Public Health (Human Tissues, Cells And Organs) Act 2009

Link to law: http://www.gibraltarlaws.gov.gi/articles/2009-53o.pdf
Published: 2009-12-01

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I ASSENT Public Health (Human Tissues, Cells and Organs)
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
2009-53


PUBLIC HEALTH (HUMAN TISSUES, CELLS AND
ORGANS) ACT 2009

Principal Act

Act. No. 2009-53 Commencement 1.12.2009
Assent 21.12.2009




Amending
enactments
Relevant current
provisions
Commencement
date

LN. 2012/151 Long title, ss. 1A, 1B, 2-27, 28A-
28W, 29, Schs. 5, 6 & 12

1.11.2012
2014/157 Schs. 2 & 3 17.6.2014


English sources:
None cited

Transposing:
Directive 2004/23/EC
Directive 2006/17/EC
Directive 2006/86/EC
Directive 2010/53/EU
Directive 2012/39/EU

EU Legislation/International Agreements involved:

Public Health (Human Tissues, Cells and Organs)
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2009-53
ARRANGEMENT OF SECTIONS

Section

PRELIMINARY

1. Title and commencement.
1A. Interpretation: general.

PART 1
HUMAN TISSUES AND CELLS

1B. Designation of the competent authority.
2. Interpretation of Part 1.
3. Renumbered.
4. Application of Part 1.
5. Requirements for authorisation.
6. Authorisation of tissue establishment or procurement organisations.
7. Suspension or revocation of authorisation.
8. Responsible person for tissue establishment.
9. Requirements for the procurement and supervision of procurement
of human tissues and cells.
10. Quality management and notification and reporting to the competent
authority of serious adverse events and reactions.
11. Notification of serious adverse reactions.
12. Notification of serious adverse events.
13. Donor selection, evaluation and testing criteria.
14. Tissue and cell reception, processing, storage and distribution.
15. Principles governing tissue and cell donation and voluntary unpaid
donation.
16. Traceability and labelling of tissues and cells.
17. Import and export of human tissues and cells.
18. Relations between tissue establishments and third parties.
19. Objections to refusals of authorisation or suspension or revocation of
authorisation.
20. Disclosure of information by tissue establishments and data
protection.
21. Inspections.
22. Authorised persons.
23. Taking of samples by authorised persons.
24. Records to be kept by the competent authority.
25. Communication of information between competent authorities and to
the Commission.
26. Offences and penalties.
27. Offence to import below standard tissues and cells into Gibraltar.
28. Reports by the competent authority.

PART 2
Public Health (Human Tissues, Cells and Organs)
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2009-53
HUMAN ORGANS

28A. Subject matter and application of this Part.
28B. Interpretation of Part 2.
28C. Framework and compliance with licensing conditions and directions.
28D. Licensing requirement for procurement and transplantation activity.
28E. Granting of licences.
28F. Preconditions to grant of a licence.
28G. Consequences of failure, etc.
28H. Guidance and directions.
28I. Records, reports and information.
28J. The principles of organ donation.
28K. The quality and safety of living donation.
28L. Serious adverse events and serious adverse reactions.
28M. Traceability.
28N. Organs sent to another country.
28O. The Authority and European organ exchange organisations.
28P. Control and audit by way of inspections.
28Q. Appropriate statements.
28R. Seizure in the course of inspection or search.
28S. Requirements when exercising power of inspection or search.
28T. Protection of personal data, confidentiality and security of
processing.
28U. Offences and penalties.
28V. Offences by bodies corporate.
28W. Reports to the Commission.

PART 3
MISCELLANEOUS

29. Regulations.

SCHEDULE 1
Selection criteria for donors of tissues or cells or both (except donors of
reproductive cells).

SCHEDULE 2
Laboratory tests required for donors (except donors of reproductive cells).

SCHEDULE 3
Selection criteria and laboratory tests required for donors of reproductive
cells.

SCHEDULE 4
Cell or tissue or both donation and procurement procedures and reception at
the tissue establishment.

SCHEDULE 5
Public Health (Human Tissues, Cells and Organs)
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2009-53
Requirements for authorisation of tissue establishments.

SCHEDULE 6
Requirements for the authorisation of tissue and cell preparation processes
at the tissue establishments.

SCHEDULE 7
Notification of serious adverse reactions.

SCHEDULE 8
Notification of Serious Adverse Events

SCHEDULE 9
Annual Notification Format

SCHEDULE 10
Information on the minimum donor or recipient or both data set to be kept

SCHEDULE 11
Information contained in the European Coding System

SCHEDULE 12
Organ and Donor Characterisation


Public Health (Human Tissues, Cells and Organs)
© Government of Gibraltar (www.gibraltarlaws.gov.gi)
2009-53
AN ACT TO TRANSPOSE INTO THE LAW OF GIBRALTAR
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; 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; COMMISSION
DIRECTIVE 2006/86/EC OF 24 OCTOBER 2006 IMPLEMENTING
DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL AS REGARDS TRACEABILITY REQUIREMENTS,
NOTIFICATION OF SERIOUS ADVERSE REACTIONS AND EVENTS
AND CERTAIN TECHNICAL REQUIREMENTS FOR THE CODING,
PROCESSING, PRESERVATION, STORAGE AND DISTRIBUTION OF
HUMAN TISSUES AND CELLS; DIRECTIVE 2010/53/EU OF THE
EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 7 JULY 2010
ON STANDARDS OF QUALITY AND SAFETY OF HUMAN ORGANS
INTENDED FOR TRANSPLANTATION; AND FOR CONNECTED
PURPOSES.

PRELIMINARY

Title and commencement.

1. This Act may be cited as the Public Health (Human Tissues, Cells and
Organs) Act 2009 and shall be deemed to have come into operation on 1
December 2009.

Interpretation: general.

1A. In this Act−

“Commission” means the European Commission;

“functions” includes powers and duties, and references to the
performance of functions include, with respect to powers and
duties, references to the exercise of powers and the carrying out of
the duties;

“Gibraltar Health Authority” means the Gibraltar Health Authority
established by section 3 of the Medical (Gibraltar Health
Authority) Act 1987;

“inspect” includes search;

Public Health (Human Tissues, Cells and Organs)
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“inspection” means formal and objective control to identify
problems in accordance with standards adopted to assess
compliance with this Act;

“Minister” means the Minister with responsibility for Health;

“premises” means any place, ship or other vessel, aircraft, railway
wagon or other vehicle, and includes a container used to transport
relevant things;

“quality management” means the coordinated activities to direct
and control an organisation with regard to quality;

“quality system” means the organisational structure, defined
responsibilities, procedures, processes, and resources for
implementing quality management and includes all activities which
contribute to quality, directly or indirectly;

“record” includes, in addition to a record in writing

(a) a disc, tape, sound-track or other device in which information,
sounds or signals are embodied so as to be capable (with or
without the aid of some other instrument) of being reproduced
in legible or audible form;

(b) a film, tape or other device in which visual images are
embodied so as to be capable (with or without the aid of some
other instrument) of being reproduced in visual form; and

(c) a photograph;

and any reference to a copy of a record includes

(i) in the case of a record to which paragraph (a) of this
definition applies, a transcript of the sounds or signals
embodied therein;

(ii) in the case of a record to which paragraph (b) of this
definition applies, a still reproduction of the images
embodied therein; and

(iii) in the case of a record to which paragraphs (a) and (b) of
this definition apply, such a transcript together with such
a still reproduction.

PART 1
HUMAN TISSUES AND CELLS

Public Health (Human Tissues, Cells and Organs)
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Designation of the competent authority.

1B.(1) The Minister is designated as the competent authority for the
purpose of this Act.

(2) The Minister may enter into a contractual arrangement with a person
for the purpose of that person assisting the Minister to perform any of his
functions as competent authority under this Act.

Interpretation of Part 1.

2.(1) In this Part, unless the context otherwise requires

“allogeneic use” means cells or tissues removed from one person and
applied to another;

“authorised person” means a person appointed under section 22(1);

“autologous use” means cells or tissues removed from and applied in the
same person;

“cells” means individual human cells or a collection of human cells when
not bound by any form of connective tissue;

“Commission” means the European Commission;

“critical” means potentially having an effect on the quality or safety or
both of or having contact with the cells and tissues;

“direct use” means any procedure where cells are donated and used
without any banking;

“distribution” means transportation and delivery of tissues or cells
intended for human applications;

“donation” means donating human tissues or cells intended for human
applications;

“donor” means every human source, whether living or deceased, of
human cells or tissues;
“functions” includes powers and duties, and references to the
performance of functions include, with respect to powers and
duties, references to the exercise of powers and the carrying out of
the duties;

Public Health (Human Tissues, Cells and Organs)
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“Gibraltar Health Authority” means the Gibraltar Health Authority
established by section 3 of the Medical (Gibraltar Health
Authority) Act, 1987;

“human application” means the use of tissues or cells on or in a human
recipient and extra-corporal applications;

“implementing Directives” means 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 and Commission Directive 2006/86/EC of
24 October 2006 implementing Directive 2004/23/EC of the
European Parliament and of the Council as regards traceability
requirements, notification of serious adverse reactions and events
and certain technical requirements for the coding, processing,
preservation, storage and distribution of human tissues and cells;

“inspect” includes search;

