Article 26
Any legal or natural person developing a medicinal product intended for paediatric use may, prior to the submission of a paediatric investigation plan and during its implementation, request advice from the Agency on the design and conduct of the various tests and studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population in accordance with Article 57(1)(n) of Regulation (EC) No 726/2004. In addition, this legal or natural person may request advice on the design and conduct of pharmacovigilance and risk management systems as referred to in Article 34. The Agency shall provide advice under this Article free of charge.