Regulation 197 EU urgent action procedure
Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products F1authorised for sale or supply under a UKMA(NI), F2UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority—
may publicly announce the initiation of the EU urgent action procedure on the UK web-portal; and
must implement the measures set out in any agreement reached under Article 107k of the 2001 Directive in relation to the medicinal product or class of medicinal products in accordance with the implementation timetable determined in the agreement.
Paragraph (3) applies where an agreement under Article 107k of the 2001 Directive in relation to a medicinal product or class of medicinal products requires a variation to be made to one or more authorisation or registration.
Each holder of an authorisation or registration covered by the agreement referred to in paragraph (2) must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation in respect of the authorisation or registration including—
an updated summary of the product characteristics; and
an updated package leaflet.
In this regulation, “EU urgent action procedure” has the same meaning as it is given in regulation 196(8).
Annotations
Textual amendments
- F1
Words in reg. 197(1) inserted (31.12.2020) by S.I. 2019/775, reg. 157 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 125); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 197(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 88
Notes on Urgent action and major safety review
Textual amendments
- F1
Words in reg. 196 cross-heading inserted (31.12.2020) by S.I. 2019/775, reg. 156(ZA)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)