Guideline on How to Amend a Current Licence

This guideline is intended to provide recommendations to applicants wishing to submit an application for an amendment to their current licence to manufacture, import or export, and wholesale medicines 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 registered medicines or scheduled substances will be of the required quality, safety, and efficacy and that the manufacturer, importer or exporter, wholesaler and/or distributor complies with acceptable quality assurance principles, good manufacturing, good wholesaling, and good distributing practices as determined by SAHPRA. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.