Licence to Manufacture, Import or Export

This guideline provides recommendations for applicants seeking to submit an application for a licence to manufacture, import, or export a medicine or scheduled substance. 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 ensuring that all scheduled substances and registered medicines are of the required quality, safety, and efficacy, and that manufacturers comply with acceptable quality assurance principles and good manufacturing practices, as determined by SAHPRA, to manufacture, import, or export. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of applications