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The Human Medicines Regulations 2012, Section 58E is up to date with all changes known to be in force on or before 08 June 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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58E.—(1) When determining an application to which regulation 50H(3) (applications relating to combined advance therapy medicinal products) applies, the licensing authority must—
(a)assess the entire combined advanced therapy medicinal product in accordance with these Regulations; and
(b)recognise the results of the assessment of the notified body, if supplied.
(2) The licensing authority may request the notified body, if relevant, to provide it with information related to the results of the assessment.
(3) Paragraph (4) applies if an application to which regulation 50H(3) applies does not include the results of the assessment of a notified body, or if the notified body fails to supply information related to the results of the assessment when requested by the licensing authority.
(4) Where this paragraph applies, the licensing authority must seek an opinion on the conformity of the device part in accordance with the Medical Devices Regulations 2002 from a notified body identified in conjunction with the applicant, unless the licensing authority decides that the involvement of a notified body is not required.]
Textual Amendments
F1Regs. 58A-58G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 64 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 47); 2020 c. 1, Sch. 5 para. 1(1)
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