Long title

To provide for the registration of medicines and related substances intended for human and for animal use: to provide for the establishment of a Medicines Control Council; to provide that such council shall be a juristic person; to make other provision for the constitution of the council; to provide that a member of the council or committee shall declare his or her commercial interest related to the pharmaceutical or health care industry; to provide that the appointment of members of the executive committee is subject to the approval of the Minister; to provide for the control of medicines and scheduled substances and medical devices; to make further provision for the prohibition on the sale of medicines which are subject to registration and are not registered; to provide for procedures that will expedite the registration of essential medicines, and for the re-evaluation of all medicines after five years; to provide for measures for the supply of more affordable medicines in certain circumstances; to provide that labels be approved by the council; to prohibit sampling and bonusing of medicines; to provide for the licensing of certain persons to compound, dispense or manufacture medicines and medical devices and also to act as wholesalers or distributors; to provide for the generic substitution of medicines; to provide for the establishment of a pricing committee; to regulate the purchase and sale of medicines by manufacturers, distributors, wholesalers, pharmacists and persons licensed to dispense medicines; to make new provisions for appeals against decisions of the Director-General or the council; to provide that the council may acquire and appropriate funds; to regulate the Minister’s power to make regulations; to provide for the rationalization of certain laws relating to medicines and related substances that have remained in force in various territories on the national territory of the Republic by virtue of item 2 of Schedule 6 to the Constitution of the Republic of South Africa, 1996; and to provide for matters connected therewith.

[...amended by Act 1974_065_036_19741030]
[...amended by Act 1979_017_015_19790321]
[...amended by Act 1991_094_022_19910703]
[...amended by Act 1997_090_027_19971212]
[...substituted by Act 2002_059_013_20030117]

Table of contents

SECTION	TITLE
1.	[...Title amended by Act 1974_065_000_19741030 - was entitled "_"]   Definitions
2.	Establishment of South African Health Products Regulatory Authority [...Title amended by Act 1974_065_002_19741030 - was entitled "Establishment, powers and functions of Drugs Control Council"] [...Title amended by Act 2008_072_002_20090421 - was entitled "Establishment, powers and functions of Medicines Control Council"]  [...Title amended by Act 2015_014_002_20160108 - was entitled "Establishment, powers and functions of South African Health Products Regulatory Authority"]
2A.	Objects of Authority [...inserted by Act 2015_014_003_20160108]
2B.	Functions of Authority [...inserted by Act 2015_014_003_20160108]
2C.	Composition of Board [...inserted by Act 2015_014_003_20160108]
2D.	Appointment of members of Board [...inserted by Act 2015_014_003_20160108]
2E.	Appointment of chairperson and vice-chairperson of Board [...inserted by Act 2015_014_003_20160108]
2F.	Disqualification from membership of Board and vacation of office [...inserted by Act 2015_014_003_20160108]
2G.	Meetings of Board [...inserted by Act 2015_014_003_20160108]
2H.	Committees of Board [...inserted by Act 2015_014_003_20160108]
2I.	Dissolution of Board [...inserted by Act 2015_014_003_20160108]
3.	Chief Executive Office and other staff of Authority [...Title amended by Act 2008_072_003_20090421 - was entitled "Constitution of council"]
4.	Advisory committee [...Title amended by Act 2008_072_004_20090421 - was entitled "Period of office and remuneration of members of council"] [...repealed by Act 2015_014_005_20160108]
5.	... [...repealed by Act 2008_072_005_20090421 - was entitled "Chairman and vice-chairman"]
6.	... [...Title amended by Act1997_090_005_19971212 - was entitled "Disqualifications, vacation of office and filling of vacancies"] [...repealed by Act 2008_072_005_20090421 - was entitled "Disqualifications, vacation of office, filling of vacancies and declaration of interest"]
7.	... [...repealed by Act 2008_072_005_20090421 - was entitled "Meetings of council"]
8.	... [...repealed by Act 2008_072_005_20090421 - was entitled "Quorum, majority decision and chairman's casting vote"]
9.	... [...repealed by Act 2008_072_005_20090421 - was entitled "Appointment of executive committee and other committees"]
10.	... [...Title amended by Act 1974_065_008_19741030 - was entitled "Establishment of Drugs Control Appeal Board"] [...repealed by Act 1991_094_005_19910703 - was entitled "Establishment of Medicines Control Appeal Board"]
11.	... [...repealed by Act 1991_094_006_19910703 - was entitled "Disqualifications, vacation of office and filling of vacancies on appeal board"]
12.	... [...Title amended by Act 1974_065_010_19741030 - was entitled "Appointment of Registrar of Drugs"]  [...Title amended by Act 2002_059_003_20030117 - was entitled "Appointment of Registrar of Medicines"]  [...repealed by Act 2008_072_005_20090421 - was entitled "Appointment of Registrar and Deputy Registrar of Medicines"]
13.	Registers [...Title amended by Act 1974_065_011_19741030 - was entitled "Drugs reigster"] [...Title amended by Act 2008_072_006_20090421 - was entitled "Medicines register"]
14.	Prohibition on the sale of medicines, medical devices or IVDs which are subject to registration and are not registered [...Title amended by Act 1968_029_001_19680403 - was entitled "Prohibition on sale of drugs which are not registered"] [...Title amended by Act 1974_065_012_19741030 - was entitled "Prohibition on the sale of drugs which are subject to registration and are not registered"]  [...Title amended by Act 2008_072_007_20090421 - was entitled "Prohibition on the sale of medicines which are subject to registration and are not registered"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Prohibition on the sale of products, medical devices or IVDs which are subject to registration and are not registered"]
15.	Registration of medicines, medical devices or IVDs [...Title amended by Act 1974_065_013_19741030 - was entitled "Registratoin of drugs"] [...Title amended by Act 2008_072_008_20090421 - was entitled "Registration of medicines"]  [...Title amended by Act 2015_014_024_20160108 - was entitled "Registration of products, medical devices or IVDs"]
15A.	Amendment of entries in register [...inserted by Act 1981_020_003_00000000]
15B.	Transfer of certificate of registration [...inserted by Act 1981_020_003_00000000] [...Title amended by Act 2008_072_010_20090421 - was entitled "Transfer of certificates of registration"]
15C.	Measures to ensure supply of more affordable medication [...inserted by Act 1997_090_010_19971212]
16.	Cancellation of registration
17.	Notification of registration or cancellation thereof [...Title amended by Act 2008_072_013_20090421 - was entitled "Notification of registration or cancellation of registration in Gazette"]
18.	Labels and advertisements [...Title amended by Act 1974_065_016_19741030 - was entitled "Name under which drug is registered and number to appear on labels"]
18A.	Bonusing [...inserted by Act 1997_090_012_19971212]
18B.	Sampling of medicines, medical devices or IVDs [...inserted by Act 1997_090_012_19971212]  [...Title amended by Act 2008_072_016_20090421 - was entitled "Sampling of medicines"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Sampling of products, medical devices or IVDs"]
18C.	Marketing of medicines medical devices or IVDs [...inserted by Act 1997_090_012_19971212] [...Title amended by Act 2002_059_004_20030117 - was entitled "Code of ethics"]  [...Title amended by Act 2008_072_017_20090421 - was entitled "Marketing of medicines"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Marketing of products 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 medicines, medical devices or IVDs to the Authority [...Title amended by Act 1974_065_017_19741030 - was entitled "Prohibition on sale of drugs which do not comply with prescribed requirements and furnishing of information regarding drugs to the council"]**  [...Title amended by Act 2008_072_018_20090421 - was entitled "Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to the council"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Prohibition on sale of products, medical devices or IVDs which do not comply with prescribed requirements and furnishing of information products, medical devices or IVDs to the Authority"]**
20.	Publication or distribution of false advertisements concerning medicines, medical devices or IVDs [...Title amended by Act 1974_065_018_19741030 - was entitled "Publication or distributoin of false advertisements concerning drugs"]** [...Title amended by Act 2008_072_019_20090421 - was entitled "Publication or distribution of false advertisements concerning medicines"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Publication or distribution of false advertisements concerning products, medical devices or IVDs"]
