Dear Healthcare Professional Letters Guidelines for comment

09 Sep 2019
This guideline document is directed for comment to the pharmaceutical Industry. 

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. 



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).

Publication of the Professional Information and Product Information Leaflet

01 Jul 2019

SAHPRA publishes the first version of the PI and PIL repository.

SAHPRA has published the first version of the PI and PIL repository, containing 11 products associated with the first resubmission window of the Backlog Clearance Program. In the interest of sharing the latest SAHPRA-approved information as soon as possible, these PI and PILs are still in their current, MCC format. All published PI and PILs will be updated when relevant variation applications are finalised (e.g., imminent format updates in accordance with the latest SAHPRA PI and PIL guidelines).  



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.



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.
Click here to learn more


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