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Acts

Constitution of the Republic of South Africa, 1996

 

In terms of the constitutional provisions, the Authority is, amongst others, guided by the following sections and schedules: The Constitution of the Republic of South Africa, 1996, places obligations on the state to progressively realise socio-economic rights, including access to healthcare.

 

Section 27 of Chapter 2 of the Bill of Rights of the Constitution states the following with regard to healthcare, food, water and social security:

  • Everyone has the right to have access to healthcare services, including reproductive healthcare; sufficient food and water; and social security, including appropriate social assistance if they are unable to support themselves and their dependents.
  • The state must take reasonable legislative and other measures within its available resources to achieve the progressive realisation of each of these rights, and no one may be refused emergency medical treatment.

Acts

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
No. 25899Broad-based Black Economic Empowerment Act 200314/01/2004463Downloadactcorporate
No. 20853Promotion Of Administrative Justice Act 3 Of 200017/02/2000316Downloadactcorporate
No. 20852Promotion Of Access To Information Act 2 Of 200017/02/2000416Downloadactcorporate
No. 18491Basic Conditions Of Employment Act, 75 Of 199719/12/1997390Downloadactcorporate
No. 866Customs And Excise Act, 1964 (Act No. 91 Of 1964)09/07/1964XIIIDownloadactcorporate
No. 4442Pharmacy Act, 1974 (Act No. 53 Of 1974)18/10/1974112Downloadactcorporate
No. 8883Nursing Act, 1978 (Act No. 50 Of 1978)11/05/2006491Downloadactcorporate
Health Professions Act, 1974 (Act No. 56 Of 1974)15/02/2007Downloadactcorporate
No. 19519Environmental Management Act: Waste Management Act, 1998 (Act No. 107 Of 1998)04/11/1998401Downloadactcorporate
No. 3530Foodstuffs, Cosmetics And Disinfectants Act, 1972 (Act No. 54 Of 1972) As Amended22/06/197284Downloadactcorporate
No. 14143Drugs And Drug Trafficking Act, 1992 (Act No. 140 Of 1992)23/07/1992329Downloadactcorporate
No. 8051Veterinary And Para-veterinary Professions Act, 1982 (Act No. 19 Of 1982)10/03/1982201Downloadactcorporate
No. 9152Animal Diseases Act, 1984 (Act No. 35 Of 1984)18/04/1984226Downloadactcorporate
No. 3751Fertilisers, farm feeds, agricultural remedies and stock remedies act, 1947 (act no. 36 of 1947)08/01/1947CXLVIIDownloadactcorporate
No. 26595National Health Act, 2003 (Act No. 61 Of 2003)23/07/2004469Downloadactcorporate
No. 3834Hazardous Substances Act (Act No. 15 Of 1973)11/05/201794Downloadactcorporate
40869Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended10/05/2017Downloadactcorporate

Mandated obligations and functions of SAHPRA

 

The South African Health Products Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nuclides; and the conduct of clinical trials.

 

The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (hereinafter referred to as “the Medicines Act”); and other relevant legislation, regulations and policies.

Further, SAHPRA’s mandate has expanded to include the regulation and control of radiation emitting devices and radioactive nuclides under the Medicines Act and the Hazardous Substances Act, 1973 (Act No. 15 of 1973).