Regulation 156ZA Amendment of regulation 196 (urgent action)F1I1

in the italic heading immediately preceding it, after “Urgent action” insert “and major safety review”;

in paragraph (1), for “The licensing authority must initiate the Section 4 procedure by informing” substitute “In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform”;

omit sub-paragraph (2B);

omit paragraphs (4) to (7);

in paragraph (8), omit the definition of “EU urgent action procedure” and “Section 4 procedure”.