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Marketing authorisations, variations and licensing guidance

Guidance and regulation

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  • Apply for a licence to market a medicine in the UK

    An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: packaging, labelling and patient information leaflets

    How to package medicines for sale and what information you must provide to consumers and healthcare professionals.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: reclassify your product

    Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: apply for a variation to your marketing authorisation

    Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Supply unlicensed medicinal products (specials)

    Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Innovative Licensing and Access Pathway

    A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • 150-day assessment for national applications for medicines

    Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Apply for the early access to medicines scheme (EAMS)

    Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Patient group directions (PGDs)

    Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medical devices: UK approved bodies

    UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: get scientific advice from MHRA

    How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Types of application (legal basis)

    You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Variations to Marketing Authorisations (MAs)

    How the MHRA processes variations to Marketing Authorisations (MAs)

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • MHRA Portal: register to submit forms

    How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Blue Guide: advertising and promoting medicines

    Detailed guidance on advertising and promoting medicines.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines: apply for a parallel import licence

    How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Procedures for UK Paediatric Investigation Plan (PIPs)

    The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Medicines marketing authorisation: change of ownership

    How to change the ownership from one marketing authorisation (MA) holder to another.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Advanced therapy medicinal products: regulation and licensing in Great Britain

    How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Access New Active Substance and Biosimilar Work Sharing Initiatives

    The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access p…

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated: