Public health

Authorisation procedures - National authorisation procedures

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The mutual recognition procedure, which is applicable to the majority of conventional medicinal products, is based on the recognition of a pre-existing national marketing authorisation by one or more EU countries.

The decentralised procedure, where the application for marketing authorisation is submitted simultaneously in several EU countries, one being chosen as the "Reference Member State".

National authorisations are still available for medicinal products sold in an individual EU country.

The mutual recognition procedure

To be eligible for the mutual recognition procedure, a medicinal product must have already received a marketing authorisation in one EU country. Basic arrangements for implementing the mutual recognition procedure laid down in Directive 2001/83/EC have been made in all EU countries.

An application for mutual recognition may be addressed to one or more EU countries. The applications submitted must be identical, and all EU countries notified. The country charged with evaluating the application or Reference Member State notifies the other Concerned Member States. The Reference Member State is then charged with deciding on the product.

This evaluation process may take up to 210 days, and ends with the granting of a marketing authorisation in that EU country. The Concerned Member States then have 90 days to recognise the decision of the Reference Member State, and the summary of product characteristics, labelling and packaging. National marketing authorisations are granted within 30 days.

Should a country refuse to recognise the original national authorisation, the issue is referred to a coordination group (CMDh) which should reach a consensus within 60 days. If none is reached, the procedure is submitted to the appropriate EMA scientific committee (CHMP), for arbitration. The opinion of the EMA Committee is then forwarded to the Commission.

The decentralised procedure

The decentralised procedure was introduced by Directive 2004/27/EC. It allows the common assessment of an application submitted simultaneously to several Member States. One of the Member States will take the lead in evaluating the application as reference Member State.

At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved by the other (concerned) Member States.

Should a country refuse to approve the assessment, the issue is referred to a coordination group which should reach a consensus within 60 days. If none is reached, the procedure is submitted to the appropriate EMA scientific committee (CHMP), for arbitration. The opinion of the EMA Committee is then forwarded to the Commission.

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