Marketing authorisations, variations and licensing guidance

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Services

• Sunset clause: request for public health exemption

  Apply for a public health exemption from the sunset clause.

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Guidance and regulation

• Apply for a licence to market a medicine in the UK
  • Detailed guide
  • 11 December 2024
  • Medicines and Healthcare products Regulatory Agency
• Medicines: packaging, labelling and patient information leaflets
  • Detailed guide
  • 7 March 2024
  • Medicines and Healthcare products Regulatory Agency
• Medicines: apply for a variation to your marketing authorisation
  • Detailed guide
  • 22 April 2024
  • Medicines and Healthcare products Regulatory Agency
• Medicines: reclassify your product
  • Detailed guide
  • 17 December 2024
  • Medicines and Healthcare products Regulatory Agency
• Supply unlicensed medicinal products (specials)
  • Guidance
  • 12 May 2023
  • Medicines and Healthcare products Regulatory Agency

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News and communications

• Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD)
  • 20 December 2024
  • Medicines and Healthcare products Regulatory Agency
  • Press release
• Orphan registered medicinal products
  • 18 December 2024
  • Medicines and Healthcare products Regulatory Agency
  • Decision
• Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema
  • 10 December 2024
  • Medicines and Healthcare products Regulatory Agency
  • News story
• The MHRA issues final call to comply with Windsor Framework arrangements for medicines from January 2025
  • 29 November 2024
  • Medicines and Healthcare products Regulatory Agency
  • Press release
• MHRA approves new diagnostic agent for adult patients showing signs of cognitive impairment for Alzheimer’s disease
  • 27 November 2024
  • Medicines and Healthcare products Regulatory Agency
  • Press release

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Research and statistics

• Early access to medicines scheme applications: pending, refused, granted
  • 8 November 2023
  • Medicines and Healthcare products Regulatory Agency
  • Official statistics
• Medicines: licensing time-based performance measures
  • 31 January 2023
  • Medicines and Healthcare products Regulatory Agency
  • Official statistics
• Public Assessment Report of the Reclassification of Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension
  • 26 May 2021
  • Medicines and Healthcare products Regulatory Agency
  • Research
• Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets
  • 26 April 2021
  • Medicines and Healthcare products Regulatory Agency
  • Research
• Public Assessment Report of the Reclassification of Allevia 120mg Tablets
  • 22 December 2020
  • Medicines and Healthcare products Regulatory Agency
  • Research

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Policy papers and consultations

• Consultation on proposal to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies
  • 3 July 2023
  • Medicines and Healthcare products Regulatory Agency
  • Consultation outcome
  • Date closed 13 May 2022
• The future strategy for batch testing of medicinal products in Great Britain
  • 15 December 2022
  • Department of Health and Social Care
  • Consultation outcome
  • Date closed 26 July 2022

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Organisations

• Medicines & Healthcare products Regulatory Agency
• Department of Health & Social Care