Repealed Act
Act 6 of 1971 has been repealed by s 34 of P 21 of 1996
Repealed Act
Act 6 of 1971 has been repealed by s 34 of P 21 of 1996
Repealed Act
Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005
Repealed Act
Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005
Repealed Act
Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005
Repealed Act
Act 41 of 1967 has been repealed by s 113 of Act 70 of 1988
Repealed Act
Act 41 of 1967 has been repealed by s 113 of Act 70 of 1988
Repealed Act
Act 63 of 1972 has been repealed by s 36 of Act 108 of 1993
Repealed Act
Act 85 of 1972 has been repealed by s 36 of Act 108 of 1993
Repealed Act
Act 86 of 1972 has been repealed by s 36 of Act 108 of 1993
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 66 of 1974 has been repealed by s 6 of Act 10 of 1998
Repealed Act
Act 18 of 1976 has been repealed by s 1 of Act 49 of 1996
Repealed Act
Act 18 of 1976 has been repealed by s 1 of Act 49 of 1996
Repealed Act
Act 73 of 1976 has been repealed by s 41(1) of Act 4 of 1999
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Act 73 of 1976 has been repealed by s 41(1) of Act 4 of 1999
Repealed Act
Act 73 of 1976 has been repealed by s 41(1) of Act 4 of 1999
Repealed Act
Act 54 of 1968 has been repealed by s 36 of Act 108 of 1993
Repealed Act
Act 81 of 1977 has been repealed by s 10 of Act 45 of 2001
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Act 81 of 1977 has been repealed by s 10 of Act 45 of 2001
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Act 81 of 1977 has been repealed by s 10 of Act 45 of 2001
Repealed Act
Act 29 of 1980 has been repealed by s 60 of Act 96 of 1991Repealed Act
Act 96 of 1991 has been repealed by s 54 of Act 13 of 2002
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Act 29 of 1980 has been repealed by s 60 of Act 96 of 1991Repealed Act
Act 96 of 1991 has been repealed by s 54 of Act 13 of 2002
Repealed Act
Act 29 of 1980 has been repealed by s 60 of Act 96 of 1991Repealed Act
Act 96 of 1991 has been repealed by s 54 of Act 13 of 2002
Repealed Act
Act 83 of 1983 has been repealed by s 26 of Act 23 of 2001
Repealed Act
Act 83 of 1983 has been repealed by s 26 of Act 23 of 2001
Repealed Act
Act 83 of 1983 has been repealed by s 26 of Act 23 of 2001
Repealed Act
Act 84 of 1986 has been repealed by s 27 of Act 56 of 1996
Repealed Act
Act 21 of 1988 has been repealed by s 179(1) of Act 56 of 2003
Repealed Act
Act 21 of 1988 has been repealed by s 179(1) of Act 56 of 2003
Repealed Act
Act 21 of 1988 has been repealed by s 179(1) of Act 56 of 2003
Repealed Act
Act 93 of 1989 has been repealed by s 27 of Act 56 of 1996
MEDICINES AND RELATED SUBSTANCES AMENDMENT ACT
NO. 59 OF 2002
[ASSENTED TO 30 DECEMBER, 2002]
[DATE OF COMMENCEMENT: 2 MAY, 2003]
(English text signed by the President)
This Act has been updated to Government Gazette 24627 dated 28 March, 2003.
ACT
To amend the Medicines and Related Substances Act, 1965, so as to provide for some definitions; to provide for the appointment of one or more Deputy Registrars; to provide for a term of office of members of the Pricing Committee; to provide for the delay of the coming into operation of provisions requiring a licence before a person can compound and dispense or manufacture medicines, or act as a wholesaler or distributor; to provide for appeals against the decisions of the DirectorGeneral and the council; to provide for regulations relating to the marketing of medicines; and to provide for matters connected therewith.
BE IT ENACTED by the Parliament of the Republic of South Africa, as follows:—
1. Amends section 1 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) inserts the definition of “magistrate”; and paragraph (b) substitutes the definition of “practitioner”.
2. Amends section 6 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) deletes subsection (2) (b); and paragraph (b) substitutes subsection (3).
3. Substitutes section 12 of the Medicines and Related Substances Act, No. 101 of 1965.
4. Substitutes section 18C of the Medicines and Related Substances Act, No. 101 of 1965.
5. Amends section 22A of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (6) (p); paragraph (b) substitutes subsection (8); paragraph (c) substitutes subsection (9) (a) (i); paragraph (d) substitutes subsection (11) (a); paragraph (e) substitutes subsection (12) (a) (i); paragraph ( f ) substitutes subsection (12) (b); paragraph (g) substitutes subsection (12) (c); paragraph (h) substitutes subsection (14) (a); and paragraph (i) substitutes subsection (16) (b).
6. Amends section 22C of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (b); paragraph (b) substitutes subsection (2); paragraph (c) substitutes subsection (5); paragraph (d) substitutes subsection (6); and paragraph (e) substitutes subsection (7).
7. Amends section 22F (1) of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes the words preceding paragraph (a); and paragraph (b) substitutes paragraph (a).
8. Amends section 22G of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); paragraph (b) adds subsection (2) (c); and paragraph (c) substitutes subsection (3) (b).
9. Amends section 24 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes the heading; paragraph (b) substitutes subsection (1); paragraph (c) substitutes subsection (2) (a); paragraph (d) substitutes subsection (3); paragraph (e) substitutes subsection (4); paragraph ( f ) substitutes subsection (6); and paragraph (g) adds subsection (7).
10. Substitutes section 25 of the Medicines and Related Substances Act, No. 101 of 1965.
11. Amends section 28 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) adds subsections (5) and (6).
12. Amends section 35 (1) of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes paragraph (xxiv); and paragraph (b) substitutes paragraph (xxvii).
13. Substitutes the long title of the Medicines and Related Substances Act, No. 101 of 1965.
14. Repeal of Act 132 of 1998.—The South African Medicines and Medical Devices Regulatory Authority Act, 1998 (Act No. 132 of 1998), is repealed.
Repealed Act
Act 132 of 1998 has been repealed by s 14 of Act 59 of 2002
Repealed Act
Act 132 of 1998 has been repealed by s 14 of Act 59 of 2002
15. Short title and commencement.—This Act is called the Medicines and Related Substances Amendment Act, 2002, and shall come into operation on a date to be determined by the President by proclamation in the Gazette.
MEDICINES AND RELATED SUBSTANCES ACT
101 OF 1965
TABLE OF CONTENTS
PROPOSED REGULATIONS
GN 2007 of 9 December 2005
Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances
(Government Gazette No. 28308)
GN 449 of 31 March 2006
Amends Regulations relating to a transparent pricing system for medicine and scheduled substances
(Government Gazette No. 28673)
GNR.623 of 30 June 2006
Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee
(Government Gazette No. 28947)
GNR.1211 of 1 December 2006
Methodology for International Benchmarking of the Prices of Medicines and Scheduled Substances in South Africa
(Government Gazette No. 29443)
GNR.919 of 2 October 2007
Regulations relating to a transparent pricing system for medicines and scheduled substances
(Government Gazette No. 30342)
GN 807 of 29 July 2008
Annual review of the single exit prices of medicines and scheduled substances
(Government Gazette No. 31288)
GN 848 of 11 August 2008
Annual review of the single exit prices of medicines and scheduled substances
(Government Gazette No. 31327)
GNR.868 of 22 August 2008
General regulations
(Government Gazette No. 31334)
GNR.869 of 22 August 2008
Regulations relating to complementary and alternative medicines
(Government Gazette No. 31334)
GNR.870 of 22 August 2008
Schedules on complementary and alternative medicines in terms of the Act
(Government Gazette No. 31334)
GNR.899 of 25 August 2008
Determination of an appropriate logistic fee for medicines and scheduled substances
(Government Gazette No. 31357)
GN 1053 of 29 August 2008
Call for comment on a methodology for international benchmarking of originator medicine prices
(Government Gazette No. 31369)
GNR.967 of 12 September 2008
Determination of an appropriate logistic fee for medicines and scheduled substances
(Government Gazette No. 31404)
GN 1212 of 30 September 2008
Regulations:Transparent pricing system for medicines and scheduled substances: Amendment
(Government Gazette No. 31466)
GNR.195 of 23 February 2009
Regulations relating to the Transparent Pricing System for Medicines and Scheduled Substances: Amendment
(Government Gazette No. 31947)
GNR.688 of 19 June 2009
Regulations: Transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment
(Government Gazette No. 32330)
GN 1474 of 6 November 2009
Annual review of the single exit prices of medicines and scheduled substances: Invitation to submit representations
(Government Gazette No. 32684)
GNR.1053 of 6 November 2009
Regulations relating to a transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment
(Government Gazette No. 32685)
REGULATIONS
GNR.352 of 21 February 1975
Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council
GNR.906 of 28 May 1993
Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council
GNR.510 of 10 April 2003
General Regulations
GNR.539 of 25 April 2003
Regulations relating to Fees payable to the Registrar
GN 758 of 4 June 2003
Application fee: Application for a licence to compound or dispense medicines
GN 759 of 4 June 2003
Form: Application for a licence to compound or dispense medicines
GNR.1102 of 11 November 2005
Regulations relating to a transparent pricing system for medicines and scheduled substances
GNR.352 of 21 April 2006
„Regulasies rakende ’n deursigtige prysstelsel vir medisyne en gelyke stowwe”
(Afrikaans only)
GNR.1388 of 24 December 2008
Regulations relating to a transparent pricing system for medicines and scheduled substances
(Government Gazette No. 31735)
GUIDELINES WITH RESPECT TO THE MEDICINES AND RELATED SUBSTANCES ACT
GNR.609 of 2 May 2003
NOTICES
GNR.509 of 10 April 2003
Schedules
GNR.325 of 8 April 2005
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
GN 326 of 8 April 2005
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
GN 807 of 5 August 2005
Appointment of the Registrar of Medicines
GNR.1212 of 1 December 2006
Regulations relating to a transparent pricing system for medicines and scheduled substances: Information to be published by manufacturers and importers of medicines and scheduled substances before taking an increase in the single exit price
GNR.1213 of 1 December 2006
Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 01 July 2007
GN 1307 of 22 December 2006
Methodology for international benchmarking of the prices of medicines and scheduled substances in South Africa: Extension of the comments period
