Foreign inspections

The term "foreign inspections" refers to inspections by foreign authorities or respective delegated institutions.
According to the State Protection Law, article 2, inspections carried out by foreign governmental inspectors or respective delegated 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 inspection” in Liechtenstein related to a medical device for human use, the inspecting authority / respective delegated institution has obtained the mandatory authorization as no derogations are possible. To this purpose the inspecting authority / respective delegated institution has to submit an authorization request to the Office of Public Health 40 days prior to the planned beginning of the inspection (via e-mail: [email protected]). Alternatively, the request can be submitted to the competent Embassy*. The Embassy will ensure the transmission of the request to the Office of Public Health.

The application request must contain the following information / documents:

• The name, full address, contact person, e-mail and telephone number of the requesting regulatory authority / respective delegated institution
• The names of the inspectors and experts appointed to carry out the inspection, including:
  • details on the department or office of the authority / institution 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 passport of the appointed inspectors / experts
• The name, full address, contact person, e-mail and telephone number of the company and the sites in Liechtenstein to be inspected

• Scope of the inspection

• Detailed information on the inspection procedure (programme)
• The planned inspection date/s

After the inspection has been carried out, the authority / respective delegated institution must inform the Office of Public Health of the results by providing it with the inspection report in German or English. This inspection report must be notarially certified.

*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.