The Human Medicines Regulations 2012

[F1 Potential for return on investment U.K.

2.— (1) The following provisions apply for the purposes of establishing, pursuant to regulation 50G(2)(a) and (b)(ii), that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition in Great Britain and that the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment.

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

(a) 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;

(b) details of the costs incurred in connection with the development of the medicinal product;

(c) details of any grants, tax incentives or other cost recovery provisions received in Great Britain or any other country in relation to the development of the medicinal product;

(d) where the medicinal product is already authorised in Great Britain for any indication, or where the product is under investigation for one or more other indications, an explanation of, and justification for, the method that is used to apportion the development costs among the various indications;

(e) a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for a UK marketing authorisation;

(f) a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur in the first ten years that the medicinal product is authorised;

(g) an estimate of and justification for the expected revenues from sales of the medicinal product in Great Britain and elsewhere during the first ten years that the medicinal product is authorised; and

(h) information on the prevalence and incidence in Great Britain of the condition for which the medicinal product would be authorised at the time at which the application for an orphan marketing authorisation application is submitted.

(3) The information concerning costs and revenue referred to in sub-paragraph (2) must be determined in accordance with generally accepted accounting principles and must be certified by a person who is a member of a body of accountants which is established in the United Kingdom and which is approved by the licensing authority for the purposes of this paragraph.]

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)