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Medicines and Related Substances Control Act, 1965
Act 101 of 1965
- Published in Government Gazette 1171 on 7 July 1965
- Assented to on 19 June 1965
- Commenced on 1 April 1966 by Medicines and Related Substances Act, 1965: Commencement
- [This is the version of this document from 1 June 2017.]
- [Amended by Drugs Control Amendment Act, 1968 (Act 29 of 1968) on 1 April 1966]
- [Amended by Drugs Control Amendment Act, 1968 (Act 29 of 1968) on 3 April 1966]
- [Amended by Drugs Control Amendment Act, 1970 (Act 88 of 1970) on 21 October 1970]
- [Amended by Drugs Laws Amendment Act, 1971 (Act 95 of 1971) on 6 December 1971]
- [Amended by Drugs Control Amendment Act, 1974 (Act 65 of 1974) on 21 February 1975]
- [Amended by Medicines and Related Substances Control Amendment Act, 1976 (Act 19 of 1976) on 31 March 1976]
- [Amended by Health Laws Amendment Act, 1977 (Act 36 of 1977) on 30 March 1977]
- [Amended by Medicines and Related Substances Control Amendment Act, 1979 (Act 17 of 1979) on 21 March 1979]
- [Amended by Medicines and Related Substances Control Amendment Act, 1981 (Act 20 of 1981) on 4 March 1981]
- [Amended by Transfer of Powers and Duties of the State President Act, 1986 (Act 97 of 1986) on 3 October 1986]
- [Amended by Businesses Act, 1991 (Act 71 of 1991) on 24 May 1991]
- [Amended by Medicines and Related Substances Control Amendment Act, 1991 (Act 94 of 1991) on 12 July 1991]
- [Amended by General Law Amendment Act, 1996 (Act 49 of 1996) on 4 October 1996]
- [Amended by Abolition of Restrictions on the Jurisdiction of Courts Act, 1996 (Act 88 of 1996) on 22 November 1996]
- [Amended by Medicines and Related Substances Control Amendment Act, 1997 (Act 90 of 1997) on 2 May 2003]
- [Amended by Medicines and Related Substances Amendment Act, 2002 (Act 59 of 2002) on 2 May 2003]
- [Amended by Medicines and Related Substances Control Amendment Act, 1997 (Act 90 of 1997) on 2 May 2004]
- [Amended by Medicines and Related Substances Control Amendment Act, 1997 (Act 90 of 1997) on 1 July 2005]
- [Amended by Medicines and Related Substances Amendment Act, 2008 (Act 72 of 2008) on 1 June 2017]
- [Amended by Medicines and Related Substances Amendment Act, 2015 (Act 14 of 2015) on 1 June 2017]
1. Definitions
2. Establishment of South African Health Products Regulatory Authority
[heading substituted by section 2(a) of Act 14 of 2015]2A. Objects of Authority
The objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, Scheduled substances, clinical trials and medical devices, IVDs and related matters in the public interest.[section 2A inserted by section 3 of Act 14 of 2015]2B. Functions of Authority
2C. Composition of Board
2D. Appointment of members of Board
2E. Appointment of chairperson and vice-chairperson of Board
2F. Disqualification from membership of Board and vacation of office
2G. Meetings of Board
2H. Committees of Board
The Board may appoint one or more committees from among its members to assist it with the performance of its functions.[section 2H inserted by section 3 of Act 14 of 2015]2I. Dissolution of Board
3. Chief Executive Officer and other staff of Authority
4. ***
[section 4 amended by section 4(1) of Act 65 of 1974, by section 4 of Act 90 of 1997, substituted by section 4 of Act 72 of 2008 and repealed by section 5 of Act 14 of 2015]5. ***
[section 5 amended by section 46 of Act 97 of 1986 and repealed by section 5 of Act 72 of 2008]6. ***
[section 6 substituted by section 5 of Act 65 of 1974, by section 3 of Act 17 of 1979, by section 46 of Act 97 of 1986, by section 4 of Act 94 of 1991, by section 5 of Act 90 of 1997, amended by section 2(a) and (b) of Act 59 of 2002 and repealed by section 5 of Act 72 of 2008]7. ***
[section 7 amended by section 6 of Act 65 of 1974 and repealed by section 5 of Act 72 of 2008]8. ***
[section 8 repealed by section 5 of Act 72 of 2008]9. ***
[section 9 amended by section 7 of Act 65 of 1974, by section 6 of Act 90 of 1997 and repealed by section 5 of Act 72 of 2008]10. ***
[section 10 substituted by section 8(1) of Act 65 of 1974, amended by section 4(a) of Act 17 of 1979 and by section 46 of Act 97 of 1986, and repealed by section 5 of Act 94 of 1991]11. ***
[section 11 amended by section 9(d) of Act 65 of 1974, by section 5 of Act 17 of 1979, by section 46 of Act 97 of 1986 and repealed by section 6 of Act 94 of 1991]12. ***
[section 12 substituted by section 10(1) of Act 65 of 1974, amended by section 7 of Act 90 of 1997, substituted by section 3 of Act 59 of 2002 and repealed by section 5 of Act 72 of 2008]13. Registers
14. Prohibition on the sale of medicines, medical devices or IVDs which are subject to registration and are not registered
15. Registration of medicines, medical devices or IVDs
