News

SAHPRA Year-End Closure

02 Dec 2019
SAHPRA will close officially at 10h00 on 24 December 2019 and re-open on 2 January 2020.
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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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Publication of final versions of various guidelines

05 Jul 2019
SAHPRA is pleased to announce the publication of multiple guidelines (including Tranche 1 and Tranche 2 documents). Thank you to industry for your comments, which were duly considered. Please note that the implementation date of the Professional Information (PI) and Patient Information Leaflet (PIL) Guidelines is contingent on regulation amendments currently out for comment. The implementation date of the Variations Addendum is contingent on the go-live of the Digital Variations Portal. Development of the portal is underway, and additional communication will follow. Timelines for submitting in eCTD and eSubmission format will be detailed in the Roadmap (2.26), an updated version of which will be published shortly.
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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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