Medicinal Products (Control of Placing On the Market) Regulations 2007 (Amendment) Regulations 2009
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2009.
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paragraphs: These Regulations shall be construed as one with the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ) and may be cited together with those Regulations as the Medicinal Products (Control of Placing on the Market) Regulations 2007 and 2009.
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paragraphs: These Regulations shall come into force on 14 January 2009.
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paragraphs: (1) In these Regulations:
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paragraphs: Regulation 3(1) of the principal regulations is amended—
(a) by inserting the following after the definition of “Act”:
“ ‘advanced therapy medicinal product’ means a product as defined in Article 2 of the advanced therapy regulation;
‘advanced therapy regulation’ means Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products 19 ;”
(b) by substituting the following for the definition of “2001 Directive”:
“ ‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use 20 as amended by—
(a) Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components 21 ,
(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 22 ,
(c) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use 23 ,
(d) Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 24 , and
(e) the advanced therapy regulation;”;
(c) by substituting the following for the definition of “Regulation (EC) No. 726/2004”:
“ ‘Regulation (EC) No. 726/2004’ means Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 25 , read in conjunction with the advanced therapy regulation;”;
(d) in the definition of “relevant Community provisions”, by substituting the following for paragraphs (g) and (h):
“ (g) Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency,
(h) the Community Regulation on medicinal products for paediatric use, and
(i) the advanced therapy regulation;”;
(e) by substituting the following for the definition of “summary of product characteristics”:
“ ‘summary of product characteristics’ means the information required to accompany any application for a marketing authorisation or certificate of traditional-use registration by virtue of article 11 of the 2001 Directive. In the case of advanced therapy medicinal products, such information is instead required to contain the information listed in Annex II of the advanced therapy regulation, in the order indicated in that Annex;”.
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paragraphs: Regulation 5(2) of the principal regulations is amended by substituting the following for paragraphs (c) and (d):
“(c) Regulation (EC) No. 141/2000, of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products;
(d) Articles 4, 39.2, 49.1 and 51 of the Community Regulation on medicinal products for paediatric use; and
(e) the advanced therapy regulation.”.
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paragraphs: Regulation 6 of the principal regulations is amended by substituting the following for paragraph (4):