Regulation 157 Requests from EU member StatesF3
Paragraph (2) applies where the licensing authority F1, in relation to a UKMA(NI), is requested by the competent authority of F2a member State to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—
the assessment report for a medicinal product as mentioned in regulation 64(5) (duties of licensing authority in connection with determination); and
the marketing authorisation in force for that product.
The licensing authority must supply those documents to the competent authority before the end of the period of thirty days beginning on the day after the request is received.
Annotations
Textual amendments
- F1
Words in reg. 157(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F2
Words in reg. 157(1) substituted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)
- F3
Words in reg. 157 heading substituted (31.12.2020) by S.I. 2019/775, reg. 132A(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)