MEDICINES AND ALLIED SUBSTANCES ACT

Arrangement of Sections

PART I
PRELIMINARY

   1.   Short title

   2.   Interpretation

PART II
THE ZAMBIA MEDICINES REGULATORY AUTHORITY

   3.   Continuation and re-naming of Pharmaceutical Regulatory Authority

   4.   Seal of Authority

   5.   Functions of Authority

   6.   Powers of Authority

   7.   Constitution of Board of Authority

   8.   Functions of Board

   9.   Expert Advisory Committee

   10.   Committees

   11.   Delegation of functions of Board

   12.   Director-General

   13.   Immunity

PART III
REGISTRATION AND REGULATION OF PHARMACIES, HEALTH SHOPS AND AGRO-VETERINARY SHOPS

   14.   Prohibition of operation of unregistered pharmacy, health shop or agro-veterinary shop

   15.   Application for certificate of registration

   16.   Issue of certificate of registration

   17.   Rejection of application

   18.   Display of certificate of registration

   19.   Annual return

   20.   Surrender of certificate of registration

   21.   Transfer of certificate of registration

   22.   Amendment of certificate of registration

   23.   Suspension or cancellation of certificate of registration

   24.   Closure of pharmacy

   25.   Loss of certificate of registration

   26.   Management of hospital pharmacies

   27.   Standard of pharmacy practice

   28.   Dispensing certificate

   29.   Agro-veterinary shop permit

   30.   Health shop permit

   31.   Register of Pharmacies, Agro-veterinary Shops and Health Shops

   32.   Publication of registered pharmacies, agro-veterinary shops and health shop

PART IV
LICENCES, IMPORT AND EXPORT PERMIT

   33.   Prohibition of manufacture, distribution, etc. medicine or allied substance without pharmaceutical licence

   34.   Pharmaceutical licence

   35.   Import permit

   36.   Export permit

   37.   Additional requirements for import or export for narcotic drugs, psychotropic substances and precursors

   38.   Register of Licences and Permits

PART V
REGISTRATION OF MEDICINES AND ALLIED SUBSTANCES

   39.   Marketing authorisation

   40.   Categories of medicine

   41.   Medicines list

   42.   Prohibition of sale of prescription only medicines without prescription

   43.   Labelling of medicine

   44.   Sale of medicine, etc.

   45.   Advertising of medicines

   46.   Recall of medicine, etc. from circulation

   47.   Monitoring medicine and allied substance

   48.   Register of Marketing Authorisations

PART VI
REGULATION OF CLINICAL TRIALS

   49.   Prohibition of conducting clinical trial without certificate

   50.   Application for clinical trial certificate

   51.   Grant of clinical trial certificate

   52.   Inspection of clinical trial sites

   53.   Register of Clinical Trial Certificate

PART VII
THE NATIONAL DRUG QUALITY CONTROL LABORATORY

   54.   National Drug Quality Control Laboratory

PART VIII
INSPECTIONS

   55.   Inspectors

PART IX
GENERAL PROVISIONS

   56.   Appeals

   57.   Authority to manufacture patented medicine

   58.   General offences

   59.   Prohibition of manufacture, import, export, etc. of sub-standard, counterfeit or adulterated medicine or allied substances

   60.   Prohibition of supply of expired medicine

   61.   Prohibition of deceptive act

   62.   Prohibition of sale, etc. of harmful cosmetics

   63.   Sale and preparation of cosmetics under insanitary conditions

   64.   Standards of cosmetics

   65.   Prohibition of sale of harmful devices

   66.   General penalty

   67.   Offence by body corporate or unincorporated body

   68.   Guidelines

   69.   Regulations

   70.   Repeal of Act No. 14 of 2004

      FIRST SCHEDULE

      SECOND SCHEDULE

AN ACT

to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacies, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.

[Date of Commencement: 22 March, 2013]

Act 3 of 2013.

PART I
PRELIMINARY

1.   Short title

This Act may be cited as the Medicines and Allied Substances Act.