“inspection” means formal and objective control to identify problems in
accordance with standards adopted to assess compliance with this
Part;

“Minister” means the Minister with responsibility for Health;
“organ” means a differentiated and vital part of the human body, formed
by different tissues, that maintains its structure, vascularisation and
capacity to develop physiological functions with an important level
of autonomy;

“organisation responsible for human application” means a health care
establishment or a unit of a hospital or another body which carries
out human application of human tissues and cells;

“partner donation” means the donation of reproductive cells between a
man and a woman who declare that they have an intimate physical
relationship;

“premises” means any place, ship or other vessel, aircraft, railway wagon
or other vehicle, and includes a container used to transport relevant
things;

“prescribed activity” means an activity to which this Part applies, and
that is specified in section 4(1);

“preservation” means the use of chemical agents, alterations in
environmental conditions or other means during processing to
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prevent or retard biological or physical deterioration of cells or
tissues;
“principal Directive” means Directive 2004/23/EC of the European
Parliament and of the Council of 31 March, 2004 setting standards
of quality and safety for the donation, procurement, testing,
processing, preservation, storage and distribution of human tissues
and cells;

“processing” means all operations involved in the preparation,
manipulation, preservation and packaging of tissues or cells
intended for human applications;

“procurement” means a process by which tissue or cells are made
available;

“procurement organisation” means a health care establishment or a unit
of a hospital or another body that undertakes the procurement of
human tissues and cells and that may not be accredited, designated,
authorised or licensed as a tissue establishment;

“quality management” means the coordinated activities to direct and
control an organisation with regard to quality;

“quality system” means the organisational structure, defined
responsibilities, procedures, processes, and resources for
implementing quality management and includes all activities which
contribute to quality, directly or indirectly;

“quarantine” means the status of retrieved tissue or cells, or tissue
isolated physically or by other effective means, whilst awaiting a
decision on their acceptance or rejection;

“record” includes, in addition to a record in writing

(a) a disc, tape, sound-track or other device in which information,
sounds or signals are embodied so as to be capable (with or
without the aid of some other instrument) of being reproduced
in legible or audible form;

(b) a film, tape or other device in which visual images are
embodied so as to be capable (with or without the aid of some
other instrument) of being reproduced in visual form; and

(c) a photograph;

and any reference to a copy of a record includes

Public Health (Human Tissues, Cells and Organs)
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(i) in the case of a record to which paragraph (a) of this
definition applies, a transcript of the sounds or signals
embodied therein;

(ii) in the case of a record to which paragraph (b) of this
definition applies, a still reproduction of the images
embodied therein; and

(iii) in the case of a record to which paragraphs (a) and (b) of
this definition apply, such a transcript together with such
a still reproduction;

“relevant thing” means

(a) any tissue or cells; or

(b) any article or substance used in the donation, procurement,
processing preservation or storage of any tissue or cells or
products manufactured from tissues and cells;

“reporting year” means the period of 12 months ending on 31 December;

“reproductive cells” means all tissues and cells intended to be used for
the purpose of assisted reproduction;

“responsible person”, in relation to a tissue establishment, means the
person who has been designated under section 8 as the responsible
person for that tissue establishment;

“serious adverse event” means any untoward occurrence associated with
the procurement, testing, processing, storage or distribution of
tissues and cells

(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;

“serious adverse reaction” means an unintended response, including a
communicable disease, in the donor or in the recipient associated
with procurement or human application of tissues and cells

(a) that is fatal, life-threatening, disabling or incapacitating; or

(b) which results in, or prolongs, hospitalisation or morbidity;

Public Health (Human Tissues, Cells and Organs)
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“site” means any premises at which any prescribed activity or activities
are carried out;

“Standard Operating Procedures” (SOPs) means written instructions
describing the steps in a specific process, including the materials
and methods to be used and the expected end product;

“storage” means maintaining the tissues and cells under appropriate
controlled conditions until distribution;

“tissue” means all constituent parts of the human body formed by cells;

“tissue establishment” means a tissue bank or a unit of a hospital or
another body where activities of processing, preservation, storage
or distribution of human tissues and cells are undertaken which
may also be responsible for procurement or testing of tissues and
cells;

“traceability” means the ability to locate and identify the tissue or cell or
both during any step from procurement, through processing, testing
and storage, to distribution to the recipient or disposal, which also
implies the ability to identify the donor and the tissue establishment
or the manufacturing facility receiving, processing or storing the
tissue or cells or both and the ability to identify the recipients at the
medical facility or facilities applying the tissue or cells or both to
the recipients; traceability also covers the ability to locate and
identify all relevant data relating to products and materials coming
into contact with those tissues or cells or both;

“validation” (or ‘qualification’ in the case of equipment or environments)
means establishing documented evidence that provides a high
degree of assurance that a specific process, SOP, piece of
equipment or environment will consistently produce a product
meeting its predetermined specifications and quality attributes; a
process is validated to evaluate the performance of a system with
regard to its effectiveness based on intended use.

(2) Any term used but not defined in this Part shall be construed in
accordance with the provisions of the principal Directive and the
implementing Directives.

3. Renumbered as 1B.

Application of Part 1.

4.(1) This Act shall, subject to subsection (2), apply to any activity as
prescribed in this subsection that consists of any aspect of

Public Health (Human Tissues, Cells and Organs)
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(a) the donation, procurement, testing, processing, preservation,
storage or distribution of tissues or cells intended for human
applications;

(b) the donation, procurement, testing, processing, preservation,
storage or distribution of manufactured products derived from
tissues and cells intended for human consumption,

save that, where manufactured products referred to in paragraph (b) are
covered by other laws of Gibraltar implementing Community obligations,
this Part shall only apply to the donation, procurement and testing of such
manufactured products.

(2) This Act shall not apply to
(a) tissues and cells used as an autologous graft within the same
surgical procedure;

(b) blood and blood components as defined by the Public Health
(Blood Safety and Quality) Act 2007;

(c) organs or parts of organs if it is their function to be used for the
same purpose as the entire organ in the human body.

(3) This Act shall apply to tissues and cells that are applied to the human
body in clinical trials.

(4) This Act 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 EC Directives.

(5) The provisions of sections 5(2)(b), 9(1)(c) and 10(6) to (8) of this Part
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.

(6) This Act shall apply without prejudice to the Data Protection Act 2004
on the protection of individuals with regard to the processing of personal
data and on the free movement of such data.

Requirements for authorisation.

5.(1) No person shall carry out any prescribed activity–

Public Health (Human Tissues, Cells and Organs)
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(a) unless that person has been granted an authorisation under
section 6; and

(b) otherwise than in accordance with any conditions to which the
authorisation is subject.

(2) Tissue establishments shall comply with–

(a) the requirements for the accreditation, designation,
authorisation or licensing of tissue establishments as required
by Article 28(a) of the principal Directive; and

(b) the requirements set out in Schedule 5.

(3) Pending a decision on the requirements of Article 28(a) of the
principal Directive, tissue establishments shall comply with the standards
set by the competent authority under section 6(2).

Authorisation of tissue establishment or procurement, organisations.

6.(1) Subject to subsection (2), the competent authority may grant an
authorisation to a tissue establishment to carry out any prescribed activity at
a specified site or sites, having satisfied itself that the tissue establishment

(a) complies with the requirements referred to in Article 28(a) of
the principal Directive; and

(b) complies with other relevant requirements of the implementing
Directives and this Part.

(2) Pending decisions on the requirements pursuant to paragraphs (a), (c),
(g) and (h) of Article 28 of the principal Directive, the competent authority
shall set appropriate standards of quality and safety in respect of the matters
referred to in paragraphs (a), (c), (g) and (h) of Article 28 of the principal
Directive and the competent authority will have regard to these standards in
respect of the matters referred to in those paragraphs when granting
authorisations until such decisions have been made.

(3) An application for authorisation under subsection (1) shall be made to
the competent authority.

(4) All applications for authorisation shall–

(a) include all relevant information as determined by the
competent authority; and

(b) be accompanied by the prescribed fee.

Public Health (Human Tissues, Cells and Organs)
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(5) The competent authority may–

(a) grant or refuse any authorisation applied for under subsection
(3); and

(b) grant such authorisation–

(i) in respect of particular sites or prescribed activities only;
and

(ii) subject to conditions.

(6) Where the competent authority grants an authorisation, in the case of
prescribed activities the competent authority shall give notice in writing to
the tissue establishment specifying the prescribed activities which the tissue
establishment may undertake under this Part at each site in respect of which
authorisation is granted, and if the grant is subject to conditions, the
conditions which apply to the undertaking of those activities.

(7) Subject to the requirements of subsection (8), the competent authority
may at any time remove or vary any of the conditions referred to in
subsection 5(b)(ii), or may impose additional conditions.

(8) Where the competent authority removes or varies any condition or
imposes any additional condition under subsection (7), the competent
authority shall serve a notice on the tissue establishment concerned which
shall–

(a) give details of the conditions which the competent authority
proposes to remove, or of the variation which he proposes to
make to any existing conditions, or of any additional condition
which he proposes to impose;

(b) give the reasons for his decision; and

(c) specify the date, which shall be not less than 14 days from the
date on which the notice is served, from which the removal or
variation of any condition, or the imposition of any additional
condition shall apply.

(9) A tissue establishment shall not make any substantial change in the
prescribed activities which it undertakes without the prior written approval
of the competent authority.

(10) Any application by a tissue establishment for approval to make a
substantial change in its activities shall be–

(a) made in writing to the competent authority; and
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(b) accompanied by the prescribed fee.

(11) For the purpose of this section, a substantial change in a tissue
establishment’s activities is any change–

(a) to the site or sites from which the tissue establishment operates
or to the prescribed activities to be carried out at each site, and
which would result in a failure to comply with the
requirements of this Part; or

(b) to the quality system, as set out in accordance with Article
28(c) of the principal Directive, which is likely to have a
substantial impact on the conduct of, or might compromise the
safety of, any of the prescribed activities which the tissue
establishment has been authorised to undertake under this
section.

(12) The competent authority may authorise–

(a) the tissue and cell preparation processes, which the tissue
establishment may carry out in accordance with the
requirements set out in Article 28(g) of the principal Directive;

(b) the direct distribution of specific tissues and cells from where
the procurement is carried out to a health care establishment
for immediate transplantation in accordance with the
requirements set out in Article 28(i) of the principal Directive;

(c) the procurement of tissues and cells in accordance with the
requirements of this Part in respect of procurement
organisations; and

(d) the laboratories that carry out the tests required for donors in
accordance with this Part.

Suspension or revocation of authorisation.

7.(1) Subject to subsection (2), the competent authority may suspend or
revoke the authorisation of a tissue establishment in respect of a site or sites
or prescribed activity or both, on one or more of the following grounds–

(a) that the tissue establishment or process has not complied with
the requirements of this Part;

(b) that a prescribed activity has not been or cannot be carried out
pursuant to the requirements of this Part;

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(c) that any tissues or cells cannot be supplied to hospitals for
human application in such a state that they could be safely
used; or

(d) that the information given by the tissue establishment under
sections 6(4) and 19(3) was false or incomplete in any material
respect.

(2) Subject to subsection (3), before suspending or revoking the
authorisation of a tissue establishment, the competent authority shall serve
notice on the tissue establishment stating that it intends to suspend or revoke
the authorisation with effect from the date specified in the notice which
shall be not less than 7 days from the date on which the notice is served.

(3) Where the competent authority considers that it is necessary in the
interests of safety, it may, by a notice served on a tissue establishment,
suspend or revoke its authorisation with immediate effect.

(4) Where–

(a) the tissue establishment has failed, in any material respect, to
comply with the requirements of this Part; or

(b) the information given by the tissue establishment under
sections 6(4) and 19(3) was false or incomplete in any material
respect,

and the competent authority considers that the failure in question is not
sufficiently serious to warrant suspension or revocation of the authorisation
of the tissue establishment in the first instance, the competent authority may
serve a notice on the responsible person of the tissue establishment in
accordance with subsection (5).

(5) A notice served under this subsection shall–

(a) identify the requirements of this Part in respect of which the
tissue establishment has failed to comply with or, in the case of
false or incomplete information, the further information which
is required;

(b) identify the action which the tissue establishment is required to
take; and

(c) give the timescale within which the tissue establishment shall
take the action identified in paragraph (b).

(6) If the tissue establishment fails to comply with the requirements set
out in the notice within the specified timescale, the competent authority
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may, by a notice served on the tissue establishment, suspend or revoke the
authorisation of the tissue establishment.

(7) A suspension or revocation under subsection (6) shall take effect–

(a) in a case where the competent authority considers that it is
necessary in the interests of safety, immediately; or

(b) in all other cases, from a date specified in the notice.

(8) Any suspension under subsection (1) or (6) shall be for such period as
the competent authority shall consider necessary having regard to the
reasons for the suspension.

(9) The suspension or revocation of an authorisation under subsection (1)
or (6) may be total, or may be limited to a particular prescribed activity or to
one or more prescribed activities carried out at a particular site or sites, or to
a particular tissue or cell.

Responsible person for tissue establishment.

8.(1) Subject to subsection (2), a tissue establishment shall designate a
person who is responsible for the following functions–

(a) ensuring that all prescribed activities are carried out in
accordance with the requirements of this Part;

(b) providing information to the competent authority as required
under section 6; and

(c) the implementation in the tissue establishment of the
requirements under sections 9, 10, 11, 12, 14, 15, 16, 18, 19
and 20.

(2) A tissue establishment shall not designate a person under subsection
(1) unless that person has–

(a) a diploma, certificate or other evidence of formal qualification
in the field of medical or biological sciences awarded on
completion of–

(i) a university course of study; or

(ii) a course recognised as an equivalent course by the
competent authority; and

(b) practical post-graduate experience in areas of work relevant to
the responsibilities of the responsible person under this Part for
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at least 2 years, in an establishment (or more than one
establishment) in any Member State lawfully undertaking
activities related to the collection or testing (or both) of tissues
and cells, or to their procurement, storage and distribution.

(3) The competent authority shall, from time to time, publish in the
Gazette details of courses recognised by it for the purpose of subsection
(2)(a)(ii).

(4) Tissue establishments shall inform the competent authority of the
name of the responsible person referred to in subsection (1).

(5) The responsible person may delegate any of the functions specified in
subsection (1) to other persons who shall be qualified by training and
experience to perform them.

(6) Tissue establishments shall notify the competent authority of the name
of any persons to whom functions have been delegated by the responsible
person under subsection (5), and the specific functions which have been
delegated to such persons.

(7) Where the responsible person or a person to whom functions have
been delegated under subsection (5) is permanently or temporarily replaced,
the tissue establishment shall, without delay, provide the competent
authority with the name of the replacement, details of his qualifications and
the date on which the replacement began his duties.

(8) If the competent authority considers that the responsible person does
not meet the requirements of subsection (2), it shall serve a notice to that
effect on the tissue establishment.

(9) If, within 14 days of receiving a notice in accordance with subsection
(8), a tissue establishment is not able to demonstrate to the reasonable
satisfaction of the competent authority that the responsible person meets the
requirements of subsection (2), it shall, without delay–

(a) relieve him of the duties of responsible person in respect of the
tissue establishment;

(b) appoint a new responsible person in his place; and

(c) notify the competent authority that it has appointed a new
responsible person and provide details of the name and
qualifications of the person appointed.

Requirements for the procurement and supervision of procurement of
human tissues and cells.

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9.(1) Tissue establishments shall ensure that

(a) tissue and cell procurement and testing

(i) take place in conditions authorised for that purpose;

(ii) are carried out by persons with appropriate training and
expertise;

(b) the tests required for donors are carried out by a qualified
laboratory authorised by the competent authority; and

(c) the preparation process at the tissue establishment complies
with the requirements set out in Schedule 6.

(2) The competent authority shall ensure that the tissue and cell donation
and procurement procedures and the reception of tissues and cells at the
tissue establishment comply with the requirements set out in Schedule 4.

(3) A tissue establishment shall ensure that appropriate control measures
are in place for the procurement of tissues and cells.

(4) With the exception of partner donation of reproductive cells for direct
use, the competent authority shall authorise the procurement of human
tissues and cells only when the following requirements are met

(a) procurement of human tissues and cells shall be carried out by
persons who have successfully completed a training
programme specified by a clinical team specialising in the
tissues and cells to be procured, or a tissue establishment
authorised for procurement;

(b) the tissue establishment or procurement organisation shall have
written agreements with the staff or clinical teams responsible
for donor selection, unless they are employed by the same
organisation or establishment, specifying the procedures to be
followed to assure compliance with the selection criteria for
donors set out in Schedule 1;

(c) the tissue establishment or procurement organisation shall have
written agreements with the staff or clinical teams responsible
for tissue or cell procurement, unless they are employed by the
same establishment or organisation, specifying the type or
types of tissues or cells or test samples to be procured and the
protocols to be followed;

(d) there shall be Standard Operating Procedures (SOPs)

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(i) for the verification of

(aa) donor identity;

(bb) the details of donor or donor family consent or
authorisation;

(cc) the assessment of the selection criteria for
donors as detailed in section 13;

(dd) the assessment of the laboratory tests required
for donors as detailed in section 13;

(ii) describing the procedures for procurement, packaging,
labelling and transportation of the tissues and cells to the
point of arrival at the tissue establishment or, in the case
of direct distribution of tissues and cells, to the clinical
team responsible for their application, or in the case of
tissue or cell samples, to the laboratory for testing, in
accordance with Schedule 4;

(e) procurement shall take place in appropriate facilities, following
procedures that minimise bacterial or other contamination of
procured tissues and cells, in accordance with Schedule 4;

(f) procurement materials and equipment shall be managed in
accordance with the standards and specifications laid down in
point 1.3 of Schedule 4 and with due regard to relevant
national and international regulations, standards and guidelines
covering the sterilisation of medicines and medical devices.
Qualified, sterile instruments and procurement devices shall be
used for tissue and cell procurement;

(g) procurement of tissues and cells from living donors shall take
place in an environment that ensures their health, safety and
privacy;

(h) where appropriate, the staff and equipment necessary for body
reconstruction of deceased donors shall be provided. Such
reconstruction shall be completed effectively;

(i) the procedures for the procurement of tissues and cells shall be
carried out in accordance with the requirements specified in
Schedule 4;

(j) a unique identifying code shall be allocated to the donor and
the donated tissues and cells, during procurement or at the
tissue establishment, to ensure proper identification of the
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donor and the traceability of all donated material and the coded
data shall be entered in a register maintained for the purpose;

(k) donor documentation shall be maintained in accordance with
point 1.4 of Schedule 4.

Quality management and notification and reporting to the competent
authority of serious adverse events and reactions.

10.(1) A tissue establishment shall–

(a) establish and maintain a quality system based on the principles
of good practice and in accordance with the requirements set
out under Article 28(c) of the principal Directive;

(b) ensure that all testing and processes are validated;

(c) take all necessary measures to ensure that the quality system
includes at least documentation on the following

(i) SOPs,

(ii) guidelines,

(iii) training and reference manuals,

(iv) reporting forms,

(v) donor records, and

(vi) information on the final destination of tissues and cells,

and that this documentation is readily available for inspection
by the competent authority.

(2) Tissue establishments shall ensure that the data necessary to ensure
traceability are in accordance with section 16.

(3) Tissue establishments, through the responsible person, shall notify the
competent authority of, and provide the competent authority with, a report
analysing the cause of and ensuing outcome of

(a) any serious adverse events and reactions, which may influence
the quality and safety of tissues and cells and which may be
attributable to any prescribed activity; and

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(b) any serious adverse reactions observed during or after clinical
applications, which may be linked to the quality and safety of
tissues and cells.

(4) A tissue establishments, through the responsible person, shall
(a) ensure that an accurate, rapid and verifiable procedure is in
place, which will enable the establishment to recall from
distribution any product which may be related to any
notification referred to in subsection (3);

(b) keep a record of its activities, including the types and quantities
of tissues or cells or both procured, tested, preserved,
processed, stored and distributed, or otherwise disposed of, and
on the origin and destination of the tissues and cells intended
for human applications, in accordance with Schedule 4; and

(c) submit an annual report on its activities, which will be publicly
accessible, to the competent authority.

(5) All persons using human tissues and cells regulated by this Part shall
report any relevant information to establishments engaged in the donation,
procurement, testing processing, storage or distribution of human tissue and
cells in order to facilitate traceability and ensure quality and safety control.

Notification of serious adverse reactions.

11.(1) The competent authority shall ensure that

(a) procurement organisations 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 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 the quality
and safety of tissues and cells; and

(c) tissue establishments that distribute tissues and cells for human
application 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 paragraph (b).

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(2) The competent authority shall ensure that tissue establishments
(a) have procedures in place to communicate to the competent
authority without delay all relevant available information about
suspected serious adverse reactions as referred to in subsection
(1)(a) and (b); and

(b) have procedures in place to communicate to the competent
authority without delay the conclusion of the investigation to
analyse the cause and the ensuing outcome.

(3) The competent authority shall ensure that

(a) the responsible person designated under section 8 notifies the
competent authority of the information included in the notification
set out in Part A of Schedule 7;

(b) tissue establishments notify the competent authority of the actions
taken with respect to other implicated tissues and cells that have
been distributed for human applications; and

(c) tissue establishments notify the competent authority of the
conclusion of the investigation, supplying at least the information
set out in Part B of Schedule 7.

Notification of serious adverse events.

12. The competent authority shall ensure that

(a) procurement organisations and tissue establishments have
procedures in place to retain the records and to notify tissue
establishments without delay of any serious adverse events that
occur during procurement which may influence the quality or
safety or both of human tissues and cells;

(b) organisations responsible for human application of tissues and cells
have procedures in place to notify tissue establishments without
delay of any serious adverse events that may influence the quality
and safety of the tissues and cells; and

(c) tissue establishments provide to the organisation responsible for
human application information about how that organisation should
report serious adverse events to them that may influence the quality
and safety of the tissues and cells.

(2) In the case of assisted reproduction, any type of gamete or embryo
misidentification or mix-up shall be considered to be a serious adverse
event. All persons or procurement organisations or organisations
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responsible for human application performing assisted reproduction shall
report such events to the supplying tissue establishments for investigation
and notification to the competent authority.

(3) The competent authority shall ensure that tissue establishments

(a) have procedures in place to communicate to the competent
authority without delay all relevant available information about
suspected serious adverse events as referred to in subsection (1)(a)
and (b); and

(b) have procedures in place to communicate to the competent
authority without delay the conclusion of the investigation to
analyse the cause and the ensuing outcome.

(4) The competent authority shall ensure that

(a) the responsible person designated under section 8 notifies the
competent authority of the information included in the
notification set out in Part A of Schedule 8;

(b) tissue establishments evaluate serious adverse events to
identify preventable causes within the process; and

(c) tissue establishments notify the competent authority of the
conclusion of the investigation, supplying at least the
information set out in Part B of Schedule 8.

Donor selection, evaluation and testing criteria.

13.(1) Tissue establishments shall ensure that

(a) donors of tissues and cells, except donors of reproductive cells,
undergo the biological tests set out in point 1 of Schedule 2;

(b) the tests referred to in paragraph (a) are carried out in
compliance with the general requirements set out in point 2 of
Schedule 2;

(c) donors of reproductive cells undergo the biological tests set out
in points 1, 2 and 3 of Schedule 3; and

(d) the tests referred to in paragraph (c) are carried out in
compliance with the general requirements set out in point 4 of
Schedule 3.

(2) Tissue establishments shall ensure that donors comply with the
selection criteria set out in
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(a) Schedule 1 for donors of tissues and cells, except donors of
reproductive cells; and

(b) Schedule 3 for donors of reproductive cells.

(3) Tissues and cells shall not be procured unless the information required
under subsection (4) has been provided by the tissue establishment or
procurement organisation to the donor (in the case of a living adult donor)
or the next of kin (in the case of a deceased donor or a person who is unable
to give consent) and informed consent has been given for such procurement.

(4) The person in charge of the donation process in a tissue establishment
or procurement organisation, prior to the procurement of such tissues or
cells or both, in relation to living donors, shall ensure that–

(a) the donor, or the donor’s next of kin, (in the case of a person
who is unable to give consent) has been properly informed of
at least those aspects relating to the donation and procurement
process outlined in paragraph (c);

(b) the information is given by a trained person able to transmit it
in an appropriate and clear manner, using terms that are easily
understood by the donor;

(c) the information covers–

(i) the purpose and nature of the procurement, its
consequences and risks,

(ii) analytical tests, if they are performed,

(iii) recording and protection of donor data,

(iv) medical confidentiality,

(v) therapeutic purpose and potential benefits,

(vi) the applicable safeguards intended to protect the donor;

(d) the donor is informed that he has the right to receive the
confirmed results of the analytical tests, clearly explained; and

(e) information is given on the necessity for requiring the
applicable mandatory consent, certification and authorisation in
order that the tissue or cell or both procurement can be carried
out.

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(5) The person in charge of the donation and procurement processes in a
tissue establishment or procurement organisation, prior to the procurement
of such tissues or cells or both, in relation to deceased donors, shall ensure
that–

(a) all information is given and all necessary consents and
authorisations are obtained in accordance with this Part; and

(b) the confirmed results of the donor’s evaluation are
communicated and clearly explained to the relevant persons in
accordance with this Part.

(6) The tissue establishment or procurement organisation shall, in relation
to the donation and procurement of tissues and cells

(a) put and keep in place procedures for the evaluation of donors;

(b) apply selection and evaluation criteria for all donors of tissues
or cells or both in accordance with this section; and

(c) maintain records of the results of donor evaluations and tests
and report to donors any relevant abnormal findings from the
evaluations, and tests.

(7) In the case of autologous donation, the suitability criteria of the donor
shall be established in accordance with the requirements in point 2.1 of
Schedule 1.

Tissue and cell reception, processing, storage and distribution.

14.(1) Tissue establishments shall ensure that human tissue and cells and
associated documentation comply with the requirements set out in Schedule
4.

(2) Tissue establishments shall ensure that the reception of tissues and
cells at the tissue establishment complies with the requirements set out in
Schedule 4.

(3) Tissue establishments shall verify and record the fact that the
packaging of tissues and cells received complies with the requirements of
point 1.5 of Schedule 4.

(4) Tissues and cells that do not comply with point 1.5 of Schedule 4,
shall be discarded.

(5) Tissue establishments shall document the acceptance or rejection of
received tissues or cells.

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(6) Tissue establishments shall ensure that human tissues and cells are
correctly identified at all times. Each delivery or batch of tissues or cells
shall be assigned an identifying code, in accordance with section 16.

(7) Tissue establishments shall hold tissue and cells in quarantine until
such time as the requirements relating to donation, testing and information
have been met in accordance with section 13.

(8) Tissue establishments shall

(a) include in their SOPs all processes that affect quality and
safety and shall ensure that they are carried out under
controlled conditions;

(b) ensure that the equipment used, the working environment and
process design, validation and control conditions are in
compliance with the requirements in Article 28(h) of the
principal Directive;

(c) ensure that any modifications to the processes used in the
preparation of tissues and cells shall also meet the criteria laid
down in paragraphs (a) and (b) of this subsection;

(d) include in their SOPs special provisions for the handling of
tissue and cells to be discarded, in order to prevent the
contamination of other tissues or cells, the processing
environment or personnel;

(e) ensure that all procedures associated with the storage of tissues
and cells are documented in the SOPs and that the storage
conditions comply with the requirements under Article 28(h) of
the principal Directive;

(f) ensure that all storage processes are carried out under
controlled conditions;

(g) establish and apply procedures for the control of packaging and
storage areas, in order to prevent any situation arising that
might adversely affect the functioning or integrity of tissues
and cells; and

(h) not distribute processed tissues or cells until the requirements
laid down in this Part are met.

