Application based on a complete dossier

If you want to apply for a marketing authorisation for a new veterinary medicinal product for which you cannot refer to another veterinary medicinal product already on the market, you must submit an application based on a complete dossier.

If you want to apply for a marketing authorisation for a new veterinary medicinal product for which you cannot refer to another veterinary medicinal product already on the market, you must submit an application based on a complete dossier.

In this case, you must submit a complete, independent dossier containing all the documents as described in Article 12 of Directive 2001/82/EC and the dossier must meet all the requirements set out in Annex I of 2001/82/EC. This means that you must provide information about the quality, efficacy and safety for the animal, the environment, the user and the consumer of the relevant veterinary medicinal product.

Evidence of the efficacy should primarily be provided by conducting clinical studies.

In addition, public literature studies can also be included as part of the dossier. These literature studies can serve as additional evidence. You can also substantiate the efficacy by comparing it with a positive control. A positive control is a treatment with an authorised veterinary medicinal product with a proven therapeutic effect. If the veterinary medicinal product is intended for food-producing animals, the safety of the residues of all components present in the veterinary medicinal product must be assessed on the basis of Regulation 470/2009/EC.

The legal basis for an application based on a complete dossier is Article 12(3) of Directive 2001/82/EC.