Pharma Licencing

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

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-LIC-05GWP Guideline for the Importers and Distributors of Scheduled Substances13/04/20261Downloadguidelinelicencing
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , Downloadguidelinecannabis licencing regulatory-compliance
SAHPGL-LIC-03Guideline on How to Amend a Current Licence13/04/20262Downloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler13/04/20263Downloadguidelinelicencing
SAHPGL-LIC-01Licence to Manufacture, Import or Export13/04/20264Downloadguidelinelicencing
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, Downloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, Downloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-02SA Guide to Good Manufacturing Practice for Medicines24/04/202610, , Downloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing

Pharma Licencing Forms

Submission for the following licence applications only:

Document NumberTitleCategoriesDate UpdatedVersionUnitsLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-LIC-05BLicence Application for the Importing and the Distribution Scheduled Substances, 24/04/20241, Downloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines, 18/08/20221, Downloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances, 18/08/20221, Downloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories, 18/08/20221, Downloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes, 10/08/20221, , , Downloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance

Application Supporting Documents

Completed application forms with the following supporting documents:

 

  1. Licence application cover Letter
  2. Proof of payment with the correct reference as per Annexure A – SAHPRA Fee Categorisation Guideline
  3. Latest Inspection resolution if applicable
  4. Existing Licence being renewed/amended if applicable
  5. CIPC/CIPRO/DTI CERTIFICATES OR DOCUMENTS proving ownership of the business
  6. NDOH PREMISES LICENCE (OR COPY OF COMPLETED APPLICATION FORM – evidence of having applied)
  7. REGISTRATION AS RESPONSIBLE PHARMACIST (OR SAPC CASE NUMBER)
  8. SAPC CERTIFICATE OF RECORDING OF A PHARMACY (OR SAPC CASE NUMBER)
  9. SAPC CERTIFICATE OF RECORDING OF A PHARMACY OWNER (OR SAPC CASE NUMBER)
  10. Copy of POP of the licence annual retention fee for all preceding years if licence is older than a year.
  11. 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

Key Contacts

Naven Naidoo

Tel: 012 501 0395
naven.naidoo@sahpra.org.za

Dedicated Email Address for Licence Applications for facilities handling Pharmaceuticals/Orthodox Medicines/Scheduled Substances ONLY: for Manufacturers, Importers, Exporters and Wholesalers (other non-applicable applications will be automatically deleted): pharmalicensing@sahpra.org.za

Dedicated Email Address for Pharma Licence application queries and responses ONLY: pharmalicqueries@sahpra.org.za

Dedicated email address for submission of site master files (for pharmaceutical facilities only, NOT for Medical Device Establishments): smf@sahpra.org.za

Ms Dikeledi Yvonne Motepe

Tel: 012 501 0360
Email: dikeledi.motepe@sahpra.org.za

 

Mr. Khotso Bokaba

Tel: 012 501 0475

Email: Khotso.bokaba@sahpra.org.za

Pharma Establishment Licence Renewal and Amendment Applications

Dear Stakeholder,

The Pharma Licensing dedicated inbox will be amended from gmplicensing@sahpra.org.za to pharmalicensing@sahpra.org.za from 1st March 2026. Applicants are urged to forward their applications to the new dedicated email address.

The Pharma Licensing unit of SAHPRA emphasises that any critical changes (refer Regulation23(7) of the Medicines Act) to the pharmaceutical facility be approved by SAHPRA prior to implementation: Guideline on how to amend a current licence.

Additionally, licence holders are reminded to apply for the renewal of the licence every 5 years, at least 180 days before the expiry of the existing licence.

Regards,
Pharma Licensing Unit

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