Snapshot

The Decentralised and mutual recognition reliance procedure for marketing authorisations (MRDCRP) pathway has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom.

This pathway can be used where The MHRA has the power to have regard to Marketing Authorisations (MAs) approved in EU Member States (or Iceland, Liechtenstein, Norway) through decentralised and mutual recognition procedures with a view to granting the MA in the UK or Great Britain (England, Scotland and Wales). This route – the MRDC Reliance Procedure (MRDCRP) - can be used to apply for a UK MA [PL] or for a Great Britain MA [PLGB]. The MRDCRP is not available to products with MAs in EU Member States (or Iceland, Liechtenstein, Norway) granted only through National Procedures..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from EU-EMA Europe Iceland Liechtenstein Norway

All applications will be assessed to ensure they comply with UK regulatory requirements, including those related to: Great Britain Reference Medicinal Products, product name, labelling, patient information legibility, supply status, controlled drug scheduling where necessary, and paediatric and orphan medicine requirements, where relevant. The first round of assessment should be completed by Day 42, at which point the marketing authorisation will be granted if no concerns are raised.