Seychelles

Medicines oversight in Seychelles is administered by the Ministry of Health through the Regulation and Registration Section and its Medicines Regulatory Unit, which is responsible for regulating the safety, quality and distribution of medicines. The Ministry’s Pharmaceutical Services also support pre-market and post-market quality surveillance. Companies supplying medicinal products should maintain suitable arrangements to collect, assess and communicate safety information, cooperate with Ministry requests, keep product information current and address quality or safety signals affecting products supplied locally. However, the official Seychelles material currently accessible does not clearly publish a comprehensive national Good Pharmacovigilance Practice guideline or universal numerical requirements for a locally resident QPPV, PSMF location, post-marketing ICSR timelines, PSUR/PBRER frequency, RMP format or routine pharmacovigilance-inspection cycle applicable to every MAH. These requirements should not be imported from EU or other foreign systems and presented as Seychelles law. The applicable pharmacovigilance and reporting conditions should therefore be confirmed with the Medicines Regulatory Unit during registration and for each authorised product. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.