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5European Commission-Enterprise and Industry DG-Pharmaceutical Unit. Volume 2B, Notice to Applicants Medicinal products for human use, Presentation and format of the dossier CTD Edition June 2004.http:∥pharmacos. eudra. org/F2/eudralex/vol-2/home. htm
6DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31March 2004amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union L, 30.4.2004:136/85-90