Requests for the UK to act as Reference Member State

Pre-submission advice for Decentralised Procedures (DCPs)
Applicants wishing to apply for a marketing authorisation through the Decentralised Procedure (DCP) with the UK as Reference Member State (RMS) should inform the MHRA at an early stage and agree a date for submission (a 'slot')

Advice concerning New Drug applications (Article 8)
Please contact the relevant assessment team manager as soon you know the date you would like to make your submission. Details of the assessment manager can be obtained from the Regulatory Information Service on 020 3080 7400 or by email at RIS.NA@mhra.gsi.gov.uk

Advice on available slots
The slot booking table shows slot availability for the next 12 months. If there is a suitable slot it can be secured by submitting a completed Common Request Form (125Kb) to MR-Dcprocedures@mhra.gsi.gov.uk This form gives us all the information we need and will speed up consideration of your request. Confirmation will be received within three working days.

If you would like to discuss alternative options or the date you require shows no availability, email MR-DCprocedures@mhra.gsi.gov.uk or call 020 3080 6709 . At this stage we will need to know :

• your preferred submission date
• the intended product name, pharmaceutical form and strength(s)
• active substance
• ATC code,
• therapeutic area
• the complexity of the submission (new drug, line extension, generic, etc).

Agreeing a submission date
Once we agree a suitable submission date, you should respond within one week to confirm whether you want the slot or not.

The MR-DC Procedures Team at MR-DCprocedures@mhra.gsi.gov.uk will assign the DCP number for your application, if this is not already known.

To get a Product Licence (PL) number, which is necessary to submit the application, please email Submissions.Centre@mhra.gsi.gov.uk

The email should include:

• the name/strength of the product
• marketing authorisation holder (MAH) details.

It is not necessary to have the PL number before your slot is agreed.

Confirming or changing a submission date
Dates must be re-confirmed two months in advance of the agreed date. Please let the MR-DC Procedures Team of any change to an agreed/confirmed date as early as possible so an alternative date can be agreed.

Bringing forward a booked submission date
As a result of delayed or cancelled submissions, a small number of slots become available at short notice. When this happens we can accept submissions from applicants with booked slots who would prefer earlier submission dates.

If you would like to be considered for an earlier date please tell the MR-DC Procedures Team who will inform the assessment team of your request.

If an earlier slot becomes available the team will contact you to offer you the date.

If you are unable to meet your submission date
It is important that you notify the MR-DC Procedures Team MHRA as soon as possible if there is likely be any change to confirmed submission date.

Applicants who miss the submission slot date will have to wait until the next available slot.

Other information
Please contact MR-DCprocedures@mhra.gsi.gov.uk for any query regarding your DCP once you have booked a slot.

For any general advice regarding the DCP not related to a specific application please contact the Regulatory Information Service in the first instance on 0203 080 7400 or by email at RIS.NA@mhra.gsi.gov.uk

Points to remember when applying for slots

• Please make your request for a slot as soon as possible.
• Use the table to check availability.
• Attach the Common Request Form (125Kb) when applying for a slot – this gives us all the required information and will speed up consideration of your request.
• Ensure the data protection period of the reference product will have expired by the requested submission date to avoid the application being made invalid upon receipt.
• Dates must be confirmed two months in advance of the agreed date.
• Any proposed change to a booked slot should be notified as soon as possible. While a slot in the following month cannot be guaranteed we will do our best to find you the earliest possible submission date.
• If you would like to bring forward your agreed submission date please inform the MR-DC Team.