Textual Amendments
F1Sch. 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)
3.—(1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(c), that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in Great Britain, or if such method exists, that the medicinal product will be of significant benefit to those affected by the condition.
(2) The material provided pursuant to regulation 50G(3) must include—
(a)details of any existing methods of diagnosis, prevention or treatment of the condition in question that have been authorised in Great Britain, making reference to scientific or medical literature or other relevant information, including information relating to authorised medicinal products, medical devices or other methods of diagnosis, prevention or treatment which are used in Great Britain; and
(b)a justification as to why either—
(i)the methods referred to in paragraph (a) are not considered satisfactory; or
(ii)the medicinal product for which an orphan marketing authorisation is sought will be of significant benefit to those affected by the condition.
(3) In this paragraph, “significant benefit” means a clinically relevant advantage or a major contribution to patient care.]