European Medicines Agency - Human Medicines - Medicines for children - Cooperation with Member States

Medicines for children
Global cooperation
List of measures adopted by EU Member States to support research, development and availability of medicinal products for paediatric use
The European Commission has published a list of measures that Member States have taken to support research, development and availability of medicinal products for paediatric use (in accordance with art. 39).

Cooperation with Member States
For information on paediatric data assessment of products authorised through the decentralised or mutual-recognition procedures, please refer to the Heads of Medicines Agencies (HMA) website.

Guidance on the Content and Format of Data to be collected on All Existing Uses of Medicinal Products in the Paediatric Population

The EMEA's Paediatric Committee has drawn up and adopted on 26 October 2007 a Guidance on the content and format of data to be collected by the Member States on all existing uses of medicinal products in the paediatric population. This data from this survey by the Member States is to be communicated to the Agency by 26 January 2009.

The Paediatric Committee will establish the inventory of paediatric needs, based on the information obtained from the survey. In addition to the Guidance document, a spreadsheet document for communicating a Member State's data to the Agency is also available.

Guidance on the content and format of data to be collected by the Member States on all existing uses of medicinal products in the paediatric population
Spreadsheet template

abrir aquí para acceder a los documentos EMEA precitados:
European Medicines Agency - Human Medicines - Medicines for children - Cooperation with Member States