- 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
- 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
- Inventory of Community and Member State rewards and incentives to support research into, and the development and availability of, medicinal products for paediatric use
- Inventory of paediatric needs
- European Commission public announcement on symbol for medicines authorised for a paediatric indication
- Paediatric clinical trials
- 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)
- European Commission Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
- Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice
- Contact details for PDCO members and alternates for sending PIP applications