<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/1" level="1" class="item" period="#period1">
<inline name="tocNum">Article 1</inline>
<inline name="tocHeading">Definitions</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/2" level="1" class="item" period="#period1">
<inline name="tocNum">Article 2</inline>
<inline name="tocHeading">Provision of information to prospective donors</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/3" level="1" class="item" period="#period1">
<inline name="tocNum">Article 3</inline>
<inline name="tocHeading">Information required from donors</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/4" level="1" class="item" period="#period1">
<inline name="tocNum">Article 4</inline>
<inline name="tocHeading">Eligibility of donors</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/5" level="1" class="item" period="#period1">
<inline name="tocNum">Article 5</inline>
<inline name="tocHeading">Storage, transport and distribution conditions for blood and blood components</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/6" level="1" class="item" period="#period1">
<inline name="tocNum">Article 6</inline>
<inline name="tocHeading">Quality and safety requirements for blood and blood components</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/7" level="1" class="item" period="#period1">
<inline name="tocNum">Article 7</inline>
<inline name="tocHeading">Autologous donations</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/8" level="1" class="item" period="#period1">
<inline name="tocNum">Article 8</inline>
<inline name="tocHeading">Validation</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/9" level="1" class="item" period="#period1">
<inline name="tocNum">Article 9</inline>
<inline name="tocHeading">Transposition</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/10" level="1" class="item" period="#period1">
<inline name="tocNum">Article 10</inline>
<inline name="tocHeading">Entry into force</inline>
...</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/article/11" level="1" class="item" period="#period1">
<inline name="tocNum">Article 11</inline>
<inline name="tocHeading">Addressees</inline>
...</tocItem>
<tocItem href="" level="1" class="schedules" period="#period2"/>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/annex/I" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX I</inline>
<inline name="tocHeading">DEFINITIONS</inline>
...</tocItem>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">‘Autologous donation’ means blood and blood components collected from an...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">‘Allogeneic donation’ means blood and blood components collected from an...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">‘Validation’ means the establishment of documented and objective evidence that...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">‘Whole blood’ means a single blood donation. </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">‘Cryopreservation’ means prolongation of the storage life of blood components...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">‘Plasma’ means the liquid portion of the blood in which...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">‘Cryoprecipitate’ means a plasma component prepared from plasma, fresh-frozen, by...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">‘Washed’ means a process of removing plasma or storage medium...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">‘Red cells’ means the red cells from a single whole...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">‘Red cells, buffy coat removed’ means the red cells from...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">‘Red cells, leucocyte-depleted’ means the red cells from a single...</inline>
<inline name="tocNum">12.</inline>
<inline name="tocHeading">‘Red cells in additive solution’ means the red cells from...</inline>
<inline name="tocNum">13.</inline>
<inline name="tocHeading">‘Additive solution’ means a solution specifically formulated to maintain beneficial...</inline>
<inline name="tocNum">14.</inline>
<inline name="tocHeading">‘Red cells, buffy coat removed, in additive solution’ means the...</inline>
<inline name="tocNum">15.</inline>
<inline name="tocHeading">‘Buffy coat’ means a blood component prepared by centrifugation of...</inline>
<inline name="tocNum">16.</inline>
<inline name="tocHeading">‘Red cells, leucocyte-depleted, in additive solution’ means the red cells...</inline>
<inline name="tocNum">17.</inline>
<inline name="tocHeading">‘Red cells, apheresis’ means the red cells from an apheresis...</inline>
<inline name="tocNum">18.</inline>
<inline name="tocHeading">‘Apheresis’ means a method of obtaining one or more blood...</inline>
<inline name="tocNum">19.</inline>
<inline name="tocHeading">‘Platelets, apheresis’ means a concentrated suspension of blood platelets obtained...</inline>
<inline name="tocNum">20.</inline>
<inline name="tocHeading">‘Platelets, apheresis, leucocyte-depleted’ means a concentrated suspension of blood platelets,...</inline>
<inline name="tocNum">21.</inline>
<inline name="tocHeading">‘Platelets, recovered, pooled’ means a concentrated suspension of blood platelets,...</inline>
<inline name="tocNum">22.</inline>
<inline name="tocHeading">‘Platelets, recovered, pooled, leucocyte-depleted’ means a concentrated suspension of blood...</inline>
<inline name="tocNum">23.</inline>
<inline name="tocHeading">‘Platelets, recovered, single unit’ means a concentrated suspension of blood...</inline>
<inline name="tocNum">24.</inline>
<inline name="tocHeading">‘Platelets, recovered, single unit, leucocyte-depleted’ means a concentrated suspension of...</inline>
<inline name="tocNum">25.</inline>
<inline name="tocHeading">‘Plasma, fresh-frozen’ means the supernatant plasma separated from a whole...</inline>
