

4. Constitution of Authority.
5. Conditions of office of members.
6. Disqualification for appointment as member.
7. Vacation of office of member.
8. Minister may require member to vacate office or suspend him.
9. Filling of vacancies on Authority.
10. Meetings and procedure of Authority.
11. Committees of Authority.
12. Remuneration and expenses of members of Authority or committee.

12A. Disclosure of interest of members of Authority and committees.

13. Funds, accounts and audit.

13A. Annual report of Authority.

14. Powers of Authority.

14A  Pensions benefits for certain employees of Authority.

15. Validity of decisions and acts of Authority.

PART III

CLINICALTRIALS

16. Conduct of clinical trials.
17. Application for conduct of clinical trials.
18. Director-General to submit applications to Authority.
19. Conditions for conduct of clinical trials.
20. Consents for clinical trials.
21. Supply of information prior to clinical trials etc.
22. Council’s power to stop or suspend clinical trials.
23. Monitoring of clinical trials by Authority.
24. Reports on clinical trials.
25. [Repealed].

PART IIIA

ZIMBABWEREGIONALMEDICINESCONTROL LABORATORY

25A. Transfer of Laboratory to Authority. 25B. Functions of Laboratory.

25C. Director of Laboratory.-

PART IV

REGISTRATION OFMEDICINES

26. Director-General of Authority.
27. Medicines Register.
28. Declaration of specified medicines.
29. Sale of specified medicines.
30. Registrability of medicines.
31. Applications for registration of medicines.
32. Lapsing of application for registration of medicine.
33. Registration of medicines.
34. Cancellation and variation of conditions of registration.
35. Notifications in professional journals.
36. Medicines to be labelled.
37. [Repealed]
38. Prohibitions, controls and restrictions in respect of medicines, veterinary medicines and certain substances, devices and articles.
39. Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to Authority.
40. Advertisement of medicines.
41. Prohibition of sale of undesirable medicines.

PART V

PROHIBITED DRUGS

[Part V sections 42 –52 repealed]

PART VI

LICENSING AND CONTROL OF PHARMACEUTICALPREMISES AND PERSONS

53. Interpretation in Part VI.
54. Register of licensed premises and persons.
55. Premises and persons to be licensed.
56. Application for licence.
57. Licensing of premises.
58. Licensing of persons.
59. General disqualifications for licences.
60. Validity and renewal of licences.
61. Cancellation, suspension, alteration and variation of licences.

PART VII

APPEALS 62. Appeals.

PART VIII

GENERAL

63. Compounding or dispensing of medicines and veterinary medicines.
64. Exemption of Authority from liability.
65. Appointment of inspectors and analysts for purposes of this Act.
66. Powers of inspectors.
67. Offences and penalties.
68. [Repealed]
69. Special jurisdiction of magistrates courts.
70. Procedure and evidence.

70A. Registers as evidence.

71. Special defence for contravention of section 39.
72. Act or omission by manager, agent or employee.
73. Preservation of secrecy. 73A. Laboratory fees.
76. Savings and transitional provisions.

SCHEDULES

FIRST SCHEDULE: Powers of Authority.

SECOND SCHEDULE: Pension Rights of Staff of Authority.

THIRD SCHEDULE: Savings and Transitional Provisions: Drugs and Allied Substances Control Amendment Act, 1996.

AN ACT to establish a Medicines Control Authority of Zimbabwe and to confer functions on such Authority in relation to the registration of medicines; to provide for the Zimbabwe Regional

Medicines Control Laboratory and for its functions; to provide for the appointment of a DirectorGeneral of the Authority and for the keeping of a Medicines Register; to provide for certain prohibitions, controls and restrictions relating to medicines and other substances; and to provide for matters connected with or incidental to the foregoing.

[Long title as substituted by section 37 of Act 1 of 1996.]

[Date of commencement: 1st September, 1969.]

PART I

PRELIMINARY

                       1    Short title

This Act may be cited as the Medicines and Allied Substances Control Act [Chapter 15:03].

[Section as amended by section 2 of Act 1 of 1996.]

                       2    Interpretation

(1) In this Act—

“advertisement”, in relation to any medicine, means any written, pictorial, visual or other descriptive matter or verbal statement or reference—

• appearing in any newspaper or other publication; or
• appearing on any television or cinematograph film; or
• distributed to members of the public; or
• brought to the notice of members of the public in any manner whatsoever; which is intended to promote the sale of that medicine ;

“analyst” means a person who is an analyst, pathologist or person having a special knowledge of the action and application of medicines appointed in terms of paragraph (b) of subsection (1) of section sixty-five for the purpose of the testing, examination or analysis of medicines in terms of this Act;

[Definition as amended by section 3 of Act 1 of 1996.]

