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The Human Medicines (Amendment) Regulations 2013
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- UK Statutory Instruments
- 2013 No. 1855
- PART 2
- Regulation 21
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Amendment of regulation 177
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21.—(1) Regulation 177 (application of Part 11 and interpretation) is amended as follows.
(2) For paragraph (4) substitute—
“(4) The following provisions of this Part and Schedule 33 apply in relation to medicinal products that are the subject of an EU marketing authorisation—
(a)regulation 206 (infringement notices);
(b)regulation 210 (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004), and paragraphs 2 and 4 of Schedule 33 (transitional arrangements: pharmacovigilance), but that regulation and those paragraphs do not apply in relation to the medicinal products specified in paragraph (1); and
(c)regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation).”
(3) In paragraph (5) after the definition of “Eudravigilance database” insert—
““Implementing Regulation” means Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council(1).”
(1)
OJ No L 159, 20.6.2012, p5.
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