DCP: decentralised procedure
The decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
Set out in Article 28(3) of Directive 2001/83/EC, the DCP has the applicant choose a reference member state (RMS) to prepare the assessment, while the concerned member states (CMS) comment and must agree before national authorisations are granted. It is the usual route for generics and other products outside the mandatory scope of the centralised procedure.
Common problems: choosing an RMS without checking its capacity and slot availability, sending CMS a dossier that differs from the RMS version, and underestimating the national phase, when translations and mock-ups must be ready quickly. Objections on potential serious risk to public health that remain at the end go to the CMDh and, failing agreement there, to a CHMP referral.
Timing
After validation the procedure starts at Day 0. The RMS circulates a preliminary assessment report by Day 70 and CMS comment by Day 100. The clock usually stops at Day 105 for the applicant's responses. The RMS issues the draft assessment report by Day 120, after which the procedure can close if all parties agree, or continue to Day 210 after a further clock-stop. Without consensus at Day 210, the issue goes to the CMDh for 60 days. National authorisations follow within 30 days of closure.
Used in
Before committing to a DCP, estimate the authority fees for the RMS and every CMS with the Regunaut fee calculator.
Related terms
- MRP: mutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
- RMS: reference member stateThe reference member state (RMS) is the EU/EEA Member State that leads the assessment in a decentralised or mutual recognition procedure.
- CMDh: Co-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.
- Centralised procedure: single EU marketing authorisation via EMAThe centralised procedure grants one marketing authorisation valid across the EU and EEA after a single EMA assessment and a Commission decision.
- National procedure: authorisation in a single Member StateA national procedure authorises a medicine in one EU Member State only, assessed by that country's competent authority under Directive 2001/83/EC.
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