Gambia

Pharmacovigilance activities in The Gambia are regulated by the Medicines Control Agency (MCA) under the Medicines and Related Products Act and Regulations and the national MCA pharmacovigilance guidelines. MAHs must maintain an appropriate pharmacovigilance system and permanently have a QPPV at their disposal. Non-resident MAHs must have a local representative residing in The Gambia, although MCA may accept a regional representative residing in a West African country. MAHs must maintain a PSMF available for inspection and provide a copy to MCA within seven days upon request. Serious suspected adverse reactions occurring in The Gambia must be reported immediately and no later than 15 calendar days. MAHs are also subject to PSUR/PBRER submission requirements, risk-management obligations including RMPs where required, signal management and emerging-safety-issue reporting, post-authorisation safety activities, and pharmacovigilance inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.