Appendix on transparency rules to the Functional ...
Send a question via our ... Reproduction is authorised provided the source is acknowledged. 2 October 2015 . EMA/228383/2015 Endorsed . Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” Draft reviewed with the clinical trials information system expert group . 8 ...
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