15A. Amendment of entries in register
15B. Transfer of certificate of registration
15C. Measures to ensure supply of more affordable medicines
The Minister may prescribe conditions for the supply of more medicines in certain circumstances so as to protect the health of the public, and in particular may—16. Cancellation of registration
17. Notification of registration or cancellation thereof
The Chief Executive Officer shall give notice in the Gazette of the registration or cancellation of registration of any medicine, medical device or IVD in terms of this Act, and shall in such notice specify—18. Labels and advertisements
18A. Bonusing
18B. Sampling of medicines, medical devices or IVDs
18C. Marketing of medicines, medical devices or IVDs
The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries.[section 18C inserted by section 12 of Act 90 of 1997, substituted by section 4 of Act 59 of 2002 and by section 17 of Act 72 of 2008]19. Prohibition on sale of medicines, medical devices or IVDs which do not comply with prescribed requirements and furnishing of information regarding medicines, medical devices or IVDs to the Authority
20. Publication or distribution of false advertisements concerning medicines, medical devices or IVDs
21. Authority may authorize sale of unregistered medicines, medical devices or IVD's for certain purposes
22. Authority to cause certain information to be furnished
22A. Control of medicines, Scheduled substances, medical devices and IVDs
[heading substituted by section 14(a) of Act 14 of 2015]22B. Publication of information relating to medicines, Scheduled substances, medical devices or IVDs
[heading substituted by section 15(a) of Act 14 of 2015]22C. Licensing
22D. Period of validity and renewal of licence
A licence issued under section 22C shall be valid for the prescribed period but may be renewed on application in the prescribed manner and before the prescribed time or such later time as the Director-General or the Authority, as the case may be, may allow and on payment of the prescribed fee.[section 22D inserted by section 14 of Act 90 of 1997 and substituted by section 25 of Act 72 of 2008]22E. Suspension and cancellation of licence
22F. Generic substitution
22G. Pricing committee
22H. Purchase and sale of medicines, medical devices, IVDs and Scheduled substances by wholesalers
[heading substituted by section 17(a) of Act 14 of 2015]23. Disposal of undesirable medicines, medical devices or IVDs
24. Appeal against decision of Director-General
24A. Appeal against decision of Authority
25. Privileges of Authority and committees
The Authority, persons contracted by the Authority to perform work for the Authority, committees appointed in terms of this Act or their members are not liable in respect of anything done in good faith under this Act.[section 25 substituted by section 32 of Act 88 of 1996, by section 10 of Act 59 of 2002 and by section 32 of Act 72 of 2008]26. Inspectors
27. Analysts, pharmacologists, engineers, technicians and pathologists
Chief Executive Officer may grant such authority to such analysts, pharmacologists, engineers, technicians and pathologists or any other appropriately qualified person as he or she may consider necessary for the proper enforcement of this Act.[section 27 substituted by section 25(1) of Act 65 of 1974, by section 11 of Act 17 of 1979 and by section 34 of Act 72 of 2008]28. Powers of inspectors
29. Offences
Any person who—30. Penalties
31. Procedure and evidence
32. ***
[section 32 amended by section 30 of Act 65 of 1974 and repealed by section 20 of Act 90 of 1997]33. Act or omission by manager, agent or employee
33A. Funds of Authority
34. Preservation of secrecy
No person shall, except for the purpose of the exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings under this Act, or when required to do so by any competent court or under any law, or with the written authority of the Director-General, disclose to any other person any information acquired by him in the exercise of his powers or the performance of his functions under this Act and relating to the business or affairs of any person, or use such information for self-gain or for the benefit of his employer.[section 34 substituted by section 14 of Act 94 of 1991]34A. Delegation of powers
35. Regulations
36. Exclusion of any medicine, Scheduled substance, medical device or IVD from operation of Act
36A. Minister may prohibit the manufacture, sale or use of certain veterinary medicines
Notwithstanding anything to the contrary in this Act or in any other law contained, the Minister may by notice in the Gazette for any reason other than the safety, quality or therapeutic efficacy of a veterinary medicine—37. ***
[section 37 substituted by section 33 of Act 65 of 1974 and by section 18 of Act 94 of 1991, and repealed by section 24 of Act 90 of 1997]37A. Amendment of Schedules
