# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 6: Offences


Any holder of a marketing authorization who fails promptly to—
(a) update information concerning the product or any connected matter as required by Article 4 of the 1965 Directive or Article 6 of Council Regulation (EEC) No. 2309/93; or
(b) take any steps reasonably necessary to take account of technical and scientific progress for the purposes of making any changes or amendments as required by Article 9a of the 1965 Directive or Article 15.1 of Council Regulation (EEC) No. 2309/93; or
(c) introduce any changes or make any amendments that may be required in accordance with those Articles; or
(d) provide information to the EMEA, the Commission or the licensing authority as required by Article 15.2 of Council Regulation (EEC) No. 2309/93; or
(e) submit any application to the licensing authority or the Community to make any changes or variation as required by Article 9a of the 1965 Directive or Article 15.3 of Council Regulation (EEC) No. 2309/93,
shall be guilty of an offence.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/6 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.