欧洲议会和理事会第2004/9/EC号指令:有关良好实验室规范(GLP)的检查和认可,2004

2020/11/22 12:49:59 次 0

DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Directive 88/320/EEC of 7 June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (3) has been significantly amended several times. In the interests of clarity and rationality the said Directive should be codified. (2) The application of standardised organisational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the...


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