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S.I. No. 33/2019 - European Communities (Quality And Safety Of Human Tissues And Cells) (Amendment) Regulations 2019
Table of Provisions (31)
Statutory Text (31 Articles)
1. Detailed information on the specifications of the importing tissue establishment aimed at ensuring that the quality and safety standards laid down in Directive 2004/23/EC are met and the mutually agreed roles and responsibilities of both parties in ensuring that imported tissues and cells are of equivalent standards of quality and safety;
2. A clause ensuring that the third country supplier provides the information set out in Annex III B to this Directive to the importing tissue establishment;
3. A clause ensuring that the third country supplier informs the importing tissue establishment of any suspected or actual serious adverse events or reactions which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;
4. A clause ensuring that the third country supplier informs the importing tissue establishment of any substantial changes to its activities, including any revocation or suspension, in part or in full, of its authorisation to export tissue and cells or other such decisions of non-compliance by the third country competent authority or authorities, which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;
5. A clause guaranteeing the competent authority or authorities the right to inspect the activities of the third country supplier, including on-site inspections, should it wish to do so as part of its inspection of the importing tissue establishment. The clause should also guarantee the importing tissue establishment the right to regularly audit its third country supplier;
6. The agreed conditions to be met for the transport of tissues and cells between the third country supplier and importing tissue establishment;
7. A clause ensuring that donor records relating to imported tissues and cells are kept by the third country supplier or its sub-contractor, in line with EU data protection rules, for 30 years following procurement and that suitable provision is made for their retention should the third country supplier cease to operate;
8. Provisions for the regular review and, where necessary, revision of the written agreement including in order to reflect any changes in the requirements of the EU quality and safety standards laid out in Directive 2004/23/EC;
9. A list of all standard operating procedures of the third country supplier relating to the quality and safety of imported tissues and cells and a commitment to provide these on request.
GIVEN under my Official Seal,
5 February 2019
SIMON HARRIS,
Minister for Health.
Explanatory Note
(This note is not part of the instrument and does not purport to be a legal interpretation)
These Regulations give effect to Commission Directive (EU) 2015/566 of 08 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of imported tissues and cells.
The Regulations provide procedures for verifying that tissues and cells imported from a third country (i.e. from outside the European Union), meet standards of quality and safety equivalent to those laid down in Directive 2004/23/EC, in order to ensure a high level of protection of human health.
The Regulations amend the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (
S.I. No. 158 of 2006
).
The Regulations may be cited as the European Communities (Quality and Safety of Human Tissues and Cells) (Amendment) Regulations 2019.
1 OJ No. L93, 9.4.2015, p.56.
2 OJ No. L 93, 9.4.2015, p.56.
3 OJ No. L 38, 9.2.2006, p.40
4 OJ No. L 327, 27.11.2012, p. 24.
5 OJ No. L 93, 9.04.2015, p.43.
10. Postal address of the site of reception
(if different)
.
B. Contact Details for the Application
11. The Principal Regulations are amended by the insertion of the following Regulation after Regulation 10
“10A. (1) An importing tissue establishment shall seek the prior written approval of the Health Products Regulatory Authority for any planned substantial changes to its import activities, in particular the substantial changes referred to in Regulation 6 (11A), and inform the Health Products Regulatory Authority of its decision to cease its import activities in part or in full.
(2) An importing tissue establishment shall notify the Health Products Regulatory Authority, without delay, of any suspected or actual serious adverse events or reactions, reported to it by third country suppliers which may influence the quality and safety of the tissues and cells it imports.
(3) A notification referred to in paragraph (2) shall include the information required by Schedules 3 and 4 to the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007 (
S.I. No. 598 of 2007
).
(4) An importing tissue establishment shall notify the Health Products Regulatory Authority, without delay, of -
(
a
) any revocation or suspension, in part or full, of a third country supplier’s authorisation to export tissues and cells, and
(
b
) any other decision taken for reasons of non-compliance by the competent authority or authorities of the country in which the third country supplier is based which may be relevant to the quality and safety of imported tissues and cells.”.
Amendment of Regulation 11 of Principal Regulations
12. Regulation 11 of the Principal Regulations is amended -
(
a
) in paragraph (1), by the substitution of “Tissue establishments and importing tissue establishments” for “The IMB and tissue establishments”, and
(
b
) in paragraph (2), by the substitution of “Tissue establishments and importing tissue establishments” for “The IMB and tissue establishments”.
