News

For Comment- Strategic framework for communication

08 Jan 2020
Strategic framework for Communication
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Cannabis Q & A

13 Dec 2019
The Cannabis Q & A document will assist in providing clarity on issues relating to cannabis.
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API names updated to align with WHO INN

02 Aug 2019

Update - 
SAHPRA has updated and amended the approved South African API names to bring them in line with WHO INN.

The amendment process allows for a five-year transition period to allow industry to bring medicine labelling in line with the policy commencing in June 2019 and ending in June 2024. 

 


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Submission of Business as Usual (BAU) registration and variation applications

01 Aug 2019
To Industry Partners

The aim of this communication is to guide industry regarding the submission of BAU registration and variation applications for human medicines (excluding Complementary Medicines).
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WHO or WHAT is SAHPRA

10 May 2019
SAHPRA is the South African Health Products Regulatory Authority formaly known as the Medicines Control Councel (MCC).  
Click here to find out more about SAHPRA as the new regularor.

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Welcome

The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, which governs the manufacture, distribution, sale, and marketing of medicines.
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Publications

Acts, regulations, notices, registrations, application forms, guidelines, safety alerts and workshops are available for download when selecting the publications section.
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safety information

Access the latest medicines safety information, updates and press releases
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