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:

Legal basis

The legal basis for the informed consent procedure is Article 21 of the Veterinary Medicinal Products Regulation.

More information

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.