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Table of Contents
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 [Repealed] Advisory committee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 [Repealed] Chairman and vice-chairman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 [Repealed] Disqualifications, vacation of office, filling of vacancies and declaration of interest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 [Repealed] Meetings of the council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 [Repealed] Quorum, majority decision and chairman's casting vote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 [Repealed] Appointment of executive committee and other committees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 [Repealed]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 [Repealed]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 [Repealed] Appointment of Registrar and Deputy Registrar of Medicines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
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, 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
Schedule 0
Schedule 1
Schedule 2
Schedule 3
Schedule 4
Schedule 5 and Specified Schedule 5
Schedule 6
Schedule 7
Schedule 8
[Repealed] Schedule 9
Regulations
Regulations relating to Transparent Pricing System for Medicines and Scheduled Substances
Notice No. R. 1102 of 2005
Appendix A
Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)
Notice No. 1515 of 2016
1. Definitions
2. Manner and conditions for allowing international tendering
3. Importation of medical devices and IVDs into the Republic
4. Transmission of medical devices or IVDs through the Republic
5. Licence to manufacture, import, export, or act as a distributor or wholesaler of medical devices or IVDs
6. Period of validity of licence and renewal of licence
7. Appeal against decision of Council
8. Application for registration of a medical device or IVD
9. Information that must appear in the register for medical devices or IVDs
10. Amendment to the medical device and IVD register
11. Classification of medical devices and IVDs
12. Registration certificate
13. Parts and components
14. Destruction of medical devices or IVDs
15. Method of taking samples during investigation, certificate to be issued and reporting of analysis results
16. Conduct of clinical trial and clinical investigation
17. Adverse event reporting and vigilance for medical devices or IVDs
18. Investigation
19. Offences and penalties
20. Compliance with requirements
21. Advertising of medical devices or IVDs
22. Labelling of medical device or IVD
23. Instructions for use of medical device
24. Instructions for use of IVD
25. Custom made medical device
26. Record of implantable medical device and custom made medical device
27. Transitional arrangements regarding unlicensed manufacturer, distributor and wholesaler
28. Transitional arrangements regarding unregistered medical devices and IVDs
29. Short title
General Regulations
Notice No. 859 of 2017
Supply of Medicines
1. Definitions
2. Requirements for therapeutic equivalence
3. Conditions for compounding medicine
4. The manner and conditions for allowing international tendering
5. Importation of medicines in terms of section 15C
6. Importation of medicines into Republic
7. Transmission of medicines through Republic
8. Personal medicinal use by persons entering Republic
Registration of Medicines
9. Categories and classification of medicines
10. Labelling of medicines intended for human use
11. Professional information for medicines for human use
12. Patient information leaflet
13. Labelling for veterinary medicines
14. Professional information for veterinary medicines
15. Batch release for biological medicines
16. Application for the registration of a medicine
17. Particulars to be published in respect of applications received for registration in terms of section 14(3)
18. Information that must appear in register for medicines
19. Transfer from register for medicines to register for medical devices or IVs
20. Application for amendment to the register for medicines
21. Certificate of registration
Permits, Licensing and Authorisation
22. Licence to dispense or compound and dispense medicines
23. Licence to manufacture, import, export, act as a wholesaler or distribute medicines or scheduled substances
24. Period of validity and renewal of licence issued in terms of regulations 23 and 24
25. Exemption in terms of section 22H
26. Permits and authorisation in terms of section 22A
27. Importation or exportation of specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8
28. Information to be furnished annually to Chief Executive Officer
29. Authorisation of sale of unregistered medicine for certain purposes
30. Conduct of clinical trials for humans and animals
31. Obtaining pain control medicines by registered midwives
32. Acquisition and use of medicines by masters of ships and officers in charge of any aircraft
Management of Medicines
33. Particulars which must appear on prescription for medicine
34. Particulars which must appear on order for medicine or scheduled substance
35. Prescription book or permanent record
36. Register for specified Schedule 5 or Schedule 6 medicines or substances
37. Returns to be furnished in respect of specified Schedule 5 and Schedule 6, 7 or 8
38. Control of medicines in hospitals
39. Repackaging of medicines
40. Vigilance
41. Pricing Committee
42. Advertising of medicines
