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Article R1221-20-5 of the French Public Health Code

November 5, 2023

I.-The refusal of authorisation to manage a blood establishment, its renewal or the substantial modification of one of its elements is notified to the director of the health establishment or to the administrator of the consortium by the director general of the regional health agency. A copy of this decision is sent to the regional haemovigilance and transfusion safety coordinator and to the Etablissement Français du Sang or, where applicable,…

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Article R1221-21 of the French Public Health Code

November 5, 2023

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 products from the circuit. An order by the Minister for Health sets the conditions under which health establishments may store in their departments labile blood products issued, with a view to a transfusion procedure, by their referral blood establishment or by the…

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Article R1221-22 of the French Public Health Code

November 5, 2023

The aim of transfusion safety is to identify hazards that have caused, are causing or are likely to cause incidents or adverse reactions that have threatened, are threatening or may threaten the health of donors or recipients, in order to eliminate or reduce the associated risks. Haemovigilance is a component of transfusion safety. It involves, for any donation of blood or blood components and for any labile blood product: 1°…

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Article R1221-23 of the French Public Health Code

November 5, 2023

For the purposes of this section, the following definitions shall apply 1° Adverse reaction: a harmful reaction in donors associated or possibly associated with the collection of blood or in recipients associated or possibly associated with the administration of a labile blood product; 2° Serious adverse reaction: an adverse reaction resulting in death or life-threatening, disabling or incapacitating, or causing or prolonging hospitalisation or any other morbid condition; 3° Incident…

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Article R1221-25 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing haemovigilance and transfusion safety. It defines the guidelines, leads and coordinates the actions of the various parties involved and ensures compliance with the monitoring procedures organised by this section. Where necessary, it shall take appropriate measures to ensure transfusion safety or refer the matter to the competent authorities. In order to carry out this…

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Article R1221-26 of the French Public Health Code

November 5, 2023

The Agence nationale de sécurité du médicament et des produits de santé provides the Etablissement français du sang and the centre de transfusion sanguine des armées with information relating to the safety and quality of labile blood products resulting from the performance of the vigilance tasks relating to health products mentioned in article R. 1413-61-4.

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Article R1221-27 of the French Public Health Code

November 5, 2023

Each year, the Agence nationale de sécurité du médicament et des produits de santé draws up a summary report on haemovigilance and transfusion safety. This report is sent to the Minister for Health and to the European Commission by 30 June of the following year at the latest.

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  • Armenia (Հայաստան)+374
  • Aruba+297
  • Ascension Island+247
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  • Austria (Österreich)+43
  • Azerbaijan (Azərbaycan)+994
  • Bahamas+1
  • Bahrain (‫البحرين‬‎)+973
  • Bangladesh (বাংলাদেশ)+880
  • Barbados+1
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  • Botswana+267
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  • Namibia (Namibië)+264
  • Nauru+674
  • Nepal (नेपाल)+977
  • Netherlands (Nederland)+31
  • New Caledonia (Nouvelle-Calédonie)+687
  • New Zealand+64
  • Nicaragua+505
  • Niger (Nijar)+227
  • Nigeria+234
  • Niue+683
  • Norfolk Island+672
  • North Korea (조선 민주주의 인민 공화국)+850
  • Northern Mariana Islands+1
  • Norway (Norge)+47
  • Oman (‫عُمان‬‎)+968
  • Pakistan (‫پاکستان‬‎)+92
  • Palau+680
  • Palestine (‫فلسطين‬‎)+970
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  • Rwanda+250
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  • Saint Kitts and Nevis+1
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  • Saint Martin (Saint-Martin (partie française))+590
  • Saint Pierre and Miquelon (Saint-Pierre-et-Miquelon)+508
  • Saint Vincent and the Grenadines+1
  • Samoa+685
  • San Marino+378
  • São Tomé and Príncipe (São Tomé e Príncipe)+239
  • Saudi Arabia (‫المملكة العربية السعودية‬‎)+966
  • Senegal (Sénégal)+221
  • Serbia (Србија)+381
  • Seychelles+248
  • Sierra Leone+232
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  • Solomon Islands+677
  • Somalia (Soomaaliya)+252
  • South Africa+27
  • South Korea (대한민국)+82
  • South Sudan (‫جنوب السودان‬‎)+211
  • Spain (España)+34
  • Sri Lanka (ශ්‍රී ලංකාව)+94
  • Sudan (‫السودان‬‎)+249
  • Suriname+597
  • Svalbard and Jan Mayen+47
  • Sweden (Sverige)+46
  • Switzerland (Schweiz)+41
  • Syria (‫سوريا‬‎)+963
  • Taiwan (台灣)+886
  • Tajikistan+992
  • Tanzania+255
  • Thailand (ไทย)+66
  • Timor-Leste+670
  • Togo+228
  • Tokelau+690
  • Tonga+676
  • Trinidad and Tobago+1
  • Tunisia (‫تونس‬‎)+216
  • Turkey (Türkiye)+90
  • Turkmenistan+993
  • Turks and Caicos Islands+1
  • Tuvalu+688
  • U.S. Virgin Islands+1
  • Uganda+256
  • Ukraine (Україна)+380
  • United Arab Emirates (‫الإمارات العربية المتحدة‬‎)+971
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  • Uruguay+598
  • Uzbekistan (Oʻzbekiston)+998
  • Vanuatu+678
  • Vatican City (Città del Vaticano)+39
  • Venezuela+58
  • Vietnam (Việt Nam)+84
  • Wallis and Futuna (Wallis-et-Futuna)+681
  • Western Sahara (‫الصحراء الغربية‬‎)+212
  • Yemen (‫اليمن‬‎)+967
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is a Registered Trademark of
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75001, Paris France
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is a Registered Trademark of
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75001, Paris France
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