- Latest available (Revised)
- Original (As adopted by EU)
Commission Implementing Directive 2012/25/EUShow full title
Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (Text with EEA relevance)
You are here:
What Version
More Resources
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.
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:
This is the original version (as it was originally adopted).
Article 7Reporting of serious adverse events and reactions
Member States shall ensure that the following procedure is implemented by their competent authorities or delegated bodies:
(a)
Whenever the competent authority or delegated body of the Member State of destination is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another Member State, it shall immediately inform the competent authority or delegated body of the Member State of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in Annex I, in so far as this information is available.
(b)
The competent authority or delegated body of the Member State of origin shall immediately inform the competent authorities or delegated bodies of each concerned Member State of destination and transmit them each an initial report containing the information set out in Annex I, whenever it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States.
(c)
When additional information becomes available following the initial report, it shall be transmitted without undue delay.
(d)
The competent authority or delegated body of the Member State of origin shall, as a rule within three months of the initial report transmitted pursuant to point (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in Annex II. The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely manner to the competent authority or delegated body of the Member State of origin. The final report shall be drawn up after collecting relevant information from all Member States involved.
Options/Help
Print Options
PrintThe Whole Directive
PrintThis Article only
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.
Opening Options
Different options to open legislation in order to view more content on screen at once
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
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
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.