Decentralised procedure

The decentralised procedure makes it possible to obtain national marketing authorisations simultaneously in several Member States for a medicinal product that is not yet authorised in any Member State. It is provided for by Directive 2001/83/EC. The applicant files an identical dossier in all the States concerned and chooses one of them as reference Member State, responsible for conducting the assessment. The procedure is the usual route for generic medicinal products that do not fall within the centralised procedure.

Conduct of the procedure

Within 120 days of validation of the application, the reference Member State prepares a draft assessment report, summary of product characteristics, labelling and package leaflet. The States concerned then have 90 days to approve those documents. If agreement is reached, each State adopts its national decision within 30 days. The result is a bundle of separate national authorisations with a harmonised summary of product characteristics.

Disagreement between States and arbitration

A State concerned may refuse to approve the assessment only on the ground of a potential serious risk to public health. The dispute is then referred to the Coordination Group for Mutual Recognition and Decentralised Procedures, which brings together representatives of the Member States and has 60 days to reach agreement. Failing that, the matter is referred to the Committee for Medicinal Products for Human Use of the European Medicines Agency, and the Commission adopts a decision binding on all the States concerned.

The decentralised procedure and generics litigation

Each authorisation resulting from the procedure remains national. It may be obtained well before the patents expire, since the necessary trials benefit from the Bolar exemption and the authority does not check the patent position. The filing of a decentralised application by a generics manufacturer, where it becomes known, therefore signals a launch in the States concerned. Obtaining the authorisation is not in principle sufficient to constitute infringement, but it informs the assessment of whether an at-risk launch is imminent at the stage of provisional measures.

Key points

The decentralised procedure produces coordinated national authorisations for a medicinal product not yet authorised in the Union, around a reference State that leads the assessment. The time limits are fixed, and only a serious risk to public health justifies disagreement. For a patent holder, the list of States concerned and the timetable of the procedure reveal the competitor’s launch strategy. Authorisations granted and publications by national authorities should be monitored in order to prepare, State by State, the appropriate litigation response.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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