“approved name”, in relation to a medicine , means the internationally recognized non-proprietary name of that medicine or any other name approved by the Authority;

“Authority” means the Medicines Control Authority of Zimbabwe established by section three;

[Definition inserted by section 3 of Act 1 of 1996.]

“clinical trial” means a systematic study in human beings or animals in order to establish the efficacy of, or to discover or verify the effects or adverse reactions of medicines, and includes a study of the absorption, distribution, metabolism and excretion of medicines; “Council” ...

[Definition repealed by section 3 of Act 1 of 1996.]

“dental practitioner” means a person registered as such under the Health Professions Act [Chapter 27:19];

[Definition amended by section 151 of Act 6 of 2 000.]

“Director-General” means the Director-General of the Authority appointed in terms of section twenty-six;

[Definition inserted by section 3 of Act 1 of 1996.]

“Director of the Laboratory” means the Director of the Laboratory appointed in terms of section twentyfive C;

[Definition inserted by section 3 of Act 1 of 1996.] “drug” ...

[Definition repealed by section 3 of Act 1 of 1996.]

“fixed date” …

[Definition inserted by section 3 of Act 1 of 1996 - all references to fixed date revised to refer to 1st August, 1997]

“former Council” means the Drugs Control Council which was in existence in terms of this Act immediately before the 1st August, 1997;

[Definition inserted by section 3 of Act 1 of 1996.]

“inspector” means a person appointed in terms of paragraph (a) of subsection (1) of section sixty-five to be an inspector;

“Laboratory” means the Zimbabwe Regional Medicines Control Laboratory referred to in section twenty-five

A;

[Definition inserted by section 3 of Act 1 of 1996.]

“manufacture” includes compound, process or pack for sale but does not include the compounding of a medicine by a medical practitioner, dental practitioner, veterinary surgeon or pharmacist if that medicine

—

• has not been advertised for sale in Zimbabwe; and
• does not contain any component the sale of which is prohibited by this Act; and
• is supplied for the treatment of a particular person or animal;

“medical practitioner” means a person registered as such under the Health Professions Act [Chapter 27:19];

[Definition amended by section 151 of Act 6 of 2000.]

“medicine”, subject to section seventy-five, means any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in—

• the diagnosis, treatment, mitigation or prevention of disease or any abnormal physical or mental state or the symptoms thereof in man or in animals; or
• restoring, correcting or modifying any physical, mental or organic function in man or in animals;

[Definition inserted by section 3 of Act 1 of 1996.]

“member” means a member of the Authority;

“Minister” means the Minister of Health and Child Welfare or any other Minister to whom the President may, from time to time, assign the administration of this Act;

“package” means anything in or by which any medicine is enclosed, covered, contained or packed; “pharmaceutical chemist” ...

[Definition repealed by section 3 of Act 1 of 1996.]

“pharmacist “ means a person registered as such under the Medical, Dental and Allied Professions Act [Chapter 27:08];

[Definition inserted by section 3 of Act 1 of 1996.]

“possess” includes keep, store or have in custody or under control or supervision;

“Register” means the Medicines Register kept in terms of section twenty-seven;

“registered” means registered in terms of this Act;

“registered name”, in relation to a registered medicine , means the approved name or generic name under which that medicine is registered; “Registrar” ...

[Definition repealed by section 3 of Act 1 of 1996.]

“Secretary” means the Secretary of the Ministry for which the Minister is responsible;

“sell” means sell by wholesale or retail and includes— (a)        import;

• export;
• advertise, label, prepare, expose, offer or possess for sale;
• smuggle, administer, hawk, supply, barter or dispose of to any person;
• distribute, deliver or transmit by way of gift or sample or in any other way whatsoever; “specified drug” ...

[Definition repealed by section 3 of Act 1 of 1996.]

“specified medicine” means a medicine which is declared in terms of section twenty-eight to be a specified medicine for the purposes of this Act if the declaration is in operation in terms of subsection (2) of that section in relation to that medicine;

[Definition inserted by section 3 of Act 1 of 1996.]

“veterinary medicine” means any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in—

• the diagnosis, treatment, mitigation or prevention of disease or abnormal physical or mental state or the symptoms thereof in an animal; or
• restoring, correcting or modifying any physical, mental or organic function in an animal.

“veterinary surgeon” means a person registered as such under the Veterinary Surgeons Act [Chapter 27:15].

(2) Where a medicine is required by this Act to be labelled with any information, such information shall be written, printed or otherwise marked on a label which is— (a) attached or affixed to the package of that medicine ; or (b) packed with and refers to that medicine.