Amendment of Directive 2001/83/EC
Article 109 of Directive 2001/83/EC shall be replaced by the following:
"Article 109
For the collection and testing of human blood and human plasma, Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(17) shall apply."
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 8 February 2005. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive.
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Addressees
This Directive is addressed to the Member States.
Done at Brussels, 27 January 2003.
For the European Parliament
The President
P. Cox
For the Council
The President
G. Drys
(1) OJ C 154 E, 29.5.2001, p. 141 and
OJ C 75 E, 26.3.2002, p. 104.
(2) OJ C 221, 7.8.2001, p. 106.
(3) OJ C 19, 22.1.2002, p. 6.
(4) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 289), Council Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the European Parliament of 12 June 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.
(5) OJ L 311, 28.11.2001, p. 67.
(6) OJ C 164, 30.6.1995, p. 1.
(7) OJ C 374, 11.12.1996, p. 1.
(8) OJ C 268, 4.10.1993, p. 29.
(9) OJ C 329, 6.12.1993, p. 268.
(10) OJ C 249, 25.9.1995, p. 231.
(11) OJ C 141, 13.5.1996, p. 131.
(12) OJ L 281, 23.11.1995, p. 31.
(13) OJ L 203, 21.7.1998, p. 14.
(14) OJ L 184, 17.7.1999, p. 23.
(15) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of the Council (OJ L 6, 10.1.2002, p. 50).
(16) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
(17) OJ L 33, 8.2.2003, p. 30.