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5. The European Parliament and the Council of the European Union (2001) 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. In Official Journal of the European Union, L311, pp. 67–128 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:EN:PDF)