Search Legislation

Commission Directive 2006/17/ECShow full title

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance)

 Help about what version

What Version

 Help about advanced features

Advanced Features

More Resources

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Changes over time for: Introductory Text

 Help about opening options

Status:

EU Directives are being published on this site to aid cross referencing from UK legislation. After exit day no further amendments will be applied to this version.

U.K.+E.U.

Commission Directive 2006/17/EC

of 8 February 2006

implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,

Having regard to 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(1), and in particular points (b), (d), (e), (f), and (i) of Article 28 thereof,

Whereas:

(1) Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement and testing of all human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.

(2) In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissue and cell application process.

(3) The use of tissues and cells for application in the human body carries a risk of disease transmission and other potential adverse effects in recipients. That risk can be reduced by careful donor selection, testing of each donation and the application of procedures to procure tissues and cells in accordance with rules and processes established and updated according to the best available scientific advice. Therefore, all tissues and cells, including those used as starting material for the manufacture of medicinal products, to be used in the Community should meet the quality and safety requirements laid down in this Directive.

(4) Reproductive cells have, due to the specific nature of their application, specific quality and safety characteristics that are taken into account in this Directive.

(5) For the donation of reproductive cells between partners that have an intimate physical relationship, it is justified to require less stringent biological testing, given that in this case the risk for the recipient is considered less than for donation from third parties. In order to minimise the risk of cross-contamination, biological testing of the donor will be necessary only when the donated cells will be processed, cultured or stored.

(6) This Directive is based on international experience drawn upon through an extensive consultation, the Council of Europe’s Guide to safety and quality assurance for organs, tissues and cells, the European Convention on Human Rights, the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), with its additional protocols, and recommendations from the World Health Organisation. In particular, with regard to further additional biological testing for donors originating from high-incidence areas of specific diseases or whose sexual partners or parents originate from high-incidence areas, Member States will refer to existing international scientific evidence. The Directive is consistent with the fundamental principles set out in the European Charter of Fundamental Rights.

(7) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2004/23/EC,

HAS ADOPTED THIS DIRECTIVE:

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

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

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 as well as any subsequent versions created after exit day 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 exit day 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