Snapshot

The European Commission Decision Reliance Procedure (ECDRP) pathway has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom.

This pathway can be used where The EC Decision Reliance Procedure (ECDRP) is available to Marketing Authorisations approved via the EMA's centralised procedure..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA

When a submission is made within 5 days of CHMP positive opinion, the date of CHMP positive opinion will be designated Day 0 of the ECDRP, and the MHRA will aim to determine the Great Britain marketing authorisation as soon as possible after European Commission (EC) approval, and by Day 67 at the latest provided that EC decision has been received. If the application is submitted more than 5 days after the CHMP positive opinion, Day 0 of the ECDRP will be the date of MAA validation, and determination may be delayed. All applications will be reviewed to ensure they comply with Great Britain 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. Any concerns relating to the approvability in Great Britain will be raised with the Applicant at the earliest opportunity. If it is found during the assessment phase that the dossier is incomplete or assessment reports have been omitted, this will be raised as a Point for Clarification, and may cause a delay to the timetable. The Applicant is responsible for confirming the EC decision to the MHRA; the EC decision letter should be forwarded to the ECDRP mailbox on the day that it is received. For orphan medicines, the Applicant is also responsible for confirming the COMP (Committee on Orphan Medicinal Products) decision using the ECDRP mailbox. Any delay in providing these confirmations will impact the timing of the Great Britain application determination.