2.   Interpretation

In this Act, unless the context otherwise requires—

"administer" means to give a substance to a human being or animal orally, by injection or by introduction into the body in any other way or by external application, whether by direct contact with the body or not;

"adulterated medicine" means any medicine—

      (a)   consisting in whole or in part of any filthy, putrid, decomposed, deleterious or foreign substance;

      (b)   that is prepared or stored under unsanitary conditions;

      (c)   whose container is composed of any poisons or deleterious substance;

      (d)   that contains a colouring agent that is not prescribed; or

      (e)   that contains any harmful or toxic substance;

"agro-veterinary shop" means a place or premises permitted to sell prescribed veterinary medicinal products and allied substances under the control of a relevant veterinary professional as determined by the Authority;

"allied substances" include acaricides, cosmetics, disinfectants, food supplements, feed additives and supplements, medical and surgical sundries, medical devices and condoms;

"animal" has the meaning assigned to it in the Animal Health Act, 2010;

"animal health facility" has the meaning assigned to it in the Veterinary and Veterinary Para-Professions Act, 2010;

"assemble" in relation to a medicine, means enclosing the medicine or allied substance of the same description in a container before the medicine or allied substance is sold or supplied;

"Authority" means the Zambia Medicines Regulatory Authority provided for under section 3;

"biological product" includes vaccine, immune sera, anti-toxin, anti-venom, toxoid, blood and blood components, allergy products used in the prevention, treatment or cure of disease or condition in human beings and animals synthesised from living organisms or other product;

"Board" means the Board of the Authority constituted under section 7;

"certificate of registration" means the certificate of registration of a pharmacy;

"Chairperson" means the person appointed as Chairperson of the Board under section 7;

"clinical trial" means the systematic study involving human participants or animal subjects that serves to answer the efficacy of a medicine, biological products or method of prevention or treatment;

"committee" means a committee of the Board established under section 10;

"cosmetic" means any substance manufactured or sold for use in cleansing, beautifying or altering the hair, eyes, teeth or nails, or complexion of the skin, and includes deodorants and perfumes;

"counterfeit medicine or allied substance" means a medicine or allied substance which is deliberately or fraudulently mislabeled or misrepresented with respect to identity or source, or a medicine or allied substance which—

      (a)   has wrong ingredients;

      (b)   contains active ingredients or not;

      (c)   has insufficient or excess active ingredients; or

      (d)   has fake packaging;

"deal" means to sell or offer for sale or trade by wholesale;

"dental surgeon" means a person registered as such under the Health Professions Act, 2009;

"Director-General" means the person appointed as Director- General under section 12;

"dispense" means to count, measure or decant a medicine from a bulk supply or to prepare, mix, dissolve or supply a medicine for the treatment of a person or animal, but does not include the administration of medicine;

"distribute" means the division and movement of pharmaceutical products from the premises of the manufacturer of the products or from another central point or to an intermediate point or to the end user by means of any method of transport;

"Expert Advisory Committee" means the Expert Advisory Committee established under section 9;

"former Authority" means the Pharmaceutical Regulatory Authority established under the repealed Act;

"health facility" has the meaning assigned to it in the Health Professions Act, 2009;

"health shop" means a place or premises permitted to sell a prescribed list of medicine by the Authority, under the control of an authorised person as determined by the Authority;

"hospital" has the meaning assigned to it in the Health Professions Act, 2009;

"hospital pharmacy" means a pharmacy which is part of a health facility;

"ingredient" in relation to the manufacture or preparation of a substance, includes anything which is the sole active or inactive ingredient of that substance;

"inspector" means a person appointed as an inspector under section 55;

"label" means to affix to, or otherwise display on, a container or package, a notice describing the ingredients and contents thereof;

"Laboratory" means the National Drug Quality Control Laboratory established under section 54;

"manufacture" in relation to a medicine or allied substance, includes any process carried out in the course of making that medicine or allied substance, but does not include the process of—

      (a)   dissolving or dispensing a product in, or diluting or mixing it with, some other substance for purposes of administering it; or

