Application for marketing authorisation of a generic veterinary medicinal product
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, you can do so via the generic marketing authorisation application.
To prevent unnecessary repetition of pharmacological, toxicological and clinical studies, a complete dossier does not have to be submitted for a generic veterinary medicinal product. You may partly refer to the complete dossier of another veterinary medicinal product, the reference product, provided that the requirements for the abbreviated procedure are met. The aforementioned reference does not apply to all parts of the dossier.
A generic veterinary medicinal product is a veterinary medicinal product with the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, whose bioequivalence with the reference product has been demonstrated in bioavailability studies. In other words, you must demonstrate that your product is bioequivalent to the reference product. More information about this can be found at: EMA - conduct of bioequivalence studies.
The dossier of the reference product must contain the pharmacological, toxicological and clinical data. The marketing authorisation of the reference product must therefore be granted on the basis of a complete dossier. The Veterinary Medicinal Products Unit of the MEB Agency does not need to have this information. Therefore, there is no need to grant a marketing authorisation for the reference product in the Netherlands.
An application cannot be submitted sooner than 8 years after a marketing authorisation has been granted for the reference product. You will receive the marketing authorisation of your generic veterinary medicinal product no sooner than 10 years after the authorisation of the reference product.
The legal basis of the generic application is Article 13(1) of Directive 2001/82/EC.