To guide the relevant authority holders involved in the decision to subject radiation workers to radiation to make informed and correct request for such examination, thereby protecting the radiation workers from unnecessary exposure to ionizing radiation....
This document specifies Module 1 and the regional sections 2.3.R/3.2.R of the electronic 2 Common Technical Document (eCTD) for South Africa (“ZA”)....
Afterloaders containing small radioactive cobalt or iridium sources are commonly used in radiation oncology. ...
This document provides the principles behind the minimum requirements in terms of quality, security and standard operating procedures relating to the cultivation of Cannabis and the manufacture and use of Cannabis-related pharmaceutical products for medicinal and research purposes that will need to be in place...
This document guides access to unregistered medicines for animal 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 General Regulations...
This document has been archived....
This guideline is intended to provide recommendations to applicants wishing to submit an application for an amendment to their current licence to manufacture, import or export, and wholesale medicines or scheduled substances. It is not intended as an exclusive approach and should not be taken...
Comprehensive guideline on How to Apply for a Licence to Act as a Wholesaler (namely Private, Government Depots and Bond Stores) of medicines and scheduled substances. The guide was updated recently so that all the information required by the Authority when applying for a...
This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: SAHPRA RENEWAL PROCESS...
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...