Section 7: Importation of labile blood products and plasma pastes

This section applies to plasma pastes and labile blood products intended for the preparation of health products. It also applies to labile blood products for direct therapeutic use included on the list referred to in 1° of Article L. 1221-8, and to those which are the subject of a biomedical research protocol prior to their inclusion on the aforementioned list. The provisions of this section apply to the Armed Forces…

A plasma paste is any intermediate product resulting from the fractionation of plasma, whatever its level of processing, which cannot be used as it is for administration to humans, and which is intended for the preparation of health products.

Any importation of a labile blood product or a plasma paste is subject to prior authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The import authorisation may be suspended or revoked by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Except in urgent cases, these decisions may only be taken after…

The authorisation referred to in article D. 1221-58 indicates in particular the name and address of the supplier establishment, the natural or legal person responsible for the import and, where applicable, the recipient establishment if it is not the importer, the nature and quantity of the imported product and the intended use. It specifies its period of validity and must be presented during a customs inspection. The import authorisation is…

The importation of a labile blood product or a plasma paste may be authorised only if the samples of blood or its components from which this product has been prepared meet the requirements of section 2 of this chapter.

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)…

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…