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Home | French Legislation Articles | French Public Health Code | Regulatory part | Part One: General health protection | Book II: Donation and use of human body parts and products | Title IV: Tissues, cells and products | Chapter V: Common provisions | Section 5: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in article R. 1245-1 intended for the manufacture of medicinal products | Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in article R. 1245-1 from or to countries outside the European Union and the European Economic Area and intended for the manufacture of medicinal products | Article R1245-25 of the French Public Health Code

French Public Health Code
- Regulatory part
  - Part One: General health protection
    - Book II: Donation and use of human body parts and products
      - Title IV: Tissues, cells and products
        Chapter V: Common provisions
        Section 5: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in article R. 1245-1 intended for the manufacture of medicinal products
        Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in article R. 1245-1 from or to countries outside the European Union and the European Economic Area and intended for the manufacture of medicinal products

Article R1245-25 of the French Public Health Code

Article R1245-25 of the French Public Health Code

November 5, 2023
3:47 pm

The authorisations shall specify the elements listed in Annex II of Directive (EU) 2015/566.

Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions set out in Article L. 1245-1.

A copy of the decisions to authorise, suspend or withdraw is sent to the Minister for Health, the Minister for Customs and the Agence de la biomédecine.

Original in French 🇫🇷

Article R1245-25

Les autorisations précisent les éléments figurant à l’annexe II de la directive (UE) 2015/566.

Les autorisations ainsi délivrées peuvent être modifiées, suspendues ou retirées en tout ou partie par le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé dans les conditions prévues à l’article L. 1245-1.

Une copie des décisions d’autorisation, de suspension ou de retrait est transmise au ministre chargé de la santé, au ministre chargé des douanes et à l’Agence de la biomédecine.

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