(9) 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 authorised in accordance with section 6 without prejudice to
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any Gibraltar law concerning the disposal of donated tissues or cells,
according to the consent pertaining to them.

(10) Tissue establishments shall ensure that personnel directly involved in
activities relating to the procurement, 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
principal Directive.

(11) Tissue establishments shall ensure–

(a) the quality and safety of tissues and cells during distribution;
and

(b) that distribution conditions comply with the requirements
referred to in Article 28(h) of the principal Directive.

Principles governing tissue and cell donation and voluntary unpaid
donation.

15.(1) The Government shall draw up guidelines setting out the conditions
under which promotion and publicity activities in support of the donation of
human tissues and cells may be carried out. Such guidelines shall include
appropriate restrictions or prohibitions on advertising the need for, or
availability of, human tissues and cells, with a view to offering or seeking
financial gain or comparable advantage.

(2) The guidelines referred to in subsection (1) shall endeavour to ensure
that the procurement of tissues and cells is carried out on a non-profit basis.

(3) Tissue establishments shall

(a) comply with guidelines laid down for the promotion and
publicity activities in support of the donation of human tissues
and cells; and

(b) make every effort to ensure voluntary and unpaid donations of
tissues and cells.

(4) Without prejudice to subsection (3), the tissue establishments may
make good the expenses and inconveniences related to the donation in
accordance with the guidelines.

Traceability and labelling of tissues and cells.

16.(1) Every tissue establishment shall ensure that it has in place an
effective and accurate system to uniquely identify, trace and label all tissues
and cells, which it procures, processes, stores or distributes, from donor to
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end user, or disposal, and vice versa, and this traceability will also apply to
all relevant data relating to products and materials coming into contact with
these tissues and cells.

(2) Every tissue establishment shall implement a donor identification
system which assigns a unique code to each tissue or cell donation and to
each of the products associated with it.

(3) A single European identifying code shall be allocated to all donated
material at the tissue establishment to

(a) ensure proper identification of the donor and the traceability of
all donated material; and

(b) provide information on the main characteristics and properties
of tissues and cells,

and the code shall incorporate at least the information set out in Schedule
11.

(4) Subsection (3) shall not apply to partner donation of reproductive
cells.

(5) Every tissue establishment must use a labelling system that contains
the information or references allowing a link to the information referred to
in Schedule 4 and Article 28(h) of the principal Directive.

(6) Every tissue establishment shall keep such records of the information
referred to in Schedule 4 and such additional records as are necessary–

(a) for the identification and traceability of each single tissue or
cell donation and each single tissue or cell unit and its
components (including tissues and cells which are imported
into the European Union), and products coming into contact
with these tissues and cells; and

(b) to ensure full traceability from donation and procurement,
processing or storage to the point of delivery to a hospital or
site, and at all stages, for a period of not less than 30 years after
clinical use, and data storage may also be in electronic form.

(7) Every tissue establishment shall ensure that the labelling,
documentation and packaging on each tissue or cell supplied by it, shall
conform to the requirements of this Part.

(8) Tissue establishments and organisations responsible for human
application shall retain the data set out in Schedule 10 for at least 30 years,
in an appropriate and readable storage medium.
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Import and export of human tissues and cells.

17.(1) The competent authority shall ensure that–

(a) all imports of tissues and cells from third countries; and

(b) all exports of tissues and cells to third countries,

are undertaken by authorised tissue establishments.

(2) Tissue establishments shall ensure that imported tissues and cells–

(a) can be traced from donor to the recipient and vice versa in
accordance with the procedures and requirements laid down by
section 16; and

(b) meet standards of quality and safety equivalent to those laid
down in this Part.

(3) Tissue establishments shall ensure that all exports to third countries
comply with the requirements of this Part.

(4) The competent authority may directly authorise the import or export
of–

(a) tissues and cells referred to in section 6(12)(b); and

(b) certain tissues and cells, in case of emergency.

(5) The competent authority shall take all necessary measures to ensure
that imports and exports of tissues and cells referred to in subsection (4)
meet the quality and safety standards equivalent to those laid down in this
Part.

Relations between tissue establishments and third parties.

18.(1) 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;
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(c) where a tissue establishment provides services to a tissue
establishment which is not authorised; and

(d) where a tissue establishment distributes tissue or cells
processed by third parties.

(2) Agreements between tissue establishments and third parties shall be
examined by the competent authority within the authorisation framework of
section 6.

(3) Tissue establishments shall evaluate and select third parties on the
basis of their ability to meet the standards laid down in this Part.

(4) Tissue establishments shall keep a complete list of the agreements
referred to in subsection (1) that they have established with third parties.

(5) Agreements between tissue establishments and third parties shall
specify the responsibilities of third parties and detailed procedures.

(6) Tissue establishments shall provide copies of agreements with third
parties at the request of the competent authority.

Objections to refusals of authorisation or suspension or revocation of
authorisation.

19.(1) A tissue establishment which objects to–

(a) the refusal of authorisation, or the imposition of any condition
under section 6(5); or

(b) any suspension or revocation of authorisation, or any notice
served, under section 6(8) or (7),

may notify the competent authority of its desire to make written
representations to, or to appear before and be heard by, a person appointed
by the competent authority for that purpose pursuant to subsection (3).

(2) Any notification of an objection under subsection (1) shall be made
within 14 days of service on the tissue establishment of the notice to which
the notification under subsection (1) relates.

(3) Where the competent authority receives a notification under subsection
(1), competent authority shall appoint a person to consider the matter.

(4) The person appointed under subsection (3) shall determine the
procedure to be followed with respect to the consideration of any objection.

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(5) The person appointed under subsection (3) shall consider any written
or oral objections made by the tissue establishment in support of its
objection, and shall make a recommendation to the competent authority.

(6) A recommendation made under subsection (5) shall be made in writing
to the competent authority, and a copy of it shall be sent to the tissue
establishment concerned, or to its nominated representative.

(7) The competent authority shall take into account any recommendation
made under subsection (5).

(8) Within 14 days of receipt of any recommendation made under
subsection (5), the competent authority shall inform the tissue establishment
whether it (the competent authority) accepts the recommendation and, if it
does not accept it, of the reasons for its decision.

(9) Subject to subsection (11), where the competent authority is notified of
an objection under subsection (1)(b) before the date upon which the
suspension or revocation or the notice is due to take effect, the suspension
or revocation or notice in respect of which the objection is made shall not
take effect until–

(a) the person appointed under subsection (3) has considered the
matter in accordance with the provisions of this section and
made a recommendation; and

(b) the competent authority has informed the tissue establishment
concerned of its decision with regard to the recommendation
under subsection (8).

(10) Subject to subsection (11), where the competent authority is notified
of an objection under subsection (1)(b), within the period specified in
subsection (2), to a suspension, revocation or other notice which has already
taken effect on the date the notification was made, the suspension,
revocation or notice in respect of which the objection is made shall cease to
have effect until–

(a) the person appointed under subsection (3) has considered the
matter in accordance with this section and made a
recommendation; and

(b) the competent authority has informed the tissue establishment
concerned of its decision with regard to the recommendation
under subsection (8).

(11) Subsections (9) and (10) shall not apply–

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(a) in relation to a suspension or revocation, which takes
immediate effect in accordance with section 7(3); or

(b) in any other case, where the competent authority determines
that it is necessary in the interests of public safety for the
suspension, revocation or notice to take effect on the date
originally specified, and serves a notice in writing to that effect
on the tissue establishment concerned.

Disclosure of information by tissue establishments and data protection.

20.(1) A tissue establishment shall ensure that all information, including
genetic information which is collected for the purposes of this Part is held
securely so that it is–

(a) available for the purpose of tracing donations;

(b) not disclosed except–

(i) in accordance with one or more of the requirements of
subsection (2); or

(ii) where it has been rendered anonymous so that donors
and recipients are no longer identifiable; and

(c) subject to safeguards against unauthorised additions, deletions
or modifications to donor files or deferral records and transfer
of information.

(2) The requirements of this section are–

(a) the disclosure is made in accordance with an order of a court or
is otherwise required by law;

(b) the disclosure is to an authorised person; or

(c) the disclosure is for the purpose of tracing a donation from
donor to recipient or recipient to donor.

(3) Where a disclosure is made to an authorised person under subsection
(2)(b), the authorised person shall not further disclose the information
received unless

(a) the disclosure is made in accordance with an order of a court or
is otherwise required by law;

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(b) the disclosure is to another authorised person or an officer of
the Gibraltar Health Authority where this is necessary for the
proper performance of any function of any such officer; or

(c) the information has been rendered anonymous so that the
donors are no longer identifiable.

(4) Where a disclosure is made under subsection (3), the person to whom
the disclosure is made shall not further disclose the information he receives
other than in accordance with the requirements of that subsection.

(5) The responsible person shall ensure that he puts in place procedures to
resolve data discrepancies.

(6) The responsible person shall ensure that the identity of the recipient is
not disclosed to the donor or his family and vice versa, without prejudice to
any provision of law on the conditions for disclosure, notably in the case of
gametes donation.

