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,...
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)....
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...
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....
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. ...
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...
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...
The South African Health Products Regulatory Authority (SAHPRA) launched the Online Medicines Directory for over-the-counter (OTC) medicines in June 2022. The platform, available at www.medsinfo.sahpra.org.za, serves as a single, trusted source of information for patients, consumers, and healthcare professionals on all medicines approved by SAHPRA. Phase...
This guideline specifies the basic security conditions for obtaining a transport authority for Group IV hazardous substances as defined in the Hazardous Substances Act 15 of 1973, referred to in this guideline as radioactive material. This represents the guidance of the South African Health Products...
This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...