25 Jan Revised Guideline – Donations of Medicines Medical Devices And IVDs
This guideline is provided to outline the principles and process to be followed in the donation of medicines, medical devices and in-vitro diagnostics (IVDs). The guideline is applicable to both persons and entities wishing to make donations and the recipients of such donations. The South African Health Products Regulatory Authority (the Authority), may at any time in terms of Section 19(2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), (the Medicines Act), request any additional information relating to the donation of a medicine, medical device or IVD. In addition, the Authority may make amendments to this guideline in keeping with the knowledge which is current at the time. The Authority is committed to ensuring that all medicines, medical devices and IVDs that are donated are of the required quality, safety, efficacy or performance.
Download Version 3 (5.08)