Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
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1.Member States shall ensure that the competent authority organise inspections and appropriate control measures in blood establishments to ensure that the requirements of this Directive are complied with.
2.Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed two years.
3.Such inspection and control measures shall be carried out by officials representing the competent authority who must be empowered to:
(a)inspect blood establishments as well as facilities of any third parties on its own territory entrusted by the holder of the designation, authorisation, accreditation or licence referred to in Article 5 with the task of carrying out evaluation and testing procedures pursuant to Article 18;
(b)take samples for examination and analysis;
(c)examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of the entry into force of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.
4.The competent authority shall organise inspection and other control measures as appropriate in the event of any serious adverse event or reaction or suspicion thereof in accordance with Article 15.
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