Moldova

Pharmacovigilance in the Republic of Moldova is regulated by the Agenția Medicamentului și Dispozitivelor Medicale (AMDM). The current Romanian-language informații pentru deținătorii autorizațiilor sets out the MAH’s pharmacovigilance duties under the current medicines framework: each MAH must operate a pharmacovigilance system, scientifically evaluate safety information, record suspected adverse reactions occurring in Moldova, maintain a standard pharmacovigilance system file (PSMF-equivalent) and a risk-management system, and have a permanently and continuously available appropriately qualified person responsible for pharmacovigilance. The AMDM material also requires the national pharmacovigilance contact to reside and work in the Republic of Moldova, while QPPV/contact information must be kept current with the authority. MAHs must regularly audit their pharmacovigilance systems and record principal audit findings in the master file until corrective actions are completed. Suspected reactions can be submitted through AMDM’s official Raportează o reacție adversă pathway. Where a numerical MAH ICSR deadline or periodic-report frequency is not explicitly stated in the current public holder page, the applicable AMDM legal instrument and product conditions should be checked rather than assuming EU timelines. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.