Foreign inspections

The term "Foreign inspections" refers to inspections by foreign authorities.
According to the State Protection Law, article 2, inspections carried out by foreign governmental inspectors in Liechtenstein are illegal, unless an authorization (waiver) has been obtained for a specific inspection during a limited period of time. Consequently, any inspection that is carried out without a written authorization by the government constitutes an illegal act under article 2 of the Liechtenstein State Protection Law that may result in the prosecution of the foreign inspectors and the management of the inspected company.

Please ensure that, for any foreign governmental inspection in Liechtenstein related to a medical device for human use, the inspecting authority has obtained the necessary authorization as no derogations are possible. To this purpose the inspecting authority has to submit an authorization request to the Office of Public Health 40 days prior to the planned beginning of the inspection. Alternatively the request can be submitted to the competent Embassy*. The Embassy will ensure the transmission of the request to the Office of Health.

The application must contain the following information:

  • The name, full address and telephone number of the requesting regulatory authority
  • The names of the inspectors and experts appointed to carry out the inspection, including:
    • details on the department or office of the authority the inspectors / experts belong to
    • details on the function the inspectors / experts hold in that department or office
    • (e.g. inspector, investigator, assessor)
    • details on the professional background of the inspectors / experts (e.g. pharmacist, chemist, microbiologist)
    • photocopies of the travel documents of the appointed inspectors / experts
  • The name and address of the company and the sites in Liechtenstein to be inspected
  • Detailed information on the intent and scope of the inspection
  • The planned inspection date/s

*In all countries in which Liechtenstein has no offical representation, Switzerland assumes the role of safeguarding Liechtenstein's interests. In these countries the request can be submitted to the Swiss Embassy.

 

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