Fixed combination application
An application for a fixed combination consists of the combination of known active ingredients to create a new medicinal product for veterinary use. Despite the fact that data only has to be provided relating to the combination and not for each of the individual ingredients, this can be seen as a complete and independent application. This is because it is a new veterinary medicine.
An application for a fixed combination cannot be submitted if any of the ingredients is described in a protected dossier. In such a case, only the marketing authorisation holder of that original dossier may request fixed combinations based on that dossier.
In the Guideline on pharmaceutical fixed-combination products issued by the CVMP, the requirements imposed on fixed-combination veterinary medicines are discussed in detail.
The indication for which a fixed-combination veterinary medicine is being claimed must, for instance, be such that every active ingredient contributes to the stated therapeutic effect. The fixed-combination veterinary medicine must also be better than the products based on the individual components. The nature of this improvement can vary widely, such as improved pharmacodynamics, pharmacokinetics or safety. Both the safety and the efficacy must be demonstrated for the target animal species in question and this must have involved studying the possible interactions.
The legal basis of the application for a fixed combination is Article 13 (1b) of Directive 2001/82/EC. As of 28 January 2022, the legal basis will be Article 20 of the new Veterinary Medicinal Products Regulations (EU) 2019/6.