BAKGRUNN (fra Kommisjonens konsultasjonnettside, engelsk utgave)

Public consultation on Commission guideline on paediatric investigation plans
In accordance with the Paediatric Regulation (EC) 1901/2006 the Commission has to draw up detailed arrangements concerning the format and content of paediatric investigation plans. In September 2008 the Commission published a relevant guideline. Choose translations of the previous link, which has been in use for the last five years. In its recent report on the Paediatric Regulation. Choose translations of the previous link, the Commission undertook to review the guideline in order to take into account the experience gained.

The Commission therefore requested the European Medicines Agency and its Paediatric Committee to suggest amendments to the current guideline.

In order to further explore which parts of the current guideline should be updated the Commission has prepared a concept paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.

The period of consultation ends on 18 December 2013. All citizens and organisations (public and private) are invited to contribute.