Regulation 55 Applications relating to new combinations of active substancesF1

(1)

This regulation applies to an application for a UK marketing authorisation for a relevant medicinal product that contains active substances, provided those active substances—

(a)

have not been used in that combination for therapeutic purposes; and

(b)

where the application is for—

(i)

a UKMA(NI), have been used in medicinal products that have been the subject of a marketing authorisation under these Regulations, the 2001 Directive or Regulation (EC) No 726/2004;

(ii)

F2... or

(iii)

a UKMA(UK), have been used in medicinal products that have been the subject of—

(aa)

a UKMA(UK) under these Regulations; or

(F3bb)

a UKMA(NI).

(2)

The applicant must provide the results of new pre-clinical tests or new clinical trials relating to that combination in accordance with paragraph 10 of Schedule 8, but does not need to provide scientific references relating to each individual active substance.

F4(3)

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

Annotations

Textual amendments

F1: Reg. 55 substituted (31.12.2020) by S.I. 2019/775, reg. 60 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 44)
F2: Reg. 55(1)(b)(ii) 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), 43(a)(i)
F3: Reg. 55(1)(b)(iii)(bb) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 43(a)(ii)
F4: Reg. 55(3) 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), 43(b)