PRESENTATION TO THE NCC- MINISTER OF HEALTH- 19 MAY 2020
03 Jun Communication to Industry – Applications for GMP and CPP Certificates
Posted at 14:35h
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Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...
27 May Application Form for Lot Release of Human Vaccine
Posted at 16:15h
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The application form shall be used for an application for lot release of a human vaccine submitted to the South African Health Products Regulatory Authority....
27 May Guideline for Lot Release of Human Vaccines
Posted at 16:11h
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This document is intended to provide guidance to applicants for lot release requirements for all human vaccines. This will be a “living document” and will be updated on a regular basis. It is important that applicants adhere to the prescribed requirements in order to avoid...
25 May Payment of annual retention fees for registered products
Posted at 15:40h
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The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, (“the Medicines Act”) makes provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. Further to the above, Regulation...
25 May Application for rescheduling of a substance or medicine
Posted at 14:12h
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This document is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...
10 May Pharmacovigilance systems
Posted at 10:20h
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This document provides guidance to the applicants/holders of Certificate of Registration on the pharmacovigilance system requirements. It is meant to facilitate compliance by applicants/HCRs with the regulatory authority on pharmacovigilance requirements....