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
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
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.