Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to the Agency without delay.
Home | French Legislation Articles | Part five: Health products | Book I: Pharmaceutical products | Title II: Medicinal products for human use | Chapter I: General provisions | Section 9: Medicinal products subject to registration | Subsection 3: Traditional herbal medicinal products | Article R5121-107-13 of the French Public Health Code
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to the Agency without delay.
A la suite de l’établissement d’une nouvelle monographie communautaire de plantes médicinales ou de la révision d’une monographie existante, le titulaire de l’enregistrement adresse sans délai à l’agence une demande de modification du dossier d’enregistrement.
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