Medicines and Related Products Regulations, 2020.

These Regulations, implementing the Medicines and Related Products Act, 2014, divided into fifteen parts, apply to medicines and related products for human and veterinary use to be placed on the market in the Gambia, and thus concern guidelines and good practices for the proper usage of medicines and related products. The Regulations define the following matters: adverse drug reaction; batch number; bioequivalence; biological products; counterfeit; good clinical practice; good manufacturing process; herbal medicine; inspection; nutritional supplement; brand name.
The Regulations concern the following matters: classification of medicines and related products, including herbal medicines, veterinary medicines, cosmetics, pharmacy medicines, homeopathic medicines, medical devices; manufacturing licence; import, export, storage of medicines and related products, and specific requirements for veterinary products; application for a research permit; application by governmental and non-governmental health facility; personal use of medicines and related products; application for registration of medicines and related products; registration of veterinary products; establishment and functions of the Pharmacovigilance System Agency; measures for preventing public health hazards and for ensuring risk assessment system; pharmacovigilance inspection; labelling requirements for medicines intended for human use and for medicines intended for veterinary use; access to information for medicines for human use; marketing of medicines and related products; enforcement and penalties; disposal of medicines and related products; international cooperation and harmonisation of initiatives regarding medicines and related products; monitoring and evaluation; compliance with standards; access to information and protection of information.