To make sure that you benefit from all the advantages of DCP – Book your slots early!

DCP & MRP Europe’s (Regulatory) Mutual Recognition Procedures

What is Mutual Recognition?

Both the mutual recognition procedure (MRP)and the decentralised procedure (DCP) aim at facilitating access to a single market by relying upon the principle of mutual recognition by the member states.

Mutual recognition is a process by which the marketing authorisation or the assessment in one Member State (the so-called reference Member State) ought in principle to be recognised by the competent authorities of the other Member States (the so-called concerned Member States), unless there are grounds for supposing that the authorisation of the medicinal product concerned may present a potential serious risk to public health.

What are the benefits?

Mutual Recognition Procedures were introduced to save time for both parties.

Health Authorities do not have to reassess data already assessed and approved by another EU member state. They can simply “recognise” the work of other competent assessors.

Pharma companies benefit from a shorter process than making separate national applications (N.B: The process of making multiple parallel national applications is no longer allowed)‘Refer to Article 28 of Directive 2001/83/EC.

What is involved?

MRP (Mutual Recognition Procedure)

Pharma companies make initial submission to an EU member of state of their choice- the Reference Member State (RMS).

National approval is given ie a marketing authorisation is granted. This is a 210 day Procedure.

The Pharma company then submits in parallel an identical dossier to any number of Concerned Member States (CMS).

The concerned member states (CMS) are expected to mutually recognise the original decision with a 90 day period.

DCP (Decentralised Procedure)

No previous national application is necessary a

A RMS is chosen and a DCP “Slot” date applied for.

The RMS makes an initial assesment. Identical dossiers are submitted to RMS and CMS in parallel.

Legislation

The provisions for the MR of product approvals are set out in Article 28 of Directive 2001/83/EC.

What is the best route, DCP or MRP?

Many factors come into play when deciding which route to choose, if you have no previous experience with the use of the EU mutual recognition procedures give CambReg a call on 01480 465753 or go to contact and we can help you to decide the best route.

Tip

If DCP is your preferred route it is essential to book your “Slot” early as availability is limited. Slot bookings need to be done at least 18 months in advance of expected submission date.

Please contact us if you wish to discuss your DCP requirements in more detail.