# The Human Medicines Regulations 2012, Regulation 80: Urgent safety restrictions


The holder of a UK marketing authorisation is guilty of an offence if the holder —
(a) fails—
(i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or
(ii) in respect of a UKMA(NI) or UKMA(UK)(Category 2), to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,
that the holder has taken urgent safety restrictions on the holder’s own initiative;
(b) fails—
(i) in respect of a UKMA(GB) or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or
(ii) in respect of a UKMA(NI) or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or
(c) fails in respect of a UKMA(NI) to submit an application for variation of the marketing authorisation to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after—
(i) the taking under Article 22(1) or, as the case may be,
(ii) the imposition under Article 22(2),
of that Regulation of an urgent safety restriction.
(d) fails in respect of a UKMA(GB) or UKMA(UK)(Category 1) to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—
(i) the taking under paragraph 14(1) of Schedule 10A or, as the case may be,
(ii) the imposition under paragraph 14(3) of that Schedule,
of an urgent safety restriction.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/80 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-80
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.