Marketing authorisations, variations and licensing guidance

Services

  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. Supply unlicensed medicinal products (specials)
  2. Medicines: packaging, labelling and patient information leaflets
  3. Decide if your product is a medicine or a medical device
  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. Marketing authorisations granted in July 2018
  2. MHRA Innovative Medicines Symposium - supporting innovative medicines development
  3. New fees calculator for initial marketing authorisation applications
  4. New case study shows how MHRA helps Fujifilm future-proof manufacturing facility
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Research and statistics

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