Collection

Medicines: licensing and applications

Information about new applications, post-licensing, advertising, product information and fees.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 21 September 2023

New applications

• Apply for a licence to market a medicine in the UK
  • 14 May 2024
  • Guidance
• Medicines: apply for a parallel import licence
  • 8 April 2024
  • Guidance
• Innovative Licensing and Access Pathway
  • 20 November 2024
  • Guidance
• Early Access to Medicines Scheme - Information for Applicants
  • 12 November 2024
  • Guidance
• Supply unlicensed medicinal products (specials)
  • 12 May 2023
  • Guidance
• Advanced therapy medicinal products: regulation and licensing in Great Britain
  • 19 March 2024
  • Guidance
• Decentralised and mutual recognition reliance procedure for marketing authorisations
  • 23 February 2021
  • Guidance
• Unfettered Access Procedure for marketing authorisations approved in Northern Ireland
  • 5 January 2024
  • Guidance
• European Commission (EC) Decision Reliance Procedure
  • 18 November 2022
  • Guidance
• Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations
  • 31 December 2020
  • Guidance
• 150-day assessment for national applications for medicines
  • 16 April 2024
  • Guidance
• Rolling review for marketing authorisation applications
  • 18 October 2024
  • Guidance
• Project Orbis
  • 18 October 2024
  • Guidance
• Access Consortium
  • 26 February 2024
  • Guidance

Post-licensing

• Medicines marketing authorisation: change of ownership
  • 17 November 2023
  • Guidance
• Medicines: apply for a variation to your marketing authorisation
  • 22 April 2024
  • Guidance
• Cancel a medicine's marketing authorisation or other licence
  • 2 October 2015
  • Guidance
• Patient group directions (PGDs)
  • 4 December 2017
  • Guidance
• Periodic Safety Update Reports (PSURs) for medicinal products
  • 31 December 2020
  • Guidance
• Sunset clause: request for public health exemption
  • 6 July 2023
  • Form
• Apply to release a vaccine or a blood product to market
  • 25 September 2024
  • Guidance

Advertising and product information

• How to advertise and promote medicines
  • 18 December 2014
  • Collection
• Blue Guide: advertising and promoting medicines
  • 31 December 2020
  • Guidance
• Advertising investigations by MHRA
  • 20 August 2024
  • Collection
• How to reclassify your medicine
  • 18 December 2014
  • Collection
• Medicines: packaging, labelling and patient information leaflets
  • 7 March 2024
  • Guidance

Other

• Medicines: get scientific advice from MHRA
  • 25 March 2022
  • Guidance
• Legal requirements for children's medicines
  • 31 December 2020
  • Guidance
• Medicines: licensing time-based performance measures
  • 31 January 2023
  • Official Statistics
• Marketing authorisations: lists of granted licences
  • 8 February 2024
  • Collection
• Parallel import licences: lists of approved products
  • 8 February 2024
  • Collection

Payment, fees and applying

• MHRA Portal: register to submit forms
  • 8 October 2019
  • Guidance
• How to use RamaXL
  • 27 January 2015
  • Guidance
• Make a payment to MHRA
  • 21 December 2023
  • Guidance
• MHRA fees
  • 20 November 2023
  • Statutory guidance

Published 21 September 2023