The laboratory of Fimea collaborates with other national authorities including The Customs, Police and Evira (The Finnish Food Safety Authority). The co-operation covers areas related to falsified and counterfeit medicines, doping agents and food supplements.
The laboratory has a food laboratory status granted by Evira. This authorises the laboratory to study food supplements and medicine-like products suspected to contain active pharmaceutical ingredients.
The laboratory is a full member of the European Official Medicines Control Laboratory–network. This network collectively performs quality control of the centrally, decentrally and mutually approved medicines in the European market, facilitating a more efficient surveillance of the market.
The European Pharmacopoeia is a collection of legally binding quality standards for medicines. The personnel of the laboratory participate in the development of these regulatory norms by providing their expertise to the working groups of the European Pharmacopoeia.
The OMCL-network and the European Pharmacopoeia working groups are coordinated by EDQM (European Directorate for the Quality of Medicines & HealthCare).
Monograph for Infliximab
European Pharmacopoeia Commission adopts a new monograph for Infliximab concentrated solution ‒ the first monograph on a monoclonal antibody.
The monograph for Infliximab concentrated solution (2928) will be published in Ph. Eur. Supplement 9.6 and will become effective in January 2019.