LICENCE APPLICATION PROCESS

Submission for the following licence applications only:

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
GLF-LIC-05AForm for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes,

2022 Aug

1, , , docxDownloadapplication-forms formcannabis inspectorate-and-good-manufacturing-practices licencing regulatory-compliance
GLF-LIC-01AForm for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-02ALicence Application to act as a Wholesaler of Medicines and Scheduled Substances,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing
GLF-LIC-04AForm for Licence Application for a Wholesaler to Export Medicines,

2022 Aug

1, docxDownloadapplication-forms forminspectorate-and-good-manufacturing-practices licencing

 

Guidelines below:

Document NumberTitleCategoriesDate updatedVersionUnitsFile TypeLinkdoc_categories_hfilterdoc_tags_hfilter
4.01SA Guide to Good Manufacturing Practice

2019 Jul

7, , Downloadguidelinegeneral-ectd-human-medicines-guidelines inspectorate-and-good-manufacturing-practices licencing
4.02South African Good Wholesaling Practice for Wholesalers

2019 Nov

2, Downloadguidelineinspectorate-and-good-manufacturing-practices licencing
4.08Guidelines for preparation of Site Master file

2019 Nov

1, Downloadguidelineinspectorate-and-good-manufacturing-practices licencing
SAHPGL-LIC-01Licence to Manufacture, Import or Export

2022 Jun

3pdfDownloadguidelinelicencing
SAHPGL-LIC-02Guideline on How to Apply for A Licence to Act as A Wholesaler

2022 Jun

2pdfDownloadguidelinelicencing
SAHPGL-LIC-03Guideline on How to Amend a Current Licence

2022 Jun

1pdfDownloadguidelinelicencing
2.44Guideline For Cultivation Of Cannabis And Manufacture Of Cannabis-Related Pharmaceutical Products For Medicinal And Research Purposes

2017 Sep

2, , Downloadguidelinecannabis licencing regulatory-compliance

 

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.