The Human Medicines Regulations 2012

[F1 Prevalence of a condition in Great Britain U.K.

1.— (1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(i), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in Great Britain.

(2) The material provided pursuant to regulation 50G(3) must include—

(a) material which demonstrates that the disease or condition for which the medicinal product would be authorised affects not more than five in 10,000 persons in Great Britain at the time at which the application for an orphan marketing authorisation is submitted, where this is available;

(b) details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references; and

(c) copies of, or references to, relevant scientific literature, as well as copies of information from relevant databases in Great Britain, where available.

(3) If there are no databases as referred to in paragraph (2)(c), information from relevant databases in other countries may be supplied, provided appropriate extrapolations are made.]

Textual Amendments

F1 Sch. 9A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 191); 2020 c. 1, Sch. 5 para. 1(1)