Inspections: Switzerland changes Conditions

The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. This refers both to inspections by foreign authorities in Switzerland and inspections by the Swiss authority abroad.
This means that, starting from 1 January 2018:

  • An inspection by a foreign authority is possible if the company agrees with the inspection (approval by SECO is no longer required for that). This requires direct contact between the Swiss company to be inspected and the foreign authority as a consequence.
  • Swissmedic must be informed in advance that an inspection is planned by a foreign inspectorate. The company will be informed in time by Swissmedic in case the inspection will be accompanied.
  • After the inspection, the inspection report should be made available to Swissmedic.
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