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News about GMP/cGMP

2017-10-11

Swissmedic: Changes in Cross-border Inspections

According to Swissmedic, the new Article 64a of the revised Therapeutic Products Act (revTPA) will already enter into force on 1 January 2018. This Article governs cross-border inspections and includes inspections carried out in Switzerland by foreign authorities, as well as inspections by Swiss authorities abroad.

 

What are the changes from January 1, 2018?

  • A foreign authority is entitled to carry out its inspection if the establishment to be inspected gives its consent.
  • Authorisation by SECO (Staatssekretariat für Wirtschaft) is no longer required.
  • Swissmedic must be notified by the inspecting agency in advance and provide the Agency with a copy of the inspection report after any inspection.
  • Any arrangements necessary between foreign authorities and Swiss companies have to be made directly between the parties concerned.

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.

Source:

Swissmedic: Announcements

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