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Proposals for MA annexes / registrations (SmPC, package leaflet, labelling)

ANSM is updating its MA style sheet to the « full » T10 format. This new version is dated January 19, 2023. The changes concern the address of the adverse reaction reporting site updated by the Ministry of Health https://signalement.social-sante.gouv.fr/ to replace www.signalement-sante.gouv.fr Find the new model to download on https://ansm.sante.fr/documents/reference/recommandations-relatives-a-la-redaction-des-projets-dannexes-de-lamm