GovWire

Decision: Orphan registered medicinal products

Medicines Healthcare Products Regulatory Agency

February 14
17:35 2024

The Orphan Register comprises:

  • EU marketing authorisations converted into Great Britain marketing authorisations in accordance with paragraph 6(7) of Schedule 33A the Human Medicines Regulations 2012 (as amended) where there is an existing European Union (EU) orphan designation, and the Great Britain marketing authorisation continues in effect with the remaining period of orphan market exclusivity.
  • Medicinal products that have received a marketing authorisation with orphan status on or after 1 January 2021 from the UK Licensing Authority, the MHRA. Under regulation 58D of the Human Medicines Regulations 2012 (as amended), a period of 10 years orphan market exclusivity is awarded from the date of marketing authorisation by the MHRA. An additional two years of exclusivity may be added where paediatric data requirements have been met.

This is in accordance with regulation 58C(2) of the Human Medicines Regulations 2012 (as amended).

The scope of orphan market exclusivity is defined by the authorised indication.

Products with an orphan designation in the EU can be considered for a Great Britain orphan marketing authorisation.

A UK-wide orphan marketing authorisation can only be considered in the absence of an active EU orphan designation.

There is no pre-authorisation orphan designation in Great Britain.

An orphan designation effective in Great Britain or UK is reflected in PLGB or PL, respectively, in the orphan designation number.

Published 9 February 2021
Last updated 14 February 2024 +show all updates
  1. Spexotras has been added to the Orphan register

  2. Moved Imnovid, Opsumit, & Soliris from Orphan Register, to the Expired Orphan register.

  3. Moved 'Hepcludex' from 'Orphan Register' to 'Expired orphan registrations' list.

  4. Added 'Loargys 5 mg/ml solution for injection/infusion' to the orphan register

  5. Added 'Enspryng' to the orphan register

  6. Orphan register updated with new entries: Casgevy for ? thalassaemia intermedia and major and Casgevy for sickle cell disease

  7. Orphan register updated with new entry: Hyftor.

  8. Updated Orphan register removing Defitelio and adding it to the expired register list.

  9. 'Evrysdi' moved to Expired Orphan Register.

  10. 'Columvi 2.5 mg and 10mg concentrate for solution for infusion' added to Orphan register.

  11. Updated Orphan Register to update Orphan market exclusivity date on the Imcivree injection 10mg/ml to 17 November 2032

  12. Added 'ELZONRIS' to Orphan Register.

  13. TOBI Podhale entry removed from the Orphan register.

  14. Added Tecartus for mantle cell lymphoma to the orphan register

  15. Orphan register updated to include TIBSOVO

  16. Added 'Pombiliti 105 mg powder for concentrate for solution for infusion' to the Orphan Register.

  17. Iclusig removed from the Orphan register.

  18. Updated Orphan Register - added Voraxaze 1000 units powder for solution for injection

  19. Added 'Ebvallo 2.8 x 10^7 - 7.3 x 10^7 cells/mL dispersion for injection ' to Orphan register.

  20. Added 'Nexviadyme 100 mg powder for concentrate for solution for infusion' to the Orphan Register.

  21. Moved 'Adempas' to Expired orphan registrations

  22. Orphan register updated

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