PART 11Pharmacovigilance
Urgent action F1and major safety review
EU urgent action procedure197
1
Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products F2authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority—
a
may publicly announce the initiation of the EU urgent action procedure on the UK web-portal; and
b
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.
2
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.
3
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—
a
an updated summary of the product characteristics; and
b
an updated package leaflet.
4
In this regulation, “EU urgent action procedure” has the same meaning as it is given in regulation 196(8).
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)