# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 156ZA: Amendment of regulation 196 (urgent action)


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”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/156ZA (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-156ZA
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.