San Marino

Pharmacovigilance in San Marino is supervised by the Authority for Authorization, Accreditation and Quality of Health Services, the national competent authority responsible for monitoring medicines and medical devices placed on the market. Operational pharmaceutical activities are supported by the Istituto per la Sicurezza Sociale (ISS) through its official UOC Farmaceutica–Farmacie. Under the official annex to Decree-Law No. 72/2022, San Marino may import and use medicines authorised by AIFA, EMA, EU national agencies, and other listed reference authorities. As San Marino is not an EU Member State, EU pharmacovigilance requirements should not be described as automatically applicable to every locally supplied product. Publicly available national sources do not establish blanket requirements for every marketing authorisation Holder (MAH) to appoint a resident QPPV, maintain a local PSMF, or follow fixed national ICSR and PSUR timelines. Companies and importers should nevertheless maintain a documented safety system, an accessible local contact, and procedures for communicating significant risks, recalls, suspensions, and safety-related changes to the competent authorities. The Authority provides official adverse-reaction reporting instructions and forms for medicines and vaccines. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.