<inline name="tocNum">26.</inline>
<inline name="tocHeading">‘Plasma, cryoprecipitate-depleted for transfusion’ means a plasma component prepared from...</inline>
<inline name="tocNum">27.</inline>
<inline name="tocHeading">‘Granulocytes, apheresis’ means a concentrated suspension of granulocytes obtained by...</inline>
<inline name="tocNum">28.</inline>
<inline name="tocHeading">‘Statistical process control’ means a method of quality control of...</inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/annex/II" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX II</inline>
<inline name="tocHeading">INFORMATION REQUIREMENTS</inline>
...</tocItem>
<inline name="tocNum">PART A</inline>
<inline name="tocHeading">Information to be provided to prospective donors of blood or blood components</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accurate educational materials, which are understandable for members of the...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">For both allogeneic and autologous donations, the reasons for requiring...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Information on the protection of personal data: no unauthorised disclosure...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">The reasons why individuals are not to make donations which...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Specific information on the nature of the procedures involved either...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Information on the option for donors to change their mind...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">The reasons why it is important that donors inform the...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Information on the responsibility of the blood establishment to inform...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Information why unused autologous blood and blood components will be...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">Information that test results detecting markers for viruses, such as...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">Information on the opportunity for donors to ask questions at...</inline>
<inline name="tocNum">PART B</inline>
<inline name="tocHeading">Information to be obtained from donors by blood establishments at every donation</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Identification of the donor </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Health and medical history of the donor </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Signature of the donor </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/annex/III" level="2" class="schedule" period="#period2">
<inline name="tocNum">ANNEX III</inline>
<inline name="tocHeading">ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS</inline>
...</tocItem>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS...</inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Age and body weight of donors </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Haemoglobin levels in donor's blood </inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">Protein levels in donor's blood </inline>
<inline name="tocNum">1.4.</inline>
<inline name="tocHeading">Platelet levels in donor's blood </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS...</inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Permanent deferral criteria for donors of allogeneic donations </inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">Temporary deferral criteria for donors of allogeneic donations </inline>
<inline name="tocNum">2.2.1.</inline>
<inline name="tocHeading">Infections </inline>
<inline name="tocHeading">Duration of deferral period </inline>
<inline name="tocNum">2.2.2.</inline>
<inline name="tocHeading">Exposure to risk of acquiring a transfusion-transmissible infection </inline>
<inline name="tocNum">2.2.3.</inline>
<inline name="tocHeading">Vaccination </inline>
<inline name="tocNum">2.2.4.</inline>
<inline name="tocHeading">Other temporary deferrals </inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">Deferral for particular epidemiological situations </inline>
<inline name="tocNum">2.4.</inline>
<inline name="tocHeading">Deferral criteria for donors of autologous donations </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/annex/IV" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX IV</inline>
<inline name="tocHeading">STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS</inline>
...</tocItem>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">STORAGE </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Liquid storage </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Cryopreservation </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">TRANSPORT AND DISTRIBUTION </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">Autologous blood and blood components must be clearly identified as...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">Autologous blood and blood components must be labelled as required...</inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2004/33/annex/V" level="2" class="schedule" period="#period2">
<inline name="tocNum">ANNEX V</inline>
<inline name="tocHeading">QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS</inline>
...</tocItem>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">THE BLOOD COMPONENTS </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Blood and blood components must comply with the following technical...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">Appropriate bacteriological control of the collection and manufacturing process must...</inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">Member States must take all necessary measures to ensure that...</inline>
<inline name="tocNum">2.4.</inline>
<inline name="tocHeading">For autologous donations, the measures marked with an asterisk (*)...</inline>