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Detailed guide: Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021

Medicines Healthcare Products Regulatory Agency

September 1
14:01 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on grandfathering of CAPs, which covers the issuing of Great Britain marketing authorisations for products subject to Community Marketing Authorisations (CMAs) already issued by the European Commission following an application through the European Medicines Authoritys (EMA) centralised procedure.

Currently pending and future applications for Community Marketing Authorisations will continue to include Northern Ireland, and when granted the authorisation will cover marketing of the product in Northern Ireland.

This guidance sets out how the MHRA, acting for Great Britain, will handle centralised applications that are still pending on 1 January 2021.

The handling will be determined by the regulatory route chosen by the company and the stage of the procedure the application was at on that day, as detailed in the table at the end of this guidance.

The company has two options:

  1. To apply to MHRA for an in-flight assessment of a Great Britain MA in parallel with the application for an EU MA. In that case the approach of the MHRA will be to take into account any assessment that has already been reported on before 1 January 2021 with a view to completing the application no later than the issue of the EU Commission Decision.
  2. To wait for the Commission for Medicinal Products for Human Use (CHMP) positive opinion and to apply to Great Britain using the new Reliance Route as explained in published guidance on new application routes to market. The application will be determined when the EC decision has been confirmed.

In all cases, as the MHRA does not hold supporting data for applications made to the EMA, applicants will need to submit an application and supporting dossier to the MHRA accompanied by all iterations of the CHMP assessment report.

Completed procedures

Procedures that have been completed with a positive opinion from CHMP and are waiting to receive a Commission Decision will be determined as soon as practicable by MHRA. This will be done in line with the CHMP opinion, unless the UK recorded a divergent decision.

In other cases, MHRA will need to undertake a review.

If the procedure has reached day 181 of the assessment timetable

Route 1: In-flight assessment in parallel with EU

In this circumstance, the MHRA will complete the assessment tailored to the outstanding issues to reach an assessment decision and determine the application as soon as practicable.

Route 2: Reliance on EU decision

The applicant makes an application relying on the CHMP positive opinion and the marketing authorisation approval decision issued by the European Commission.

Applications should be submitted following receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision.

If the procedure has reached day 120 of the assessment timetable

If the procedure has reached day 120 (the first clock stop) but has not reached day 181.

Route 1: In flight assessment in parallel with EU

The applicant submits the same application to MHRA as has been submitted to the EMA. They also include responses to the list of questions raised by CHMP to enable the MHRA to independently complete its assessment of the application while the EMA centralised procedure is ongoing.

In this case the application will follow a schedule (including a set start date) that will enable MHRA to seek advice from the Commission on Human Medicines (CHM) with a view to reaching an assessment decision no later than 60 days following the start date. Start dates will be aligned with published CHM dates to facilitate the 60-day process.

Route 2: Reliance on EU decision

The applicant makes an application relying on the CHMP positive opinion and the marketing authorisation approval decision issued by the European Commission.

Applications should be submitted following receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision.

Procedures still in the first phase of assessment

Route 1: Application in parallel with EU

If a procedure is in the first phase of assessment (before Day 120) the company may choose to submit to GB in parallel with the EU for an independent assessment by the MHRA after a submission has been made through one of the routes for assessment.

Route 2: Reliance on EU decision

The applicant makes an application relying on the CHMP positive opinion and the marketing authorisation approval decision issued by the European Commission.

Applications should be submitted following receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision.

Procedures with a positive CHMP opinion where UK has recorded a divergent opinion

In these cases, if the applicant intends to pursue the application in Great Britain the application will need to be submitted for independent assessment according to assessment routes.

After independent assessment, taking into account the conclusion of the CHMP, if the decision is not to grant, the usual national appeal processes are available to the applicant and will be explained in the MHRA decision letter.

In all cases, the MHRA will contact applicants individually to address any questions, establish how they wish to proceed and confirm which documentation to submit and when to submit it.

The handling of applications at all stages of the EU procedure is summarised in this table.

To avoid delay to the completion of these applications and to take account of timetable changes for any applications following an accelerated timetable, an application manager will be assigned to each one.

CHMP Procedure on exit day End of Procedure (usually Day 210) Day 181-209 Day 180 Day 121 179 Day 120 Day 80 - 119 Before Day 80
Application status Application is the subject of a CHMP positive scientific opinion Assessment of Responses In Clock Stop; List of outstanding issues available Assessment of Responses In Clock Stop; Review of scientific data available and List of Questions sent to applicant Application in the first assessment phase Application in the first assessment phase
Applicant action Submit application to MHRA for determination in line with CHMP Scientific Opinion, except in cases where UK has recorded a divergent decision, or (ii) Apply through Reliance Route (i) Submit EU application and responses to MHRA to complete assessment tailored to outstanding issues or (ii) Await CHMP positive opinion then apply through Reliance Route (i) Whe

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