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The Directive 2005/28/EC or Good Clinical Practice Directive, of 8 April 2005 of the European Parliament and of the Council, lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Additional recommended knowledge
The Directive deals with the following items:
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Directive_2005/28/EC". A list of authors is available in Wikipedia.|