[The implementation of European directives into national law, demonstrated by the example of the EC Tissues and Cells Directive 2004/23/EC].
For the most part, the law of the European Community (EC) is specified in directives. This also applies to the field of medicinal products, medical devices, blood and tissue preparations. As a rule, the provisions stipulated in the EC directives shall not enter into force before they have been implemented into national law in the Member States of the European Union (EU). The implementation is mandatory and makes Community Law binding in the EU Member States. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (EC Tissues and Cells Directive) was finally implemented into German law when the Tissues Act of 20 July 2007 entered into force. Due to the special features of this directive, the national legislators may stipulate stricter provisions, thus exceeding the minimum standards specified in this EC directive. The national legislators are free to choose the legal instrument for the legally binding transposition of EC law. In Germany, the requirements set forth in the EC Tissues and Cells Directive have been implemented within the national legal framework, especially by virtue of the Medicinal Products Act, the Transplantation Act and the Transfusion Act.
von Auer
Friedger
F
Bundesministerium für Gesundheit, Bonn, BRD. friedger.vonauer@bmg.bund.de
D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D040541:Marketing / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014015:Tissue Banks / Q000331:legislation & jurisprudence*