Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013
Source: Iris Oifigiúl 2013-05-28

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paragraphs: (1) These Regulations may be cited as the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013.
(2) These Regulations shall be construed as one with the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010, the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2011 (S.I. 722 of 2011) and the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (S.I. 272 of 2012) and may be cited together with those Regulations as the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2013.
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paragraphs: In these Regulations “Principal Regulations” means the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ).
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paragraphs: Regulation 3(1) (as amended by the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 ( S.I. No. 272 of 2012 )) of the Principal Regulations is amended—
(a) by substituting for the definition of “2001 Directive” the following:
“‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20012, as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 20034 , Commission Directive 2003/63/EC of 25 June 20035 , Directive 2004/24/EC of the European Parliament and of the Council of 31 March 20046 , Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20047 , the Community Regulation on medicinal products for paediatric use, the advanced therapy regulation, Directive 2008/29/EC of the European Parliament and of the Council of 11 March 20088 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 20099 , Commission Directive 2009/120/EC of 14 September 200910 , Directive 2010/84/EU of the European Parliament and of the Council of 15 December 20103 and Directive 2011/62/EU of the European Parliament and of the Council of 8 June 20111;”,
(b) by inserting after the definition of “European Economic Area” the following definition:
“‘falsified medicinal product’ means any medicinal product with a false representation of—
(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients,
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or
(c) its history, including the records and documents relating to the distribution channels used,
but does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights;”, and
(c) by inserting after the definition of “relevant Community provision” the following definition:
“‘relevant date’ means—
(a) in the case of a medicinal product placed on the market in the State, the date 3 years after the date of publication of the delegated acts adopted by the Commission pursuant to Article 54a(2) of the 2001 Directive, or
(b) in the case of a medicinal product placed on the market in an EEA State which, on 21 July 2011, had in place a system of safety features, the date 6 years after the date of publication of the delegated acts adopted by the Commission pursuant to Article 54a(2) of the 2001 Directive;”.
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paragraphs: Regulation 10 (as amended by the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 ( S.I. No. 272 of 2012 )) of the Principal Regulations is amended—
(a) by substituting for paragraph (9) the following paragraphs: