France: Article 43 evaluation grouping for products containing more than one active substance

Anses has published a note detailing the requirements for grouping article 43 renewal applications in accordance with Regulation (EC) No.1107/2009.

It is noted that the applicant shall apply for a renewal of authorisation within 3 months of the renewal of each  active substance contained in the product. When the product contains more than one active substance, evaluations of the renewal dossiers of the product can be grouped, if the approval expiry dates of the substances are spaced by less than 12 months. The decision of grouping is granted by the zonal Rapporteur Member State (zRMS). When evaluations are grouped, only one fee is requested. The fee can also be adjusted  in some cases.

To download:

Gestion d’une demande de renouvellement d’AMM pour un produit phytopharmaceutique comportant au moins deux substances actives dont les dates de fin d’approbation sont espacées de moins d’un an (in French – Version dated  10 April 2019)

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us!