MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK

Introducing the International Recognition Procedure

On 1st January 2024, the MHRA is launching the International Recognition Procedure (IRP). This new regulatory framework seeks to build and expand upon the experience and knowledge gained by the agency from the initial reliance routes such as ECDRP.

IRP aims to facilitate the UK registration of pharmaceutical products previously authorised in seven regions using the assessment already conducted by the medicines regulators of these regions. The IRP is available for medicines authorised and assessed by their respective ‘reference regulators’ (RR) in the following regions:

This new reliance procedure will help to facilitate the registration of new medicines for patients in the UK, increasing the speed and efficiency of the assessment process. The IRP route can be used provided that both the product authorised by the RR and the proposed product have the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, in addition to applicants belonging to the same company or group of companies or which are ‘licensees’.

Product types covered by IRP include:

• New chemical entities
• New fixed combination products
• Generic medicines (including hybrid applications)
• New biologicals (including gene and cell therapies)
• Vaccines
• Biosimilars

Two IRP assessment routes

Applications via IRP are subject to two assessment routes

• **Recognition A:**60-day timetable

  • No clock stop is foreseen following validation

• **Recognition B:**110-day timetable

  • Recognition B will have published submission deadlines
  • This is to allow for discussion of the application by the UK’s Commission on Human Medicines (CHM)
  • Clock stop at Day 70, with up to 60d clock-off period

Pre-submission

To be eligible for the IRP the applicant must be established in the UK or in the EU/EEA. At least 6 weeks before the planned MAA submission date, the applicant will need to submit via email an eligibility form to recognition@mhra.gov.uk. The form is generated by completing the ‘eligibility checker tool’ which will aid applicants to determine whether their application is eligible for recognition route A or B. The submission instructions at the top of the form must be followed. The eligibility form must also be included in the MAA submission.

Supporting documents

As with the current reliance route, the ECDRP information should be provided within the text of the cover letter some of which include:

• The cover letter will need to include certain declarations regarding compliance and conformity to the dossier approved by the RR.
• A statement on whether the route is International Recognition, and whether it is Recognition A or Recognition B, and the RR.
• A tabulated list of assessment reports should be presented at the end of the cover letter.
• A statement on whether there are differences in the wording of the proposed therapeutic indications
• A summary of global regulatory history of the medicinal product
• State whether the application has previously been approved, withdrawn, refused, or rejected by another RR.
• State whether a marketing authorisation has been withdrawn, revoked or suspended or not renewed by another RR.
• Details of any significant changes since the approval of the medicinal product.

All IRP applications should be submitted using a consolidated electronic Common Technical Document (eCTD) sequence through the MHRA Submissions Platform. All modules of eCTD should be in EU format (Module 1-5) with UK specific regional information in Module 1.

QbD Group can support you in complying with specific UK requirements in, for example, for pharmacovigilance, product information and artwork management. For products manufactured outside of the EU/EEA, we can support importation, QC testing and QP release steps via our dedicated facility.

Post-approval

The same principles apply to the current ECDRP route in that the IRP route can also be utilised for post-authorisation procedures such as line extensions, variations (Type IB, Type II), and renewal applications.

For products currently authorised via ECDRP, it is advised to continue using EMA as the RR but, if appropriately justified this can be changed. It is also acceptable to submit standalone national post-authorisation procedures including variations for products authorised via the IRP route. The standard MHRA timetables for national post-authorisation procedures apply.

Conclusions

The establishment of IRP is an exciting development as MHRA seeks to establish itself as the UK’s sovereign regulator following Brexit. This, together with the implementation of the Windsor Framework provides a clear path forward for applicants wishing to register and supply medicines to the UK market.

QbD will be attending future MHRA webinars designed to cover key aspects of the IRP route and to address frequently asked queries raised by industry stakeholders. Stay tuned to our blog for further updates on the IRP route by subscribing to our newsletter.

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