Regulation (EC) No 1901/2006 of the European Parliament and the Council, as amended, on medicinal products for paediatric use (herein the 'Paediatric Regulation')
Ethical Considerations for Clinical Trials on Medicinal Products conducted with the paediatric population- Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use
United Nations Convention on the Rights of the Child of 20 November 1989
20/11/1989. Convention on the Rights of the Child. New York. Optional Protocols on the involvement of children in armed conflict and on the sale of children, child prostitution and child pornography. New York, 25/05/2000.