Article 109 of Directive 2001/83/EC shall be replaced by the following:
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(1) shall apply.’
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.
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.