pdf Archives - Page 31 of 45

28 Jul The Innovation In Regulatory Sciences Capacity Development In Africa Meeting

Posted at 20:47h in

There is a critical skills gap on the African continent in the regulatory sciences, and an acknowledged need to develop a long-term strategy for training and professional development of African regulatory personnel. A virtual meeting of 40 senior level participants from regional African agencies, African...

28 Jul Guideline On Afterloader Source Exchange Forms (RNXM)

Posted at 18:28h in

Afterloaders containing small radioactive cobalt or iridium sources are commonly used in radiation oncology. ...

27 Jul National Health Act, 2003 (Act No. 61 Of 2003)

Posted at 18:51h in

The Act provides a framework for a structured uniform health system within the Republic, taking into account the obligations imposed by the Constitution and other laws on national, provincial and local government with regard to health services. The objectives of the National Health Act (NHA) are to: ...

27 Jul Medicines And Related Substances Act, 1965 (Act no. 101 Of 1965) as amended

Posted at 17:07h in

The Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), which was amended by Amendment Act, 2008 (Act No. 72 of 2008) and Amendment Act, 2015 (Act No. 14 of 2015) and enacted in May 2017, enabled, amongst others, the establishment of SAHPRA, the licensing...

27 Jul Guideline For Cultivation Of Cannabis

Posted at 16:54h in

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...

25 Jul Guideline on application for use of unregistered veterinary medicines

Posted at 13:23h in

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...

14 Jul Cannabis and related substances

Posted at 15:23h in

What is Cannabis?

Cannabis refers to the plants in the genus Cannabis, which includes various species or sub-species. Cannabis species in the genus include C.sativa, C.indica and C.ruderalis....

22 Jun Renewal of Human and Veterinary Medicines Requirements and Process

Posted at 14:17h in

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: Annexure 1: Renewals Process Flow Diagram...

22 Jun Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

Posted at 13:23h in

This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...

21 Jun Guidelines for Post Marketing Surveillance of Medicines and Health Products

Posted at 22:51h in

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...

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