Regulation 175 Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)

Regulation 210A^f1 is amended as follows.

In the heading, for “the Implementing Regulation” substitute “Schedule 12A”.

In paragraph (1)—

For paragraph (2) substitute—

“(2)

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 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.”.