MEB 48: National informed consent application
An Article 10c 'Informed Consent' application (article 10c of Directive 2001/83/EC) is an application for marketing authorisation based on the full reference to the dossier of another product (=the reference product), with the consent/authorisation of the authorisation holder of that reference product.
Download "MEB 48: National informed consent application"
Download "Declarations MEB 48: National informed consent application"
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