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
- In force
- CELEX number: 32002L0098
- Official Journal: JOL_2003_033_R_0030_01
- Form: Directive
- Procedure number: 2000/0323(COD), 2000/0323/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - January 27, 2003
- February 8, 2003
- February 8, 2003
- Entry into force - Date pub. See Art 33
- February 8, 2005
- At the latest See Art 32.1
- August 6, 2027
- Repealed by 32024R1938
Modified by
Modified by:
- Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four - detail
All documents based on this document:
- Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance)
- Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)
- Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance)
- Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic (Text with EEA relevance)
- Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life Text with EEA relevance
- Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations Text with EEA relevance
- Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance)
Modifies
Affected by case
- Judgment of the Court (First Chamber), 13 March 2014. Octapharma France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Ministère des Affaires sociales et de la Santé. Request for a preliminary ruling from the Conseil d’État (France). Approximation of laws — Directive 2001/83/EC — Directive 2002/98/EC — Scope — Labile blood product — Plasma prepared by means of an industrial process — Simultaneous or exclusive application of the directives — Option for a Member State to provide for a more rigorous regime for plasma than for medicinal products. Case C‑512/12.
- A04P2
- Judgment of the Court (Eighth Chamber) of 10 March 2021. Ordine Nazionale dei Biologi and Others v Presidenza del Consiglio dei Ministri. Request for a preliminary ruling from the Corte suprema di cassazione. Reference for a preliminary ruling – Public health – Article 168 TFEU – Directive 2002/98/EC – Standards of quality and safety of human blood and of blood components – Objective of ensuring a high level of protection of human health – Article 4(2) and Article 9(2) – Blood establishments – Responsible person – Minimum conditions of qualification – Option for a Member State to provide for a more stringent regime – Discretion afforded to the Member States. Case C-96/20.
- A04P2
- A09P2LA
- Case C-296/15: Request for a preliminary ruling from the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (Slovenia) lodged on 18 June 2015 — Medisanus d.o.o. v Splošna Bolnišnica Murska Sobota
- article 4 paragraph 2
- Case C-96/20: Request for a preliminary ruling from the Corte suprema di cassazione (Italy) lodged on 24 February 2020 — Ordine Nazionale dei Biologi, MX, NY, OZ v Presidenza del Consiglio dei Ministri
- article 9 paragraph 2
Legal basis
- Treaty establishing the European Community (Amsterdam consolidated version) Part Three: Community policies Title XIII: Public health Article 152 Article 129 - EC Treaty (Maastricht consolidated version) Article 129 - EEC Treaty
- Treaty establishing the European Community (Amsterdam consolidated version) Part Five: Institutions of the Community Title I: Provisions governing the institutions Chapter 2: Provisions common to several institutions Article 251 Article 189b - EC Treaty (Maastricht consolidated version)
EuroVoc Vocabulary
- Blood transfusion
- Health protection
- Health control
- Therapeutics
- Public health
- Substances of human origin