Guideline Archives

13 Oct Guideline on the Quality and Clinical Aspects of Synthetic Peptides

Posted at 11:27h in

This guideline provides recommendations to applicants who wish to submit application for the registration of synthetic peptide medicines. The South African Health Products Regulatory Authority (SAHPRA) is committed to the safety, quality and efficacy of medicines. This document should be regarded as recommendations not as...

22 Sep Guideline for Selection of Reference Products for Applications of Generic Medicines

Posted at 11:38h in

This document guides applicants who seek to apply for new registration of generics supported by Bioequivalence studies. The South African Health Products Regulatory Authority (SAHPRA) can request additional information to establish whether the health products meet the safety, quality and performance standards. While other approaches...

15 Sep Guideline for Use Licence Applications and the Requirements for the Safe Use of Class 3b and Class 4 Lasers or Laser Systems

Posted at 14:18h in

This guideline provides information to applicants wishing to submit applications for the use of Class 3B and Class 4 lasers or laser systems...

26 Aug Guideline for Borderline Products

Posted at 18:01h in

This guideline provides information on the process to be followed when the appropriate regulatory pathway for a specific product is unclear. It also outlines the criteria to be applied to determine whether the product is regulated in terms of the Medicines and Related Substances Act,...

18 Aug Guideline for the Completion of the Annual Submission of Compliance Information Form

Posted at 15:22h in

The objective of this guideline is to give clear guidance on the Annual Submission of Compliance Information process from the perspective of an importer/ License Holder and Completion of the Annual Submission of Compliance Information Form (OF-RDN-NM-06A, replacing Old Form: 41BM-2)....

30 Jun Guideline for Industry e-reporting

Posted at 13:38h in

This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the...

10 Jun Guideline on Minimum Requirements for Inspecting Group III and Group IV Hazardous Substances

Posted at 14:24h in

This guideline delineates the mandatory regulatory framework of the Radiation Control Inspectorate sub-unit including the inspection requirements to all Group III and Group IV Hazardous Substances, in terms of the Hazardous Substances Act No. 15 of 1973 and Regulations R1332 and R247....

01 Jun Guideline for Submission of Extension Applications

Posted at 09:03h in

This guideline is intended to provide guidance to applicants who intend to submit extension applications for registration. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current position on the safety, quality and efficacy of these medicines. ...

19 May Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices

Posted at 10:50h in

This document serves as a guideline to assist applicants to comply with the requirements for a Site Master File (SMF) regarding the wholesaling of medical devices (including In vitro diagnostics (IVDs)). The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all...

14 Apr Guidelines for Submission of Plasma Master File

Posted at 15:13h in

These guidelines provide recommendations for manufacturers seeking to submit Plasma Master Files to support the quality of the starting materials for Plasma-Derived Medicinal Products (PDMP). These apply to applications for the registration or variations of PDMP. These guidelines emphasise the South African Health Products Regulatory...

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