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Art. 67b

812.21TPAFederal ActJan 1, 2002Original source
  1. 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.
  2. 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.
  3. The Federal Council:
    1. designates the authority responsible for maintaining the database;
    2. specifies the duties and procedure with regard to publication;
    3. determines the content and form of the results to be published;
    4. determines the requirements for the content and operation of the database;
    5. regulates the access to and use of the data.

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