Acts Online
GT Shield

Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)


Notice No. 1002 of 1965


1. Definitions

2. Establishment of South African Health Products Regulatory Authority

2A. Objects of Authority

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

2I. Dissolution of Board

3. Chief Executive Officer and other staff of Authority

4. [Repealed] Advisory committee

5. [Repealed] Chairman and vice-chairman

6. [Repealed] Disqualifications, vacation of office, filling of vacancies and declaration of interest

7. [Repealed] Meetings of the council

8. [Repealed] Quorum, majority decision and chairman's casting vote

9. [Repealed] Appointment of executive committee and other committees

10. [Repealed]

11. [Repealed]

12. [Repealed] Appointment of Registrar and Deputy Registrar of Medicines

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 certificates of registration

15C. Measures to ensure supply of more affordable medicines

16. Cancellation of registration

17. Notification of registration or cancellation thereof

18. Labels and advertisements

18A. Bonusing

18B. Sampling of medicines, medical devices or IVDs

18C. Marketing of medicines, medical devices or IVDs

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 authorise sale of unregistered medicines, medical devices or IVDs for certain purposes

22. Authority to cause certain information to be furnished

22A. Control of medicines and Scheduled substances, medical devices and IVDs

22B. Publication of information relating to medicines, Scheduled substances,medical devices or IVDs

22C. Licensing

22D. Period of validity and renewal of licence

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

23. Disposal of undesirable medicines, medical devices or IVDs

24. Appeal against decision of the Director-General

24A. Appeal against decision of Authority

25. Privileges of Authority and committees

26. Inspectors

27. Analysts, pharmacologists, engineers, technicians and pathologists

28. Powers of inspectors

29. Offences

30. Penalties

31. Procedure and evidence

32. [Repealed] Special defences in case of prosecutions

33. Act or omission by manager, agent or employee

33A. Funds of Authority

34. Preservation of secrecy

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

37. [Repealed] Medicines manufactured for export

37A. Amendment of Schedules

38. Operation of Act in relation to other laws

39. State bound

40. Short title