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Medicines and Related Substances Control Amendment Act (No. 90 of

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Medicines and Related Substances Control Amendment Act (No. 90 of

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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.

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