This document provides the principles behind the minimum requirements in terms of quality, security and standard operating procedures relating to the cultivation of Cannabis and the manufacture and use of Cannabis-related pharmaceutical products for medicinal and research purposes that will need to be in place...
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...
Comprehensive guideline on How to Apply for a Licence to Act as a Wholesaler (namely Private, Government Depots and Bond Stores) of medicines and scheduled substances. The guide was updated recently so that all the information required by the Authority when applying for a...
An application form for the purpose of obtaining a licence by a licensed wholesaler to export medicinal products (i.e. medicines and scheduled substances) in terms of the provisions of the Medicines and Related Substances Act, 101 of 1965, Section 22C and 22D read together with...
An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines...
An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of Section 22C(1)(b) and Section 22D of the Medicines and Related Substance Act 101 of 1965 as amended, read together with Regulations 23 and 24 of...
An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of Section 22C(1)(b) and Section 22D of the Medicines and Related Substance Act 101 of 1965 as amended, read together with Regulations 23 and 24 of...
SAHPRA will be embarking on a survey to determine the latest annual company turnover of licence holders to understand the impact of inspection fees on the licence holders within local industry....
Applicants who are in possession of a Licence to Cultivate Cannabis for Purposes of Producing Scheduled Substances in terms of section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) may apply for a GMP certificate for their facility. ...
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...