Annex I: INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2) - 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