Application based on informed consent
If you want to apply for a marketing authorisation for a veterinary medicinal product that is identical to another veterinary medicinal product that is already on the market, you can do so with the informed consent authorisation application.
With an informed consent authorisation application, the application for a marketing authorisation is based on full reference, with permission, to another product (the reference product). This reference product must be based on a complete dossier. You can also make an informed consent application based on a reference product for which you are the marketing authorisation holder.
You must hold the dossier for the reference product or have full access to it. The two products must have different trade names.
After approval of the marketing authorisation, the informed consent stands alone. This means that the veterinary medicinal product does not have to remain identical to the reference product. You can submit change requests and substantiate them based on your own data.
The European application form must be used for an application for a marketing authorisation. The following data must be provided with the application:
- A letter of permission from the marketing authorisation holder of the reference product allowing you to apply for the informed consent, in which you, as the applicant, also declare that you hold the dossier for the reference product.
- A declaration in which the marketing authorisation holder of the reference product declares that the dossier is up to date and which contains an overview of the composition, specifications and manufacturers.
- The European application form with all the necessary attachments.
- Word versions of the SPC/label/package leaflet in accordance with the Veterinary Medicinal Products Regulation. See the EMA website for the most recent template. This requirement applies even if the reference product dossier was not prepared using the most recent template.
- Environmental Risk Assessment: You can use the ‘CVMP Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6’ to determine whether you need to provide an Environmental Risk Assessment.
The legal basis for the informed consent procedure is Article 21 of the Veterinary Medicinal Products Regulation.
More information about the informed consent procedure can be found in the ‘Best Practice Guide for Informed consent for MRP and DCP procedures’ on the CMDv website.