Directive 2003/94/EC

EU Commission directive 2003/94/EC of 8 October 2003 is laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. It outlines the legal requirements for GMP within the EU. The specified requirements include the maintenance of a documentation system and data in legible form, which are protected against loss or damage for a stipulated period of time.