# The Human Medicines (Amendment) Regulations 2013, Regulation 25: Insertion of regulation 210A


After regulation 210 insert—
“Offences in relation to pharmacovigilance obligations under the Implementing Regulation
210A. (1) A holder is guilty of an offence if the holder—
(a) fails to comply with any requirement or obligation contained in a provision of the Implementing Regulation listed in paragraph (2); 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).
(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 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/2013/1855/regulation/25 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-regulations-2013/regulation-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.