PART 8U.K.Article 126a authorisations

Application of these RegulationsU.K.

158.  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).