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Showing 7811–7820 of 69703 articles for “Art. I and II”
The Agence nationale de sécurité du médicament et des produits de santé and the regional haemovigilance and transfusion safety coordinator simultaneously receive serious incident report forms, adverse…
If adverse reactions observed in a blood donor or in a recipient are likely to be due to a product mentioned in II of article L. 5311-1 falling within the scope of another vigilance, a copy of the adv…
Decisions by the Director General of the Agence nationale de sécurité des médicaments et des produits de santé, following consultation with the Etablissement français du sang and the Armed Forces Bloo…
I. - Any healthcare professional who observes or has knowledge of a serious incident shall report it without delay to the haemovigilance and transfusion safety correspondent of the establishment where…
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 hea…
Blood establishments, health establishments and health cooperation groups authorised to store labile blood products intended for therapeutic use must have a procedure for withdrawing any unit of such…
Blood banks are subject to at least one inspection by the regional health agency during the period of validity of the authorisation.
For the application of this section, the Minister of Defence shall exercise the powers conferred on the competent regional health agency for army hospitals, whose technical opinion he may seek if nece…
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 agenc…
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 establishme…
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