The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
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Eudralex Volume 10 Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordan
This guidance sets out the nature of the information to be
entered into EudraCT, the information to be made accessible to
the public, the paediatric clinical trial results to be submitted and made public and on the responsibilities of the EMEA and related tasks in this context.