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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This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to act as a wholesaler of medicine and/or scheduled substances. It is not intended as an exclusive approach and should not be taken as a complete or authoritative...
This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to act as a wholesaler of medicine and/or scheduled substances. It is not intended as an exclusive approach and should not be taken as a complete or authoritative statement...
This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...
To develop a medicine information data bank on the quality of medicines in circulation and disseminate such information to stakeholders involved in the medicines supply chain. To promote communication and cooperation between stakeholders and partners involved in the medicines supply chain. To identify possible causes of inferior...
This document has been prepared to serve as a guidance document regarding SAHPRA requirements for release of import health products at Ports of Entry - Regulatory Compliance Unit....
This document has been prepared to serve as a guidance document regarding SAHPRA requirements for advertisement of medicines and health products- Regulatory Compliance Unit....
This guideline intends to assist applicants in differentiating between various types of permits, the requirements
for each permit and the relevant fees applicable.
This guideline is applicable to Section 22A permits and related authorizations in Regulatory Compliance. The
scope includes the application process, fee applicable and...
