European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007
Source: Iris Oifigiúl 2007-09-04

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paragraphs: These Regulations may be cited as the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007.
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paragraphs: (1) These Regulations, other than Regulation 22, shall come into operation on 1 September 2007.
(2) Regulation 22 shall come into operation on 1 September 2008.
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paragraphs: (1) In these Regulations—
(a) that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or
(b) which might result in, or prolong, hospitalisation or morbidity;
(a) that is fatal, life-threatening, disabling or incapacitating, or
(b) which results in, or prolongs, hospitalisation or morbidity;
(2) A word or expression that is used in these Regulations and is also used in the Commission Directive 2006/86/EC of 24 October 2006 has, unless the contrary intention appears, the same meaning in these Regulations as it has in that Directive.
(3) A word or expression that is used in these Regulations and is also used in the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 ( S.I. No. 158 of 2006 ) has, unless the contrary intention appears, the same meaning in these Regulations as it has in those Regulations.
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paragraphs: (1) These Regulations shall apply to the coding, processing, preservation, storage and distribution of:
(a) human tissues and cells intended for human applications; and
(b) manufactured products derived from human tissues and cells intended for human applications where those products are not covered by other Regulations.
(2) The provisions of Regulations 7 to 21 concerning traceability and the reporting of serious adverse reactions and events shall also apply to the donation, procurement and testing of human tissues and cells.
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paragraphs: A tissue establishment shall comply with the requirements set out in Schedule 1.
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paragraphs: Preparation processes at all tissue establishments shall comply with the requirements set out in Schedule 2.
7. (a) Each procurement organisation shall have procedures in place to retain the records of tissues and cells procured and to notify tissue establishments without delay of any serious adverse reactions in the living donor which may influence the quality and safety of tissues and cells;
(b) Organisations responsible for human application of tissues and cells shall have procedures in place to retain the records of tissues and cells applied and to notify tissue establishments without delay of any serious adverse reactions observed during and after clinical application which may be linked to quality and safety of tissues and cells;
(c) Each tissue establishment that distributes tissues and cells for human application shall provide information to the organisation responsible for human application of tissues and cells about how that organisation should report serious adverse reactions as referred to in (b).
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paragraphs: Each tissue establishment shall:
(a) have procedures in place to communicate to the Irish Medicines Board without delay all relevant available information about suspected serious adverse reactions as referred to in Regulation 7(a) and (b);
(b) have procedures in place to communicate to the Irish Medicines Board without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.
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paragraphs: The responsible person designated for each tissue establishment shall notify the Irish Medicines Board of the information included in the notification set out in Part A of Schedule 3.
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paragraphs: Each tissue establishment shall:
(a) notify the Irish Medicines Board of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications;