Submission for the following licence applications only:
- Cannabis Cultivation Licence
- GMP/Pharma Establishment Licence: Manufactures, Importers & Exporters
- GMP & CPP certificates
- Wholesalers of Medicine & Scheduled Substances(APIs)
- Licence Application for a Wholesaler to Export Medicine
Any other submission/correspondence will automatically be deleted and the sender’s email blocked.
Guidelines below:
- Guidelines for preparation of site master file
- South African good wholesaling practice for wholesalers
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:
- 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.