Regulation 210A Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12AF1F9

F2in relation to a UKMA(NI), F3UKMA(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

in relation to a UKMA(GB) F5, 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

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.

Chapter I (pharmacovigilance system master file);

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

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

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

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

Chapter VII (periodic safety update reports); and

Chapter VIII (post-authorisation safety studies).

Part 1 (pharmacovigilance system master file);

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

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

paragraph 24 (update of risk management plans);

Part 8 (periodic safety update reports); and

Part 9 (post-authorisation safety studies).

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

on conviction on indictment to a fine.

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

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