Medicinal products for human use

Public consultation on the Commission guideline on paediatric investigation plans

 
 

Period of consultation

From 9 October 2013 to 3 January 2014.

Contributions to and results of the consultation

A summary of the responses is available here.

Below are the public responses to the above-mentioned public consultation:

Targeted stakeholders

All citizens and organisations (public and private) are welcome to contribute to this consultation.

Objective of the consultation

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, which has been in use for the last five years. In its recent report on the Paediatric Regulation 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 consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Please consult the Privacy Statement to be downloaded here.

Additional information: