What are the changes from January 1, 2018?
Inspections by Swiss Authorities abroad
By arrangement with the competent authorities, the Agency can inspect establishments abroad that operate in the therapeutic products sector if this is necessary to guarantee health protection.
For example, GCP inspections can be carried out abroad even if there is no link to a trial being carried out in Switzerland; i.e. they do not have to be triggered by a preceding inspection. Accordingly, an inspection abroad may be triggered by an application for authorisation. In all cases, Swissmedic must notify the foreign authority of the inspection in advance.
The Agency will notify all foreign authorities that have carried out inspections in Switzerland over the last four years of the change. The information sheet ““General procedure for foreign governmental inspections in Switzerland related to therapeutic products” is currently being revised and will be available by the end of 2017.
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