Blood and its components may only be used to prepare in vitro diagnostic medical devices if the results of the tests and analyses provided for in b, c and d of 5° of Article D. 1221-6 are negative. However, an in vitro diagnostic medical device may be manufactured from a sample containing one or more antibodies or antigens sought by the tests and analyses mentioned in the above paragraph and…
Blood and its components may only be transferred to an educational establishment or vocational training organisation for teaching purposes, to the exclusion of any administration to humans, and on condition that: -the tests and analyses provided for in 5° of article D. 1221-6 have been carried out on each sample; -the results comply with the provisions of article D. 1221-7.
For the purposes of this section, : 1° Distribution of labile blood products: a) The supply of labile blood products by a blood establishment to other blood establishments, health establishments and health cooperation groups authorised to manage a blood depot and manufacturers of health products derived from human blood or its components ; b) The supply of labile blood products between different sites of the same blood establishment. 2° Delivery…
I.-The distribution and supply of labile blood products required by health establishments and health cooperation groups authorised to manage a blood depot are carried out by a single blood establishment, known as the “referent blood establishment”, determined in application of the blood transfusion organisation plan drawn up under the conditions laid down by articles R. 1224-1 to R. 1224-4. II – When changes in fact or in law are likely…
Healthcare establishments store labile blood products intended for direct therapeutic use in units known as blood depots. A blood depot is a unit that stores and dispenses, under the authority of a doctor or pharmacist, labile blood products intended exclusively for administration in the departments of the health establishment, and carries out compatibility tests where necessary. It also stores labile blood products issued by its referral blood establishment for administration…
The health cooperation groupings mentioned in articles L. 1221-10 and L. 6133-1 may be authorised to manage a blood bank. The authorisation for a blood depot is issued by the Director General of the Regional Health Agency for the needs of several health establishments that are members of the group, in compliance with the following cumulative conditions: 1° The time taken to supply or transfer labile blood products from the…
Blood depot authorisations are granted under one of the following categories: 1° Dispensing depot: a depot which stores labile blood products distributed by the referring blood establishment and dispenses them for a patient hospitalised in the health establishment; 2° Emergency depot: depot which stores group O red blood cell concentrates and, if necessary, group AB plasma or lyophilised plasma distributed by the referring blood establishment and issues them in a…
To be authorised, a blood depot must meet the following conditions: 1° Have an organisation and resources enabling it to carry out its activities in accordance with the procedures defined by order of the Minister for Health, ensuring the supply of labile blood products, the safety of these products and their traceability; 2° It must have a doctor or pharmacist with the qualifications mentioned in article R. 1222-23 and at…
The authorisation to manage a blood depot referred to in article L. 1221-10 is granted by the regional health agency with territorial jurisdiction, after obtaining the opinion of the Etablissement français du sang for the health establishments and health cooperation groups referred to in article L. 6133-1. When a health establishment or a health cooperation group applies for authorisation to manage a blood depot, it first signs an agreement with…
I.-The application for an initial authorisation to manage a blood establishment is sent by the director of the health establishment or by the administrator of the grouping to the regional health agency, by any means enabling receipt of the application to be dated with certainty. The order of the Minister for Health provided for in article R. 1221-20-1 defines the content of the application for authorisation, which includes in particular…
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is a Registered Trademark of
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75001, Paris France
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