Paragraph 123

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”.”.