Applying for a UK Marketing Authorisation for Medicines

Overview of Marketing Authorisation Requirement

You must have a Marketing Authorisation (MA) before you can sell a prescription or over-the-counter medicine in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) assesses applications for MAs to ensure medicines are safe, effective and of acceptable quality. This applies to both new medicines and generics. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Types of Marketing Authorisation Procedures

There are several routes to obtain an MA in the UK:

• National procedure: Application made directly to the MHRA for the UK only.
• Decentralised procedure (DCP): Application made simultaneously in several EU Member States (including UK if applicable post-transition), with one Reference Member State (RMS) leading assessment.
• Mutual recognition procedure (MRP): Builds on an existing national authorisation in one Member State, seeking recognition in others.
• Centralised procedure: Managed by the European Medicines Agency (EMA), resulting in a single authorisation valid across EU Member States (UK participation depends on post-Brexit arrangements; national route often used for UK-specific needs). Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Specific Pathways for Different Medicine Types

Generics and Biosimilars

• Generics: Use abridged applications referencing an originator product (reference medicinal product) with bioequivalence data.
• Biosimilars: Similar abridged pathway, but require more extensive comparability data demonstrating similarity to the reference biologic product in quality, safety and efficacy. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Novel and Complex Medicines

• Full applications with complete clinical, non-clinical and quality dossiers.
• Additional requirements may apply for advanced therapy medicinal products (ATMPs), orphan medicines, or those with conditional marketing authorisations. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Application Requirements and Process

• Submit via the MHRA portal (electronic Common Technical Document – eCTD format strongly preferred).
• Provide comprehensive data on quality (manufacturing, controls), non-clinical (pharmacology, toxicology) and clinical (efficacy, safety) aspects.
• Pay relevant fees (application, assessment, annual maintenance).
• Assessment timelines vary: standard national ~210 days (active), with clock-stops for questions.
• If approved, receive MA with product information (SmPC, PIL, labelling) approved.
• Post-authorisation obligations include pharmacovigilance, variations, renewals. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Additional Considerations

• Parallel import: Medicines authorised in another EEA country may be imported and relabelled/relabelled under certain conditions without full MA.
• Specials and unlicensed medicines: Allowed under specific exemptions (e.g., unmet need) but not marketed.
• Northern Ireland considerations: Due to Windsor Framework, some EU centralised authorisations remain valid in NI; separate UK-wide or GB-only routes for Great Britain.
• Guidance documents: Refer to MHRA specific product guidance for generics, biosimilars, paediatric investigation plans, etc. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Related Resources

• Apply for a licence to market a medicine in the UK (main page)
• Guidance on specific types (generics, biosimilars, herbal, homeopathic)
• Fees information
• Post-authorisation procedures
• Contact MHRA for pre-submission advice Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk