# The Human Medicines Regulations 2012, Regulation 210A: Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A


(1) A holder is guilty of an offence if the holder—
(a) in relation to a UKMA(NI), UKMA(UK)(Category 2), 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
(aa) in relation to a UKMA(GB) , UKMA(UK)(Category 2) 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).
(2A) The provisions of Schedule 12A mentioned in paragraph (1)(aa) 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 , 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/210A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-210A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.