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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
- Short title.
PART II
MEDICINESCONTROL AUTHORITY
- Establishment of Medicines Control Authority of Zimbabwe.
3A Succession to former Council.
- Constitution of Authority.
- Conditions of office of members.
- Disqualification for appointment as member.
- Vacation of office of member.
- Minister may require member to vacate office or suspend him.
- Filling of vacancies on Authority.
- Meetings and procedure of Authority.
- Committees of Authority.
- Remuneration and expenses of members of Authority or committee.
12A. Disclosure of interest of members of Authority and committees.
- Funds, accounts and audit.
13A. Annual report of Authority.
- Powers of Authority.
14A Pensions benefits for certain employees of Authority.
- Validity of decisions and acts of Authority.
PART III
CLINICALTRIALS
- Conduct of clinical trials.
- Application for conduct of clinical trials.
- Director-General to submit applications to Authority.
- Conditions for conduct of clinical trials.
- Consents for clinical trials.
- Supply of information prior to clinical trials etc.
- Council’s power to stop or suspend clinical trials.
- Monitoring of clinical trials by Authority.
- Reports on clinical trials.
- [Repealed].
PART IIIA
ZIMBABWEREGIONALMEDICINESCONTROL LABORATORY
25A. Transfer of Laboratory to Authority. 25B. Functions of Laboratory.
25C. Director of Laboratory.-
PART IV
REGISTRATION OFMEDICINES
- Director-General of Authority.
- Medicines Register.
- Declaration of specified medicines.
- Sale of specified medicines.
- Registrability of medicines.
- Applications for registration of medicines.
- Lapsing of application for registration of medicine.
- Registration of medicines.
- Cancellation and variation of conditions of registration.
- Notifications in professional journals.
- Medicines to be labelled.
- [Repealed]
- Prohibitions, controls and restrictions in respect of medicines, veterinary medicines and certain substances, devices and articles.
- Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to Authority.
- Advertisement of medicines.
- 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
- Interpretation in Part VI.
- Register of licensed premises and persons.
- Premises and persons to be licensed.
- Application for licence.
- Licensing of premises.
- Licensing of persons.
- General disqualifications for licences.
- Validity and renewal of licences.
- Cancellation, suspension, alteration and variation of licences.
PART VII
APPEALS 62. Appeals.
PART VIII
GENERAL
- Compounding or dispensing of medicines and veterinary medicines.
- Exemption of Authority from liability.
- Appointment of inspectors and analysts for purposes of this Act.
- Powers of inspectors.
- Offences and penalties.
- [Repealed]
- Special jurisdiction of magistrates courts.
- Procedure and evidence.
70A. Registers as evidence.
- Special defence for contravention of section 39.
- Act or omission by manager, agent or employee.
- Preservation of secrecy. 73A. Laboratory fees.
- 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.
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