GWP Guideline for the Importers and Distributors of Scheduled Substances

This guideline is intended to provide recommendations to applicants wishing to apply for a licence to import and /or distribute substances listed in the schedules in terms of the Medicines Act intended for use in the manufacturing and/or compounding of medicines or scheduled substances. Furthermore, this guideline document does not provide stand-alone guidance on GWP and GMP for importers and distributors of scheduled substances used in the manufacturing and/or compounding of medicines and related substances. It is also not intended as an exclusive approach leaflet and should thus 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 any scheduled substance used in the manufacturing and/or compounding of medicines or related substances in keeping with the knowledge current at the time of evaluation. SAHPRA is committed to ensuring that any scheduled substance used in the manufacturing of all registered medicines will be of the required quality, safety, and efficacy and that the manufacturer of such scheduled substances complies with acceptable quality assurance principles and good manufacturing practices as determined by SAHPRA during the manufacturing and importation of such scheduled substances into the Republic of South Africa. Applicants must adhere to the administrative requirements to avoid delays in the processing and evaluation of their applications.

The guidance in this Guidelines and application forms are available from the Office of the SAHPRA Chief Executive Officer and the SAHPRA website: www.sahpra.org.za or https://www.sahpra.org.za/inspectorate-pharma licencing-and-regulatory-compliance/