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UK MHRA: Navigating UK Medicines Regulation: Licensing, Assessment and Variations

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has modernised its processes for evaluating, approving, and maintaining marketing authorisations (MAs) under a post-Brexit regulatory framework aligned with the Windsor Framework (effective January 2025). The MHRA’s guidance documents provide a clear roadmap for each of these phases:

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1. Applying for a Licence to Market a Medicine in the UK

The journey begins with securing a Marketing Authorisation (MA) — the legal requirement to market a medicinal product in the UK. The MHRA’s guidance on “Applying for a licence to market a medicine in the UK” provides the foundational steps for submission and validation.

Applications must be filed electronically through the MHRA Submissions Portal in eCTD format. The submission should include:

  • A completed electronic Application Form (eAF) and cover letter

  • Supporting documentation as per Schedule 8 of the Human Medicines Regulations 2012 (HMRs)

  • A valid PL number (UK-wide), requested in advance from MHRA

  • A Summary of Product Characteristics (SmPC) in the prescribed MHRA template

The MHRA validates applications using the Lorenz Docubridge system for technical conformity. Applications failing validation can be corrected and resubmitted without charges.

Fast-track requests may be made in health emergencies or for shortages of essential medicines, through justified submissions to RIS.NA@mhra.gov.uk. The MHRA may waive fees for technical rejections but requires prompt payment post-validation.

For detailed procedures:Read the full guidance – Apply for a Licence to Market a Medicine in the UK


2. National Assessment Procedure for Medicines

The National Assessment Procedure (NAP) is the MHRA’s central route for authorising innovative and established medicines post-Brexit. It applies to UK-wide marketing authorisations and aligns timelines with international partners under initiatives such as Project Orbis and the Access Consortium Work-Sharing Initiative (NASWSI).

The MHRA conducts initial assessments within 90 days, issues requests for information (RFIs), and targets final authorisation within 210 clock-on days once deficiencies are resolved. Clarification meetings are offered during clock-stops to streamline resolution.

Applications undergo one or more review rounds:

  • First RFI by Day 90 if key deficiencies exist

  • Second RFI or CHM (Commission on Human Medicines) referral by Day 150 for unresolved issues

  • Grant or refusal issued by Day 210 following compliance checks

Aligned with the Windsor Framework, medicines will be designated Category 1 (UK-wide) or Category 2 (EU-aligned NI products). This ensures harmonised authorisation under UK law and facilitates same-time publication with NICE recommendations for faster patient access.

Access the official guidance here: National Assessment Procedure for Medicines


3. Variations to Marketing Authorisations (MAs)

Once a product is authorised, companies must maintain compliance throughout its lifecycle via variations — updates to manufacturing, analytical, or clinical documentation.

The MHRA’s “Variations to Marketing Authorisations (MAs)” guidance outlines the updated regulatory pathway following the Windsor Framework implementation on 1 January 2025.

Core Aspects

  • The UK continues to apply procedures under Chapter IIa of EC Regulation 1234/2008, integrated into UK law via the Human Medicines Regulations 2012 (HMR).

  • Type IA, IAIN, IB, and Type II variations remain applicable; the EU’s classification guidelines continue to apply unless the MHRA issues revised national guidance.

  • Variations can be submitted via two routes:

    • Direct National Applications — for purely UK MAs

    • International Recognition Procedure (IRP) — when based on other regulators’ approvals


Post-2025 Transition Rules

  • UK-wide MAs: Great Britain (GB) and Northern Ireland (NI) now operate under unified authorisations.

  • Former EU/NI MAs: From January 2025, all EU centralised authorisations cease to apply in NI. Existing GB MAs automatically convert to UK-wide authorisations.

  • Pending Variations: Applications not determined before 1 January 2025 will continue under the respective process active at the time of submission.

For ongoing and future submissions, MA holders must contact variationqueries@mhra.gov.uk for procedural clarification.

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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