21.	Authority may authorize sale of unregistered medicines, medical devices or IVDs for certain purposes [...Title amended by Act 1974_065_019_19741030 - was entitled "Council may authorize sale of unregistered drug for certain purposes"]**  [...Title amended by Act 2008_072_020_20090421 - was entitled "Council may authorize sale of unregistered medicine for certain purposes"] [...Title amended by Act 2008_072_019_20090421 - was entitled "Publication or distribution of false advertisements concerning medicines"] [...Title amended by Act 2015_014_024_20160108 - was entitled "Authority may authorize sale of unregistered products, medical devices or IVDs for certain purposes"]
22.	Authority to cause certain information to be furnished [...Title amended by Act 1974_065_019_19741030 - was entitled "Council to furnish certain information to medical and dental practitioners and chemists and druggists"] [...Title amended by Act 1979_017_008_19790321 - was entitled "Council to furnish certain information to medical practitioners, dentists and pharmacists"] [...Title amended by Act 1981_020_006 - was entitled "Secretary to cause certain information to be furnished"] [...Title amended by Act 2008_072_021_20090421 - was entitled "Director-General to cause certain information to be furnished"]
22A.	Control of medicines [ , ]  Scheduled substances, medical devices and IVDs [...inserted by Act 1974_065_021_19741030] [...Title amended by Act 1991_094_000_19910703 - was entitled "Control of medicines and Scheduled substances"]  [...Title amended by Act 1997_090_013_19971212 - was entitled "Control of medicines, categories of medicines and substances"] [...Title amended by Act 2015_014_014_20160108 - was entitled "Control of medicines and Scheduled substances"]
22B.	Publication of information relating to medicines, Scheduled substances, medical devices or IVDs [ or medical device ] [...inserted by Act 1991_094_010_19910703] [...Title amended by Act 2008_072_023_20090421 - was entitled "Publication of information relating to medicine, Scheduled substance or medical device"] [...Title amended by Act 2015_014_015_20160108 - was entitled "Publication of information relating to products, medical devices or IVDs [ or medical device ]"]
22C.	Licensing [...inserted by Act 1997_090_014_19971212]
22D.	Period of validity and renewal of licence [...inserted by Act 1997_090_014_19971212]
22E.	Suspension and cancellaton of licence [...inserted by Act 1997_090_014_19971212]
22F.	Generic substitution [...inserted by Act 1997_090_014_19971212]
22G.	Pricing committee [...inserted by Act 1997_090_014_19971212]
22H.	Purchase and sale of medicines, medical devices, IVDs and Scheduled substances by wholesalers [...inserted by Act 1997_090_014_19971212] [...Title amended by Act 2015_014_017_20160108 - was entitled "Purchase and sale of medicines by wholesalers"]
23.	Disposal of undesirable medicines, medical devices or IVDs [...Title amended by Act 1974_065_022_19741030 - was entitled "Disposal of undesirable drugs"] [...Title amended by Act 2008_072_029_20090421 - was entitled "Disposal of undesirable medicines"]  [...Title amended by Act 2015_014_024_20160108 - was entitled "Disposal of undesirable products, medical devices or IVDs"]
24.	Appeals against decision of Director-General [...Title amended by Act 1991_094_011_19910703 - was entitled "Appeals"] [...Title amended by Act 1997_090_015_19971212 - was entitled "Appeals against decision of Council"] [...Title amended by Act 2002_059_009_20030117 - was entitled "Appeals against decision of Director-General or council"]  [...Title amended by Act 2008_072_030_20090421 - was entitled "Appeals against decision of council or Director-General"]
24A.	Appeal against decision of Authority [...inserted by Act 2008_072_031_20090421]
25.	Privileges of Authority and committees [...Title amended by Act 2008_072_032_20090421 - was entitled "Privileges of council and committees"]
26.	Inspectors [...Title amended by Act 1974_065_024_19741030 - was entitled "Appointment of inspectors"]
27.	Analysts, pharmacologists, engineers, technicians and pathologists [...Title amended by Act 1974_065_025_19741030 - was entitled "Appointment of analysts, pharmacologists and pathologists"] [...Title amended by Act 2008_072_034_20090421 - was entitled "Analysts, pharmacologists and pathologists"]
28.	Powers of inspectors
29.	Offences
30.	Penalties
31.	Procedure and evidence
32.	... [...repealed by Act 1997_090_020_19971212 - was entitled "Special defences in case of prosecutions"]
33.	Act or omission by manager, agent or employee
33A.	Funds of Authority [...inserted by Act 1997_090_021_19971212] [...Title amended by Act 2008_072_039_20090421 - was entitled "Funds of council"]
34.	Preservation of secrecy
34A.	Delegation of powers [...inserted by Act 1976_019_002_19760331]
35.	Regulations
36.	Exclusion of any [ [ product] ]  [ [ medicine ] ] , Scheduled substance [ [ product ] ] [ , medical device or IVD ] from operation of Act [...Title amended by Act 1974_065_032_19741030 - was entitled "Exclusion of any drug from operation of Act"] [...Title amended by Act 2008_072_039_20090421 - was entitled "Exclusion of any medicine from operation of Act"] [...Title amended by Act 2015_014_023_20160108 - was entitled "Exclusion of any [ medicine ] [ product, medical device or IVD ] from operation of Act"]
36A.	Minister may prohibit the manufacture, sale or use of certain veterinary medicines [...inserted by Act 1991_094_017_19910703]
37.	... [...Title amended by Act 1974_065_033_19741030 - was entitled "Drugs manufactured for export"] [...repealed by Act 1997_090_024_19971212 - was entitled "Medicines manufactured for export"]
37A.	Amendment of Schedules [...inserted by Act 1974_065_034_19741030] [...repealed by Act 1991_094_019_19910703 - was entitled "Amendment of Schedules"] [...inserted by Act 1997_090_025_19971212]
38.	Operation of Act in relation to other laws
39.	State bound [...repealed by Act 1991_094_020_19910703 - was entitled "Application of Act in South-West Africa"] [...inserted by Act 1997_090_026_19971212]
40.	Short title [...Title amended by act 1974_065_035_19741030 - was entitled 'Short title and commencement"]
Sch. 1.	SCHEDULE 1. [sic - no title] [s1; s22A; s35; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"]
Sch. 2.	SCHEDULE 2. [sic - no title] [s22A; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 3.	SCHEDULE 3. [sic - no title] [s22A; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch 4.	SCHEDULE 4. [sic - no title] [s22A; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 5.	SCHEDULE 5. [sic - no title] [s22A; s35; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 6.	SCHEDULE 6. [sic - no title] [s22A; s35; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 7.	SCHEDULE 7. [sic - no title] [s22A; s35; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 8.	SCHEDULE 8. [sic - no title] [s22A; s35; s37A] [...inserted by Act _1974_065_036_19741030 [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**
Sch. 9.	SCHEDULE 9. [sic - no title] [s22A; s35; s37A] [...inserted by Act 1974_065_036_19741030] [...repealed by Act 1991_094_021_19910703 - was entitled "_"] [...repealed by Act 1997_090_027_19971212 - was entitled "_"]**

 

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