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.

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).  


Update of the South African approved Active Pharmaceutical Ingredient (API) names in the schedules to WHO International Non-Proprietary Names (INN)

20 Jun 2019

The South African Health Products Regulatory Authority (SAHPRA) is updating certain active pharmaceutical ingredient (API) names used in South Africa to bring them into line with international nomenclature.

SAHPRA Publishes latest amendments guidelines for Biological Medicines

20 Jun 2019

The latest guidelines for are intended to provide recommendations to applicants wishing to submit amendments for registered BIOLOGICAL medicines.

Exemption of certain products containing Cannabidiol from certain provision of the Act for a period of 12 months

28 May 2019

The Miniter of Health in recognition of the known safety profiles of the low-dose Cannabidiol (CBD) has decided to exclude certain CBD containing products from Schedule 4 for a period of 12 Months as stipulated in the govermament Notice No. R756, Goverment Gazette No. 42477.

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10 May 2019
SAHPRA is the South African Health Products Regulatory Authority formaly known as the Medicines Control Councel (MCC).  
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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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Acts, regulations, notices, registrations, application forms, guidelines, safety alerts and workshops are available for download when selecting the publications section.
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