A company that wants to apply for a marketing authorisation for a medicinal product that is identical to another product that is already on the market, can do so using the national informed consent marketing authorisation application.
An informed consent marketing authorisation application for a medicinal product is a marketing authorisation application based on a full reference to the dossier of another product (the reference product).
The key requirement for an informed consent marketing authorisation application is that the company submits a copy of the complete dossier of the reference product (or can inspect it at all times). The company must have been given permission to do so by the marketing authorisation holder of the reference product.
An informed consent product has its own legal basis (Article 10c of Directive 2001/83/EC).
Duration of the proceedings
If the marketing authorisation for the reference product is not older than 5 years, the informed consent application is an administrative procedure which will last no longer than 45 days.
If the marketing authorisation for the reference product is older than 5 years, an assessment of content will be necessary. The application procedure will then last a maximum of 210 days.