Guideline for Marketing Authorisation (Registration) of Medicines.

This Guideline applies to medicines as defined in the Medicines and Related Products Act, 2014, and includes herbal medicinal products, biologicals and biotherapeutics products and vaccines manufactured in country or imported into The Gambia for human and animal use. The Guideline concerns: compliance of medicines and medical products with international standards of quality, safety and efficacy; marketing authorisation of medicines; documentation required; manufacturing information; pharmacovigilance system; risk management plan; registration of products; definition of relevant terms.