Informed consent application: application under Article 10c relying on another holder's dossier

Article 10c of Directive 2001/83/EC lets a marketing authorisation holder allow its pharmaceutical, pre-clinical and clinical documentation to be used by another applicant, or by itself, for a product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. The applicant files a letter of consent and either the full dossier or a cross-reference to it, so the authority assesses an identical product without re-examining the science. The route is also called a duplicate application.

Informed consent applications are used for second brands, co-marketing deals, licence arrangements and portfolio moves where the same product is sold under two names or by two companies. In the centralised procedure the European Commission applies additional rules for duplicates of centrally authorised products: a duplicate marketing authorisation is normally granted only for co-marketing with a different company or to resolve intellectual property issues, and the applicant explains the reason in the submission. National authorities apply the route more freely, and many Member States grant duplicate national authorisations on request, provided the consent letter is current and names the specific product and dossier. The applicant becomes a marketing authorisation holder in its own right, with its own pharmacovigilance system, qualified person and PSUR duties, even though the data belong to someone else.

Because the dossier is identical, the product information is identical apart from the name and holder details, and the two products should be kept aligned throughout their lifecycle. Variations approved for the original have to be filed for the informed consent product as well, which is why the two are often handled as a grouped or worksharing submission. The informed consent product does not get its own data exclusivity, and the consent does not transfer any protection periods.

What goes wrong: a consent letter that covers the initial dossier but not later variations, so the copy cannot follow the original; products that drift apart because one holder files a change the other does not; confusion between an informed consent application and a generic application, which has different timing and evidence rules; and marketing status obligations such as the sunset clause that apply to each authorisation separately, so an unmarketed second brand can lapse.