Draft proposal for an addendum, on transparency, to the 'functional specifications for the European Union (EU) portal and EU database to be audited'

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Document details

Download document Draft proposal for an addendum, on transparency, to the 'functional specifications for the European Union (EU) portal and EU database to be audited'
Reference number EMA/641479/2014
Status draft: consultation open
First published 21/01/2015
Last updated 21/01/2015
Consultation start date 21/01/2015
Consultation end date 18/02/2015
Email address for submissions ctreg@ema.europa.eu

Summary

This consultation document sets out proposals and options on the application of exceptions in relation to the transparency provisions of the European Clinical Trial Regulation. Once finalised, this addendum will complement the functional specifications for the EU portal and database to be audited, which were drawn up by the Agency and endorsed by its Management Board in December 2014.