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2.—(1) Regulation 8(1) of the 2012 Regulations (general interpretation) is amended as follows.
(2) For the definition of “the 2001 Directive” substitute—
““the 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;(1)”.
(3) For the definition of “Regulation (EC) No 726/2004” substitute—
““Regulation (EC) No 726/2004” means Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;(2)”.
Directive 2002/83/EC was last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ No L 299, 27.10.2012, p.1).
Regulation (EC) No 726/2004 was last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 (OJ No L 316, 14.11.2012, p.38).
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