European Commission (EC) Decision Reliance Procedure
How to apply for marketing authorisation via this new procedure.
For a period of 3 years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.
Great Britain refers to England, Scotland and Wales.
This route – the EC Decision Reliance Procedure (ECDRP) - is available to MAs approved via the centralised procedure.
The intended operation of the ECDRP is submission of the Marketing Authorisation Application (MAA) to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of a European Union Marketing Authorisation.
The MHRA aims to determine the Great Britain MA as soon as possible after EC approval. A delay in submission may affect the delivery of a decision within the 67-day timeline.
How to apply
If the Applicant intends to apply for an MA in Great Britain via the EC Decision Reliance Procedure they should inform the MHRA at the earliest opportunity by emailing ECDRP@mhra.gov.uk.
If the company does not have a 5-digit company number, to allow registration on the MHRA Submissions Portal, then this should be requested from Reference.Data@mhra.gov.uk. A PLGB number can then be obtained through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk prior to submission.
It is anticipated that the Marketing Authorisation Holder (MAH) for an application via the ECDRP route is the same company or belongs to the same (legal) group of companies as the MAH in the European procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all of their legal obligations as holder of a marketing authorisation (MA), such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).
In exceptional circumstances, provided an applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept applications from third parties.
These measures are intended to provide reassurance to the Licensing Authority that the MAHs of licences authorised via the reliance route are able to keep legislative and safety information up-to-date to ensure that a positive benefit:risk balance is maintained throughout the validity of the MA.
Letter of intent
To facilitate scheduling, prior to receiving a positive CHMP opinion, companies should submit a ‘letter of intent to submit an ECDRP’ to the MHRA at least 4 weeks before submission of the ECDRP MAA. This should be submitted to the ECDRP mailbox once a positive CHMP opinion is anticipated, for example after receiving confirmation that no major concerns remain.
The letter should state when the company intends to submit the application and should be accompanied by all iterations of the CHMP assessment reports that have been received to date.
The letter should also state whether the company intends to apply for an orphan designation in Great Britain. Fees will be payable only after the dossier is received and not during this pre-procedure stage.
On receipt of the positive CHMP opinion, or as soon as possible after this date, the ECDRP MAA should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions.
The submission should include the entire dossier as reviewed by the CHMP (and approved by the EC if the EC decision has already been received), including the full responses to CHMP questions.
The Working Documents Folder should include:
- all iterations of the CHMP assessment reports and the CHMP opinion for the initial MAA and any subsequent variations,
- the proposed product information in Microsoft Word format.
If an orphan designation is sought, the Great Britain Orphan Drug Designation Application Form should be submitted in module 1.2 of the eCTD. Email RIS.NA@mhra.gov.uk if you have any questions about submitting your application.
For submissions which will trigger paediatric requirements, applicants should ensure the latest European Union and/or Great Britain-PIP / waiver opinion / decision or class waiver decision is included in the dossier. If the application has been subject to a European Union or Great Britain compliance check the outcome documents should be included in the dossier.
The applicant should also indicate any parallel, ongoing or previous applications containing paediatric data relevant for the full PIP compliance verification (if applicable). An overview table of the PIP results, indicating in which application(s) they were/are going to be submitted, status of the application(s), as well as their location in the present application must be included.
The cover letter accompanying the application should:
- clearly state the regulatory route as ECDRP to ensure appropriate handling, including the relevant procedure number for the centralised MAA.
- include a declaration of conformity of the Great Britain application with the dossier that received a positive opinion from the CHMP (and was approved by the EC if the EC decision has already been received), including approved variations.
- include a declaration that all iterations of the CHMP assessment reports and End of Procedure documents have been submitted. These assessment reports should also be listed.
- include a declaration that the proposed product information is identical to that which received a positive opinion from the CHMP (and was approved by the EC if the EC decision has already been received), and that the product information in Microsoft Word format has been included with the submission.
- confirm that the Great Britain Orphan Drug Designation Application Form has been submitted in module 1.2 of the eCTD, if an orphan designation is sought
- indicate whether paediatric requirements will be triggered, and if so, that the paediatric information is included in the dossier. The applicant should indicate if this application has been subject to a European Union or Great Britain-PIP compliance check and confirm whether any PIP studies were due to initiate or complete since compliance verification.
- if the procedure includes an ASMF, include a declaration that the ASMF Holder has submitted the Applicant’s and Restricted Parts of the ASMF, including approved variations and all iterations of the assessment reports on the Applicant’s and Restricted Parts.
- include a declaration that the proposed Risk Management Plan (RMP) is identical to RMP which received a CHMP positive opinion (and was approved by the EC if the EC decision has already been received).
- state any conditions associated with the Marketing Authorisation.
You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.
The submission will attract a fee.
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 MA as soon as possible after 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.
Any issues identified during assessment will be communicated to the applicant by Day 46 and should be resolvable within the 67-day timetable without clock-stop.
If Major Objections are raised
If Major Objections are identified or substantial amendments to the product information are necessary, the timetable will move to the standard National Procedure timetable. It is anticipated that this will be necessary only on rare occasions.
Last updated 18 November 2022 + show all updates
On 30 September 2022 it was announced that the ECDRP will continue to be available until 31 December 2023, an extension of 12 months. Therefore the text “For a period of 2 years from 1 January 2021” was amended to “For a period of 3 years from 1 January 2023”. This amendment was made on 5 October 2022.
IPUenquiries@mhra.gov.uk has been updated to RIS.NA@mhra.gov.uk as the email for enquiries on submitting applications for orphan designations.
Added new information under 'How to apply'