If you want to apply for a marketing authorisation for a veterinary medicinal product that is essentially the same as another veterinary medicinal product that has been on the market for more than 10 years (the so-called reference product), you can do so via the generic marketing authorisation application. However, if the veterinary medicinal product differs in part from the reference product, you can use the hybrid application for that purpose.
For those elements of the dossier that are referred to the reference product, the rules apply as described under ‘generic veterinary medicinal product marketing authorisation application’.
In a hybrid application, the veterinary medicinal products may have a different strength, a different route of administration, or a somewhat different indication than the reference product. The applicant must provide own studies for those elements that differ from the reference product.
The legal basis of the hybrid application is Article 13(3) of Directive 2001/82/EC.