4.

The EU database shall be publicly accessible unless, for all or part of the data and information contained therein, confidentiality is justified on any of the following grounds: protecting personal data in accordance with Regulation (EC) No 45/2001; protecting commercially confidential information, in particular through taking into account the status of the marketing authorisation for the medicinal product, unless there is an overriding public interest in disclosure; protecting confidential communication between Member States in relation to the preparation of the assessment report; ensuring effective supervision of the conduct of a clinical trial by Member States.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.