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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:
  • Send and receive information on adverse drug reactions (ADRs)

    How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

    • 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:
  • 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:
  • 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:
  • 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:
  • 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:
  • Variations to Marketing Authorisations (MAs)

    How the MHRA processes variations to Marketing Authorisations (MAs)

    • 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:
  • 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:
  • 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:
  • Blue Guide: advertising and promoting medicines

    Detailed guidance on advertising and promoting medicines.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Comparator products in Bioequivalence/Therapeutic Equivalence studies

    This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications

    • 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:
  • Reference Medicinal Products (RMPs)

    There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications

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