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 document has been prepared as a guidance document on the fees structure employed to calculate the fees for GxP and product related inspections....
This guideline is intended to provide guidance to the applicants responding to the inspection report following a GMP, GWP, GCP, GVP, inspection at their site....
This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master Files with regard to all sites for pharmaceutical business....
This document has been prepared to serve as a recommendation to applicants wishing to conduct business as medicine wholesalers....
The objective of this procedure is to define the process to be followed and to provide instruction to the Holder of the Certificate of Registration (HCR) when submitting an application for Post-Importation Testing Exemption or imported products. ...