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  1. Home
  2. Medicines, medical devices and blood regulation and safety
Medicines, medical devices and blood regulation and safety

Marketing authorisations, variations and licensing guidance: detailed information

From:
Medicines and Healthcare products Regulatory Agency and Department of Health and Social Care

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New applications

  • Apply for a licence to market a medicine in the UK
  • Medicines: apply for a parallel import licence
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  • Supply unlicensed medicinal products (specials)
  • Advanced therapy medicinal products: regulation and licensing
  • Decentralised and mutual recognition reliance procedure for marketing authorisations
  • Unfettered Access Procedure for marketing authorisations approved in Northern Ireland
  • European Commission (EC) Decision Reliance Procedure
  • Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations
  • 150-day assessment for national applications for medicines
  • Rolling review for marketing authorisation applications
  • Project Orbis
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Post-licensing

  • Medicines marketing authorisation: change of ownership
  • Medicines: apply for a variation to your marketing authorisation
  • Renew: marketing authorisation for a human medicine
  • Cancel a medicine's marketing authorisation or other licence
  • Patient group directions (PGDs)
  • Periodic Safety Update Reports (PSURs) for medicinal products
  • Sunset clause: request for public health exemption
  • Apply to release a vaccine or a blood product to market

Advertising and product information

  • How to advertise and promote medicines
  • Blue Guide: advertising and promoting medicines
  • Advertising investigations by MHRA
  • How to reclassify your medicine
  • Medicines: packaging, labelling and patient information leaflets

Other

  • Medicines: get scientific advice from MHRA
  • Legal requirements for children's medicines
  • Medicines: licensing time-based performance measures
  • Marketing authorisations: lists of granted licences
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