Transparency rules: general information
The CTR (article 81.4) states that the EU database (CTIS) shall be publicly available unless one or more exceptions apply.
These exceptions are:
- to protect personal data;
- to protect commercially confidential information, in particular taking into account the marketing authorisation status of the medicinal product, unless there is an overriding public interest in disclosure;
- to protect confidential communication between Member States in preparing their assessment;
- to protect the supervision of clinical trials by Member States.
Rules and criteria for the application of these exceptions are set out in the appendix to the document “Functional specifications for the EU portal and database to be audited – EMA/42176/2014 ” (Appendix on disclosure rules EMA/228383/2015). Overriding public interest in disclosure can be considered, in this context, as meaning that the general public interest in having information made publically available may outweigh considerations that the same information should remain confidential. A decision making process will be established by the European Commission in order to invoke use of the overriding public interest in ad hoc cases. The sponsor may also elect to make information public at an earlier stage than foreseen.