      (b)   the incorporation of a medicine in any animal feed;

"marketing authorisation" means the authorisation granted, under section 39, for the placement of a medicine or allied substance on the market;

"medical device" includes an instrument, apparatus, component, part or accessory manufactured or sold for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or the symptoms of the disease, or abnormal physical state in human beings or animals;

"medical doctor" means a person registered as a medical doctor under the Health Professions Act, 2009;

"medicine" means human medicine, veterinary medicine, medicinal product, herbal medicine or any substance or mixture of substances for human or veterinary use intended to be used or manufactured for use for its therapeutic efficacy or for its pharmacological purpose in the diagnosis, treatment, alleviation, modification or prevention of disease or abnormal physical or mental state or the symptoms of disease in a person or animal;

"medicinal product" means any substance or combination of substances which may be administered to human beings or animals in order to make a medical diagnosis or to restore, correct or modify the physiological functions in human beings or animals;

"member" means a person appointed as a member of the Board under section 7;

"midwife" means a person registered as a midwife under the Nurses and Midwives Act, 1997;

"nurse" means a person registered as a nurse under the Nurses and Midwives Act, 1997;

"package" means anything in or by which any medicine, herbal medicine, therapeutic substance or allied substance is enclosed, covered or contained, and includes primary and secondary packaging;

"pharmaceutical licence" means the licence issued, under section 34, to a person to manufacture, distribute or deal in a medicine or allied substance;

"pharmacist" means a person registered as a pharmacist under the Health Professions Act, 2009;

"pharmacy" means a drugstore, druggist, chemist or any business or premises registered as such under section 16;

"prescription" means a written direction given by an authorised prescriber directing that a stated amount of a medicine specified in the direction be dispensed for the person or animal named in the direction;

"prescription only medicine" means a medicine dispensed only on prescription;

"Register" means, in relation to—

      (a)   pharmacies, health shops and agro-veterinary shops, the Register provided for under section 31;

      (b)   licences and permits, the Register of Licences and Permits provided for under section 38;

      (c)   marketing authorisation, the Register of Marketing Authorisations provided for under section 48; and

      (d)   clinical trial certificates, the Register of Clinical Trial Certificates provided for under section 53;

"repealed Act" means the Pharmaceutical Act, 2004;

"sell" means to offer for sale, expose for sale, have in possession for sale, and supply, whether the supply is made for consideration or not;

"substance" means any natural or artificial material, whether in the form of solid, liquid, gas, vapour or any active or inactive substance or pharmaceutical ingredient;

"sub-standard medicine" means a product whose composition and ingredients do not meet the approved quality specifications and which may be consequently ineffective and often dangerous to the patient;

"veterinary surgeon" means a person registered as a veterinary surgeon under the Veterinary and Veterinary Para-Professions Act, 2010; and

"Vice-Chairperson" means the person elected as Vice-Chairperson under section 7.

PART II
THE ZAMBIA MEDICINES REGULATORY AUTHORITY

3.   Continuation and re-naming of Pharmaceutical Regulatory Authority

   (1) The Pharmaceutical Regulatory Authority established under the repealed Act shall continue to exist as if established under this Act and is hereby renamed the Zambia Medicines Regulatory Authority.

   (2) The Authority shall be a body corporate with perpetual succession and a common seal, capable of suing and of being sued in its corporate name, and with power, subject to the provisions of this Act, to do all such acts and things as a body corporate may, by law, do or perform.

   (3) The provisions of the First Schedule apply to the Authority.

4.   Seal of Authority

   (1) The seal of the Authority shall be such device as may be determined by the Authority and shall be kept by the Director- General.

   (2) The affixing of the seal shall be authenticated by the Chairperson or the Vice Chairperson and the Director-General or any other person authorised in that behalf by a resolution of the Board.

   (3) Any contract or instrument which if entered into or executed by a person not being a body corporate, would not be required to be under seal, may be entered into or executed without seal on behalf of the Authority by the Director-General or any other person generally or specifically authorised by the Board in that behalf.

   (4) Any document purporting to be a document under the seal of the Authority or issued on behalf of the Authority shall be received in evidence and shall be deemed to be so executed or issued, as the case may be, without further proof, unless the contrary is proved.

5.   Functions of Authority

The functions of the Authority are to—

      (a)   grant pharmaceutical licences and marketing authorisations;

      (b)   inspect any premises used for the purpose of manufacturing, distribution, sale, importation or exportation of medicines or allied substances or for any other purposes regulated under this Act;

      (c)   regulate and control the manufacture, importation, exportation, distribution and sale of medicines and allied substances;

      (d)   regulate and control the advertising and promotion of medicines and allied substances;

      (e)   register and regulate pharmacies, health shops and agro-veterinary shops;

      (f)   in consultation with the relevant professional bodies, establish, maintain and develop standards for the operation of pharmacies, health shops and agro-veterinary shops;

      (g)   serve and protect the public interest in all matters relating to the sale of medicines and allied substances;

      (h)   regulate and monitor the conduct of clinical trials;

      (i)   establish, maintain and enforce standards relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances;

      (j)   conduct post-marketing surveillance;

      (k)   establish, maintain and enforce standards for drug quality control laboratories;

      (l)   advise the Minister on policies relating to the regulation and control of medicines and allied substances;

      (m)   collaborate with corresponding medicines regulatory authorities in other countries;

      (n)   in consultation with relevant research institutions, determine national priorities in pharmaceutical research; and

      (o)   do all such things as are connected with, or incidental to, the functions of the Authority under this Act.

6.   Powers of Authority

The Authority may—

      (a)   direct any pharmacy, health shop or agro-veterinary shop or any person providing services relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances to deliver the services in such manner as to ensure compliance with this Act;

      (b)   require any pharmacy, health shop or agro-veterinary shop, manufacturer, wholesale dealer, distributor, importer, exporter or person to submit such information and records as may be necessary to enable the Authority to monitor the performance of the pharmacy, health shop, agro-veterinary shop, manufacturer, wholesale dealer, distributor, importer or exporter;

      (c)   consider any matter relating to the manufacture, importation, exportation, distribution and sale of medicines and allied substances and make representations thereon to the Minister;

      (d)   declare certain substances as medicine; and

      (e)   determine the method of sale of medicines.

7.   Constitution of Board of Authority

   (1) There is hereby constituted a Board of the Authority which shall consist of the following part-time members appointed by the Minister—

      (a)   a representative of the Pharmaceutical Society of Zambia;

      (b)   a representative of the Medical Association of Zambia;

      (c)   a representative of the Health Professions Council of Zambia;

      (d)   a representative of the department of pharmacy of a higher education institution;

      (e)   a representative of the School of Veterinary Medicine of a higher education institution;

      (f)   a representative of the pharmaceutical industry;

      (g)   a representative of the Ministry responsible for health;

      (h)   a representative of the Ministry responsible for commerce;

      (i)   a representative of the Ministry responsible for veterinary services;

      (j)   a representative of the Ministry responsible for community development;

      (k)   a representative of the Veterinary Association of Zambia;

      (l)   a representative of the Attorney-General; and

      (m)   two other persons.

   (2) The members referred to in subsection (1) shall be recommended by their respective institutions.

   (3) The Minister shall appoint the Chairperson of the Board from amongst the members.

   (4) The members shall elect the Vice-Chairperson of the Board from amongst themselves.

   (5) A person shall not be nominated or appointed as a member of the Board if the person—

      (a)   is an undischarged bankrupt;

      (b)   has been convicted of an offence involving fraud or dishonesty;

      (c)   has been convicted of an offence under any written law and sentenced to imprisonment for a period exceeding six months without the option of a fine;

      (d)   has been found guilty of professional misconduct; or

      (e)   is an employee of the Authority.

8.   Functions of Board

The Board shall, subject to the provisions of this Act, perform the following functions—

      (a)   review the policy and strategic plan of the Authority;

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