OpenLegislation

Part 2 Fees relating to marketing authorisations

United Kingdom

  1. 7Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product
  2. 7AApplication for a marketing authorisation for specific applications
  3. 8Decentralised pharmaceutical application where the United Kingdom is the reference member State
  4. 9Application for a marketing authorisation for an immunological or biosimilar product
  5. 10Decentralised immunological application where the United Kingdom is the reference member State
  6. 11Application for a marketing authorisation based on informed consent
  7. 12Application for an exceptional marketing authorisation (pharmaceutical)
  8. 13Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)
  9. 14Fee for the conversion from an exceptional to a full marketing authorisation
  10. 15Application for a marketing authorisation relating to a parallel import
  11. 15AFee for a generic marketing authorisation
  12. 16Application to change the distribution category of a product authorised through the centralised procedure
  13. 17Application for a variation to a marketing authorisation ....
  14. 18Application for a variation to a marketing authorisation dealt with under worksharing procedures
  15. 19Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State
  16. 20Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension
  17. 21Exception for a variation relating to animal testing
  18. 22Application for a reassessment of an exceptional marketing authorisation
  19. 23Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure
  20. 24Registration of a homeopathic remedy
  21. 25Renewal of a homeopathic remedy
  22. 26Annual fees for marketing authorisations
  23. 27Auditor’s certificate