Directive 2002/98/EC of the European Parliament and of the CouncilShow full title

CHAPTER I U.K. GENERAL PROVISIONS

Article 1 U.K. Objectives

This Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection.

Article 2 U.K. Scope

1. This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.

2. Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g).

3. This Directive shall apply without prejudice to Directives 93/42/EEC(1), 95/46/EC or 98/79/EC(2).

4. This Directive does not apply to blood stem cells.

Article 3 U.K. Definitions

For the purposes of this Directive:

(a)

‘blood’ shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing;

(b)

‘blood component’ shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods;

(c)

‘blood product’ shall mean any therapeutic product derived from human blood or plasma;

(d)

‘autologous transfusion’ shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used;

(e)

‘blood establishment’ shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks;

(f)

‘hospital blood bank’ shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities;

(g)

‘serious adverse event’ shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;

(h)

‘serious adverse reaction’ shall mean an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;

(i)

‘blood component release’ shall mean a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;

(j)

‘deferral’ shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary;

(k)

‘distribution’ shall mean the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.

(l)

‘haemovigilance’ shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors;

(m)

‘inspection’ shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.

Article 4 U.K. Implementation

1. Member States shall designate the competent authority or authorities responsible for implementing the requirements of this Directive.

2. This Directive shall not prevent a Member State from maintaining or introducing in its territory more stringent protective measures which comply with the provisions of the Treaty.

In particular, a Member State may introduce requirements for voluntary and unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to ensure a high level of health protection and to achieve the objective set out in Article 20(1), provided that the conditions of the Treaty are met.

3. In carrying out the activities covered by this Directive the Commission may have recourse to technical and/or administrative assistance to the mutual benefit of the Commission and of the beneficiaries, relating to identification, preparation, management, monitoring, audit and control, as well as to support expenditure.

(1)

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of the Council (OJ L 6, 10.1.2002, p. 50).

(2)

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).