Regulation 52 Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etcF1

(1)

This regulation applies where—

(a)

an application is made for a UKMA(NI) by reference to another medicinal product as reference medicinal product; and

(b)

one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.

(2)

The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.

(3)

F2Paragraph (2) of regulation 51 applies to the application as it applies in relation to an application made in accordance with paragraph (1) of that regulation.

Annotations

Textual amendments

F1: Regs. 52-52B substituted for reg. 52 (31.12.2020) by S.I. 2019/775, regs. 1, 57 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 42)
F2: Words in reg. 52(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 37