1. 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;The European Parliament and the Council of the European Union;Off J Eur Communities,2001
2. European Commission, A guideline on the readability of the label and package leaflet of medicinal products for human use, Brussels 29; September 1998. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/gl981002.pdf (accessed September 29, 2006).
3. European Commission, Draft—Guideline on the readability of the label and package leaflet of medicinal products for human use. Revision September 2006. http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/09_2006/readability_consultation_2006_09_25.pdf (accessed October 2, 2006).
4. EMEA, Compilation of QRD decisions on stylistic matters in product information. Version 9, December 2005. http://www.emea.europa.eu/htms/human/qrd/qrdplt/2509002.pdf (accessed October 28, 2006).
5. CMD(h), CMD(h) annotated QRD template for MR/’DC procedures. Based on version 7.2 of the QRD template for CP; revision 3rd October 2006. http://heads.medagencies.org/mrfg/docs/pi/QRD_annotated_template_CMDh.pdf (accessed November 9, 2006).