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Article R5121-27 of the French Public Health Code

The dossiers provided in support of the application for authorisation of the medicinal products mentioned in articles R. 5121-25 and R. 5121-26 are considered to contain all the necessary and sufficient data for the evaluation of these medicinal products within the meaning of article L. 5121-1.

Original in French 🇫🇷
Article R5121-27

Les dossiers fournis à l’appui de la demande d’autorisation des médicaments mentionnés aux articles R. 5121-25 et R. 5121-26 sont considérés comme comportant l’ensemble des données nécessaires et suffisantes pour l’évaluation de ces médicaments au sens de l’article L. 5121-1.

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