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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 R1245-26
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 activiti…
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 R1245-27
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 esta…
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 in vitro diagnostic medical devices.
Article R1245-20
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…
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
Article R1245-22
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…
Subsection 2: Provisions relating to the entry into or exit from national territory of elements or products of the human body mentioned in article R. 1245-1 coming from or destined for Member States of the European Union or parties to the Agreement on the European Economic Area and intended for the manufacture of medicinal products
Article R1245-29
Pharmaceutical establishments and establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 may procure tissues, their derivatives and cells from the human body, whatever their level of pro…
Subsection 2: Provisions relating to the entry into or exit from national territory of elements or products of the human body mentioned in Article R. 1245-1 coming from or destined for Member States of the European Union or parties to the Agreement on the European Economic Area and intended for the manufacture of in vitro diagnostic medical devices.
Article R1245-21
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 o…
…d to in Article R. 1243-6 may be suspended or withdrawn in whole or in part, pursuant to Article L. 1245-1, and in particular in the event of danger to public health or the environment or breach of th…
…1242-7 to L. 1242-9, L. 1242-12, L. 1242-13, L. 1242-17, L. 1243-7 to L. 1243-10, L. 1243-13 to L. 1245-1, L. 1246-1 and L. 1248-1 to L. 1248-11 relating to fixed-term employment contracts.
Subsection 3: Application to the Ministry of Defence
Article R1243-67
…provisions of this section apply to the Ministry of Defence establishments mentioned in Article L. 1245-8. For their application, army hospitals are considered to be health establishments. For these…
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Mariela Petrova
Avocate au Barreau de Paris
Toque #C2396
15+ Years In French Corporate Practice
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