7. Types of Marketing Authorisation Applications

The marketing authorisation application for a product  is called an ‘informed consent application’, if it possesses the same qualitative and quantitative composition in terms of active substance(s) and the same pharmaceutical form as a reference product already authorised, using that dossier. For such application it is a prerequisite that consent has been obtained from the marketing authorisation holder of the reference product for all three modules containing the pharmaceutical, pre-clinical and clinical data (modules 3, 4 and 5). Permanent access to this documentation or possession of the information should be ensured.

For the informed consent application, only a complete module 1 should be submitted, including the eApplication Form with relevant Annexes and the letter of consent from the MAH of the authorised medicine allowing access to modules 2, 3, 4, 5 of the initial dossier and any subsequent documentation submitted.

Of note: Despite the fact that the provision contains some criteria that are common to the definition of a generic medicine in Article 10, Article 10c does not concern generic medicines.

Legal basis: Article 10c of Directive 2001/83 (EC)