Medicines and Related Substances Control Act, 2015

This Act establishes the Medicines Regulatory Authority of Swaziland and provides rules for its operation, as well as registration of medicines and medical devices; the control of medicines and scheduled substances, and incidental matters. The Registrar shall enter into the register any information or particulars of a medicine or medical device which the Authority has approved for registration, including the conditions, if any, under which that medicine or medical device has been registered; any cancellation of the registration or variation of the conditions of registration of any medicine or medical device in terms of this Act; or any information which has been prescribed in the regulations. A person shall not sell any medicine or medical device unless the immediate container and the package in which it is sold are labelled with its registered name, registered number and any other prescribed particulars. The Act defines “medicine” as, among others, any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in the diagnosis, treatment, mitigation, modification, prevention of diseases or any abnormal physical or mental state or symptoms of any abnormal or mental state in humans or animals; or restoring, correcting or modifying a physical, mental or organic function in humans or animals.