Insertion of regulation 210A
25. 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)(1);
(b)Sections 1 and 2 of Chapter II (minimum requirements for the quality systems for the performance of pharmacovigilance activities)(2);
(c)Chapter III (minimum requirements for the monitoring of data in the Eudravigilance database)(3);
(d)Chapter V (transmission of reports of suspected adverse reactions)(4);
(e)Article 32 of Chapter VI (updates of risk management plans)(5);
(f)Chapter VII (periodic safety update reports)(6); and
(g)Chapter VIII (post-authorisation safety studies)(7).
(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.”
Chapter 1 imposes requirements and obligations on holders in relation to the following aspects of the pharmacovigilance system master file: structure (Article 1), content (Article 2 and 3), maintenance and notification of certain changes (Article 4), form of documents contained in the pharmacovigilance system master file (Article 5) and availability and location (Article 7). Chapter 1 also imposes requirements on holders in relation to the sub-contracting of pharmacovigilance responsibilities (Article 6) and the submission of a logbook (Article 7).
Chapter II imposes requirements and obligations on holders in relation to the following aspects of the pharmacovigilance quality system: general matters (Article 8), content (Article 8(2)), basis of system (Article 8(3)), documentation (Article 8(4)), resource management (Article 10), compliance management (Article 11), record management (Article 12) and audit (Article 13).
Chapter III imposes requirements and obligations on holders in relation to the following aspects of monitoring data in the Eudravigilance database: general matters (Article 18), identification of new and changed risks (Article 19), methodology for determining signal value (Article 20) and signal management process (Article 21).
Chapter V imposes requirements and obligations on holders in relation to the following aspects of transmitting suspected adverse reaction reports: use of individual case safety reports (Article 27), content of individual case safety reports (Article 28) and format of electronic transmission (Article 29).
Article 32 in Chapter VI imposes requirements and obligations on holders in relation to updated risk management plans, including a requirement that updated risk management plans are submitted to the national competent authority.
Chapter VII imposes requirements and obligations on holders in relation to the following aspects of periodic safety update reports: content (Article 34) and format (Article 35).
Chapter VIII imposes requirements and obligations on holders in relation to the following aspects of post-authorisation safety studies: language of study information (Article 36(2)), handling and storage of study information (Article 36(3)) and format of study information (Article 38).