New list of minor marketing-authorisation variations exempt from the fee collected for national health insurance
Decree No. 2025-1445 reinstates Article 326 quater of Annex II to the General Tax Code: minor type IA variations to marketing authorisations for medicinal products for human use are no longer subject to the fee under Article 1635 bis AE of the Code, collected for the national health insurance fund (CNAM), except for a list of variations set by the decree. It replaces Decree No. 2019-388 of 30 April 2019.
Measure originators
No official estimate found for this measure.
Measure impact
For minor type IA marketing authorisation variations filed from 15 January 2026, the exemption from the fee collected for the national health insurance fund, in place since Decree No. 2019-388, continues, but the list of variations that remain chargeable is replaced by the one in the new decree. Applications filed before that date remain governed by the 2019 decree.
Official references
Sources
Procedure timeline
Follow the progress of this fiscal measure through the different stages of the parliamentary procedure.