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What is the Decentralised Procedure (DCP)?
The Decentralised Procedure is for applicants who wish to market a product in various EU countries and for which the product has not yet received an authorisation in any EU country.
One Member State will act as Reference Member State (RMS) and assess the application. The application will include:
- the assessment report
- the Summary of Product Characteristics
- labelling
- the package leaflet.
The RMS then liaises with the Concerned Member States (CMSs), ie those states in which the applicant wishes to market the product. The application can then be approved by the CMSs and national marketing authorisations can be granted.
If the RMS and CMSs cannot reach agreement the matter is referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
How long will it take to get a decision on a product through the DCP?
The complete process will take place in a maximum of 210 days. A strict timetable must be adhered to be all concerned parties, including the RMS, the CMS and the applicant.
Timetable for the Decentralised Procedure (external link)
How do I submit a request for the UK to act as Reference Member State?
Applicants wishing to apply for a marketing authorisation through the DCP with the UK as Reference Member State (RMS) need to inform the MHRA at an early stage of their intentions and agree a date for submission (a ‘slot’).
To agree a slot please email MR-DCprocedures@mhra.gsi.gov.uk or call 020 3080 6709. It would be useful if you could fill out the request form before you contact the MHRA.
Request for RMS in a Decentralised Procedure, medicinal products for human use (external link)
