Facts
By order dated September 30, 2003, the Swiss Agency for Therapeutic Products Swissmedic approved an amendment to the product information and patient information for the medicinal products Spedifen® granules and film-coated tablets for X. AG. On December 13, 2004, it granted Swissmedic authorization (valid until December 12, 2009) to replace the IKS registration for Spedifen®. On April 27, 2005, the Agency for Therapeutic Products informed X. AG that additional corrections to the text were necessary, as the application underlying the order of September 30, 2003 had been approved "without detailed examination" of the data. X. AG opposed the proposed adjustments to the extent that they excluded a comparative reference to the faster onset of action of Spedifen® as ibuprofen in the form of arginate salt compared to other ibuprofen-containing medicinal products. On July 6, 2007, Swissmedic maintained its position and requested X. AG to amend the disputed product information on the medicinal product in several points regarding the information on the speed of action compared to other ibuprofen products.
By judgment of May 7, 2009, the Federal Administrative Court dismissed the appeal filed by X. AG against this. The Federal Supreme Court dismisses the appeal filed by X. AG against this, insofar as it has not become obsolete.
Considerations
The Federal Supreme Court bases its judgment on the facts as established by the lower instance. It can only correct or supplement these if they are obviously incorrect, incomplete or have been determined in violation of essential procedural rights. In pharmaceutical law, the question of what effects the preparations have and what the studies say about them is part of the establishment of the facts.
The Federal Administrative Court has presented its reasoning comprehensively and without limiting its cognition. It was not obliged to go into all the scientific explanations of the appellant in detail. Swissmedic has plausibly explained that the values from the Dental Surgery…