The Human Medicines Regulations 2012 No. 1916

PART 5 U.K. Marketing authorisations

Offences relating to specific requirements U.K.

Failure to provide information on marketing authorisations to EMA U.K.

79.—(1) The holder of [F1 a UKMA(NI) or UKMA(UK)] is guilty of an offence if the holder—

(a) has not submitted information to the EMA as required by Article 57(2)(b) of Regulation (EC) No 726/2004 (information on all existing medicinal products for human use authorised or registered in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted before 2nd July 2012; and

(b) fails to do so as soon as is reasonably practicable after the coming into force of these Regulations.

(2) The holder of [F2 UKMA(NI) or UKMA(UK)] is guilty of an offence if the holder fails to submit information to the EMA as required by Article 57(2)(c) of Regulation (EC) No 726/2004 (information on any new or varied authorisations granted in the EU) in relation to any medicinal product that is the subject of a marketing authorisation granted on or after 2nd July 2012 as soon as is reasonably practicable after the grant of the authorisation.

Textual Amendments

F1 Words in reg. 79(1) substituted (31.12.2020) by S.I. 2019/775, reg. 88(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)

F2 Words in reg. 79(2) substituted (31.12.2020) by S.I. 2019/775, reg. 88(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 65)

Urgent safety restrictions U.K.

80.  The holder of a [F3 UK] marketing authorisation is guilty of an offence if the holder —

[F4 (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), UKMA(UK) or EU marketing authorisation, 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;]

[F5 (b) fails—

(i) in respect of a UKMA(GB), 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), 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 [F6 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.

[F7 (d) fails in respect of a UKMA(GB) 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.]

Textual Amendments

F3 Word in reg. 80 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 89(2); 2020 c. 1, Sch. 5 para. 1(1)

F4 Reg. 80(a) substituted (31.12.2020) by S.I. 2019/775, reg. 89(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(a))

F5 Reg. 80(b) substituted (31.12.2020) by S.I. 2019/775, reg. 89(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(b))

F6 Words in reg. 80(c) inserted (31.12.2020) by S.I. 2019/775, reg. 89(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(c))

F7 Reg. 80(d) inserted (31.12.2020) by S.I. 2019/775, reg. 89(5) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(d)(ii)(iii)); 2020 c. 1, Sch. 5 para. 1(1)

[F8 Urgent safety restrictions: parallel import licences U.K.

80A.   The holder of a parallel import licence is guilty of an offence if the holder—

(a) fails to inform the licensing authority that the holder has taken urgent safety restrictions on the holder’s own initiative;

(b) fails to implement an urgent safety restriction imposed on the holder by the licensing authority; or

(c) fails to submit an application for variation of the parallel import licence to the licensing authority before the end of a period of fifteen days beginning on the day after—

(i) the taking of urgent safety restrictions under paragraph (a) or, as the case may be,

(ii) the imposition of urgent safety restrictions under paragraph (b).]

Textual Amendments

F8 Reg. 80A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 15 and reg. 80A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 15