Archive

01 Feb Form for Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories

Posted at 11:41h in

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...

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01 Feb Form for Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes

Posted at 11:39h in

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...

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28 Jan SAHPRA survey to determine company turnover

Posted at 14:29h in

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....

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28 Jan GMP CERTIFICATES FOR CANNABIS CULTIVATED BY CULTIVATORS HOLDING A SECTION 22C(1)(b) LICENCE (LICENCE TO CULTIVATE CANNABIS FOR THE PURPOSES OF PRODUCING SCHEDULED SUBSTANCES)

Posted at 14:27h in

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. ...

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25 Jan Guideline for Fee determination and Payment of GxP and Product related Inspection

Posted at 13:50h in

This document has been prepared as a guidance document on the fees structure employed to calculate the fees for GxP and product related inspections....

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25 Jan Guideline on how to respond to a GMP, GWP, GCP and GVP Inspection report

Posted at 13:49h in

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....

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25 Jan Guideline for preparation of site master file

Posted at 13:44h in

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....

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25 Jan Guideline for Good Wholesaling Practice for Wholesaler

Posted at 13:35h in

This document has been prepared to serve as a recommendation to applicants wishing to conduct business as medicine wholesalers....

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25 Jan Guideline for Post Importation Testing

Posted at 13:32h in

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. ...

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25 Jan Guideline for Good Manufacturing Practice

Posted at 10:30h in

This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach....

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