53.—(1) This regulation applies if an applicant for a UKMA(NI) for a biological medicinal product is not able to show that product meets a condition for its being a generic version of a similar medicinal product because of any of the reasons described in Article 10(4) of the 2001 Directive.
(2) The applicant must provide information in accordance with Article 10(4) and (6) of the 2001 Directive.
(3) Paragraphs (2) to (4) of regulation 51 apply to the application as they apply in relation to an application made in accordance with paragraph (1) of that regulation.]
Textual Amendments
F1Regs. 53-53B substituted for reg. 53 (31.12.2020) by S.I. 2019/775, regs. 1, 58 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 43)