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).