7. Roles & Responsibilities

All persons authorised or entitled to supply medicinal products to the public are obliged to verify the safety features of the medicines packs they are dispensing according to the Delegated Regulation (EU) 2016/161 and to decommission the unique identifiers from the medicines verification system. If the verification of the unique identifier indicates that the medicine pack may not be genuine, it must not be distributed or dispensed. Investigations should be initiated without delay.

The marketing authorisation holder bears primary responsibility for addressing suspected or actual falsification. All entities operating in the pharmaceuticals sector are responsible for taking the appropriate measures to address any cases of suspected or actual falsification in products they manufacture, import, distribute or release for consumption.

FiMVO maintains the Finnish Medicines Verification System and monitors its operation and alerts generated in the system. When necessary, FiMVO assists system users in resolving alerts. Upon request, FiMVO is obliged to provide Fimea with information stored in the system in order to investigate possible cases of falsification and to inspect whether individual marketing authorisation holders, manufacturers, wholesalers and pharmacies / hospital pharmacies / dispensaries comply with the Delegated Regulation (EU) 2016/161.

FiMVO is occasionally contacted by end users requesting the permission to dispense a pack which has generated an alert in the system. FIMVO is not the national competent authority, but a non-profit company responsible for the setting up and managing the Medicines Verification System in Finland as required by the EU legislation. FiMVO offers support to distribution chain actors in questions regarding medicines verification, but the responsibility for the assessment and decisions regarding the required actions lies on the actors themselves.