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Article R5211-61 of the French Public Health Code

Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicament et des produits de santé for specific recommendations on their application.

Original in French 🇫🇷
Article R5211-61

Lorsque l’organisme habilité rencontre des difficultés dans la mise en oeuvre des procédures d’évaluation de la conformité, celui-ci en saisit le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé pour obtenir des recommandations précises quant à leur application.

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