Amendment of Regulation 12 of Principal Regulations
13. Regulation 12 of the Principal Regulations is amended -
(
a
) in paragraph (1), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments”,
(
b
) in paragraph (2), by the substitution of “tissue establishment, or the importing tissue establishment as the case may be,” for “tissue establishment,”,
(
c
) by the substitution of the following paragraph for paragraph (3)
“(3) Every tissue establishment and importing tissue establishment shall comply with the requirements set out in Schedule 4.”,
(
d
) in paragraphs (5), (6), (7) and (8), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments” in each place that it occurs,
(
e
) by the substitution of the following paragraph for paragraph (9)
“(9) Tissue establishments and importing tissue establishments shall have agreements and procedures in place to ensure that, in the event of termination of activities for whatever reason, stored tissues and cells shall be transferred to other tissue establishment or establishments, or if appropriate to other importing tissue establishment or establishments, authorised in accordance with Regulation 6 without prejudice to any domestic law concerning the disposal of donated tissues or cells, according to the consent pertaining to them.”,
(
f
) by the substitution of the following paragraph for paragraph (10)
“(10) Tissue establishments and importing tissue establishments shall ensure that personnel directly involved in activities relating to the procurement, importing, processing, preservation, storage and distribution of tissues and cells shall be qualified to perform such tasks and shall be provided with the training referred to in Article 28 (c) of the Directive.”, and
(
g
) in paragraph (11), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments”.
Amendment of Regulation 13 of Principal Regulations
14. Regulation 13 of the Principal Regulations is amended, in paragraph (3), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments”.
Amendment of Regulation 14 of Principal Regulations
15. Regulation 14 of the Principal Regulations is amended, in paragraphs (3), (4) and (5), by the substitution of “Tissue establishments and importing tissue establishments” for “A tissue establishment” in both places that it occurs.
Amendment of Regulation 15 of Principal Regulations
16. Regulation 15 of the Principal Regulations is amended -
(
a
) by the substitution of the following paragraph for paragraph (1)
“(1) The Health Products Regulatory Authority shall ensure that -
(a) all imports of tissues and cells from third countries are undertaken by authorised importing tissue establishments, and
(b) all exports of tissues and cells to third countries are undertaken by authorised tissue establishments.”,
(
b
) in paragraph (2), by the substitution of “An Importing tissue establishment” for “Tissue establishments”, and
(
c
) by the substitution of the following paragraphs for paragraph (5)
“(5) An importing tissue establishment shall take all necessary measures to ensure that imports of tissues and cells at paragraph (4) meet quality and safety standards equivalent to those laid down in the Directives and these Regulations.
(5A) A tissue establishment shall take all necessary measures to ensure that exports of tissues and cells at paragraph (4) meet quality and safety standards equivalent to those laid down in the Directives and these Regulations.”.
Amendment of Regulation 16 of Principal Regulations
16B. (1) An importing tissue establishment shall keep a record of its activities for a period of not less than 30 years, including -
(
a
) the types and quantities of tissues and cells imported, and
(
b
) the origin and destination of tissues and cells imported.
(2) A record referred to in paragraph (1) shall include the same information for any one-off imports carried out.
(3) An importing tissue establishment shall include the information referred to in paragraph (1) in the annual report submitted to the Health Products Regulatory Authority under Regulation 10(4)(c).
(4) The Health Products Regulatory Authority shall include importing tissue establishments in the publicly accessible register of tissue establishments laid down in Article 10(2) of the Directive.
(5) The Health Products Regulatory Authority shall make information on the authorisation of importing tissue establishments available through the network of registers referred to in Article 10(3) of the Directive”.
Amendment of Regulation 17 of Principal Regulations
17. Regulation 16 of the Principal Regulations is amended -
(
a
) by the substitution of the following paragraph for paragraph (1)
“(1) Tissue establishments and importing tissue establishments shall establish written agreements with a third party each time an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, and in particular in the following circumstances
(
a
) where a tissue establishment entrusts one of the stages of tissue or cell processing to a third party;
(
b
) where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution;
(
c
) where a tissue establishment, or an importing tissue establishment, as the case may be, provides services to that establishment which is not authorised;
(
d
) where a tissue establishment, or an importing tissue establishment as the case may be, distributes tissue or cells processed by third parties.”,
(
b
) by the insertion of the following paragraph after paragraph (2)
“(2A) Agreements between importing tissue establishments and third parties must be examined by the Health Products Regulatory Authority, within the authorisation framework of Regulation 6.”,
(
c
) in paragraphs (3), (4) and (6), by the substitution of “Tissue establishments and importing tissue establishments” for “Tissue establishments” in each place where it occurs, and
(
d
) by the insertion of the following paragraph after paragraph (5)
“(5A) Agreements between importing tissue establishments and third parties shall specify the responsibilities of third parties and detailed procedures.”.
