Paragraph 123 I1

Before regulation 156 insert—

“Amendment of regulation 196 (urgent action)

156ZA

In regulation 196—

(a)

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

(b)

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 ”;

(c)

omit sub-paragraph (2B);

(d)

omit paragraphs (4) to (7);

(e)

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