Drugs and drug trafficking act



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Repealed Act

Act 6 of 1971 has been repealed by s 34 of P 21 of 1996


Repealed Act

Act 6 of 1971 has been repealed by s 34 of P 21 of 1996


Repealed Act

Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005


Repealed Act

Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005


Repealed Act

Act 57 of 1972 has been repealed by s 313 of Act 38 of 2005


Repealed Act

Act 41 of 1967 has been repealed by s 113 of Act 70 of 1988


Repealed Act


Act 41 of 1967 has been repealed by s 113 of Act 70 of 1988
Repealed Act

Act 63 of 1972 has been repealed by s 36 of Act 108 of 1993


Repealed Act

Act 85 of 1972 has been repealed by s 36 of Act 108 of 1993


Repealed Act

Act 86 of 1972 has been repealed by s 36 of Act 108 of 1993


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 37 of 1973 has been repealed by s 20 of Act 59 of 1992


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996




Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 57 of 1973 has been repealed by s 34 of Act 21 of 1996


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act

Act 76 of 1973 has been repealed by s 27 of Act 18 of 2006


Repealed Act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


Repealed Act

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


Repealed Act

Act 81 of 1977 has been repealed by s 10 of Act 45 of 2001


Repealed Act

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


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 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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