43. Use of medicines for exhibition purposes
44. Destruction of medicines or scheduled substances
The Authority
45. Skills of staff of Authority
46. Time frames for considering applications
Appeals
47. Appeal against decision of Director-General
48. Appeal against decision of Authority
Investigations, Offences and Penalties
49. Investigations
50. Method of taking samples, certificate to be issued and reporting of analysis results
51. Seizure of medicines
52. Offences and Penalties
53. Compliance with requirements
General
54. Repeal
Schedules
Annexure 1 : Classes of Medicines in categories A and D (human complementary medicine)
Annexure 2 : Classes of Medicines in categories C and D (veterinary complementary medicines)
Annexure 3 : Certificate of registration for medicines
Regulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 2020
Notice No. R. 1379 of 2020
1. Definitions
2. Fees
3. Fees for Clinical Trials
4. Fee for New Licences
5. Fees for Inspections to assess the quality, safety and efficacy of medicines or scheduled substances
6. Fees for Permits and Certificates
7. Amendment of entries in Register
8. Transfer of Certificates of Registration
9. Appeal against the decision of the Authority
10. Repeal of Laws
11. Short Title
Notices
Licence to Compound or Dispense Medicines: Application fee
Notice No. 758 of 2003
Form: Application for a Licence to Compound or Dispense Medicines
Notice No. 759 of 2003
Form
Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965
Notice No. 784 of 2015
1. Category A medicines
2. Category C medicines
3. Category D medicines (Human medicines)
4. Category D medicines (Veterinary medicine)
5. Use of unregistered medicines
6. In respect of licences
7. Inspections to assess the quality of medicines
8. Permits and Certificates
9. Amendment of entries in register
10. Transfer of certificates of registration
11. Withdrawal of Notice
Registration of Oral Preparations containing Bacterial Strains
Notice No. 1256 of 2017
Annual Single Exit Price Adjustment [SEPA] of Medicines and Scheduled Substances for the year 2019
Notice No. 29 of 2019
Information and Instructions for the Single Exit Price Adjustment (SEPA) Submissions for 2019
Preamble
1. Acronyms
2. Applicant Information
3. How to complete template columns
4. Annexures
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
Notice No. R. 685 of 2019
[Repealed] Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965
Notice No. 695 of 2019
1. Category A medicines
2. Category C medicines
3. Category D medicines (Human medicines)
4. Category D medicines (Veterinary medicine)
5. Use of unregistered medicines
6. In respect of licences
7. Inspections to assess the quality, safety and efficacy of medicines or scheduled substances
8. Desktop inspection to assess quality, safety and efficacy of medicines or scheduled substances
9. Permits and Certificates
10. Amendment of entries in register
11. Transfer of certificates of registration
12. Appeal against the decision of the Authority
13. Withdrawal of Notice
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
Notice No. 696 of 2019
Exclusion of Schedules 2, 3 and 4 substances from the operation of certain provisions of the Act
Notice No. R. 481 of 2020
Exclusion of Schedules 2, 3 and 4 substances from the operation of certain provisions of the Act
Notice No. 514 of 2020
Exclusion of Medicines, Medical Devices and In Vitro Diagnostics (IVDs) donated to the State from the Operation of certain provisions of the Act
Notice No. R. 585 of 2020
Exclusion of certain alcohol-based hand-rubs from the operation of specified provisions of the Act
Notice No. R. 721 of 2020
Schedule
Notification of Retention Fee Payment
Notice No. R. 164 of 2021
Exclusion of Schedule 2, 3 and 4 substances from the operation of certain provisions of the Act
Notice No. 252 of 2021
Exclusion of certain alcohol-based hand-rubs from the operation of specified provisions of the Act
Notice No. R. 756 of 2021
Schedule
Exclusion of COVID-19 Vaccines from the operation of certain provisions of the Act
Notice No. 1502 of 2021
Exclusion of Schedule 0 Medicines from the operation of Sections 22G and 18A of the Act
Notice No. 1581 of 2021
Extension to the Exemption of Medical Devices and In-Vitro Diagnostics (IVDs) from the provisions of Section 18A and Section 18B of the Act
Notice No. R. 1632 of 2021
Annual Single Exit Price Adjustment [SEPA] of Medicines and Scheduled Substances for the year 2023
Notice No. 2940 of 2023
Information to be provided by Manufacturers and or Importers of Medicines and Scheduled Substances when submitting for the Single Exit Price Adjustment for 2023
Preamble
1. Acronyms
2. Applicant Information
3. How to complete template columns
4. Annexures
Exclusion of certain alcohol-based hand-rubs from the operation of certain provisions of the Act
Notice No. 3382 of 2023
Schedule
Exclusion of Schedule Zero (0) Medicines from the operations of Sections 22G and 18A of the Act
Notice No. 3800 of 2023
Second Single Exit Price Increase [SEPI] of Medicines and Scheduled Substances for the year 2023 [Top-up SEPI]
Notice No. 3801 of 2023
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
Notice No. 4406 of 2024
Proclamations
Commencement of Medicines and Related Substances Amendment Act, 2008
Proclamation No. 20 of 2017
Registration of Oral Preparations containing Bacterial Strains
Purchase
Notice No. 1256 of 2017
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