Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Pre submission advice for DCPs
Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure (DCP) with UK as RMS 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.
Information update – New slots available
New DCP slots available – The MHRA has recently reviewed the rate of DCP cancellations and delays over the last 6 month period. Over the coming months new slots may be available for use by applicants who have previously reserved a later slot with MHRA. As a result, applicants with a confirmed booking slot with UK as RMS up to end of August 2009, whose dossier is ready for submission, and who would like to submit their application earlier, are invited to contact
MR-DCprocedures@mhra.gsi.gov.uk with details of their application. The request for an earlier submission slot will then be considered, and the applicant notified if their request for an earlier timeslot is successful.
Note - Please consult the MHRA website regularly, as any further information on availability of earlier timeslots will be published at:
›
Updated Guidance for marketing authorisation application using the Decentralised procedure with the UK as Reference Member State (RMS)
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, line extension, generic, etc.) and your preferred submission date. For advice concerning a timetable for new drug applications (Article 8), please contact the relevant assessment team manager as soon as the preferred submission date is known. Details of the assessment manager can be obtained from the Regulatory Information Service on 020 7084 3400 or by e-mail 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 e-mail 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 and we will assign the DCP number for your application. This will now secure the slot and you will be requested to complete the 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 must be re-confirmed 2 months in advance of the intended submission or the slot will be lost and offered to another applicant. Any proposed change to an agreed/confirmed date of submission should be notified as early as possible so that an alternative submission date can be agreed.
Failure to meet your submission date - It is important that you notify MHRA as soon as possible if there is likely be any change to a previously agreed/confirmed submission date. If a slippage occurs so that an outgoing DCP application booked for one month cannot be submitted 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.
Other information
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.
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 020 7084 3400 or by e-mail at RIS.NA@mhra.gsi.gov.uk.
