AFAR Gazette, from the Courts

The November AFAR Gazette looks back at the two Council of State rulings handed down this summer concerning registration in the generic group repertoire and the hybrid marketing authorisation procedure.

Validation of the new conditions for inclusion in the repertoire of generic groups

The 1st judgment of 7 July 2021 validates the new conditions of registration in the repertoire of generic groups, set by the decree of 19 November 2019, the legality of which was contested. The simplification of the identification and registration of generic and reference specialities in the repertoire of generic groups is therefore validated. From now on, as soon as a speciality meets the conditions to be defined as a generic medicinal product, it is necessarily identified as such by the Director General of the ANSM, followed by an automatic registration in the repertoire of generic groups.

Cancellation of the listing in the repertoire of generic groups of medicinal products whose marketing authorisation was issued under the hybrid procedure

In its 2nd decision, also rendered on 7 July 2021, the Conseil d'Etat annulled the decisions of the Director General of the ANSM identifying the specialties "Fluticasone propionate/Salmeterol Mylan" as generics of the specialties "Seretide Diskus". He considered in this case that these specialties having been authorised under the hybrid marketing authorisation procedure, they could not be identified as generic specialties of their reference speciality. Indeed, it follows from the provisions of Articles L. 5121-10 and R. 5121-5 of the PHC that the identification of a medicinal product as a generic of a reference medicinal product with a view to its registration in the repertoire of generic groups is carried out following the granting of marketing authorisation to this medicinal product as a generic, which is subject to verification that the medicinal product fulfils the conditions for being identified as a generic, which cannot be the case for hybrid medicinal products.

You can find and read this article in the AFAR Gazette n°110.

Thanks to the AFAR Publishing Committee for this publication.