Inspections.

21.(1) The competent authority shall conduct a regular inspection of each
site of a tissue establishment, not less than once every 2 years, for the
purpose of ensuring that–

(a) the procedures and activities carried out by tissue
establishments comply with the requirements of this Part;

(b) documents or other records relating to the requirements of the
this Part are examined;

(c) problems relating to compliance with those requirements are
identified; and

(d) the site complies with the requirements of this Part.

(2) The competent authority may conduct such additional inspections of
tissue establishment sites or facilities of third parties, as the competent
authority considers necessary for the purpose of ensuring compliance with
the requirements of this Part.

(3) The competent authority may also serve a notice on a tissue
establishment requiring that it furnish the competent authority with such
information concerning its compliance with this Part and as shall be
specified in the notice within such period as shall be specified in the notice.

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(4) Any tissue establishment which receives a request for information in
accordance with subsection (3) shall provide the information requested
within the period specified in the notice.

(5) In the event of any serious adverse event or any serious adverse
reaction or suspicion thereof, the competent authority shall request such
information, conduct such inspections, or carry out control measures, in
accordance with this section, as it shall consider appropriate.

(6) Any reference to an inspection of a site which the competent authority
is required or empowered to conduct by virtue of this section, shall be
construed so as to include an inspection of premises within a Member State
at which any of the prescribed activities are carried out by any person on
behalf of, and pursuant to a contractual arrangement with, a tissue
establishment.

(7) The competent authority’s functions under this section in relation to a
tissue establishment are also applicable in the case of a tissue establishment
seeking authorisation under section 6.

(8) The competent authority, on receipt of a duly justified request from the
competent authority in a Member State, shall organise such inspection or
carry out control measures.

(9) The competent authority shall, upon the request of a Member State, or
the Commission, provide information on the results of inspections and
control measures carried out, in relation to the requirements of this Part.

Authorised persons.

22.(1) The competent authority–

(a) may appoint such and so many persons as it (the competent
authority) thinks fit to be authorised persons for the purposes
of this Part; and

(b) shall furnish each such authorised person with a warrant of the
authorised person’s appointment.

(2) An authorised person shall, when performing a function imposed
under this Part on an authorised person, produce his warrant for inspection
if requested to do so by a person affected by the performance of that
function.

(3) For the purposes of enforcing compliance with this Part or conducting
inspections under section 19, an authorised person may–

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(a) subject to subsection (5), enter (if necessary by the use of
reasonable force), at all reasonable times, any premises at
which he has reasonable grounds to believe that it is necessary
to visit, including–

(i) any premises owned or managed by a tissue
establishment, or at which the tissue establishment
carries out any prescribed activities,

(ii) any premises of any person who carries out any
prescribed activities on behalf of, and pursuant to a
contractual arrangement with a tissue establishment,

(iii) where any facilities for donor evaluation and testing are
in the premises of any person other than a tissue
establishment, those facilities in that person’s premises,
and

(iv) any premises at which books, records or other documents
(including documents stored in non-legible form)
relating to any prescribed activities are stored or kept,

(b) at such premises inspect and take copies of, any books, records,
other documents (including documents stored in non-legible
form) or extracts therefrom, which he finds in the course of his
inspection;

(c) remove any such books, records or other documents from such
premises and detain them for such period as he reasonably
considers to be necessary for the purposes of his functions
under this Part;

(d) carry out, or have carried out, such tests, examinations,
analyses, inspections and checks of–

(i) the premises,

(ii) any relevant thing at the premises, or

(iii) any equipment, machinery or plant at the premises, as he
reasonably considers to be necessary for the purposes of
his functions under this Part;

(e) require any person at the premises or the owner or person in
charge of the premises and any person employed there to give
to him such assistance and information and to produce to him
such books, records or other documents (and in the case of
documents stored in non-legible form, produce to him a legible
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reproduction thereof) that are in that person’s power or
procurement, as he may reasonably require for the purposes of
his functions under this Part;

(f) without payment, take samples of any relevant thing found at
the premises for the purposes of any test, examination or
analysis;

(g) direct that such relevant thing found at the premises as he,
upon reasonable grounds, believes does not comply with the
requirements of this Part not be sold or distributed or moved
from the premises, without his consent;

(h) secure for later inspection any premises or part of any premises
in which a relevant thing is found or ordinarily kept, or books,
records or other documents are found or ordinarily kept, for
such period as may reasonably be necessary for the purposes of
his functions under this Part;

(i) without payment, take possession of and remove from the
premises for any test, examination or analysis any relevant
thing found there, and detain it for such period as he considers
reasonably necessary for the purposes of performing his
functions under this Part;

(j) without payment, take samples of any relevant thing, detained
under paragraph (i), for the purposes of any test, examination,
or analysis; or

(k) where the taking of samples of any relevant thing under
paragraph (f) or (j) is, for whatever reason, not practicable,
without payment take the relevant thing concerned for the
purposes of any test, examination or analysis.

(4) In performing a function under this Part, an authorised person may,
subject to any warrant under subsection (6), be accompanied by any–

(a) other authorised person; or

(b) persons with expertise relating to any relevant thing, as he
considers appropriate in the circumstances of the case.

(5) An authorised person shall not enter a dwelling, other than–

(a) with the consent of the occupier; or

(b) in accordance with a warrant issued under subsection (6).

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(6) Upon the application of an authorised person, the Stipendiary
Magistrate, if satisfied that there are reasonable grounds for believing that–

(a) a relevant thing is to be found in any dwelling, or is being or
has been subjected to any process or stored in any dwelling;

(b) books, records or other documents (including documents stored
in non-legible form) referred to in subsection (3)(a)(iv) are
being stored or kept in any dwelling; or

(c) a dwelling is occupied in whole or in part by an undertaking
carrying out any prescribed activity,

may issue a warrant authorising a police officer accompanied by the
applicant and such other authorised persons or persons with expertise
relating to any relevant thing, as may be necessary, at any time or times,
within one month of the date of issue of the warrant, to enter the dwelling
and perform any of the functions of an authorised person under paragraphs
(b) to (k) of subsection (3).

(7) Where a police officer or an authorised person, upon reasonable
grounds, believes that a person has committed an offence under this Part, he
may require that person to provide him with his name and the address at
which he ordinarily resides.

(8) A statement or admission made by a person pursuant to a requirement
under subsection (3)(e) shall not be admissible as evidence in proceedings
brought against that person for an offence (other than an offence under
section 26(6)).

(9) Nothing in this section shall be taken to compel the production by any
person of a document of which he would be exempt from production in
proceedings in a court on the ground of legal professional privilege.

Taking of samples by authorised persons.

23.(1) Subject to subsection (3), where an authorised person takes a sample
of a relevant thing, he shall–

(a) divide the sample into 3 approximately equal parts;

(b) place each part into separate containers; and

(c) forthwith seal and mark each such container in such a manner
as to identify it as part of the sample taken by that authorised
person.

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(2) Where an authorised person has complied with subsection (1), he
shall–

(a) offer one of the sealed containers to the owner or person for the
time being in charge or possession of the relevant thing from
which the sample concerned was taken;

(b) retain one of the sealed containers; and

(c) forward, or cause to be forwarded, the other sealed containers
for test, examination or analysis of the sample.

(3) Where a relevant thing is contained in a container and its division into
parts under subsection (1) is, for whatever reason, not practicable, an
authorised person, who wishes to take samples of such relevant things for
the purposes of any test, examination or analysis, shall take possession of 3
such containers belonging to the same batch, and each such container shall
be deemed to be part of a sample for the purposes of subsection (1), and
subsections (1) and (2) shall apply to it accordingly.

(4) Where an authorised person takes a relevant thing under section
22(3)(k), he shall–

(a) place the relevant thing in a container; and

(b) forthwith seal and mark the container in such a manner as to
identify it as a relevant thing taken pursuant to that section.

Records to be kept by the competent authority.

24.(1) The competent authority shall keep such records of information
which the competent authority receives from, or relating to, tissue
establishments as are considered appropriate in accordance with section 14
and shall, in particular, keep records relating to–

(a) authorisations under section 6;

(b) the designation of responsible persons under section 8; and

(c) notification of serious adverse events and serious adverse
reactions by tissue establishments under section 10(3); and

(d) inspections or requests for information under section 19.

(2) The competent authority shall maintain a publicly accessible register
of tissue establishments, specifying the activities for which the
establishments have been authorised.

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(3) The competent authority shall provide the assistance necessary to
enable the Commission to establish a network linking all the tissue
establishment registers in the Union.

Communication of information between competent authorities and to
the Commission.

25. The competent authority shall ensure that such information as is
appropriate with regard to serious adverse reactions and events is
communicated to the competent authorities of Member States and to the
Commission in order to guarantee that adequate actions are taken.

Offences and penalties.

26.(1) A person who contravenes any of the provisions of section 5(1),
6(9), 8 (other than subsection (3)), 9, 10, 11, 12, 15(3), 16 (other than
subsection (3)), 17(3) or 19 (4) shall be guilty of an offence and liable on
summary conviction to a fine not exceeding level 4 on the standard scale, or
to imprisonment for a term not exceeding 6 months, or to both.

