1. FDA, Approved Drug Products with Therapeutic Equivalence Evaluations, 2012. Available at the web site http://www.fda.gov/downloads/Drugs/InformationOnDrugs/ucm086233.pdf (last access on 15 February 2013).
2. FDA, Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications, 1998. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070561.pdf (last access on 15 February 2013).
3. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code Relating to Medicinal Products for Human Use.
4. Regulation (EC) n. 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency.
5. EC, 2006. Regulation of the European Parliament and of the Council of 18 December 2006, (1907/2006), Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Establishing a European Chemicals Agency, Amending Directive 1999/45/EC and Repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.