The UK MHRA has updated its guidance on Orphan medicinal products.
The original guidance was first published 1 September 2020, then republished on 31 December 2020. Information on the following has now been added:
How a review of market exclusivity period would work
Under certain circumstances, if the orphan criteria are no longer met in relation to the medicinal product, Regulation 58D of the Human Medicines Regulation 2012 (as amended) establishes the possibility for the MHRA to request that the market exclusivity be reduced from 10 to 6 years, .
The orphan register
All medicines that gain an orphan marketing authorisation from the UK Licensing Authority will be listed on its Orphan Register.
- When the period of market exclusivity for an indication ends, the orphan designation for that indication expires and is removed from the Orphan Register.
- The product will remain on the Orphan Register if other authorised orphan indications remain within their period of exclusivity.
- Upon expiry (or withdrawal by a sponsor) of all orphan designations associated with an approved medicine, the medicine ceases to be classified as an orphan medicine. It will no longer benefit from the orphan incentives. The product will be removed from the register.
Source: MHRA website