GNR.237 of 16 March 2007
Regulations relating to a transparent pricing system for medicines and scheduled substances methodology for international benchmarking of the prices of medicines and scheduled substances in South Africa: Extension of the comments period
GN 339 of 27 March 2008
Regulations relating to a transparent pricing system for medicines and scheduled substances: Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 31 July 2008
(Government Gazette No. 30901)
GN 340 of 27 March 2008
Regulations relating to a transparent pricing system for medicines and scheduled substances: Information to be published by manufacturers and importers of medicines and scheduled substances before taking an increase in the single exit price
(Government Gazette No. 30901)
GN 434 of 11 April 2008
Conditions of Registration of a Medicine in Terms of the Provisions of Section 15 (7) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
(Government Gazette No. 30957)
GNR.587 of 30 May 2008
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)
(Government Gazette No. 31083)
GNR.588 of 30 May 2008
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)
(Government Gazette No. 31083)
GN 613 of 6 June 2008
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)
(Government Gazette No. 31107)
GN 614 of 6 June 2008
Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances act, 1965 (Act 101 of 1965)
(Government Gazette No. 31107)
GN 905 of 8 August 2008
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7) of the Act
(Government Gazette No. 31270)
GN 1244 of 21 November 2008
Declaration of medicine as undesirable (section 23 of Act 101 of 1965)
(Government Gazette No. 31632)
GN 1534 of 19 December 2008
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 31696)
GNR.1389 of 24 December 2008
Regulations relating to a transparent pricing system for medicines and scheduled substances: Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 30 September 2009
(Government Gazette No. 31735)
GN 1269 of 17 October 2008
Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 31497)
GN 163 of 20 February 2009
Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No.31881)
GNR.713 of 1 July 2009
Application fees: Application for a licence to compound or dispense medicines
(Government Gazette No. 32358)
GN 1005 of 31 July 2009
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 32440)
GN 821 of 4 August 2009
Medicines Control Council: Declaration of medicine as undesirable
(Government Gazette No. 32477)
GN 1105 of 14 August 2009
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 32491)
GN 1341 of 9 October 2009
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 32620)
GN 1105 of 9 December 2009
Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)
(Government Gazette No. 32774)
TABLE OF REPEALS
The following notices have hereby been repealed:
Repealed Notices
As repealed by
GNR.553 of 30 April 2004
Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances
GNR.1102 of 11 November 2005
Regulations relating to a transparent pricing system for medicines and scheduled substances
PROPOSED REGULATIONS
GN 2007 of 9 December 2005: Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances
(Government Gazette No. 28308)
GN 449 of 31 March 2006: Amends Regulations relating to a transparent pricing system for medicine and scheduled substances
(Government Gazette No. 28673)
GNR.623 of 30 June 2006: Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee
(Government Gazette No. 28947)
GNR.1211 of 1 December 2006: Methodology for International Benchmarking of the Prices of Medicines and Scheduled Substances in South Africa
(Government Gazette No. 29443)
GNR.919 of 2 October 2007: Regulations relating to a transparent pricing system for medicines and scheduled substances
(Government Gazette No. 30342)
GN 807 of 29 July 2008: Annual review of the single exit prices of medicines and scheduled substances
(Government Gazette No. 31288)
GN 848 of 11 August 2008: Annual review of the single exit prices of medicines and scheduled substances
(Government Gazette No. 31327)
GNR.868 of 22 August 2008: General regulations
(Government Gazette No. 31334)
GNR.869 of 22 August 2008: Regulations relating to complementary and alternative medicines
(Government Gazette No. 31334)
GNR.870 of 22 August 2008: Schedules on complementary and alternative medicines in terms of the Act
(Government Gazette No. 31334)
GNR.899 of 25 August 2008: Determination of an appropriate logistic fee for medicines and scheduled substances
(Government Gazette No. 31357)
GN 1053 of 29 August 2008: Call for comment on a methodology for international benchmarking of originator medicine prices
(Government Gazette No. 31369)
GNR.967 of 12 September 2008: Determination of an appropriate logistic fee for medicines and scheduled substances
(Government Gazette No. 31404)
GN 1212 of 30 September 2008: Regulations:Transparent pricing system for medicines and scheduled substances: Amendment
(Government Gazette No. 31466)
GNR.195 of 23 February 2009
Regulations relating to the Transparent Pricing System for Medicines and Scheduled Substances: Amendment
(Government Gazette No. 31947)
GNR.688 of 19 June 2009: Regulations: Transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment
(Government Gazette No. 32330)
GN 1474 of 6 November 2009: Annual review of the single exit prices of medicines and scheduled substances: Invitation to submit representations
(Government Gazette No. 32684)
GNR.1053 of 6 November 2009: Regulations relating to a transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment
(Government Gazette No. 32685)
REGULATIONS
GNR.352 of 21 February 1975: Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council
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