Updated Guidance for marketing authorisation application using the Decentralised procedure with the UK as Reference Member State (RMS)

Pre submission advice for DCPs

Applicants wishing to apply for a product licence through the Decentralised Procedure (DCP) need to inform the MHRA at an early stage of their intentions and agree a date for submission. This allows the agency to plan work in advance and this is achieved through a booking system. The process for obtaining a ‘slot’ is described below.

For advice on available slots - please e-mail: MR-DCprocedures@mhra.gsi.gov.uk with the product name, active substance, ATC code, its therapeutic area, the complexity of the submission (new drug, generic, etc.) and your preferred submission date. For advice concerning suitability of timetables for new drug applications (Article 8), please contact the relevant assessment team manager as soon as the timeline for the submission is known. Details can be obtained from the Regulatory Information Service on 0207 084 3400 or by e-mail at RIS.NA@mhra.gsi.gov.uk 

Agreeing a submission date - Once we advise you of a suitable submission date, you must respond within 1 week of any tentative enquiry confirming whether you want the slot or not. Please note you will need to provide PL numbers to secure the slot. To request a PL number please email Submissions.Centre@mhra.gsi.gov.uk Include in your request e-mail the name/strength of the product and MAH details.

Once you have the PL number, please e-mail the MR/DCP Procedures team at MR-DCprocedures@mhra.gsi.gov.uk (including the proposed SPC if there is one) and we will assign the DCP number for your application. This will now secure the slot and you will be requested to complete the relevant booking form. The form will be sent to you by e-mail upon agreement of the submission date and when the DCP number has been issued.

Confirming a submission date - Dates should be confirmed 2 months in advance of the intended submission and any change to the intended date of submission should also be notified. You should consult Special MAIL 5 when preparing for your submission and please note that you will need to contact MR-DCprocedures@mhra.gsi.gov.uk for any future query regarding your DCP.

On the occasion that you fail to meet your submission date - It is important that you notify us as soon as possible if there is likely be any change to a previously agreed submission date.

If a slippage occurs so that an outgoing DCP application booked for one month cannot be delivered by the applicant until the next month, then the applicant will have to wait for the next available start date. A revised slot may occur in the next month to fit the applicants modified plan, however, it could require the start date to be delayed until such a slot occurs This may become available if an assessor becomes free ahead of schedule or because another submission has been cancelled or delayed.

For any general advice regarding the Decentralised Procedure not related to a specific application please contact the Regulatory Information Service in the first instance on 0207 084 3400 or by e-mail at RIS.NA@mhra.gsi.gov.uk