Medicines and Related Substances Control Amendment Act 90 of 1997

The Medicines and Related Substances Control Amendment Act 90 of 1997 intends:

• to amend the Medicines and Related Substances Control Act, 1965, in relation to the definitions:
• to provide that the 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 a 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 shall be subject to the approval of the Minister;
• 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 require labels to be approved by the council;
• to prohibit bonusing and sampling of medicines; to further regulate the control of medicines and Scheduled substances;
• to provide for the licensing of certain persons to compound, dispense or manufacture medicines;
• to provide for generic substitution of medicines;
• to provide for the establishment of a pricing committee: to regulate the purchase and sale of medicines by wholesalers; to make new provision for appeals against decisions of the Director-General or the council;
• to further regulate the powers of inspectors;
• to increase the jurisdiction of magistrates’ courts in respect of penalties in terms of this Act;
• to provide that the council may acquire and appropriate funds;
• to regulate anew the Minister’s power to make regulations: and
• to provide for the rationalisation of certain laws relating to medicines and related substances that have remained in force in various territories of the national territory of the Republic by virtue of section 229 of the Constitution of the Republic of South Africa, 1993; and
• to provide for matters connected therewith.

Amends

• Medicines and Related Substances Control Amendment Act 94 of 1991
• Businesses Act 71 of 1991
• Allied Health Professions Act (previously Chiropractors, Homeopaths and Allied Health Service Professions Act and Associated Health Service Professions Act) 63 of 1982
• Health Laws Amendment Act 36 of 1977
• Drugs Control Amendment Act 65 of 1974
• Drugs Laws Amendment Act 95 of 1971

Commencement

• 2 May 2003 (Gazette 24627 of 28 March 2003)
• 2 May 2004, Section 12 to the extent that it inserts Section 18A(Gazette 24627 of 28 March 2003) 
• 1 July 2005, Secion 26 (Gazette 24627 of 28 March 2003)

Amendment

Amended by South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998