Licence to Manufacture, Import or Export

This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to manufacture, import or export a medicine 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 or scheduled substance in keeping with the knowledge current at the time of evaluation. SAHPRA is committed to ensure that all scheduled substances and registered medicines will be of the required quality, safety, and efficacy and that the manufacturer complies with acceptable quality assurance principles and good manufacturing practices as determined by SAHPRA to manufacture, import, or export. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.