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LICENCE APPLICATION PROCESS

Submission for the following licence applications only:

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-LIC-05BLicence Application for the Importing and the Distribution Scheduled Substances, 24/04/20241, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines, 18/08/20221, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances, 18/08/20221, docxDownloadapplication-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, docxDownloadapplication-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, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance

 

Guidelines below:

Document NumberTitleCategoriesDate UpdatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
SAHPGL-LIC-05GWP Guideline for the Importers and Distributors of Scheduled Substances24/04/20241pdfDownloadguidelinelicencing
SAHPGL-INSP-RC-13Guideline For Cultivation Of Cannabis10/11/20223, , pdfDownloadguidelinecannabis licencing regulatory-compliance
SAHPGL-LIC-03Guideline on How to Amend a Current Licence22/06/20221pdfDownloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler22/06/20222pdfDownloadguidelinelicencing
SAHPGL-LIC-01Licence to Manufacture, Import or Export09/06/20223pdfDownloadguidelinelicencing
SAHPGL-INSP-04Guideline for preparation of site master file14/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-03Guideline for Good Wholesaling Practice for Wholesaler07/09/20225, pdfDownloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-INSP-02Guideline for Good Manufacturing Practice18/09/20228, , pdfDownloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing

 

Fees below:

 

Applicant to confirm submission of the following documents prior to accessing the email: gmplicensing@sahpra.org.za

 

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.