The Human Medicines Regulations 2012

[F1Offences in relation to pharmacovigilance obligations under the Implementing Regulation [F2and Schedule 12A] U.K.

This adran has no associated Memorandwm Esboniadol

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

(a)[F3in 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