Search Legislation

Directive 2004/23/EC of the European Parliament and of the CouncilShow full title

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

 Help about what version

What Version

More Resources

 Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Status:

EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Objective

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Implementation

  3. CHAPTER II OBLIGATIONS ON MEMBER STATES' AUTHORITIES

    1. Article 5.Supervision of human tissue and cell procurement

    2. Article 6.Accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes

    3. Article 7.Inspections and control measures

    4. Article 8.Traceability

    5. Article 9.Import/export of human tissues and cells

    6. Article 10.Register of tissue establishments and reporting obligations

    7. Article 11.Notification of serious adverse events and reactions

  4. CHAPTER III DONOR SELECTION AND EVALUATION

    1. Article 12.Principles governing tissue and cell donation

    2. Article 13.Consent

    3. Article 14.Data protection and confidentiality

    4. Article 15.Selection, evaluation and procurement

  5. CHAPTER IV PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS

    1. Article 16.Quality management

    2. Article 17.Responsible person

    3. Article 18.Personnel

    4. Article 19.Tissue and cell reception

    5. Article 20.Tissue and cell processing

    6. Article 21.Tissue and cell storage conditions

    7. Article 22.Labelling, documentation and packaging

    8. Article 23.Distribution

    9. Article 24.Relations between tissue establishments and third parties

  6. CHAPTER V EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

    1. Article 25.Coding of information

    2. Article 26.Reports

    3. Article 27.Penalties

  7. CHAPTER VI CONSULTATION OF COMMITTEES

    1. Article 28.Technical requirements and their adaptation to scientific and technical progress

    2. Article 29.Committee

    3. Article 30.Consultation of one or more scientific committees

  8. CHAPTER VII FINAL PROVISIONS

    1. Article 31.Transposition

    2. Article 32.Entry into force

    3. Article 33.Addressees

    1. ANNEX

      INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES

      1. A. Living donors

        1. 1. The person in charge of the donation process shall ensure...

        2. 2. The information must be given by a trained person able...

        3. 3. The information must cover: the purpose and nature of the...

        4. 4. The donor must be informed that he/she has the right...

        5. 5. Information must be given on the necessity for requiring the...

      2. B. Deceased donors

        1. 1. All information must be given and all necessary consents and...

        2. 2. The confirmed results of the donor's evaluation must be communicated...

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources