Orphan registered medicinal products
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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.
Orphan medicinal products
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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The MHRA offers incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees to encourage the development of medicines in rare diseases. Waiver from scientific advice fees will also be available for UK based
SMEs.
Application process
The MHRA is responsible for reviewing applications from companies for orphan designation at the time of a marketing authorisation application (
MAA).
There is no pre-marketing authorisation orphan designation.
Products with an orphan designation in the EU can be considered for a Great Britain orphan marketing authorisation (MA). In accordance with Regulation 50G of the Human Medicines Regulation 2012 (as amended), a UK-wide orphan marketing authorisation can only be considered in the absence of an active E
Guidance on MAH and QPPV location from 1 January 2021 gov.uk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from gov.uk Daily Mail and Mail on Sunday newspapers.