The Human Medicines Regulations 2012

[F1 Offences in relation to pharmacovigilance obligations under the Implementing Regulation [F2 and Schedule 12A] U.K.

210A.— (1) A holder is guilty of an offence if the holder—

(a) [F3 in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation,] fails to comply with any requirement or obligation contained in a provision of the Implementing Regulation listed in paragraph (2); or

[F4 (aa) in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or]

(b) provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in the Implementing Regulation.

(2) The provisions mentioned in paragraph (1)(a) are—

(a) Chapter I (pharmacovigilance system master file);

(b) Sections 1 and 2 of Chapter II (minimum requirements for the quality systems for the performance of pharmacovigilance activities);

(c) Chapter III (minimum requirements for the monitoring of data in the Eudravigilance database);

(d) Chapter V (transmission of reports of suspected adverse reactions);

(e) Article 32 of Chapter VI (updates of risk management plans);

(f) Chapter VII (periodic safety update reports); and

(g) Chapter VIII (post-authorisation safety studies).

[F5 (2A) The provisions of Schedule 12A mentioned in paragraph (1)(a) are—

(a) Part 1 (pharmacovigilance system master file);

(b) Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);

(c) Part 6 (transmission of reports of suspected adverse reactions);

(d) paragraph 24 (update of risk management plans);

(e) Part 8 (periodic safety update reports); and

(f) Part 9 (post-authorisation safety studies).]

(3) Subject to paragraph (4), a person guilty of an offence under this regulation is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine.

(4) A person guilty of an offence under this regulation which relates to a breach of Article 34(5) or 36(3) of the Implementing Regulation [F6 , or of paragraph 26(8) or 29(1) of Schedule 12A,] is liable—

(a) on summary conviction to a fine not exceeding the statutory maximum; or

(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.]

Textual Amendments

F1 Reg. 210A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 25

F2 Words in reg. 210A heading inserted (31.12.2020) by S.I. 2019/775, reg. 175(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(a))

F3 Words in reg. 210A(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))

F4 Reg. 210A(1)(aa) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))

F5 Reg. 210A(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 175(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c))

F6 Words in reg. 210A(4) inserted (31.12.2020) by S.I. 2019/775, reg. 175(5) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(d))