F1The adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements set out in Annexes III and IV.

F1The following technical requirements and their adaptation to technical and scientific progress shall be decided by the Commission:

1. (a)

   traceability requirements;

2. (b)

   information to be provided to donors;

3. (c)

   information to be obtained from donors including the identification, health history, and the signature of the donor;

4. (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;

5. (e)

   storage, transport and distribution requirements;

6. (f)

   quality and safety requirements for blood and blood components;

7. (g)

   requirements applicable to autologous transfusions;

8. (h)

   Community standards and specifications relating to a quality system for blood establishments;

9. (i)

   Community procedure for notifying serious adverse reactions and events and notification format.

F2Technical requirements referred to in points (a) to (i) of the second paragraph, being measures designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).

On imperative grounds of urgency the Commission may have recourse to the urgency procedure referred to in Article 28(4) as regards technical requirements referred to in points (b), (c),(d), (e), (f) and (g) of the second paragraph.