The Federal Council may, taking into account internationally recognised regulations, provide that the results of clinical trials carried out with a view to developing a medicinal product for human use shall be published after the authorisation decision.
For this purpose, the Confederation may operate a database or have it operated by third parties. This database may not contain any data that would allow any reference to persons participating in clinical trials.
The Federal Council:
designates the authority responsible for maintaining the database;
specifies the duties and procedure with regard to publication;
determines the content and form of the results to be published;
determines the requirements for the content and operation of the database;
regulates the access to and use of the data.
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