With the exception of army pharmacists, pharmacists practising in health establishments, when they are responsible for supervising a blood depot mentioned in article R. 1221-20, must, for this activity, be registered in sections G or H of the national order of pharmacists, or in section E if they practise in an overseas department or in the territorial collectivity of Saint-Pierre-et-Miquelon.
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…
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.
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…
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.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
