Guideline Archives - Page 10 of 16

21 Jun Guidelines for Post Marketing Surveillance of Medicines and Health Products

Posted at 22:51h in

To develop a medicine information data bank on the quality of medicines in circulation and disseminate such information to stakeholders involved in the medicines supply chain. To promote communication and cooperation between stakeholders and partners involved in the medicines supply chain. To identify possible causes of inferior...

21 Jun Guideline for Release of Import Health Products at Ports of Entry

Posted at 22:47h in

This document has been prepared to serve as a guidance document regarding SAHPRA requirements for release of import health products at Ports of Entry - Regulatory Compliance Unit....

21 Jun Guidelines for Advertisement of Medicines and Health Products

Posted at 22:25h in

This document has been prepared to serve as a guidance document regarding SAHPRA requirements for advertisement of medicines and health products- Regulatory Compliance Unit....

21 Jun Guideline to Fee Determination and Payments of Permits and Related Authorisations

Posted at 22:19h in

This guideline intends to assist applicants in differentiating between various types of permits, the requirements for each permit and the relevant fees applicable.

This guideline is applicable to Section 22A permits and related authorizations in Regulatory Compliance. The scope includes the application process, fee applicable and...

21 Jun Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

Posted at 13:18h in

This document has been prepared to serve as a recommendation to applicants regarding the recalls and withdrawal of medicines, and the South African Health Products Regulatory Authority's current thinking on the safety, quality, and efficacy of medicines. SAHPRA reserves the right to request any additional...

15 Jun Post-marketing Reporting of Adverse Drug Reactions for Human Medicines in South Africa

Posted at 18:24h in

This document serves as a guideline to Applicants/ holders of certificates of registration (HCRs) on the reporting of adverse drug reactions/ events. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality, and efficacy of medicines. The Authority reserves the right...

27 May Guideline for Lot Release of Human Vaccines

Posted at 16:11h in

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 Application for rescheduling of a substance or medicine

Posted at 14:12h in

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 in

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....

06 May Pharmacovigilance Inspections for Human Medicinal Products

Posted at 16:23h in

This document has been prepared to serve as a guideline to those involved in the conduct of Pharmacovigilance inspections. It is meant to facilitate compliance with Good Pharmacovigilance Practice relating to the conduct and monitoring of Pharmacovigilance inspections. It is not intended as an exclusive...

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