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.
What does this mean?
An inspection by a foreign authority is possible if the company agrees with the inspection (approval by the Swiss State Secretariat for Economic Affairs, 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.
The new approach will be effective as of 1 January 2018. The leaflet "General procedure for foreign governmental inspections in Switzerland related to therapeutic products" will be adjusted accordingly by the end of 2017.