North Macedonia

Pharmacovigilance in North Macedonia is administered by the Agency for Medicinal Products and Medical Devices (MALMED), including its Department of Pharmacovigilance and Materiovigilance. The Law on Medicines and Medical Devices requires every MAH to maintain a pharmacovigilance system and appoint a medically or pharmaceutically qualified, continuously available responsible person. The Rulebook on obtaining a marketing authorisation requires that person's address, qualifications and contact details and a description of the pharmacovigilance and, where applicable, risk-management system; it does not expressly identify a separate PSMF. The Rulebook on reporting adverse reactions and organising the pharmacovigilance system requires serious suspected reactions to be reported immediately, but the reviewed national wording does not state a universal numerical deadline. PSURs are required six-monthly for two years, annually for the next three years and every three years thereafter or when requested. MALMED has statutory inspection powers, but no fixed pharmacovigilance-inspection frequency was identified. Signal and product-specific RMP arrangements should be confirmed with MALMED. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.