Decentralised procedure

Decentralised procedure

The decentralised procedure (DCP) is used to apply for market authorisation for products not authorised in any EU member state. In this procedure, marketing authorisation is applied for simultaneously in the Reference Member State (RMS) and Concerned Member States (CMS). The procedure is undertaken by the Reference Member State (RMS) but Concerned Member States (CMS) take part in the assessment of the application before marketing authorisation is granted in any CMS.

The decentralised evaluation procedure may not take longer than 210 days.

Should any Member State refuse to grant marketing authorisation, on the grounds of potential serious risk to human or animal health or to the environment, the application will be referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, Veterinary (CMDv) for a 60-day arbitration procedure. If a consensus is not reached in the procedure, the application will be referred to the European Commission, which issues a decision, which is binding on all parties.

If the marketing authorisation is approved, a national marketing authorisation will be granted as soon as a translation of the summary of product characteristics, package leaflet and labelling – equivalent to the SPC agreed in the decentralised procedure and approved for nationwide use – is available.

EN Eläinlääkkeet / Myyntiluvat-sivu ja sen alasivut (Lisätietoja antaa)

Ask more:

  • Virve Aromaa, Coordinator for Marketing Authorisations, Head of Section, tel. +358 29 522 3302