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- Recitals
CHAPTER I — GENERAL PROVISIONS
CHAPTER II — OBLIGATIONS ON MEMBER STATES AUTHORITIES
CHAPTER III — PROVISIONS FOR BLOOD ESTABLISHMENTS
CHAPTER IV — QUALITY MANAGEMENT
CHAPTER V — HAEMOVIGILANCE
CHAPTER VI — PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS
- Article 16 — Provision of information to prospective donors
- Article 17 — Information required from donors
- Article 18 — Eligibility of donors
- Article 19 — Examination of donors
- Article 20 — Voluntary and unpaid blood donation
- Article 21 — Testing of donations
- Article 22 — Storage, transport and distribution conditions
- Article 23 — Quality and safety requirements for blood and blood components
CHAPTER VII — DATA PROTECTION
CHAPTER VIII — EXCHANGE OF INFORMATION, REPORTS AND PENALTIES
CHAPTER IX — COMMITTEES
CHAPTER X — FINAL PROVISIONS
- 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)
- ANNEX II — REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY
- ANNEX III — LABELLING REQUIREMENTS
- ANNEX IV — BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS