AFRICAN UNIONUNION AFRICAINEUNIÃO AFRICANA
Addis Ababa, ETHIOPIA P. O. Box 3243 Telephone: 011-551 7700 Fax: 011-551 7844
Website: www.africa-union.org

AFRICAN UNION MODEL LAW ON MEDICAL PRODUCTS REGULATIONP a g e |1

Preamble
We Member States of the African Union:
RECOGNISING that the right to health is an international human right as expressed in
Article 25 of the Universal Declaration of Human Rights and Article 12 of theInternational Covenant on Civil and Political Rights;
REAFFIRMING the right to health guaranteed by Article 16 of the African Charter;
CONSCIOUS of the obligation of states to protect the health of their people towards theattainment of the highest possible physical and mental wellbeing of all;
BEARING IN MIND that it is the duty of the State to regulate medical products and toprovide adequate mechanisms for guaranteeing their quality, safety, and efficacy;
MINDFUL of the need to promote and protect the public health of citizens by developing
regulatory systems that satisfy minimum regulatory capacity;
FURTHER MINDFUL of the need to implement the policies, legislation, guidelines andrelated standards as recommended by the World Health Organization (WHO);REITERATING Assembly Decision {Assembly/AU/Dec.55(IV)} taken during the Abuja
Summit in January 2005 which requested
the AU Commission to develop a
Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of the New
Partnership for Africa’s Development-NEPAD;
FURTHER REITERATING the 19th African Union Assembly decision {Assembly
AU/Dec.442(XIX)} on Roadmap for Shared Responsibility and Global Solidarity for the
AIDS, TB and malaria response in Africa which among others, emphasises the need toaccelerate and strengthen regional medicines regulatory harmonization initiatives andlay foundations for a single African regulatory agency;
RECALLING Executive Council Decision, {EX.CL/Dec.857 (XXVI)} which endorsed themilestones for the establishment of a single medicines regulatory agency in Africa within
the context of the African Medicines Regulatory Harmonization (AMRH) Programme,
which is part of the framework of the PMPA, and contributes to the development of ahealthy human capital for the fulfilment of the African Union’s human and social
development as enshrined in the Agenda 2063;
CONCERNED that the proliferation of Substandard/Spurious/Falsified/Falselylabelled/Counterfeit (SSFFC) medical products on the continent poses a major publichealth threat and NOTES that despite the importance of health legislation and medical
product regulation in ensuring national public health, regulatory systems of many Africancountries remain inadequate;
RECOGNIZING the importance of harmonization of policies, legislation and legal
frameworks relating to medical products through Regional Economic Communities

P a g e |2RECs) and the African Union as an effective way of ensuring access to medical
products that are safe, efficacious, and of assured quality to the African population;
CONVINCED that the adoption and domestication of a Model Law on medical products
regulation in Africa is essential for the creation of a harmonized regulatory environmenton the continent;
HAVE AGREEDTo adopt the following African Union Model Law on Medical Products Regulation

P a g e |3

African Union Model Law on Medical Products Regulation

P a g e |4

CONTENTSPART I: GENERAL PROVISIONS .................................................................................................... 6
Article 1: Short Title.............................................................................................................................. 6
Article 2: Scope of Application and other laws ................................................................................ 6
Article 3: Purpose ................................................................................................................................. 6
Article 4: Definitions ............................................................................................................................. 6
PART II: ADMINISTRATION AND GOVERNANCE ..................................................................... 11
Article 5: Establishment of the Agency/Authority .......................................................................... 11
Article 6: Powers of the Agency/Authority ...................................................................................... 11
Article 7: Functions of the Agency/Authority .................................................................................. 12
Article 8: Establishment of the Board .............................................................................................. 12
Article 9: Functions of the Board ...................................................................................................... 13
Article 10: Management of the Agency/Authority .......................................................................... 13
Article 11: Technical Committees .................................................................................................... 14
Article 12: Funding of the Agency/Authority ................................................................................... 14
PART III: NATIONAL REGULATORY SYSTEM ........................................................................... 15
Article 13: Marketing Authorisation .................................................................................................. 15
Article 14: Consideration of Applications for Marketing Authorisation ....................................... 16
Article 15: Licensing of Manufacturers, Importers, Exporters, Wholesalers and Distributors 16
Article 16: Post-Marketing Surveillance and Safety Monitoring .................................................. 17
Article 17: Regulatory Inspection and Enforcement...................................................................... 18
Article 18: Control of Clinical Trials of Medical Products ............................................................. 20
Article 19: Control of Promotion and Advertisement of Medical Products................................. 20
Article 20: Quality Control Laboratory ............................................................................................. 20
Article 21: Scheduling, Classification and Control of Medical Products .................................... 21
Article 22: Prohibition of Substandard/Spurious/Falsified/Falsely-labelled/Counterfeit(SSFFC) Medical Products ............................................................................................................... 22
PART IV: OFFENCES AND LEGAL PROCEEDINGS ................................................................. 22
Article 23: Offences............................................................................................................................ 22
Article 24: Penalties ........................................................................................................................... 23
PART V: ADMINISTRATIVE APPEALS PROCEDURES ............................................................ 23
Article 25: Establishment of an Administrative Appeals Committee........................................... 23
Article 26: Administrative Appeals Procedures.............................................................................. 24

P a g e |5PART VI:

INTERNATIONAL COOPERATION AND HARMONISATION OF

REGULATION OF MEDICAL PRODUCTS.................................................................................... 24
Article 27: International Cooperation ............................................................................................... 24
Article 28: Regulatory Harmonisation Initiatives ............................................................................ 24
Article 29: Monitoring and Evaluation of National Regulatory System....................................... 25
PART VIII: REGULATIONS AND GUIDELINES ........................................................................... 26
Article 30: Regulations....................................................................................................................... 26
Article 31: Guidelines ......................................................................................................................... 26
PART IX: MISCELLANEOUS PROVISIONS ................................................................................. 26
Article 32: Declaration and Conflict of Interests ........................................................................... 26
Article 33: Restriction of Liability ...................................................................................................... 26
Article 34: Protection of and Access to Information ...................................................................... 27
Article 35: Regulation of Other Related Products ......................................................................... 27
PART X: COMMENCEMENT .......................................................................................................... 27

P a g e |6PART I: GENERAL PROVISIONS
Article 1: Short Title
1) The Short Title of this Model shall be‘’Law on Medical Products Regulation”
Article 2: Scope of Application and other laws
1) This law shall apply to all medical products alongside existing laws related toregulation of medical products.
2) In the event of any conflict with any other law on medical products the provisionsof this law shall prevail.
3) Provisions of any existing law in conflict with this law shall to the extent of theinconsistency stand repealed or amended.
Article 3: Purpose
The purpose of this Law is to establish an effective and efficient system of medical
products regulation and control and ensure that such products meet required standardsof safety, efficacy and quality.
Article 4: Definitions
In this Law, unless the context requires otherwise requires:“advertisement” in relation to a medical product, means any pictorial, visual orotherwise descriptive matter or verbal statements or references:a) appearing in a print or electronic publication or medium;b) broadcast on television or radio; orc) brought to the notice of members of the public in any manner whatsoever,which is intended to directly or indirectly advise of the existence and benefits of a
medical product, and “advertise” has a corresponding meaning;“agency/authority” means the National Regulatory Agency/Authority as stated in thislaw;“appointing or supervising authority” means the governmental body, minister orofficial to which the [National] Medical Products Regulatory Agency/Authority is
accountable;“board” means the Board of the National Regulatory Agency/Authority as constituted
under this law;“clinical trial" means any systematic study on pharmaceutical products in humansubjects, whether in patients or other volunteers, in order to discover or verify the effectsof, and/or identify any adverse reaction to, investigational products, and/or to study theabsorption, distribution, metabolism and excretion of the products with the object ofascertaining their efficacy and safety;P a g e |7“code of conduct” means an official document of the Agency/Authority describing the
behaviour expected of staff, members of the Board and Technical Committees, andcontractors;“compassionate use” means access to unregistered medical products in special or
emergency situations. In general, either the patient has a severe or life-threatening
illness and existing therapy has failed, or the disease is a rare one for which specialist
medicines do not have a local marketing authorization. The medical products are still
experimental, or at any rate unproven, and the government is not obliged to fund their
supply;“dispense” means to prepare and supply to a patient a course of therapy on the basisof a prescription;“dispenser” means anyone who dispenses medicines. It is specifically used to mean
anyone who is not a graduate pharmacist but is trained to dispense medications,maintain stock records and assist in procurement activities;“distribution” means division and movement of medical products from the premises ofthe manufacturer of such products, or another central point, to the end user thereof, or to
an intermediate point by means of various transport methods, via various storage and/or
health establishments;“ethics committee/institutional review board” means a multidisciplinary body
responsible for reviewing biomedical research for safeguarding the dignity, rights, safety,
and well-being of all actual or potential research participants;“export” includes to deliver or supply within the country for dispatch to a destination
outside of the country;“harmonisation” means alignment or adjustment of differences and inconsistencies
among different laws, regulations, methods, procedures, schedules, specifications, or
systems of National Medical Products Regulatory Agencies/Authorities;"import" means bringing into the national territory whether on one’s body, by land, sea
or air with the intent to distribute, dispense and retail and consume;“information management system” means database and transaction management
system that is designed to facilitate the storage, organization, and retrieval of
information within the Agency/Authority;“inspection” means an officially conducted examination (i.e. review of the conduct of
the trial, including quality assurance, personnel involved, any delegation of authority andaudit) by relevant authorities at the site of investigation and/or at the site of the sponsor
in order to verify adherence to Good Clinical Practice (GCP) and Good Laboratory
Practice (GLP) as set out in this document;“inspector” means a person authorized to perform inspection activities by the [National]
Medical Products Regulatory Agency, pursuant to this Law;P a g e |8“interchangeable pharmaceutical product” means apharmaceutical product which istherapeutically equivalent to a reference product;“manufacture” means all operations of purchase of materials and starting materials,
preparation of the active pharmaceutical ingredient (API) and of the pharmaceuticalproduct, including packaging and repackaging, labelling and re-labelling, quality control,
release, storage and distribution and the related controls.
“market”
includesavarietyofsystems, institutions, procedures, social
relations and infrastructures for medical products sale, and barter or exchange or supply
or dispose of to a person;“marketing authorization” means a legal document issued by the competent
Agency/Authority for the purpose of marketing or free distribution of a product which has
been approved after evaluation for safety, efficacy and quality.
‘‘medical device” means any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or other similar or related
article:a) intended by the manufacturer to be used, alone or in combination, for humans or
animals for:(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an
injury;(iii) investigation, replacement, modification or support of the anatomy or of aphysiological process;(iv) supporting or sustaining life;(v) control of conception;(vi) disinfection of medical devices; or(vii) providing information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body; andb) which does not achieve its primary intended action in or on the human or animal
body by pharmacological, immunological or metabolic means, but which may beassisted in its intended function by such means;.
“medical products” include medicines, vaccines, diagnostics and medical devices.
“medicine” means any substance or mixture of substances used or purporting to besuitable for use or manufactured or sold for use in:a) the diagnosis, treatment, mitigation, modification or prevention of disease,abnormal physical or mental state or the symptoms thereof in humans; orb) restoring, correcting or modifying any somatic or psychic or organic function inhumans, and includes any veterinary medicine;“minister” means the Minister responsible for health matters;

P a g e |9“mutual recognition” means the acceptance of one National Medical Products
Regulatory Agency’s certification of standards and procedures for medical productregulation by another National Medical Products Regulatory Agency;“other regulated products” may include complementary medicines, cosmetics, foodand related products;“pharmacist” means a holder of a degree or diploma in pharmacy from a recognizedhigher institution of learning and is registered or licensed to practise pharmacy;“pharmacovigilance” means the science and activities relating to the detection,assessment, understanding and prevention of adverse effects or any other drug-related
problem;“pharmacy” means a science and technique of producing and dispensing medical
products that links health science with chemical science and aims to ensure the safeand effective use of medical products;“prescribe” means issue an instruction in writing a certain kind of medical treatment ,ora particular medicine only upon prescription, for a specific patient or animal by alicensed medical practitioner, a dentist or a veterinary Surgeon for the collection of adrug or treatment from a dispensing unit;“prohibited medical product” means medical products with toxicity or side-effects thatoutweigh their therapeutic usefulness, so that public health and welfare are protected byprohibiting their production, manufacture, export, import, trade, distribution, supply,
possession or use, except in amounts required for medical or scientific research.
Prohibited drugs will be determined by the national or supranational
registration/licensing authority;“promotion” means all informational and persuasive activities by manufacturers anddistributors, the effect of which is to induce the prescription, supply, purchase, and/or
use of medicinal products (For the purposes of this law, promotion includes advertising);“qualified technical person” means a person responsible for the release of batches offinished product for sale. In certain countries the batch documentation of a batch offinished product must be signed by an authorized person from the production
department and the batch test results by an authorized person from the quality control
department for batch release;“Quality Management System” means a set of policies, processes and procedures
required for planning and execution of the core business area of an Agency/Authority;“reference product” means a medical product which has been granted a marketing
authorisation by a competent Agency/Authority on the basis of a complete dossier, thatis, with the submission of quality, pre-clinical and clinical data;"scheduled substance" means any medicine or other substance prescribed under
Article 21;

P a g e | 10

“sell” means to sell by wholesale or retail, and includes to import, offer, advertise, keep,
expose, transmit, consign, convey or deliver for sale or authorise, direct or allow a sale,or prepare or possess for purposes of sale, and barter or exchange or supply or disposeof to a person, whether for a consideration or otherwise, and also includes offering or
attempting to sell, or receiving for sale, or having in possession for sale, or exposing for
sale, or sending or delivering for sale, or causing or allowing to be sold, offered or
exposed for sale, and “sale” and “sold” have a corresponding meaning;“storage” means storing of medical products up to their point of use;“substandard/spurious/falsified/falsely-labelled/counterfeit
medicalproduct”
means the like-named products as defined by the World Health Organisation;“supply” means having in possession for the purpose of supply;“wholesaler” means sale of goods in large quantities, as for resale by a retailerP a g e | 11

PART II: ADMINISTRATION AND GOVERNANCE
Article 5: Establishment of the Agency/Authority
1) The [National] Medical Products Regulatory Agency/Authority hereafter ‘the
Agency/Authority’ is hereby established as a juristic person.
2) The national Agency/Authority shall be an autonomous body.
3) The national Agency/Authority shall be functionally/financially accountable to theline ministry.
4) The Agency/Authority shall be composed of:a) The Board of the Agency/Authorityb) The Head of the Agency/Authorityc) The Technical committees of the Agency/Authority

Article 6: Powers of the Agency/Authority
The Agency/Authority shall have the powers to:1) formulate regulations and guidelines for regulating the manufacture, import andexport, distribution, sale and use of medical products;
2) grant or withdraw authorisation for conducting clinical trials of medical products;
3) grant or withdraw marketing authorisation for medical products subject toappropriate conditions and revise such conditions for marketing authorisation asnecessary;4) recall medical products from the market;5) grant or withdraw licenses to manufacturers, wholesalers, retailers, importers,
exporters and distributors;6) investigate conduct related to the manufacture, import, export
distribution, sale and use of medical products;

storage,7) levy, collect and utilize fees for services rendered;8) prescribe the standards appropriate for new medical products; new uses,
dosages, and formulations of existing medical products; and such othercategories as may be appropriate;9) institute administrative, civil and/or criminal proceedings;
10) exercise such other powers as necessary for the performance of its functions.

P a g e | 12

Article 7: Functions of the Agency/Authority
The Agency/Authority shall have among others, the following functions to:1) regulate the manufacture, import and export, storage, distribution, sale and use of
medical products;2) regulate, monitor and inspect personnel and premises that are involved in the
manufacture, import and export, storage, distribution, sale, use and disposal of
medical products;3) maintain a register of medical products for which marketing authorisation has
been granted;4) regulate clinical trials of medical products;5) test medical products regulated under this law;6) conduct post-marketing surveillance of safety and quality of medical products;7) regulate the promotion, advertising and marketing of medical products;8) regulate the use of unregistered medical products for trial purposes or forcompassionate use;9) disseminate information on the quality and safety of medical products to healthprofessionals and the public;10) disseminate information on medical products to health professionals and to the
public in order to promote their responsible use;11) collaborate with other national, regional and international institutions on medical
products regulation;12) perform such functions as may be assigned by the Board.

Article 8: Establishment of the Board
1) The Board of the Agency/Authority is hereby established.
2) The Board of the Agency/Authority and its Chairperson shall be appointed by theappointing authority, under terms to be determined by regulation.
3) The Board shall consist of at least nine but not more than eleven members, toinclude the following:a) five members who each have expertise in at least one of the following:medicine, pharmacy, nursing, veterinary medicine and public health;b) one member appointed on account of his or her knowledge of the law;P a g e | 13c) one member appointed on account of his or her knowledge of financial
matters and/ or accounting;d) one representative from the pharmaceutical industry associatione) one representative from civil society or the community.

Article 9: Functions of the Board
1) The Board shall have the functions to:a) provide strategic guidance to the Agency/Authority in the discharge of its
functions.
b) approve the strategic and annual
Agency/Authority;

work plan and budgetof thec) review the annual reports presented by the Agency/Authority;d) monitor and evaluate activities of the Agency/Authority;e) establish such committees as it deems necessary for the functioning of theBoard;f) recommend persons for appointment as the head of the Agency/Authority to
the appointing authority;g) approve the appointment or removal of senior management officers of the
Agency/Authority;h) perform such functions as maybe assigned by the supervising authority.
2) The Board shall provide the appointing authority with an annual report to betabled in Parliament.

Article 10: Management of the Agency/Authority
1) Appointment of officers of the Agency/Authoritya) The Head of the Agency/Authority shall be appointed by the appointing
authority on recommendation of the Board and shall hold a suitable
qualification in medicine, pharmacy, nursing, veterinary medicine or publichealth.
b) The Head of the Agency/Authority shall be the chief executive officer andshall be accountable to the Board for the management of the business andaffairs of the Agency/Authority.
c) The senior officers of the Agency/Authority shall be appointed by the Boardon the recommendation of the Head of the Agency/Authority;P a g e | 142) Duties and Responsibilities of the Head of the Agency/Authority
The Head of the Agency/Authority shall be responsible for:a) management of the business and affairs of the Agency/Authority;b) implementation of this law governing the activities of the Agency/Authority
and report to the appointing authority through the Board;c) execution of the decisions and directives of the Board and makingperiodic
reports to the Board.
3) Directorates of the Agency/Authority
The Agency/Authority shall have directorates to facilitate execution of its operations andfunctions as it may deem fit, which may include:a. Planning, Monitoring and Evaluation; Research and Statistics.
b. Product Evaluation and Registration.
c. Inspectorate and Law Enforcement.
d. Post-marketing Surveillance.
e. Quality Control.
f.

Harmonisation and International Cooperation.

g. Human Resources, Administration and Finance.

Article 11: Technical Committees
1) The Head of Agency/Authority shall, with the approval of the Board, set up
Technical Committees to facilitate the work of the Agency/Authority as may bedeemed appropriate.
2) The reports of Technical Committees shall form the basis for decision-making by
the Agency/Authority.

Article 12: Funding of the Agency/Authority
1) The funding of the Agency/Authority shall consist of:a) funds appropriated by the State;b) fees received for services rendered;c)income that the Agency/Authority may receive from investments;

P a g e | 15d) grants and donations.
2) The Agency/Authority may, subject to the provisions of any other written law andthe approval of the Minister responsible for finance raise by way of loans fromany source in or outside the country, such money as it may require for thedischarge of its functions.
3) The receipt of funds by the Agency/Authority shall at all times be subject to theobjectives of this law and shall be free from conflict of interest.

PART III: NATIONAL REGULATORY SYSTEM
Article 13: Marketing Authorisation
1) All medical products, circulating in the area of jurisdiction of this law must be
registered and have a valid marketing authorisation and certificate of conformity
unless otherwise exempted.
2) The Agency/Authority may from time to time determine that a medical product or
category of medical products or part of any class or category of medical products
shall be subject to exemption from marketing authorisation in terms of this law.
3) Any such determination shall be published in official government publication by
the head of the Agency/Authority and shall come into operation on the datestipulated in the notice.
4) In the case of a medical product which was available for sale in the area ofjurisdiction of this law immediately prior to the date of publication by which it issubject to marketing authorisation in terms of this law, the provisions of Art. 13 (1)shall come into operation if no application for marketing authorisation of such
medical product is made within the period of twelve months immediately
succeeding that date, on the expiration of that period.
5) The provisions of Art. 13 (1) shall not apply in respect of the sale of any medical
product compounded by a pharmacist for a particular patient in the course ofcarrying professional activities in a quantity not greater than the quantity required
for treatment as determined by an authorised prescriber or the pharmacist if:a) such medical product does not contain any component the sale of which isprohibited by any law or any component in respect of which an application formarketing authorisation has been rejected; andb) the active component of such medical product appears in another medical
product which has been authorised in terms of this law.

P a g e | 16

Article 14: Consideration of Applications for Marketing Authorisation
1) Every application for marketing authorisation of medical products shall be
submitted to the head of the Agency/Authority in a prescribed form and shall beaccompanied by the prescribed particulars, samples of the relevant medical
products, particulars of a qualified technical person and the prescribed application
fee.
2) The Agency/Authority shall prescribe the standards appropriate for new medical
products; new uses, dosages, and formulations of existing medical products;
interchangeable multi-source medicines (otherwise known as genericequivalents); and such other categories as may be appropriate.
3) The Agency/Authority may prescribe standards and procedures for referencing,relying upon or otherwise weighing, the marketing assessments and approvals ofother medical product regulatory authorities or assessment mechanisms.
4) The Agency/Authority shall approve a medical product if it is satisfied;a. that it is suitable for the intended purpose in respect of its quality, safety andefficacy; andb. that marketing authorisation is in the public interest.
5) If the Agency/Authority is not so satisfied it shall notify the applicant in writing of
the reasons why it is not so satisfied and the applicant shall furnish the
Agency/Authority with a response within one month of notification.
6) If no such response is submitted by the applicant within the said period, or if after
consideration of any comments so submitted, the Agency/Authority is still notsatisfied, it shall reject the application.
7) The Agency/Authority shall publish the medicines register in the official
government publication and the official website of the Agency/Authority.

Article 15: Licensing of Manufacturers, Importers, Exporters, Wholesalers andDistributors
1) No person shall manufacture, import, export, supply, store, distribute or sell atwholesale level any medical product, unless the person has been issued with alicence by the Agency/Authority.
2) The conditions of a licence for the manufacture, import, export, wholesale, anddistribution of medical products shall be stipulated in guidelines issued by the
Agency/Authority which shall provide for the issuance, renewal, suspension,
exemptions or exceptions, cancellation and revocation of such licences.

P a g e | 173) Provisions shall be made for all manufacturers, importers, exporters, wholesalersand distributors to comply with Good Manufacturing Practice (GMP) and Good
Distribution Practice (GDP) and any other good practices as stipulated in theguidelines.
4) The supervising authority shall designate ports of entry for medical products
imported into the jurisdiction.
5) The Agency/Authority shall maintain a register of all licensed premises and shall
publish same in the official government publication and the official website of the
Agency/Authority.

Article 16: Post-Marketing Surveillance and Safety Monitoring
The Agency/Authority shall undertake the following functions:1) Pharmacovigilancea. There shall be established a national Pharmacovigilance Programme as afunction of the Agency/Authority to monitor and report on the safety of
medical products.
b. The Programme shall undertake:i) monitoring and analysis of adverse effects or events relating to
products regulated under the Law;ii) identifying and reporting adverse events relating to clinical trials;iii) establishing causality, taking remedial actions, and reporting tointernational safety monitoring systems;iv) appropriate regulatory action when necessary, including but notlimited to revising the marketing authorisation or labelling/warning
requirements of the medical product.
c. The Agency/Authority shall issue guidelines to provide for mandatory
reporting and submission of periodic safety updates by the manufacturers
and distributors, and voluntary reporting by health care professionals and the
public.
2) Quality Monitoring
The Agency/Authority may institute a risk-based testing scheme consisting of samplingof medical products throughout the supply chain, to identify the products most at risk or
likely to be falsified or sub-standard, and shall take appropriate action to protect publichealth, including enforcement measures under this Law.

P a g e | 183) Recall and Withdrawal of Medical Productsa. Whenever the Head of the Agency/Authority finds that any medical productdoes not conform with the standards of identity, strength, quality and purity,or any other requirement specified in the documentation for registration, theHead of the Agency/Authority shall:i) instruct the licensee to discontinue the sale of the remainder of thebatch and, so far as is practicable;ii) recall any portion of the batch already sold.
b. The Agency/Authority shall by order, published in the official government
publication, withdraw and strike off a medical product from the register whichon the latest available scientific evidence are shown to be hazardous to
public health and welfare, or are unsafe, inefficacious or of unacceptable
quality.
c. Upon the occurrence of the event in Art. 16(3)(b) above the Agency/Authority
shall issue notice to the public on medical products withdrawn from themarket.
d. The information shall be disseminated as widely as possible, including
through use of electronic media.
4) Disposal of Medical Products
If the Agency/Authority is of the opinion that it is not in the public interest thata medical product be made available to the public, the Agency/Authority may
direct that such products be withdrawn from the market and disposed of inaccordance with relevant laws and in the manner stipulated in the regulation.

Article 17: Regulatory Inspection and Enforcement
1) Appointment, Authorisation and Recognition of Inspectorsa) The Agency/Authority shall:i.
recommend to the appointing authority the appointment of inspectors with
relevant qualifications in pharmacy or related sciences, and with knowledge
and experience in the inspection of medical products and facilities for the
manufacture, storage, and transportation of medical products; andii.
authorise such inspectors to perform such functions as are stipulated under
this Law.
b) All inspectors appointed under this Law shall have a valid identification during theperformance of their duties.
c) All inspectors appointed under this Law shall be bound by a code of conduct.

P a g e | 19d) Inspectors exercising any powers conferred upon them by this Law shall produce,
on demand, a duly authenticated document confirming their authority to exercise thepower so conferred upon them.
2) Powers of Inspectorsa) Inspectors appointed under this Law may at all reasonable times, enter any;
i.
ii.
iii.
iv.

premises which is on the register of premises;
other premises in respect of any person who is licensed under this Law;premises used in the manufacture, marketing, or distribution of a medical
product that is the subject of a marketing authorisation or licensing request;
premises suspected of or dealing in products regulated in terms of this Law.

b) Inspectors may, at all reasonable times:i.

ii.

examine or inspect any certificate of marketing authorisation, licence, book,electronic information storage system or other document on the premises
and, for that purpose, may do such other things, including the taking ofextracts from documents in the possession of the person as may benecessary to effect the examination or inspection; andtake samples for analysis, or for other examination of any medical products
or of any substance capable of being used in the manufacture of medical
products.

c) Inspectors may:i.

ii.

iii.
iv.

seize and detain any medical products, substances or articles consisting of, or
containing any prohibited substances which they have reasonable cause tosuspect is liable to forfeiture under this Law;
seize and detain any medical products, articles, records or other items whichappear to them to constitute or contain evidence of a contravention of any
provisions under this law;
close the premises found to be in contravention of this Law; andrecommend the institution of administrative, civil and/or criminal proceedings.

3) Search and seizurea) Notwithstanding anything to the contrary contained in any other law, if any
inspectors have reasonable grounds for believing that any person is in unlawful
possession of any prohibited medical product, they may, in terms of a search
warrant: i.
ii.

Enter upon any premises on which such person is believed to be present; orSearch such premises or person; provided that the search is conducted withregard to decency and decorum.

P a g e | 20b) Any prohibited medical product in the possession of such person shall be seized,
and legal proceedings instituted as stipulated in terms of this Law

Article 18: Control of Clinical Trials of Medical Products
1) No person shall conduct clinical trials of medical products in humans without therelevant clearance from the National Ethics Committee/Institutional Review Boardand authorisation of the Agency/Authority
2) All clinical trials shall be conducted in accordance with guidelines issued by the
Agency/Authority, including provisions for Good Clinical Practice (GCP) andGood Laboratory Practice (GLP).
3) A person shall not sell, dispense, supply, assemble or manufacture medical
products for the purpose of clinical trial or medical research on a medical productunless the person is authorised to do so or has been granted an exemption by
the Agency/Authority.
4) The Agency/Authority shall maintain a register of all clinical trials conducted in its
jurisdiction.

Article 19: Control of Promotion and Advertisement of Medical Products
1) All promotion and advertisement of medical products shall be approved by the
Agency/Authority.
2) The Agency/Authority shall issue guidelines relating to the promotion andadvertising of medical products and for an enforceable Code of Marketing
Practice.

Article 20: Quality Control Laboratory
2) There shall be established a National Quality Control Laboratory as part of the
Agency/Authority.
3) The Laboratory shall perform all functions relating to the quality of products
regulated under this Law and shall in particular perform the following:a. analyse medical products and any other regulated products that may bedeemed to constitute a medical product for the purpose of this Law;b. conduct research and training; andc. undertake suchAgency/Authority.

otherfunction

as

shall

be

determined

by

the

P a g e | 21

4) In performing its functions, the Agency/Authority may utilise any accreditedLaboratory within or outside the country for analysis of medical products andattendant functions.
5) The Agency/Authority shall appoint Analysts with relevant qualifications,knowledge and experience in the analysis of medical products and authorisesuch analysts to perform such functions as stipulated under this law.

Article 21: Scheduling, Classification and Control of Medical Products
1) The scheduling and classification of any medical product or substance shall be
determined by the Agency/Authority and published in the official government
publication.
2) Control of medical products shall be based on the scheduling status of
substances, as allocated by the Agency/Authority, as follows:a) Scheduled substances that will be available for general sales, in any retail
outlet;b) Scheduled substances that will be available on the professional advice ofa pharmacist, without a prescription from an authorised prescriber, andavailable only in licensed pharmacies;c) Scheduled substances that will be available only on the prescription of an
authorised prescriber, and dispensed by a pharmacist or licensed
dispenser;d) Scheduled substances that will be available only on the prescription of an
authorised prescriber, and dispensed by a pharmacist or licensed
dispenser, subject to the control measures prescribed in accordance witheither the Single Convention on Narcotic Drugs of 1961, the Convention
on Psychotropic Substances 1971, and the UN Convention against Illicit
Traffic Drug and Psychotropic Substances, 1988;e) Scheduled substances that may not be sold, except in accordance with apermit for the purposes of education, analysis or research, or for individual
patient purposes.
3) Regulations shall be issued by the Minister, after consultation with the
Agency/Authority, dealing with:a. the requirements for a legal prescription for a scheduled substance;b. the recognition of categories of authorised prescribers;c. the licensing of dispensers other than pharmacists;d. the records to be kept in relation to scheduled substances sold on theprofessional advice of a pharmacist or on prescription of an authorisedprescriber;P a g e | 22e. the control measures to be implemented in relation to substancesscheduled as psychotropic or narcotic substances;
f. the process of obtaining permits for access to scheduled substances, forpurposes of education, analysis or research or for individual patients’purposes;g. the licensing of importers, exporters and manufacturers of psychotropic or
narcotic substances and the reporting requirements for such substances.
4) No person shall import, export or manufacture any substances scheduled as a
psychotropic or narcotic substance unless in possession of a specific licenceissued by the Agency/Authority for this purpose.
5) The Agency/Authority shall collect such data as are necessary on the importation,
exportation and manufacture of psychotropic or narcotic substances as are
required for reporting to the International Narcotics Control Board, as outlined inregulations.

Article22:
Prohibitionof
Substandard/Spurious/Falsified/Falselylabelled/Counterfeit (SSFFC) Medical Products

1) No person shall manufacture, import, export, supply, store, distribute or sell any
SSFFC medical products.
2) The Agency/Authority shall issue guidelines stipulating procedures for handling
SSFFC medical products in collaboration with other relevant institutions.

PART IV: OFFENCES AND LEGAL PROCEEDINGS
Article 23: Offences
Any person who:1) Obstructs or hinders any inspector in the exercise of his or her powers or the
performance of his or her duties under this law; or
2) With fraudulent intent, tampers with any sample taken in terms of this law; or
3) Makes any false or misleading statement in connection with any medical product orscheduled substance: a)

In an application for marketing authorization thereof; orb)

In the course of an application for a manufacturing, importing,exporting, storage, sale or distribution license thereof; orc)

In the course of the sale thereof; orP a g e | 23

4) Sells any medical product or scheduled substance upon the container of which a
false or misleading statement in connection with the contents is written; or
5) Generally with regard to medical products and scheduled substances, contravenes
any provision of the following sections, or fails to comply with any condition
imposed thereunder, namely;a)Art. 13;b)Art. 15;c)Art. 16 (3) and 16 (4);d)

Art. 18;e)Art. 19;f)Art. 21;g)Art. 22; or

6) In any other manner, contravenes the provisions of this Law, shall be guilty of an
offence.
Article 24: Penalties
1) Any person who is convicted of an offence referred to in Art. 23 shall be liable toa fine and/or imprisonment.
2) The court convicting any person of an offence under this Law may, upon theapplication of the prosecutor, declare any medicine or scheduled substance inrespect of which the offence has been committed to be forfeited to the State.
3) In addition to any civil and/or criminal penalties imposed on a person in respect ofany contravention in terms of this Law, further administrative penalties may be
imposed as stipulated in Regulations.

PART V: ADMINISTRATIVE APPEALS PROCEDURES
Article 25: Establishment of an Administrative Appeals Committee
1) An Administrative Appeals Committee shall be established by the appointing
authority to hear and determine appeals lodged by persons aggrieved by thedecisions of the Agency/Authority.
2) The Administrative Appeals Committee shall consist of:a) a judge or a legal practitioner who has practiced as such for a period of atleast seven years, and shall be the chairperson of the committee;b) practitioners who are registered as specialists in the area of medicine,
pharmacy, nursing, veterinary medicine and public health, one of whom may
be called upon depending on the nature of the complaint;P a g e | 24c) any other specialist in the area of the appeals.

Article 26: Administrative Appeals Procedures
1) Any person who is aggrieved by a decision of the Agency/Authority may appeal in
the manner, and within the period, prescribed, against such decision, to an
Administrative Appeals Committee.
2) The decision of the Administrative Appeals Committee is final.

PART VI:

INTERNATIONAL COOPERATION AND HARMONISATION OF
REGULATION OF MEDICAL PRODUCTS

Article 27: International Cooperation
1) The Agency/Authority shall cooperate with other national, regional andcontinental medical products regulatory agencies.
2) The Agency/Authority shall share pharmaceutical intelligence on products thatpose public health risks with other agencies at the regional, continental andglobal level.
3) The supervising authority shall take appropriate measures to ensure effective
bilateral, regional and international co-operation to combat the production,
circulation and use of SSFFC medical products, illicit drugs, narcotics andpsychotropic substances.

Article 28: Regulatory Harmonisation Initiatives
1) The Agency/Authority shall participate in regional and continental medical
products regulatory harmonization initiatives.
2) The appointing authority and/or the Agency/Authority, as the case may be, shalltake such measures to ensure effective co-operation with their counterparts inother countries to:a)harmonise registration of medical products, inspections, quality
management systems, information management systems, joint evaluations, joint
inspections and any other regulatory activities as may be appropriate;b)
provide for the use of accredited quality control laboratories within theharmonisation framework;c)provide for the recognition of regional, continental and other international
technical guidelines;P a g e | 25d)provide for harmonisation of the data requirements for evidence of quality,
safety, and efficacy of medical products and the grounds on which authorisation
for distribution shall be granted within the region;e)

provide for mutual recognition of marketing authorisation decisions;f)share summary evaluation and inspection reports;g)participate in common post-marketing surveillance conductedaccordance with nationally and internationally recognised standards;

Inh)provide for cooperation with other regulatory agencies/authorities for the
purpose of strengthening national regulatory capacity;i)establish networks with other regulatory agencies/authorities andcollaborate in protecting public health through enforcement activities;j)establish exchange programmes with other medical products regulatory
agencies/authorities so as to keep abreast of evolving scientific development in
the field of medical products; andk)provide for any necessary legal mechanisms for regulatory harmonisation.

l)

Provide for transparency and information sharing through:i.

Establishment of a quality management system based on common
regional and continental requirements to ensure efficiency;ii.

The creation a national information management system which allows
for sharing information at regional and continental levels inaccordance with national laws, bilateral and multilateral agreements

PART VII: MONITORING AND EVALUATION
Article 29: Monitoring and Evaluation of National Regulatory System
1) The Agency/Authority shall create a monitoring and evaluation system charged
with reviewing and assessing the performance of the Agency/Authority.
2) The Agency/Authority shall prepare periodic reports and present to thesupervising authority through the Board of the Agency/Authority.
3) The supervisory authority shall report on the performance of the Agency/Authority
to relevant governing bodies at regional and continental levels.

P a g e | 26

PART VIII: REGULATIONS AND GUIDELINES
Article 30: Regulations
1) The appointing authority shall have the power to make regulations necessary forthe efficient carrying out of the objectives of this Law, in consultation with the
Agency/Authority.
2) The Agency/Authority shall, within a reasonable time before any regulation ismade under Art. 30 (1), cause the text of the regulation, together with a noticedeclaring the intention to make the regulation to be officially published, inviting
stakeholders to furnish any comments or representations thereon.

Article 31: Guidelines
1) The Agency/Authority shall have the power to issue guidelines necessary for the
carrying out of the objects and purposes of this Law.
2) The Agency/Authority shall, within a reasonable time before any guideline are
made under Art. 31 (1), cause the text of the guideline, together with a noticedeclaring the intention to make the guideline to be officially published, inviting
stakeholders to furnish any comments or representations thereon.

PART IX: MISCELLANEOUS PROVISIONS
Article 32: Declaration and Conflict of Interests
1)

A member of staff of the Agency/Authority, of the Board or of a committee shalldeclare any interests related to any medical products, or which may be relevant
to any decision-making.

2)

Identified conflicts of interest shall be appropriately managed in accordance withpublished guidelines.

Article 33: Restriction of Liability
1)

The Agency/Authority, the Board, a committee member or a member of staff of
the Agency/Authority is not liable for any loss or damage arising from any
decision made or act carried out in good faith in the exercise of powers or
performance of functions under this Law and other applicable laws.

2)

The Agency/Authority, the Board, a committee member or a member of staff of
the Agency/Authority shall however be liable for any loss or damage if the loss orP a g e | 27

damage is due to wilful misconduct, gross negligence or failure to comply withthis Law and other applicable laws.

Article 34: Protection of and Access to Information
1) No person shall disclose to any other person/institution any information acquiredby him in the exercise of his powers or the performance of his functions under
this Law and relating to the business or affairs of any person, or use suchinformation for self-gain or for the benefit of his employer;
2) A person may be permitted to disclose information:a) for the purpose of the exercise of his powers or the performance of his
functions under this Law with the written authority of the Agency/Authority;b) when required to do so by any competent court or under any law; orc) if it is in the public interest.

Article 35: Regulation of Other Related Products
The Agency/Authority may regulate other related products, not covered by this Law. The
appointing authority shall issue regulations for such related products to ensure that they
comply with prescribed standards.

PART X: COMMENCEMENT
The law shall commernce in accordnace with the legislative proceedures of each state.