LICENCE APPLICATION PROCESS

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)

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:

• SAHPRA Fees
• SAHPRA Payment Guideline

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.