Subscribe |

Archive

Home >  (Page 11)

25 Jan

Posted at 16:49h in

This document has been prepared to serve as a guideline to healthcare professionals reporting adverse drug reactions, adverse event following immunisations and product quality problems. It represents South African Health Products Regulatory Authority’s (SAHPRA’s) current thinking on the safety, quality and efficacy of medicines....

25 Jan

Posted at 13:59h in

This document has been prepared to serve as a recommendation to those who wish to import and export medicines in South Africa. The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all medicines entering or leaving the country will retain the...

25 Jan

Posted at 13:52h in

This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to manufacture, import or export a medicine or scheduled substances. It is not intended as an exclusive approach and should not be taken as a complete or authoritative...

25 Jan

Posted at 13:32h in

The objective of this procedure is to define the process to be followed and to provide instruction to the Holder of the Certificate of Registration (HCR) when submitting an application for Post-Importation Testing Exemption or imported products. ...

25 Jan

Posted at 13:20h in

This document provides guidance on access to unregistered medicine for human use through the provisions of section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and clarifies the mandate, intent and scope of this section and regulation 29 of the...