Guideline for Donation of Medicines, Medical Devices, and IVDs

This guideline provides an outline of the principles and process to be followed in the donation of medicines, medical devices, and in vitro diagnostics (IVDs). The guideline applies to both people 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 that 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.