Marketing authorisations, variations and licensing guidance


  1. Sunset clause: request for public health exemption

    Apply for a public health exemption from the sunset clause.

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Guidance and regulation

  1. Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
  2. Medicines: packaging, labelling and patient information leaflets
  3. Supply unlicensed medicinal products (specials)
  4. Apply for a licence to market a medicine in the UK
  5. Medicines: apply for a variation to your marketing authorisation
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News and communications

  1. Parallel import licenses granted in November 2018
  2. Marketing authorisations granted in December 2018
  3. Marketing authorisations granted in November 2018
  4. Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs) – letter to industry and guidance
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Research and statistics

  1. Medicines: licensing time-based performance measures
  2. Quarterly reports on the import of unlicensed medicines
  3. Early access to medicines scheme applications: pending, refused, granted
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