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which stipulations apply to diagnostic substances?

Products that help diagnose a disease or the immunological status of an animal are regarded as a veterinary medicinal product with a marketing authorisation requirement according to the Veterinary Medicinal Products Act (biological diagnostic substance).

Only diagnostic substances that are administered on/in living material of animal origin require marketing authorisation and a license. A manufacturer of a diagnostic substance (in vivo) should have a license in accordance with art. 21 of the Veterinary Medicinal Products Act and should manufacture according to the GMP guidelines.

The cited permit and GMP requirement applies only to in vivo diagnostic substances that have marketing authorisation in the EU as a veterinary medicinal product.

Exempted from marketing authorisation are those products intended for application on non-living material of animal origin (in vitro diagnostic substances). Applications for a license for the production or distribution of an in vitro veterinary diagnostic substance that does not have marketing authorisation in the EU will not be processed.

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