Regulation 58C Consideration of applications relating to orphan medicinal productsF1

(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.

Annotations

Textual amendments

F1: Regs. 58A-58G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 64 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 47); 2020 c. 1, Sch. 5 para. 1(1)