Written agreements for importing tissue establishments
18. The Principal Regulations are amended by the insertion of the following Regulations after Regulation 16
“16A. (1) Subject to paragraph (2), an importing tissue establishment shall have a written agreement in place with a third country supplier where any of the activities of donation, procurement, testing, processing, preservation, storage or export to the European Union of tissues and cells to be imported into the European Union are carried out outside the European Union.
(2) Paragraph (1) shall not apply in relation to one-off imports of tissues and cells, provided that the importing tissue establishment concerned complies with Regulation 6(1B).
(3) A written agreement referred to in paragraph (1) shall -
(
a
) specify the quality and safety requirements to be met to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards provided for in these Regulations,
(
b
) include the contents listed in Schedule 9 and such other matters as the importing tissue establishment considers appropriate, and
(
c
) provide that the Health Products Regulatory Authority may inspect the activities, including the facilities, of any third country suppliers during the duration of the written agreement and for a period of 2 years following its termination.
Register of importing tissue establishments
19. Regulation 17 of the Principal Regulations is amended -
(
a
) in paragraph (1), by the substitution of “A tissue establishment, or an importing tissue establishment as the case may be,” for “A tissue establishment,”,
(
b
) in paragraph (2), by the substitution of “tissue establishment, or on the importing tissue establishment as the case may be,” for “tissue establishment,”,
(
c
) in paragraph (5), by the substitution of “ tissue establishment, or by the importing tissue establishment as the case may be,” for “ tissue establishment,”
(
d
) in paragraph (6), by the substitution of “tissue establishment concerned or to its nominated representative, or as the case may be, to the importing tissue establishment concerned,” for “tissue establishment concerned”,
(
e
) in paragraph (8), by the substitution of “ tissue establishment, or the importing tissue establishment as the case may be,” for “ tissue establishment,”
(
f
) in paragraph (9)(b), by the substitution of “tissue establishment concerned, or the importing tissue establishment concerned as the case may be,” for “tissue establishment concerned”,
(
g
) in paragraph (10)(b), by the substitution of “tissue establishment concerned, or the importing tissue establishment concerned as the case may be,” for “tissue establishment concerned”, and
(
h
) in paragraph (11)(b), by the substitution of “the tissue establishment concerned, or on the importing tissue establishment concerned as the case may be.” for “the tissue establishment concerned.”.
Amendment of Regulation 18 of Principal Regulations
20. Regulation 18 of the Principal Regulations is amended, in paragraph (1), by the substitution of “A tissue establishment or an importing tissue establishment, as the case may be,” for “A tissue establishment”.
Amendment of Regulation 19 of Principal Regulations
21. Regulation 19 of the Principal Regulations is amended -
(
a
) in paragraph (1) -
(i) by the substitution of “tissue establishment or of an importing tissue establishment, as the case may be (and where appropriate, its third country supplier)” for “tissue establishment”, and
(ii) in subparagraph (a), by the substitution of “tissue establishments or importing tissue establishments, as the case may be (and where appropriate, their third country suppliers) for “tissue establishments”,
(
b
) in paragraph (2), by the substitution of “ tissue establishment sites or importing tissue establishment sites” for “tissue establishment sites”,
(
c
) by the insertion of the following paragraph after paragraph (2)
“(2A) The Health Products Regulatory Authority shall evaluate and verify the procedures and activities carried out in an importing tissue establishment and the facilities of their third country suppliers that are relevant to ensuring the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards provided in the Directive and may examine any documents or other records that are relevant for this evaluation and verification.”,
(
d
) in paragraph (3), by the substitution of “a tissue establishment, or an importing tissue establishment as the case may be,” for “a tissue establishment”,
(
e
) in paragraph (4), by the substitution of “A tissue establishment or an importing tissue establishment” for “Any tissue establishment”,
(
f
) in paragraph (6), by the substitution of “prescribed activities, or importing activities as the case may be, are carried out by any person on behalf of, and pursuant to a contractual arrangement with, a tissue establishment, or an importing tissue establishment as the case may be.” for “prescribed activities are carried out by any person on behalf of, and pursuant to a contractual arrangement with, a tissue establishment.”,
(
g
) by the substitution of the following paragraph for paragraph (7)
“(7) For the avoidance of doubt, it is hereby declared that the Health Products Regulatory Authority’s functions under this Regulation in relation to
(
a
) a tissue establishment are also applicable in the case of a tissue establishment seeking authorisation under Regulation 6;
(
b
) an importing tissue establishment are also applicable in the case of an importing tissue establishment seeking authorisation under Regulation 6.”, and
(
h
) by the insertion of the following paragraphs after paragraph (9)
“(10) The Health Products Regulatory Authority shall, upon a duly justified request from another Member State or the Commission, provide information on the results of inspections and other control measures relating to importing tissue establishments and third country suppliers.
