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EU “Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community
Code Relating to Medicinal Products for Human Use,” Official Journal L 311, pp. 67
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20070126:en:PDF

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