Guideline on How to Amend a Current Licence

This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to act as a wholesaler of medicine and/or scheduled substances. It is not intended as an exclusive approach and should not be taken as a complete or authoritative statement of the law. SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a medicine and/or scheduled substances in keeping with the knowledge current at the time of
evaluation. The SAHPRA is committed to ensuring that all medicines and/or scheduled substances will be of the required quality, safety, and efficacy and that the wholesaler and/or distributor complies with acceptable quality assurance principles and good wholesaling/distributing practices as determined by SAHPRA. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.