Archive

30 Mar Submission of Post-Importation Testing Exemption requests for Biological and Biosimilar Medicines

Posted at 09:35h in

As of the 1st of April 2022, the post-importation testing exemption requests for Biological and Biosimilar medicines should be submitted as per the requirements of Guideline 2.04. For submission process, please refer to section 3.0 Post-Importation Testing Exemptions (PITE)....

Read More

01 Feb Form for Licence Application for a Wholesaler to Export Medicines

Posted at 11:44h in

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...

Read More

01 Feb Licence Application to act as a Wholesaler of Medicines and Scheduled Substances

Posted at 11:43h in

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...

Read More

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...

Read More

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...

Read More

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....

Read More

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. ...

Read More

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....

Read More

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....

Read More

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....

Read More