French Business Law - French Legislation

Article D1221-61 of the French Public Health Code

November 5, 2023

The application for an import authorisation must include : a) The name and address of the importer ; b) The nature and quantity of the product being imported; c) Where applicable, the name and address of the supplier if he is not the collector, together with his authorisation issued by the local health authorities; d) The name and address of the establishments which carried out the collection or sampling; e)…

Article D1221-62 of the French Public Health Code

November 5, 2023

The importer is required to: 1° Ensure that the establishment that collected or took the sample undertakes to pass on any information that could call into question the quality and safety of the product concerned; 2° Take all necessary measures to ensure that transport and storage are carried out under conditions that guarantee the proper preservation, integrity and safety of the product concerned; 3° Take the necessary steps to ensure…

Article D1221-63 of the French Public Health Code

November 5, 2023

The authorisation to import labile blood products for direct therapeutic use is issued by the Agence nationale de sécurité du médicament et des produits de santé to the Armed Forces Blood Transfusion Centre and to blood transfusion establishments which store labile blood products for direct therapeutic use with a view to their distribution and issue in application of article L. 1221-10.

Article D1221-64 of the French Public Health Code

November 5, 2023

By way of derogation from the provisions of g of Article D. 1221-61, when labile blood products from several samples are imported with a view to a scheduled autologous transfusion and the planned date of the procedure so requires, the importer may provide only the results of the tests and analyses performed on the first sample. The import authorisation may be issued on the basis of the results of the…

Article D1221-65 of the French Public Health Code

November 5, 2023

When the import concerns plasma pastes or labile blood products intended for the preparation of health products, the authorisation referred to in Article D. 1221-58 is issued to the following organisations or establishments: 1° The Etablissement français du sang ; 2° The Armed Forces Blood Transfusion Centre; 3° Pharmaceutical establishments authorised in accordance with the provisions of article L. 5124-3 and manufacturing medicinal products; 4° Manufacturers of other health products…

Article D1221-66 of the French Public Health Code

November 5, 2023

When applying for an import authorisation, the importer must certify, notwithstanding the provisions of g of Article D. 1221-61, that the samples of blood or its components, from which the product for which the import authorisation is requested was prepared, comply with the requirements of Section 2 of this chapter. Where this is not the case, and provided that it is justified, the importer must provide an undertaking stating that…

Article D1221-66-1 of the French Public Health Code

November 5, 2023

The authorisation referred to in Article D. 1221-58 may be issued to the Etablissement Français du Sang for the importation of blood or its components intended for the preparation of labile blood products within the framework of an international agreement providing for cross-border cooperation. By way of derogation from the provisions of article D. 1221-60 and article D. 1221-61, these imports may be authorised if the blood samples or its…

Article D1221-67 of the French Public Health Code

November 5, 2023

Notwithstanding the provisions of the first paragraph of Article D. 1221-58, the import authorisation may be issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé on the basis of a forward programme submitted by the importer. At the end of the authorisation period, the importer draws up a report on the operations carried out and the quantity imported during the period.

Article D1221-67-1 of the French Public Health Code

November 5, 2023

By way of derogation from the provisions of the first paragraph of article D. 1221-58, when the Armed Forces Blood Transfusion Centre imports labile blood products with a view to processing them for foreign armed forces, the import authorisation is issued by the Agence nationale de sécurité du médicament et des produits de santé on the basis of a three-year programme and within the limit of a specified maximum overall…

Article R1221-68 of the French Public Health Code

November 5, 2023

The provisions of Section 4 of Chapter V of Title III of this Book apply to the import and export of blood, its components and derived products for scientific purposes.

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Article D1221-61 of the French Public Health Code

Article D1221-62 of the French Public Health Code

Article D1221-63 of the French Public Health Code

Article D1221-64 of the French Public Health Code

Article D1221-65 of the French Public Health Code

Article D1221-66 of the French Public Health Code

Article D1221-66-1 of the French Public Health Code

Article D1221-67 of the French Public Health Code

Article D1221-67-1 of the French Public Health Code

Article R1221-68 of the French Public Health Code

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