CHAPTER II

OBLIGATIONS ON MEMBER STATES AUTHORITIES

Designation, authorisation, accreditation or licensing of blood establishments
Article 5
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.

Hospital blood banks
Article 6
Articles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to hospital blood banks.

Provisions for existing establishments
Article 7
Member States may decide to maintain national provisions for nine months after the date laid down in Article 32 so as to enable blood establishments operating under their legislation to comply with the requirements of this Directive.

Inspection and control measures
Article 8
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.