# The Human Medicines Regulations 2012, Regulation 58C: Consideration of applications relating to orphan medicinal products


(1) If the licensing authority is satisfied in relation to an application for a UK marketing authorisation (including an application under the unfettered access route)—
(a) the orphan criteria are met in relation to all of the therapeutic indications to which the application relates; and
(b) it is otherwise appropriate to grant a UK marketing authorisation in respect of the application under regulation 49(1)(a),
it may grant a UK marketing authorisation which is known as an orphan marketing authorisation.
(2) The licensing authority must publish and keep up to date a list of orphan marketing authorisations.
(3) Schedule 11 makes provision about advice and representations in relation to proposals to grant a UK marketing authorisation in respect of which the applicant intended to demonstrate that the orphan criteria were met, in cases where the licensing authority considers that those criteria are not met.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/58C (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-58C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.