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Regulatory procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure.
Technical requirements and their adaptation to technical and scientific progress The adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2). The following technical requirements and their adaptation to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2): (a) traceability requirements; (b) information to be provided to donors; (c) information to be obtained from donors including the identification, health history, and the signature of the donor; (d) requirements concerning the suitability of blood and plasma donors and the screening of donated blood including - permanent deferral criteria and possible exemption thereto - temporary deferral criteria; (e) storage, transport and distribution requirements; (f) quality and safety requirements for blood and blood components; (g) requirements applicable to autologous transfusions; (h) Community standards and specifications relating to a quality system for blood establishments; (i) Community procedure for notifying serious adverse reactions and events and notification format.
Consultation of scientific committee(s) The Commission may consult the relevant scientific committee(s) when establishing the technical requirements referred to in Article 29 and when adapting the technical requirements set out in Annexes I to IV to scientific and technical progress, in particular with a view to ensuring an equivalent level of quality and safety of blood and blood components used for transfusion and blood and blood components used as a starting material for the manufacture of medicinal products. CHAPTER X FINAL PROVISIONS
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