Monaco

Pharmacovigilance in Monaco is governed by Monegasque medicines legislation and the national pharmacovigilance provisions established under Arrêté Ministériel n° 2003-163. The French-language annexe on pharmacovigilance and pharmacodependence requires the person responsible for placing a medicine on the market to designate to the competent authority a permanent and qualified person responsible for pharmacovigilance, collect and centralise safety information, and prepare periodic safety information. The same framework requires serious suspected adverse reactions to be communicated immediately and no later than 15 days under the prescribed reporting pathway. Monaco is not an EU/EEA Member State, so EU GVP should not be applied automatically as Monegasque law even though the national framework interacts closely with French and European medicines systems. The current public national text reviewed does not clearly establish a universal EU-style PSMF requirement, a Monaco-residency rule for the pharmacovigilance responsible person, a current uniform PSUR/PBRER frequency, or a standardized EU RMP regime for every MAH; those points should be checked against the individual authorisation and current authority instructions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.