(2) Any person who fails to comply with a notice of suspension or
revocation of the person’s authorisation served under section 7, except
where the operation of that notice has been suspended under section 19 or
has been withdrawn or revoked by the competent authority, shall be guilty
of an offence and liable on summary conviction to a fine not exceeding level
3 on the standard scale, or to a term of imprisonment not exceeding 6
months, or to both.

(3) Any person who knowingly supplies tissue or cells which are not
labelled in accordance with the requirements of section 16(3) shall be guilty
of an offence and liable on summary conviction to a fine not exceeding level
2 on the standard scale, or to a term of imprisonment not exceeding 3
months, or to both.

(4) Any person who–

(a) contravenes section 20; or

(b) discloses any information referred to in section 20(1) to which
he has access by virtue of this Part, otherwise than in
accordance with the provision of section 20(2) and (3),

shall be guilty of an offence and liable on summary conviction to a fine not
exceeding level 2 on the standard scale, or to a term of imprisonment not
exceeding 3 months, or to both.

(5) Any person who–

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(a) obstructs or interferes with an authorised person or a person
with expertise relating to any relevant thing (within the
meaning of section 2), in the course of performing a function
conferred on him by this Part or a warrant under section 22(6);
or

(b) impedes the performance by the authorised person or person
with expertise, of such function or fails or refuses to comply
with a request or requirement of, or to answer a question asked
by, the authorised person or person with expertise, under
section 22;

(c) in purported compliance with such request or requirement or in
answer to such question gives information to the authorised
person or person with expertise, that he knows to be false or
misleading in any material respect,

shall be guilty of an offence and liable on summary conviction to a fine not
exceeding level 2 on the standard scale, or to imprisonment for a term not
exceeding 3 months, or to both.

(6) A person who falsely represents himself to be an authorised person
shall be guilty of an offence and liable on summary conviction to a fine not
exceeding level 2 on the standard scale, or to imprisonment for a term not
exceeding 3 months, or to both.

(7) Nothing in subsection (5)(b) shall be construed as requiring any person
to answer any question or to give any information if to do so might
incriminate him or, in the case of a person who is married, his or her spouse.

(8) On conviction for an offence under this Part (including an offence
under section 27), the court may, in addition to any other penalty–

(a) order any relevant thing (within the meaning of section 2) to
which the offence relates to be forfeited to the competent
authority for destruction or other disposal as the competent
authority thinks fit;

(b) upon application made to it by or on behalf of the competent
authority, order the person convicted of the offence to pay to
the relevant person all or part of the costs of such destruction
or other disposal subject to such conditions, if any, as are
specified in the order.

Offence to import below standard tissues and cells into Gibraltar.

27. Any person who imports into Gibraltar any tissues or cells (including
tissues or cells intended for use as a starting material or raw material in
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manufactured products) from a country or territory outside the European
Union which do not meet standards of quality and safety equivalent to those
laid down in this Part is guilty of an offence and liable on summary
conviction to a fine not exceeding level 4 on the standard scale, or to
imprisonment for a term not exceeding 6 months, or to both.

Reports by the competent authority.

28.(1) The competent authority shall ensure that, as soon as practicably
possible after the coming into operation of this Part, a report is sent to the
Commission on the activities undertaken in relation to the provisions of this
Part, including an account of the measures taken in relation to inspection
and control. A further such report shall be sent to the Commission on 7
April 2012 and thereafter at regular intervals of three years.

(2) The competent authority shall–

(a) ensure that each year, and by 30 June of the following year, a
report is submitted to the Commission on the notification of
serious adverse reactions and events received by the competent
authority; and

(b) make this report available to tissue establishments.

(3) Any data transmission under this Part shall–

(a) comply with the data exchange format specifications as set out
in Schedule 9, Part A and B; and

(b) provide all the information necessary to identify the sender and
maintain its reference data.

PART 2
HUMAN ORGANS

Subject matter and application of this Part.

28A.(1) This Part sets the standards of quality and safety for human organs
intended for transplantation to the human body, in order to ensure a high
level of human health protection.

(2) This Part applies to the donation, testing, characterisation,
procurement, preservation, transport and transplantation of human organs
intended for transplantation.

(3) Where human organs are used for research purposes, this Part only
applies where they are intended for transplantation into the human body.

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Interpretation of Part 2.

28B. In this Part, unless the context otherwise requires−

“Authority” means the competent authority within the meaning of section
1B;

“designated individual”, in relation to a licence under section 28E, means
the individual designated in the licence as the person under whose
supervision the licensed activity is authorised to be carried on;

“disposal” means the final placement of an organ where it is not used for
transplantation;

“donation” means donating organs for the purposes of transplantation;

“donor” means a person who donates one or several organs, whether
donation occurs during lifetime or after death;

“donor characterisation” means the collection of relevant information on
the characteristics of the donor needed to evaluate the donor’s
suitability for organ donation, in order to undertake a proper risk
assessment and to minimise the risks for the recipient, and optimise
organ allocation;

“duly authorised person”, in the context of any provision, means a person
authorised by the Authority to act for the purposes of that
provision;

“European organ exchange organisation” means a non-profit
organisation, whether public or private, dedicated to national and
cross-border organ exchange, in which the majority of its member
countries are Member States;

“licence holder” means a person who holds a licence granted under
section 28E;

“licensed activity”, in relation to a licence, means an activity which the
licence authorises under section 28E;

“organ” means a differentiated part of the human body, formed by
different tissues, that maintains its structure, vascularisation, and
capacity to develop physiological functions with a significant level
of autonomy and a part of an organ is also considered to be an
organ if its function is to be used for the same purpose as the entire
organ in the human body, maintaining the requirements of structure
and vascularisation;

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“organ characterisation” means the collection of the relevant information
on the characteristics of the organ needed to evaluate its suitability
for transplantation, in order to undertake a proper risk assessment
and minimise the risks for the recipient, and optimise organ
allocation;

“Organ Directive” means Directive 2010/53/EU of the European
Parliament and of the Council of 7 July 2010 on standards of
quality and safety of human organs intended for transplantation as
amended from time to time;

“operating procedures” means written instructions describing the steps in
a specific process, including the materials and methods to be used
and the expected end outcome;

“preservation” means the use of chemical agents, alterations in
environmental conditions or other means to prevent or retard
biological or physical deterioration of organs from procurement to
transplantation;

“procurement” means a process by which a donated organ becomes
available for transplantation;

“procurement activity” means any of the following activities, undertaken
for the purposes of procurement−

(a) donor characterisation;

(b) organ characterisation;

(c) preservation of an organ;

(d) making arrangements to transport an organ; or

(e) retrieval of an organ;

“procurement organisation” means a healthcare establishment, a team or
a unit of a hospital, a person, or any other body which undertakes
or coordinates the procurement of organs, and is authorised to do
so by the Authority;

“recipient” means a person who receives a transplant of an organ;

“serious adverse event” means any undesired and unexpected occurrence
associated with any stage of the chain from donation to
transplantation that might lead to the transmission of a
communicable disease, to death or life-threatening, disabling or
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incapacitating conditions for patients or which results in, or
prolongs, hospitalisation or morbidity;

“serious adverse reaction” means an unintended response, including a
communicable disease, in the living donor or in the recipient that
might be associated with any stage of the chain from donation to
transplantation that is fatal, life-threatening, disabling,
incapacitating, or which results in, or prolongs, hospitalisation or
morbidity;

“traceability” means the ability to locate and identify the organ at each
stage in the chain from donation to transplantation or disposal,
including the ability to−

(a) identify the donor and the licence holder who retrieved the
organ from the donor;

(b) identify the licence holder who implanted the organ in the
recipient;

(c) identify the recipient at the premises that the organ is
implanted into the recipient; and

(d) locate and identify all relevant non-personal information
relating to products and materials coming into contact with that
organ;

“transplantation” means a process which is intended to restore certain
functions of the human body by transferring an organ from a donor
to a recipient; and

“transplantation activity” means any of the following activities,
undertaken for the purposes of transplantation−

(a) donor characterisation;

(b) organ characterisation;

(c) preservation of an organ;

(d) making arrangements to transport an organ; or

(e) implantation of an organ;

“transplantation centre” means a healthcare establishment, a team or a
unit of a hospital or any other body which undertakes the
transplantation of organs and is authorised to do so by the
Authority.
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Framework and compliance with licensing conditions and directions.

28C.(1) The Authority shall establish and keep updated a Framework which
shall specify how the requirements for the quality and safety of organs for
transplantation shall be ensured to secure compliance with the Organ
Directive.

(2) The Framework shall–

(a) cover all stages of the chain from donation to transplantation or
disposal; and

(b) include information about the−
(i) procurement activities and transplantation activities that
are required to be carried on under the authority of a
licence granted under section 28E,

(ii) licensing application process,

(iii) requirements that licensees must comply with, including
the licensing conditions and any directions that the
Authority has given under section 28H(4) to (7), and
(iv) guidance that the Authority has given under section
28H(1) to (3).
(3) The Framework shall provide for the adoption and implementation of
operating procedures for−

(a) the verification of donor identity;

(b) the verification of the details of the donor's or the donor's
family's consent, authorisation or absence of any objection;

(c) the verification of the completion of the organ and donor
characterisation;

(d) the procurement, preservation, packaging and labelling of
organs;

(e) the transportation of organs;

(f) ensuring traceability, guaranteeing compliance with the
European Union and Gibraltar provisions on the protection of
personal data and confidentiality;

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(g) the accurate, rapid and verifiable reporting of serious adverse
events and reactions; and

(h) the management of serious adverse events and reactions,

in accordance with the provisions in this Part.

