Stephen Saad, Group Chief Executive, Aspen
The line between research based pharmaceutical companies and generic companies is today less and less relevant, as we have seen in the past few years generic companies climb up the…
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The MCC is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.
The registration of medicine in South Africa is governed by the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965, (hereafter ‘the Act’) and the Regulations and Guidelines published in terms thereof.
These Guidelines describe the information required for the registration of “medicines” and for an application to amend a registered medicine. The information submitted will be evaluated in terms of the provisions of the Act.
It is a legal requirement that data submitted for evaluation should substantiate all claims and should meet technical requirements of quality, safety and efficacy of the product for the purposes for which it is intended.
Regulation
Legislation requires that the Council shall register every medicine before it may be sold/marketed.
An application for the registration of a medicine should therefore be submitted for evaluation and approval.
The line between research based pharmaceutical companies and generic companies is today less and less relevant, as we have seen in the past few years generic companies climb up the…
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