Regulation 50G Applications relating to orphan medicinal productsF1

(1)

This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product—

(a)

in relation to which the applicant intends to demonstrate that the orphan criteria are metF2.

F3(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2)

The orphan criteria are that—

(a)

the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;

(b)

either—

(i)

the condition referred to in sub-paragraph (a) affects not more than five in 10,000 persons in F4the United Kingdom; or

(ii)

the medicinal product is unlikely, when marketed, to generate sufficient financial return to justify the necessary investment; and

(c)

there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the United Kingdom, or if such method exists, the medicinal product will be of significant benefit to those affected by the condition.

(3)

The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority material that demonstrates that the orphan criteria are met.

(4)

Schedule 9A makes further provision about the orphan criteria and terms used in regulation 58D.

(5)

The Ministers may by regulations amend Schedule 9A.

Annotations

Textual amendments

F1: Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Reg. 50G(1)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(a)(i)
F3: Reg. 50G(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(a)(ii)
F4: Words in reg. 50G(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 31(b)