The aim of this Guideline is to assist wholesalers in the preparation of documentation for the application
to be licensed to export medicinal products Whenever there is doubt, wholesalers are advised to consult
South African Health Products Regulatory Authority (SAHPRA) for confirmation and/or clarification before
completing and submitting an application.
This guideline applies to all wholesalers who are intending to export medicinal products.
this guideline describes the following points;
- Quality Management Systems
- Requirements to be met By The Wholesaler Intending To Export
- Requirements To Be Met By The HCR
- Requirements To Be Met By The Foreign Site