Governance

The Health Products Regulatory Authority (HPRA) is responsible for supervising the functioning of the IMVS and ensuring that IMVO, as the legal entity responsible for the establishment and management of the system, complies with the requirements of the Commission Delegated Regulation (EU) 2016/161. The HPRA also supervises compliance of pharmaceutical wholesalers, manufacturers and marketing authorisation holders with the legislation.

The Pharmaceutical Society of Ireland supervises compliance of registered retail pharmacy businesses pharmacies, and pharmacists, with the legislation.

The Department of Health is also monitoring progress with IMVO as the Irish Government has overall responsibility for ensuring that Ireland is compliant with European legislation, including the new measures relating to falsified medicines.