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

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.