# The Human Medicines Regulations 2012, Regulation 158: Application of these Regulations


The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—
(a) regulation 62 (classification of marketing authorisation);
(b) regulation 63 (frequency of periodic safety update reports);
(c) regulation 68 (revocation etc of marketing authorisation) and Schedule 11 (advice and representations in connection with revocations etc) so far as relating to that regulation;
(d) regulation 69 (suspension of use etc of medicinal product);
(e) regulation 71 (withdrawal of medicinal products from the market);
(f) regulation 72 (sale etc of suspended medicinal product);
(g) regulation 80 (urgent safety restrictions); and
(h) regulations 98 (general offence of breach of provision of this Part), 99 (penalties) and 101(1) and (2) (defences), so far as relating to the regulations mentioned in sub-paragraphs (a) and (e) to (f).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/158 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-158
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.