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 MHRA, the UK licensing authority
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 MHRA. An additional 2 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.
Updates to this page
Published 9 February 2021 Last updated 8 November 2024 +show all updates
Added FINLEE, Active substance: DABRAFENIB MESYLATE to Orphan Register
Added FABHALTA to Orphan Register
Added - in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
ADCETRIS (PLGB 16189/0093/OD1) & (PLGB 16189/0093/OD2) removed from Orphan Register and added to Expired Orphan Registrations.
Added 'IQIRVO' and 'Wainzua' to the Orphan Register.
Added Joenja to orphan register
Dacogen (PLGB 00242/0662/OD1) added to expired list.
Changed the Orphan market exclusivity expiry date of Fintepla on the Orphan Register to 5 July 2033.
Removed Revestive from orphan registered list and placed in to Expired orphan registrations
Amended to change expiry date on orphan registration of Agamree
Changed Orphan Register to add Vyloy (Active substance: zolbetuximab)
Added to remove Translarna from Orphan products to expired orphan products
Gazyvaro moved to 'Expired orphan registrations'
Updated exclusivity expiry date for Trecondi to 24 June 2031 & moved Vimizim to the 'expired' list.
Updated information in the authorised orphan indication for Carvykti.
Moved Cometriq from the orphan register to the expired orphan register
Yorvipath 168, 294 and 420 micrograms added to the orphan register
Granupas added to the expired orphan register.
Updated information in the authorised orphan indication for TAKHZYRO.
Rystiggo and Ztalmy added to the orphan register
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
