French Business Law - French Legislation

Article R1245-18 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application of the last paragraph of I of Article L. 1245-5, the Director General of the Agence nationale de sécurité du médicament et des produits de santé is considering prohibiting the departure from national territory of an…

Article R1245-19 of the French Public Health Code

November 5, 2023

The provisions of Section 4 of Chapter V of Title III of this Book are applicable to the entry into and exit from national territory from or to a Member State of the European Union or party to the Agreement on the European Economic Area, to the import and export of tissues, their derivatives and cells of the human body defined in Article R. 1245-1 for scientific purposes.

Article R1245-20 of the French Public Health Code

November 5, 2023

Manufacturers of in vitro diagnostic medical devices may import or export tissues, their derivatives and cells from the human body, whatever their level of processing, when these products are intended for the manufacture of in vitro diagnostic medical devices meeting the requirements to which they are subject for their marketing. The manufacturers concerned must declare their import activity to the Director General of the Agence nationale de sécurité du médicament…

Article R1245-21 of the French Public Health Code

November 5, 2023

Manufacturers of in vitro diagnostic medical devices may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union or a party to the Agreement on the European Economic Area. These same establishments may supply tissues, their derivatives and cells from the human body, whatever their level of processing, to a Member State of the European Union or…

Article R1245-22 of the French Public Health Code

November 5, 2023

The provisions of this section apply to tissues, their derivatives and cells derived from the human body, whatever their level of transformation, which are not active substances within the meaning of 1 of I of Article L. 5138-2.

Article R1245-23 of the French Public Health Code

November 5, 2023

I. – Applications for authorisation to import tissues, their derivatives or cells from the human body, whatever their level of processing, as provided for in the first paragraph of II of article L. 1245-5-1, are sent by pharmaceutical establishments and by establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means…

Article R1245-24 of the French Public Health Code

November 5, 2023

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will give his decision within three months of receipt of the complete application by his departments. If no response is received by the end of this period, the authorisation is deemed to have been refused. The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request any…

Article R1245-25 of the French Public Health Code

November 5, 2023

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…

Article R1245-26 of the French Public Health Code

November 5, 2023

Any modification of the elements included in the initial import authorisation application dossier, concerning the nature or origin of the tissues, their derivatives or the cells imported, the activities carried out in third countries which may have an influence on the quality and safety of the tissues and cells imported or the suppliers established in these countries, is subject to an authorisation issued by the Director General of the Agence…

Article R1245-27 of the French Public Health Code

November 5, 2023

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall keep an up-to-date list of authorised establishments, giving the names and addresses of these establishments and the category of products that each of them is authorised to import. This list is accessible to the public on the Agency’s website. Authorised establishments shall mention this activity in the annual statement for their establishment provided…

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Regulatory part

Article R1245-18 of the French Public Health Code

Article R1245-19 of the French Public Health Code

Article R1245-20 of the French Public Health Code

Article R1245-21 of the French Public Health Code

Article R1245-22 of the French Public Health Code

Article R1245-23 of the French Public Health Code

Article R1245-24 of the French Public Health Code

Article R1245-25 of the French Public Health Code

Article R1245-26 of the French Public Health Code

Article R1245-27 of the French Public Health Code

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