Call Us + 33 1 84 88 31 00

Call Us + 33 1 84 88 31 00

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 2: Conditions for entry into or exit from national territory of elements or products of the human body referred to in Article R. 1245-1, for therapeutic purposes | 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 | Paragraph 1: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1 for therapeutic purposes, as provided for in the first and third paragraphs of II of Article L. 1245-5. | Article R1245-7 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 2: Conditions for entry into or exit from national territory of elements or products of the human body referred to in Article R. 1245-1, for therapeutic purposes
        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
        Paragraph 1: Procedure for authorising the import and export of elements or products of the human body mentioned in Article R. 1245-1 for therapeutic purposes, as provided for in the first and third paragraphs of II of Article L. 1245-5.

Article R1245-7 of the French Public Health Code

Article R1245-7 of the French Public Health Code

November 5, 2023
4:05 pm

In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the case of imports, they shall also include the information listed in Annex II to 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Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions laid down in Article L. 1245-1.

Original in French 🇫🇷

Article R1245-7

Les autorisations précisent notamment le type de l’activité autorisée et la catégorie des produits importés ou exportés et pour les produits finis importés, les indications thérapeutiques. Pour l’importation, elles mentionnent en outre 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.

Need help with this article? Get help from a French lawyer

Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.