Well-established veterinary use

If an active substance has been in use for a long time, it’s possible to rely on scientific literature within the framework of the application. This is also referred to as a bibliographical application or well-established use.

In the case of a new active substance, the test results of toxicological, pharmacological, and clinical trials must be submitted in the dossier. However, if it is possible to establish, via detailed bibliographic scientific documentation, that the ingredient or ingredients of the veterinary medicinal product have already frequently been used in the field of medicine, that its effectiveness has been demonstrated, and that the product is safe in relation to humans, animals, and the environment, then it is possible, under certain conditions, to dispense with the requirement to submit the results of toxicological and clinical trials. In that case, such studies are replaced by appropriate scientific literature.

A bibliographic application is seen as a complete and independent application, and the data submitted is evaluated with the help of Annex I of 2001/82/EG. An authorisation for permission for referral is therefore not necessary. This means that the following specific components must be submitted:

  • File section II regarding the quality
  • A literature dossier. This is a complete dossier with literature instead of the applicant’s own study reports.

The documentation must cover all elements of the dossier requirements. The literature studies must be generally accessible.

The dossier must contain an expert report and a justification for the applicability of the literature submitted to the product that is the subject of the application for all parts of the application. This means that if data is submitted in relation to a different product than the product that will be marketed, an evaluation will be carried out to determine whether the veterinary medicinal product that is the subject of the study can be considered as equivalent to the product for which a permit is being requested, despite the existing differences. In some cases, it is necessary in this regard to submit study results on the biological availability in order to determine bioequivalence.

The legal basis for the bibliographic application is Article 13 (a) of Directive 2001/82/EC.