Article 5
Designation, authorisation, accreditation or licensing of blood establishments 1. Member States shall ensure that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose. 2. For the purpose of paragraph 1, the blood establishment shall submit the information listed in Annex I to the competent authority. 3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply. 4. No substantial change in activities shall be undertaken by the blood establishment without prior written approval by the competent authority. 5. The competent authority may suspend or revoke the designation, authorisation, accreditation or licence of a blood establishment if inspection or control measures demonstrate that the blood establishment does not comply with the requirements of this Directive.