Testing exemption application for veterinary medicinal products

The Veterinary Medicinal Products Unit can grant an exemption from the authorisation requirement for the use of a veterinary medicinal product for the purpose of implementing pharmaceutical trials, safety trials, residue trials, preclinical trials, clinical trials or trials to evaluate environmental risks.

This is stated in the Veterinary Medicinal Products Decree (Article 3.22, third paragraph).

According to Article 3.9 of the Veterinary Medicinal Products Regulations you can submit an application for a veterinary medicinal products trial exemption to the Veterinary Medical Products Unit. The application will be assessed by the Veterinary Medicinal Products Unit, if necessary by experts from scientific institutes. A decision for exemption will be taken within 60 days of receipt of a complete application.

The granting of a trial exemption is subject to conditions for the exemption period. You also have to observe waiting periods in the case of tests involving food producing animals.