S.I. No. 33 of 2019 European Communities (Quality and Safety of Human Tissues and Cells) (Amendment) Regulations 2019
Source: Iris Oifigiúl 13 2019-02-12

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paragraphs: These Regulations may be cited as the European Communities (Quality and Safety of Human Tissues and Cells) (Amendment) Regulations 2019.
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paragraphs: In these Regulations, “Principal Regulations” means the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 ( S.I. No. 158 of 2006 ).
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paragraphs: Regulation 2 (1) of the Principal Regulations is amended -
(a) by the insertion of the following definitions:
“ ‘emergency’ means any unforeseen situation in which there is no practical alternative other than to urgently import tissues and cells from a third country into the European Union for immediate application to a known recipient or known recipients whose health would be seriously endangered without such an import;
‘importing activity’ means any activity consisting of any aspect of -
(a) the importation of human tissues and cells intended for human application into the European Union;
(b) the importation of manufactured products derived from human tissues and cells intended for human application, where those products are not covered by other European Union legislation;
(c) the importation of human tissues and cells which are intended to be used exclusively in manufactured products which are covered by other European Union legislation;
‘importing tissue establishment’ means a tissue bank or a unit of a hospital or another body established within the European Union which is a party to a contractual agreement with a third country supplier for the import into the European Union of tissues and cells coming from a third country intended for human application;
‘Imported Tissues and Cells Directive’ means Commission Directive (EU) 2015/566 of 8 April 20152 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells;
‘one-off import’ means the import of any specific type of tissue or cell which is for the personal use of an intended recipient or recipients known to the importing tissue establishment and the third country supplier before the importation occurs, and such an import of any specific type of tissue or cell shall normally not occur more than once for any given recipient but shall not include imports from the same third country supplier taking place on a regular or repeated basis;
‘third country supplier’ means a tissue establishment or another body, established in a third country, which is responsible for the export to the European Union of tissues and cells it supplies to an importing tissue establishment, which supplier may also carry out one or more of the activities, which take place outside of the European Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the European Union;”,
(b) in the definition of “site”, by the substitution of “any prescribed activity or activities or importing activity or activities” for “any prescribed activity or activities”,
(c) by the substitution of the following definition for the definition of “the Directives”:
“ ‘the Directives’ means the Directive and Commission Directive 2006/17/EC of 8 February 20063 , as amended by Commission Directive 2012/39/EU of 26 November 20124 , Commission Directive (EU) 2015/565 of 8 April 20155 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells and the Imported Tissues and Cells Directive;”, and
(d) by the substitution of the following definition for the definition of “responsible person”:
“ ‘responsible person’, in relation to a tissue establishment or an importing tissue establishment, means the person who has been designated pursuant to Regulation 8 as the responsible person for that tissue establishment or importing tissue establishment, as the case may be;”.
(a) by the substitution of the following paragraph for paragraph (1):
“(1) Subject to paragraphs (2) and (2A), these Regulations shall apply to all prescribed activities and to all importing activities.”,
(b) in paragraph (2) –
(i) in subparagraph (c), by the substitution of “human body;” for “human body”, and
(ii) by the insertion of the following subparagraph after subparagraph (c):
“(d) the import of tissues and cells in accordance with Regulation 15(4)(a) or (b);”,
(c) by the insertion of the following paragraph after paragraph (2):
“(2A) Where the human tissues and cells to be imported are intended to be used exclusively in manufactured products which are covered by other European Union legislation, the Imported Tissues and Cells Directive shall only apply to the donation, procurement and testing which takes place outside of the European Union as well as to contributing to ensuring traceability from donor to recipient and vice versa.”, and
(d) by the substitution of the following paragraph for paragraph (4):
“(4) These Regulations shall apply without prejudice to the Data Protection Acts 1988 to 2018.”
(a) in paragraph (1), by the substitution of “any prescribed activity or any importing activity” for “any prescribed activity”, and
(b) in paragraph (2), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments”.
(a) by the substitution of the following paragraph for paragraph (1):
“(1) Subject to Regulation 6(2), the Health Products Regulatory Authority may grant an authorisation to -
(a) a tissue establishment to carry out any prescribed activity at a specified site or sites, having satisfied itself that the tissue establishment -
(i) complies with the requirements referred to in Article 28(a) of the Directive, and
(ii) complies with other relevant requirements of the Directives and these Regulations, or
(b) an importing tissue establishment to carry out any importing activity at a specified site or sites, having satisfied itself that the importing tissue establishment -
(i) complies with the requirements referred to in Article 28(a) of the Directive,
(ii) complies with the requirements referred to in Article 5(1) of the Imported Tissues and Cells Directive, and
(iii) complies with other relevant requirements of the Directives and these Regulations.”,
(b) by the insertion of the following paragraphs after paragraph (1) -