Decision: Orphan registered medicinal products

Medicines Healthcare Products Regulatory Agency

April 23
14:44 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 23 April 2024 +show all updates
  1. Yorvipath 168, 294 and 420 micrograms added to the orphan register

  2. Granupas added to the expired orphan register.

  3. Updated information in the authorised orphan indication for TAKHZYRO.

  4. Rystiggo and Ztalmy added to the orphan register

  5. Updated to add AGAMREE to orphan register, updated indication of Soliris, removed Sirturo 20 mg Tablets from orphan register and added to expired orphan registrations

  6. Updated Orphan Register with Vanflyta

  7. The day or market exclusivity for Spexotras has been updated to 13 February 2036 in the Orphan Register.

  8. Spexotras has been added to the Orphan register

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

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

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

  12. Added 'Enspryng' to the orphan register

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

  14. Orphan register updated with new entry: Hyftor.

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

  16. 'Evrysdi' moved to Expired Orphan Register.

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

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

  19. Added 'ELZONRIS' to Orphan Register.

  20. TOBI Podhale entry removed from the Orphan register.

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

  22. Orphan register update

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