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437 publications by Medicines and Healthcare products Regulatory Agency ×
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  1. Exporting active substance manufacturer in the UK if we leave the EU without a deal

  2. Guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal

  3. Quarterly reports on the import of unlicensed medicines

    • MHRA
    • Official Statistics
  4. Early access to medicines scheme applications: pending, refused, granted

    • MHRA
    • Official Statistics
  5. Early access to medicines scheme (EAMS) scientific opinion: Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%

  6. Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients

  7. Notification of intent to import an unlicensed medicinal product

  8. List of approved countries for authorised human medicines in a no deal scenario

  9. Guidance on air freight of medicines in a no deal scenario

  10. Importing medicines from an EEA State which is on an approved country for import list

  11. Guidance on importation of investigational medicinal products from approved countries

  12. Legal requirements for children's medicines

    • MHRA
    • Guidance
  13. Marketing authorisations granted in February 2019

    • MHRA
    • Decision
  14. Parallel import licenses granted in February 2019

  15. Clinical trials for medicines: authorisation assessment performance

    • MHRA
    • Transparency data
  16. Early access to medicines scheme: expired scientific opinions

    • MHRA
    • Decision
  17. Medicines: new manufacturing and wholesale dealer licences

  18. Medicines: terminated and cancelled manufacturing and wholesale dealer licences

  19. Human and veterinary medicines: register of licensed wholesale distribution sites

  20. Human and veterinary medicines: register of licensed manufacturing sites

  21. Register of brokers authorised to deal in human medicines

  22. Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal

  23. Medicines: licensing time-based performance measures

    • MHRA
    • Official Statistics
  24. Medical devices: UK notified bodies

  25. In vitro diagnostic medical devices: guidance on legislation

  26. Parallel imports of medical devices

    • MHRA
    • Guidance
  27. Medical devices regulations: compliance and enforcement

  28. Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

  29. Marketing authorisations granted in January 2019

  30. Medicines marketing authorisation: change of ownership application

  31. Blood bank compliance report template

    • MHRA
    • Form
  32. Blood facility declaration form

    • MHRA
    • Form
  33. Advertising investigations: February 2019

  34. Advertising investigations: January 2019

  35. Widening the availability of naloxone

  36. Drug Safety Update: monthly PDF newsletter

    • MHRA
    • Guidance
  37. Parallel import licenses granted in January 2019

  38. Medicines and Healthcare products Regulatory Agency Privacy Notice

    • MHRA
    • Transparency data
  39. Advertising investigations: December 2018

  40. Early access to medicines scheme (EAMS) scientific opinion: Dupilumab as a treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable