Legislative Mandate: Section 22C(1)(b) of MEDICINES AND RELATED SUBSTANCES ACT 101 OF 1965 as amended and Regulation 23.
The Pharma Licencing sub-unit is responsible for issuing to a manufacturer, wholesaler or distributor of a medicine or scheduled substance, a licence to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine and/or scheduled substance, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and/or distribution practices as the Authority may determine.
For facilities handling Medical Devices or Complementary Medicines, refer to the appropriate webpages.
Pharma Licenced Establishments
SAHPRA maintains a register of pharmaceutical establishments licensed to operate within South Africa in accordance with the Medicines and Related Substances Act. This register includes active licences, as well as revoked/suspended/cancelled licences and permanently closed establishments. SAHPRA publishes monthly updated registers to ensure transparency and protect public health. View the registers below:
Pharma Licencing Guidelines
Pharma Licencing Forms
Submission for the following licence applications only:
Application Supporting Documents
Completed application forms with the following supporting documents:
- Licence application cover Letter
- Proof of payment with the correct reference as per Annexure A – SAHPRA Fee Categorisation Guideline
- Latest Inspection resolution if applicable
- Existing Licence being renewed/amended if applicable
- CIPC/CIPRO/DTI CERTIFICATES OR DOCUMENTS proving ownership of the business
- NDOH PREMISES LICENCE (OR COPY OF COMPLETED APPLICATION FORM – evidence of having applied)
- REGISTRATION AS RESPONSIBLE PHARMACIST (OR SAPC CASE NUMBER)
- SAPC CERTIFICATE OF RECORDING OF A PHARMACY (OR SAPC CASE NUMBER)
- SAPC CERTIFICATE OF RECORDING OF A PHARMACY OWNER (OR SAPC CASE NUMBER)
- Copy of POP of the licence annual retention fee for all preceding years if licence is older than a year.
- Product List with POP of annual retention fee for each product since the product was registered.
Applicants to submit a zipped file.
Fees information below:
Application Process Flow