(11) The Health Products Regulatory Authority shall, upon a duly justified request from another Member State into which imported tissues and cells are distributed after importation into the State, consider carrying out inspections or other control measures on importing tissue establishments and the activities of any third country suppliers.
(12) The Health Products Regulatory Authority shall decide on the appropriate measures to take following consultation with the Member State which made a request under paragraph (11).
(13) Where the Health Products Regulatory Authority undertakes an on-site inspection following a request under paragraph (11), it shall agree with the competent authority or authorities of the Member State which made such a request on whether and how that Member State shall participate in the inspection.
(14) The Health Products Regulatory Authority shall decide whether or not participation in an inspection requested by the Member State that made the request under paragraph (11) is warranted.
(15) Where the Health Products Regulatory Authority is of the opinion that participation in an inspection is not warranted, the decision to refuse participation under paragraph (14) shall be explained in writing to the Member State which made the request.”.
Amendment of Regulation 20 of Principal Regulations
22. Regulation 20 of the Principal Regulations is amended -
(
a
) in paragraph (1), by the substitution of “tissue establishments and importing tissue establishments” for “tissue establishments” in both places that it occurs,
(
b
) by the substitution of the following paragraph for paragraph (2)
“(2) The Health Products Regulatory Authority shall maintain a publicly accessible register of tissue establishments and importing tissue establishments, specifying the activities for which they have been authorised.”, and
(
c
) by the substitution of the following paragraph for paragraph (3)
“(3) The Health Products Regulatory Authority shall assist the Commission to establish a network linking the national tissue establishment and importing tissue establishment registers.”.
Amendment of Regulation 21 of Principal Regulations
23. Regulation 21 of the Principal Regulations is amended by the substitution of the following definition for the definition of “relevant thing”
“ ‘relevant thing’ means -
(
a
) any tissues or cells, including any imported tissues or cells, or
(b) any article or substance used in the donation, procurement, importing, processing, preservation or storage of any tissue or cells or products manufactured from tissues and cells.”.
Amendment of Regulation 22 of Principal Regulations
24. Regulation 22 of the Principal Regulations is amended -
(
a
) in paragraph (3) -
(i) in subparagraph (iii), by the substitution of “premises,” for “premises, and”, and
(ii) by the insertion of the following subparagraphs after subparagraph (iv)
“(v) any premises owned or managed by an importing tissue establishment, or at which an importing tissue establishment carries out any importing activities,
(vi) any premises of any person who carries out any importing activities on behalf of, and pursuant to a contractual arrangement with an importing tissue establishment,
(vii) any premises at which books, records or other documents stored in non-legible form) relating to any importing activities are stored or kept,”, and
(
b
) in paragraph (6)(c), by the substitution of “prescribed activity or any importing activity,” for “prescribed activity,”.
Amendment of Regulation 24 of Principal Regulations
25. Regulation 24 of the Principal Regulations is amended, in paragraph (1), by the substitution of the following subparagraph for subparagraph (c)
“(
c
) a chemist, analyst or entity appointed by the Health Products Regulatory Authority,”.
Amendment of Regulation 25 of Principal Regulations
26. Regulation 25 of the Principal Regulations is amended, in paragraph (1), by the substitution of “6(9), 6(9A)” for “6(9),”.
Amendment of Regulation 31 of Principal Regulations
27. Regulation 31 of the Principal Regulations is amended by the substitution of “tissue establishments and importing tissue establishments” for “tissue establishments” in both places that it occurs.
Amendment of Regulation 32 of Principal Regulations
28. Regulation 32 of the Principal Regulations is amended, in paragraph (2), by the substitution of “its authorised representative, or, as the case may be, by the importing tissue establishment concerned or its authorised representative” for “its authorised representative” in both places that it occurs.
Insertion of Schedules to Principal Regulations
29. The Principal Regulations are amended by the insertion of Schedule 1 to 4 to these Regulations after Schedule 5.
Schedule 1
Minimum requirements concerning the information and documentation to be provided by importing tissue establishment applicants when applying to be accredited, designated, authorised or licensed for the purpose of import activities
When applying for an accreditation, designation, authorisation or licence for the purpose of import activities, the importing tissue establishment applicant shall, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as a tissue establishment or importing tissue establishment, provide the most up- to-date information and, for part F, documentation on the following
A. General Information on the Importing Tissue Establishment (ITE)
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of
12
th February
, 2019
I, Simon Harris, Minister for Health, in exercise of the powers conferred on me by
section 3
of the
European Communities Act 1972
(No. 27 of 1972) and for the purpose of giving effect to Commission Directive (EU) 2015/566
1
of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells, hereby make the following regulations
PART 1
PRELIMINARY AND GENERAL
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