The Act provides a framework for a structured uniform health system within the Republic, taking into account the obligations imposed by the Constitution and other laws on national, provincial and local government with regard to health services. The objectives of the National Health Act (NHA) are to: ...
Within the Medicines Act, “medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973) (hereinafter...
The General Regulations of the above Act include the arrangement of regulations for supply of medicines, registration of medicines, permits, licencing and authorisation, management of medicines, the Authority, appeals, investigations, offences, and penalties....
The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst others, the establishment of SAHPRA, the licensing...
This document provides the principles behind the minimum requirements in terms of quality, security and standard operating procedures relating to the cultivation of Cannabis and the manufacture and use of Cannabis-related pharmaceutical products for medicinal and research purposes that will need to be in place...
This document guides access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and clarifies the mandate, intent and scope of this section and Regulation 29 of the General Regulations...
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The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...
What is Cannabis?
Cannabis refers to the plants in the genus Cannabis, which includes various species or sub-species. Cannabis species in the genus include C.sativa, C.indica and C.ruderalis....
This guideline is intended to provide recommendations to applicants wishing to submit an application for an amendment to their current licence to manufacture, import or export, and wholesale medicines or scheduled substances. It is not intended as an exclusive approach and should not be taken...