Notwithstanding the provisions of section 35(2), the Minister may, on the recommendation of the Authority, from time to time by notice in the Gazette amend any Schedule prescribed under section 22A(2) by the inclusion therein or the deletion therefrom of any medicine or other substance, or in any other manner.[section 37A inserted by section 34 of Act 65 of 1974, substituted by section 25 of Act 90 of 1997 and by section 43 of Act 72 of 2008]38. Operation of Act in relation to other laws
The provisions of this Act shall be in addition to and not in substitution for any other law which is not in conflict with or inconsistent with this Act.39. State bound
This Act binds the State.[section 39 repealed by section 20 of Act 94 of 1991 and inserted by section 26 of Act 90 of 1997]40. Short title
This Act shall be called the Medicines and Related Substances Act, 1965.[section 40 substituted by section 28 of Act 90 of 1997]History of this document
01 June 2017 this version
01 July 2005
02 May 2004
02 May 2003
22 November 1996
04 October 1996
Amended by
General Law Amendment Act, 1996
Read this version
12 July 1991
24 May 1991
Amended by
Businesses Act, 1991
Read this version
03 October 1986
04 March 1981
21 March 1979
30 March 1977
Amended by
Health Laws Amendment Act, 1977
Read this version
31 March 1976
21 February 1975
06 December 1971
Amended by
Drugs Laws Amendment Act, 1971
Read this version
21 October 1970
03 April 1966
01 April 1966
07 July 1965
Published in Government Gazette 1171
Read this version
19 June 1965
Assented to
Cited documents 10
Act 10
1. | Constitution of the Republic of South Africa, 1996 | 12573 citations |
2. | Public Finance Management Act, 1999 | 2736 citations |
3. | Labour Relations Act, 1995 | 2478 citations |
4. | Banks Act, 1990 | 891 citations |
5. | Mental Health Care Act, 2002 | 369 citations |
6. | Hazardous Substances Act, 1973 | 358 citations |
7. | Trade Marks Act, 1993 | 208 citations |
8. | Patents Act, 1978 | 180 citations |
9. | Chiropractors, Homeopaths and Allied Health Service Professions Act, 1982 | 156 citations |
10. | Magistrates Act, 1993 | 104 citations |
Documents citing this one 742
Gazette 676
Judgment 50
Government Notice 8
Act 6
1. | Businesses Act, 1991 | 509 citations |
2. | National Health Act, 2003 | 459 citations |
3. | Domestic Violence Act, 1998 | 158 citations |
4. | Chiropractors, Homeopaths and Allied Health Service Professions Act, 1982 | 156 citations |
5. | Gauteng Liquor Act | 52 citations |
6. | National Health Insurance Act, 2023 | 1 citation |
By-law 2
1. | Liquor Trading Days and Hours By-law, 2013 | |
2. | Liquor Trading Days and Hours By-law, 2013 |
Subsidiary legislation
Title
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Regulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 2025
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice 5856 of 2025 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Regulations Relating to the Transparent Pricing System for Medicine and Scheduled Substances, 2005: Amendment: Dispensing fee charged by pharmacists
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice 5364 of 2024 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Regulations Relating to the Transparent Pricing System for Medicine and Scheduled Substances, 2005: Amendment: Dispensing fee to be charged by licensed persons
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice 5359 of 2024 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Exclusion of COVID-19 Vaccines From the Operation of Certain Provisions of the Act
Health and Food Safety
|
Government Notice 1502 of 2021 |
Health and Food Safety
|
Regulations Regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 2020
Repealed
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice R1379 of 2020 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Exclusion of Certain Alcohol-based Hand-rubs from the Operation of Certain Provisions of the Act
Health and Food Safety
|
Government Notice R721 of 2020 |
Health and Food Safety
|
Exclusion of Medicines, Medical Devices and In Vitro Diagnostics (IVDs) Donated to the State From the Operation of Certain Provisions of the Act
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice R585 of 2020 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Exclusion of Schedule 2, Schedule 3 and Schedule 4 Substances from the Operation of Certain Provisions
Environment, Climate and Wildlife
·
Health and Food Safety
|
Government Notice 514 of 2020 |
Environment, Climate and Wildlife
·
Health and Food Safety
|
Exclusion of Schedule 2, Schedule 3 and Schedule 4 Substances from the Operation of Certain Provisions
Health and Food Safety
|
Government Notice R481 of 2020 |
Health and Food Safety
|