This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...
Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....
This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
The objective of this guideline is to provide X-Ray equipment licence holders on how and where to dispose of electronic equipment that has reached the end of life. The unit must be confirmed to be in a state where it will never be used for...
Owner Consent Form - Use of an Unregistered Veterinary Product...
This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...
Request For Use of an Unregistered Product In Terms Of Section 21 Of Act 101 of 1965...
In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...
Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....