Centralised procedure

Centralised procedure

A centralised procedure is followed when a marketing authorisation for new biotechnological products and other innovative medicinal products is applied for in all EU countries.  

Marketing authorisation applications are submitted to the European Medicines Agency (EMA) and assessed by the Committee on Veterinary Medicinal Products (CVMP).

Each member state appoints one ordinary member and one deputy member to the CVMP for a three-year term. Five additional members are appointed to the Committee on the basis of their scientific expertise.

The Committee selects a rapporteur and a co-rapporteur from among its members, who use resources from the member states' medicines agencies to assess the applications. The other members state their opinions on the assessments of the rapporteurs.

The Committee issues a scientific opinion on the basis of the assessments and opinions within 210 days of the application, which is then submitted to the European Commission for the decision-making process. The marketing authorisation granted by the Commission is valid in all member states.

Finland may prohibit the distribution, sale and use of an immunological product in Finland on the basis of its disease-free status or a prevention programme.

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