Marketing Authorisation Applications in the UK

UK marketing authorisation application support for MHRA submissions, including national procedure, International Recognition Procedure, and UK-specific dossier requirements.

This is a UK local page. For our full MAA methodology, including pathway selection, CTD preparation, benefit-risk assessment, and submission management, see Regulatory Strategy & Operations.

UK Regulatory Landscape

Our UK team plans, prepares, and manages marketing authorisation applications submitted to the MHRA through UK-specific regulatory routes. Since Brexit, the UK operates its own authorisation pathways with distinct eligibility criteria, assessment timelines, and procedural requirements. For the full description of our MAA methodology, including pathway selection, CTD preparation, benefit-risk assessment, and submission management, see Regulatory Strategy & Operations.

The UK offers several routes to marketing authorisation, each designed for different product types and commercial strategies.

UK National Procedure

The standard route for products seeking UK-only authorisation. The MHRA conducts an independent assessment of the full CTD. Suitable for products that are not seeking EU authorisation or where the UK market is the primary target.

International Recognition Procedure (IRP)

The IRP allows the MHRA to recognise marketing authorisation decisions made by trusted international regulators, including EMA, FDA, Health Canada, TGA, and others. This can significantly shorten the UK assessment timeline for products already approved in a reference jurisdiction. The IRP is available for new active substances and generics.

Innovative Licensing and Access Pathway (ILAP)

ILAP is designed for innovative medicines that address unmet medical need. It provides a toolkit of regulatory support including an Innovation Passport, a Target Development Profile, and enhanced MHRA engagement throughout development. ILAP is not a separate authorisation route but a framework that can be applied alongside any UK submission pathway to accelerate development and assessment.

What We Handle Locally

Our UK team delivers the following within the UK marketing authorisation framework. For our full MAA methodology, including pathway selection, CTD preparation, benefit-risk assessment, and submission management, see the central Regulatory Strategy & Operations page.

  • Assess which UK authorisation route best fits the product, development status, and commercial strategy, comparing national, IRP, and ILAP options based on eligibility, timeline, and alignment with EU or global filing plans.
  • Prepare UK-specific Module 1 documentation, including MHRA application forms, administrative content, and any UK-divergent product information requirements.
  • Manage the MHRA submission process end to end, including pre-submission planning, dossier validation against MHRA requirements, electronic submission, and tracking through assessment.
  • Handle MHRA assessment interactions, including responses to Day 120 and Day 180 questions or UK equivalents, requests for information, and UK-specific scientific queries arising during review.
  • Support ILAP applications, including preparation of the Innovation Passport, development of the Target Development Profile, and coordination of enhanced MHRA engagement throughout the programme.
  • Coordinate UK and EU submissions for products filing in both jurisdictions, ensuring timeline alignment, documentation consistency, and management of divergent authority questions across MHRA and EMA or NCA assessments.
  • Manage post-approval UK-specific activities, including MHRA-required labelling implementation, product information updates, and coordination of UK launch readiness with commercial and supply chain teams.

Our UK Team

UK MAA work is managed by our regenold UK regulatory team, who have direct experience across UK national, IRP, and ILAP submissions. The team works closely with our central regulatory strategy specialists for cross-regional filing coordination.

For the full team, see Our Teams.

Planning a UK Submission?

Tell us about your product, your target timeline, and whether you are filing in the UK only or in parallel with the EU. We will outline which route fits and how we can support.

Speak with an Expert

Frequently Asked Questions (FAQ)

What is the fastest UK route to marketing authorisation?

The IRP is typically the fastest for products already approved by a trusted reference authority, such as EMA, FDA, Health Canada, or TGA. The MHRA leverages the existing assessment, which can significantly reduce the UK review timeline. For entirely new products without prior approval elsewhere, the national procedure or ILAP-supported route applies.

Can we submit in the UK and EU simultaneously?

Yes. Separate submissions are required, with the MHRA for the UK and EMA or national competent authorities for the EU, but the same core CTD can be used with jurisdiction-specific Module 1 adaptations. We coordinate parallel submissions to align timelines and manage divergent assessment questions.

What does ILAP provide that a standard submission does not?

ILAP is not a separate submission route but an overlay that provides structured MHRA engagement, an Innovation Passport confirming the product meets unmet need criteria, a Target Development Profile developed with MHRA input, and access to rolling review where appropriate. It is designed to accelerate development decisions and reduce regulatory uncertainty for innovative medicines.

How does the UK product information differ from the EU?

UK-authorised products must use MHRA product information templates, which have diverged from EU QRD templates. The UK SmPC, PIL, and labelling must reflect the UK MAH, UK legal status, and any UK-specific standard wording. Companies holding authorisations in both jurisdictions must maintain both sets independently.