GovWire

Decision: Orphan registered medicinal products

Medicines Healthcare Products Regulatory Agency

July 26
09:02 2022

Details

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 26 July 2022 +show all updates
  1. Added OXBRYTA to Orphan Register

  2. Updated 'Authorised orphan indication' for Ngenla.

  3. Orphan indication updated for Polivy.

  4. Added ABECMA to the Orphan register.

  5. Scemblix added to Orphan register

  6. Added Kimmtrak to the Orphan Register

  7. Orphan market exclusivity expiry extended to 30 Oct 2024, for PLGB 16189/0093/OD2 & PLGB 16189/0093/OD1

  8. Ngenla added to Orphan Register

  9. Xaluprine moved from Live Orphan Register to Expired Orphan Register.

  10. A new product called Sogroya was added to the Orphan Register.

  11. Updated entries on the 'Orphan Register'

  12. Plenadren moved to expired list

  13. Updates to the entries for Kaftrio and Kalydeco on the Orphan Register

  14. QINLOCK added to the Orphan Register

  15. The orphan market exclusivity period for Vyndaqel has ended. Register has been updated.

  16. Imbruvica removed from register

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