- Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)
- Notice No. 1002 of 1965
- Act
- 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 [Repealed] Advisory committee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 [Repealed] Chairman and vice-chairman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 [Repealed] Disqualifications, vacation of office, filling of vacancies and declaration of interest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 [Repealed] Meetings of the council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 [Repealed] Quorum, majority decision and chairman's casting vote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 [Repealed] Appointment of executive committee and other committees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 [Repealed]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 [Repealed]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 [Repealed] Appointment of Registrar and Deputy Registrar of Medicines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 products, medical devices or IVDs which do not comply with prescribed requirements and furnishing of information regarding products, medical devices or IVDs to the Authority
- 20. Publication or distribution of false advertisements concerning medicines, medical devices or IVDs
- 22. Authority to cause certain information to be furnished
- 22A. Control of medicines, 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
- Schedules
- Regulations
- Notices
- Licence to Compound or Dispense Medicines: Application fee
- Form: Application for a Licence to Compound or Dispense Medicines
- Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965
- Registration of Oral Preparations containing Bacterial Strains
- Annual Single Exit Price Adjustment [SEPA] of Medicines and Scheduled Substances for the year 2019
- Exemption of Medical Devices and In-Vitro Diagnostics (IVDS) from the provisions of Section 18A and 18B of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as Amended
- [Repealed] Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965
- Exemption of Medical Devices and In-Vitro Diagnostics (IVDS) from the provisions of Sections 18A and 18B of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as Amended
- Exclusion of Schedules 2, 3 and 4 substances from the operation of certain provisions of the Act
- Exclusion of Schedules 2, 3 and 4 substances from the operation of certain provisions of the Act
- Exclusion of Medicines, Medical Devices and In Vitro Diagnostics (IVDs) donated to the State from the Operation of certain provisions of the Act
- Exclusion of certain alcohol-based hand-rubs from the operation of specified provisions of the Act
- Notification of Retention Fee Payment
- Exclusion of Schedule 2, 3 and 4 substances from the operation of certain provisions of the Act
- Exclusion of certain alcohol-based hand-rubs from the operation of specified provisions of the Act
- Exclusion of COVID-19 Vaccines from the operation of certain provisions of the Act
- Exclusion of Schedule 0 Medicines from the operation of Sections 22G and 18A of the Act
- Extension to the Exemption of Medical Devices and In-Vitro Diagnostics (IVDs) from the provisions of Section 18A and Section 18B of the Act
- Annual Single Exit Price Adjustment [SEPA] of Medicines and Scheduled Substances for the year 2023
- Exclusion of certain alcohol-based hand-rubs from the operation of certain provisions of the Act
- Exclusion of Schedule Zero (0) Medicines from the operations of Sections 22G and 18A of the Act
- Second Single Exit Price Increase [SEPI] of Medicines and Scheduled Substances for the year 2023 [Top-up SEPI]
- [Repealed] Exemption of Manufacturers, Wholesalers and Distributors of Class A Medical and In Vitro Diagnostics from the Operation of the provisions of Section 22C of the Act
- Exclusion of Medicines from the application of certain provisions of Regulation 12 of the General Regulations made in terms of the Act
- Annual Single Exit Price Adjustment (SEPA) of Medicines and Scheduled Substances for the year 2025
- Notice of Extension to the Exemption of Medical Devices and In-Vitro Diagnostics (IVDs) from the provisions of Section 18A and Section 18B of the Act
- Exemption of Manufacturers, Wholesalers and Distributors of Class A Medical Devices and In-Vitro Diagnostics from the operation of the provisions of Section 22C(1) of the Act
- Proclamations