Marketing authorisation exemption

It is not always necessary to apply for a marketing authorisation in order to market a veterinary medicinal product.

  • Articles 3.16 to 3.23 of the Veterinary Medicinal Products Decree list exemptions or exceptions for marketing veterinary medicinal products without an authorisation being granted.
  • Articles 3.6 to 3.12 of the Veterinary Medicinal Products Regulations provide an elaboration of the above-mentioned stipulations.

Exemption for animal experiments

Article 3.8 of the Veterinary Medicinal Products Regulations contains information about exemption from the ban on importing, transporting, receiving, holding, stocking or using of veterinary medicinal products for animal experiments in The Netherlands (Article 2.19, first paragraph).

This exemption applies for trials performed subject to the Experiments on Animals Act, by the authorisation holders referred to in that law.

(Temporary) exemption for a diagnostic agent

A biological diagnostic medicinal product (hereinafter referred to as a 'diagnostic agent') is a veterinary medicinal product:

  • that is prepared using microorganisms or parasites and
  • that is intended for use (alone or mixed with other substances) in the identification of an animal disease, zoonosis or symptom of illness, or the immunological status of animals.

In general, a marketing authorisation must be granted for a diagnostic agent before it may be marketed and used. A diagnostic agent is applied to material of animal origin, for example blood samples, or used as an antibiotic on incubated eggs for research and the prevention of animal diseases.

Where a diagnostic agent is only intended for a so-called in vitro application on non-living material of animal origin, a temporary exemption to the authorisation requirement has been granted until 1 January 2020. This means the identification of a disease or the immunological status of animals.

The non-living animal material that the diagnostic agent is used on does not end up in the food chain. For that reason, there is no requirement from the perspectives of animal welfare or public health to demand a complete dossier for a diagnostic agent or to issue a marketing authorisation.

See also Appendix 4 of the Veterinary Medicinal Product Regulations.

More information

If you would like to know whether an exemption is applicable to a specific veterinary medicinal product and whether it meets the requirements imposed, you can ask the Veterinary Medicinal Products Unit using our contact form.