FRANCE – ANSES: Notifications for new marketing authorisation applications, major use extensions and generic products

ANSES published a new note on notifications of applications for new marketing authorisations, label extensions for major uses and generic products (PBIS), in accordance with Article 33  and or Article 34 of Regulation (EC) No 1107/2009 and in application of the European Commission guidance document SANCO/13169/2010 on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations.

This Note completes the procedures presented in the guidance document by confirming that new applications for marketing authorisations and label extensions for major uses under Article 33 or under both Articles 33 and 34 of Regulation (EC) No 1107/2009,  must be notified to Anses at least  6 months before the date on which the application is due to be submitted.

For generic product (PBIS) applications under Article 34, notifications must now be sent to Anses at least 3 months before the date on which the application is due to be submitted. The 8-month deadline for the submission of a PBIS application, which must be met before the renewal of the approval of the active substances contained in the products, remains unchanged.

For generic products, the note applies to new applications from 2 October 2025.

To download (in French): 

Note d’information relative aux notifications des demandes de nouvelles AMM, d’extensions d’usage et de produit génériques (PBIS), selon l’article 33 mobilisant ou non l’article 34 du règlement (CE) majeur n°1107/2009 et en application du document d’orientation SANCO/13169/2010

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