220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

228Selected bibliographyEuropean Commission, EudraLex volume 1–10,Vol 1 : Legislation HumanVol 2 : Notice to applicants HumanVol 3 : Guidelines HumanVol 4 : GMP Human & VeterinaryVol 5 : Legislation VeterinaryVol 6 : Notice to applicants VeterinaryVol 7 : Medicinal products VeterinaryVol 8 : MRL VeterinaryVol 9 : Pharmacovigilance Human & VeterinaryVol 10 : Clinical trialsMain page: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htmEMEADetailed guidance on the collection, verification and presentationof adverse reaction reports arising from clinical trials on medicinalproducts for human use (ENTR/CT 3, Revision 1, April 2004)Directive 2001/20/EC of the European Parliament and of the Councilof 4-April-2001 on the approximation of the laws, regulations andadministrative provisions of the member states relating to the implementationof good clinical practice in the conduct of clinical trials onmedicinal products for human use. Official Journal L 121, 01/05/2001P. 0034–0044.Commission Directive 2001/83/EC of 06. November 2001 on theCommunity code relating to medicinal products for human use; OfficialJournal L 311, 28/11/2001 P. 0067–0128.Commission Directive 2003/63/EC of 25. June 2003, amending directive2001/83/EC on the Community code relating to medicinal productsfor human use; Official Journal L 159, 27/6/2003 P. 046–094.Commission Directive 2005/28/EC of 08. April 2005, laying downprinciples and detailed guidelines for good clinical practice as regardsinvestigational medicinal products for human use, as well asthe requirements for authorisation of the manufacturing or importationof such products; Official Journal L 91, 9/4/2005 P. 013–019.