1. European Parliament and Council of the European Union (27.12.2006, a) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
2. European Parliament and the Council of the European Union (27.12.2006, b) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
3. CHMP-Committee for Medicinal Products for Human Use Guideline on Conduct of Pharmacovigilance for Medicines used by the Paediatric Population. 2007; Doc. Ref. EMEA/CHMP/PhVWP/235910/2007 : rev.1
4. European Commission Volume 9A “Pharmacovigilance for drugs for human use” of the Rules Governing Medicinal Products in the European Union. EMEA 2008 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9a_09-2008.pdf