(4) The operating procedures referred to in paragraphs (f), (g) and (h) shall
specify, inter alia, the responsibilities of procurement organisations,
European organ exchange organisations and transplantation centres.

(5) The Authority shall–

(a) ensure that the healthcare personnel involved at all stages of
the chain from donation to transplantation or disposal are
suitably qualified or trained and competent; and

(b) develop specific training programmes for such personnel.

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Licensing requirement for procurement and transplantation activity.

28D.(1) No person shall carry out a procurement activity or a
transplantation activity otherwise than under the authority of a licence
granted under section 28E.

(2) A person who contravenes subsection (1) commits an offence unless
that person reasonably believes that−
(a) the activity being undertaken is not an activity to which
subsection (1) applies; or

(b) he is acting under the authority of a licence granted under
section 28E.

Granting of licences.

28E.(1) The Authority may, on the application of any person, grant a
licence for the purposes of section 28D.

(2) A licence granted under subsection (1) must−
(a) designate an individual as the designated individual; and

(b) not authorise a procurement activity or a transplantation
activity to be carried on under the supervision of more than one
such individual.

(3) A licence granted under this section must include at least the following
conditions−

(a) that the licensed activities shall be carried on only under the
supervision of the designated individual;

(b) that the procurement activity or the transplantation activity−
(i) shall have in place operating procedures for the
management of a serious adverse event or a serious
adverse reaction,

(ii) shall ensure to rapidly report to the Authority−
(A) any serious adverse event that may influence
the quality and safety of an organ, or any
serious adverse reaction observed during or
after transplantation, which may be attributed
to the testing, characterisation, procurement,
preservation and transport of an organ, and
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(B) the management measures taken with regard to
such a serious adverse event or reaction;
(c) that the healthcare personnel directly involved in the chain
from donation to the transplantation or disposal of an organ are
suitably qualified or trained and competent to perform their
tasks and are provided with relevant training;

(d) that training programmes are developed for the personnel
referred to in subparagraph (c);

(e) that the data required to ensure the traceability of organs is kept
for 30 years from the date of the retrieval of the organ;

(f) to comply with the Data Protection Act 2004; and

(g) to have in place operating procedures demonstrating how the
requirements in paragraphs (b), (e) and (f) shall be complied
with.

(4) A licence granted under this section must require for a procurement
activity−

(a) that medical activities are performed under the advice and
guidance of a registered medical practitioner;

(b) that procurement material and equipment which could affect
the quality and safety of an organ are managed in accordance
with relevant European Union or other international obligations
and Gibraltar legislation, standards and guidelines on the
sterilisation of medical devices; and

(c) to have in place operating procedures demonstrating how the
requirements in paragraphs (a) and (b) shall be complied with.

(5) It shall be a condition of a licence for the procurement activity of
retrieval of an organ−

(a) that the retrieval take place in an operating theatre which is
designed, constructed, maintained and operated in accordance
with adequate standards and best medical practices so as to
ensure the quality and safety of the organs procured;

(b) to make endeavours to follow-up a living donor for the
purposes of identifying and managing any event potentially
relating to the quality and safety of the donated organ and any
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serious adverse reaction in the living donor that may result
from the donation;

(c) to identify, report to the Authority, and manage any event or
reaction referred to in paragraph (b); and

(d) to have in place operating procedures demonstrating how the
requirement in paragraph (a) shall be complied with.

(6) A licence granted under this section must require for a procurement
activity or transplantation activity of donor characterisation or organ
characterisation to ensure−

(a) that a registered medical practitioner, or a person acting under
the supervision of a registered medical practitioner, has
endeavoured to obtain−

(i) all necessary information from the living person and for
that purpose has provided that person with the
information that person needs to understand the
consequences of donation, or

(ii) where possible and appropriate in the case of a deceased
donor, such information from relatives of the deceased
donor or other persons and has explained to such persons
the importance of swift transmission of that information;

(b) subject to subsection (8), that donors and organs are
characterised before implantation by−
(i) the collection of at least the information specified in Part
A of Schedule 12, and

(ii) where considered appropriate by a registered medical
practitioner, or a person acting under the supervision of a
registered medical practitioner, the collection of the
information specified in Part B of Schedule 12;
(c) that tests required for donor and organ characterisation are
carried out by laboratories with suitably qualified or trained
and competent personnel and adequate facilities and
equipment; and

(d) that any organisation, body or laboratory involved in organ and
donor characterisation has appropriate operating procedures in
place to ensure that information on organ and donor
characterisation reaches the person who will be implanting an
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organ in a recipient within a time period that would not
compromise the quality and safety of the organ.

(7) It shall be a condition of a licence for the transplantation activity of
implantation−

(a) that, subject to subsection (8), the following are verified before
proceeding to implant an organ in a recipient−

(i) identification and consent of the donor,

(ii) the collection of information prescribed in subsection
(6)(b), and

(iii) compliance with the conditions in subsection (9) about
the preservation and transportation of shipped organs;
and
(b) to have in place operating procedures demonstrating how the
requirements in paragraph (a)(i) and (ii) shall be complied
with.

(8) Where any of the information specified in Part A of Schedule 12 is not
available, it shall be a licensing condition for the transplantation activity of
implantation to be permissible following the conduct of a risk-benefit
analysis to determine whether the expected benefits for the recipient of the
organ outweigh the risks posed by the lack of any information and the
particular circumstances of the case.

(9) It shall be a condition of a licence for a procurement activity or a
transplantation activity making arrangements to transport an organ−
(a) that appropriate procedures are in place to ensure the integrity
of the organ during transport and that the transport time is
suitable to ensure the quality and safety of the organ;

(b) that, subject to subsection (10), the shipping containers used
for transporting organs are labelled with the following
information−

(i) identification of the licence holder who retrieved the
organ and the place where the retrieval took place,
including their addresses and telephone numbers,

(ii) identification of the place that an organ will be implanted
in a recipient, including its address and telephone
number,

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(iii) a statement that the package contains an organ,
specifying the type of organ and, where applicable, its
left or right location and marked “HANDLE WITH
CARE”, and

(iv) recommended transport conditions, including
instructions for keeping the container at an appropriate
temperature and position;

(c) that the organs transported are accompanied by a report on the
organ and donor characterisation; and
(d) to have in place operating procedures demonstrating how the
requirements in subparagraphs (a) to (c) shall be complied
with.

(10) The conditions in subsection (9)(b) do not apply where transportation
is carried out in the same establishment.

(11) The Authority shall specify in the licence granted under this section
as to which procurement activity or transplantation activity a licence holder
may undertake.

(12) The Authority shall permit a person making an application for two or
more−

(a) procurement activities;

(b) transplantation activities; or

(c) procurement activities and transplantation activities,

to make a single application in respect of the activities.

Preconditions to grant of a licence.

28F.(1) The Authority may not grant a licence under section 28E unless the
requirements set out in this section are met.

(2) In the application for a licence, an individual must be designated who
shall−
(a) be the applicant for the licence; or

(b) consent to an application for a licence.

(3) The Authority must be satisfied that the proposed designated
individual−
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(a) is a suitable person to supervise the activity to be authorised by
the licence;

(b) will perform the duty imposed by section 28E;

(c) either−

(i) has a diploma, certificate or other evidence of formal
qualification in the fields of medical or biological
sciences awarded on completion of a university course of
study, or other courses of study recognised in Gibraltar
as equivalent, or

(ii) is otherwise considered by the Authority to be suitably
qualified on the basis of academic qualification and
practical experience; and
(d) has at least two years’ practical experience which is directly
relevant to the activity to be authorised by the licence.
(4) Where the applicant for the licence is not the proposed designated
individual, the Authority must be satisfied that the applicant is a suitable
person to be the holder of the licence.

(5) The Authority must be satisfied that the premises in which an
applicant seeks to carry out the procurement activity of retrieval or the
transplantation activity of implantation are suitable for the carrying out of
that activity and it complies with the provisions of this Part and the Organ
Directive.

(6) The Authority must be satisfied that the applicant meets−
(a) the relevant conditions in section 28E and will continue to do
so; and

(b) any other conditions or requirements that the Authority has
imposed.

(7) A copy of the conditions to be imposed by the licence must have been
shown to, and acknowledged in writing by−

(a) the applicant for the licence; and

(b) where different, the proposed designated individual.

(8) In this section, references to the proposed designated individual are to
the individual whom the application proposes that the licence should
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designate as the person under whose supervision the activity to be
authorised is to be carried on.

(9) It shall be the duty of a designated individual to secure that−
(a) the other persons to whom the licence applies are suitable
persons to participate in the carrying-on of the licensed
activity;

(b) suitable practices are used in the course of carrying on that
activity; and

(c) conditions of the licence are complied with.

(10) The designated individual and licence holder shall take all necessary
measures to ensure the highest possible protection of living donors in order
to fully guarantee the quality and safety of organs for transplantation.

Consequences of failure, etc.

28G.(1) Where an inspection under this Part demonstrates that the
designated person or the licence holder has failed to comply with the
conditions of the licence, the Authority may−

(a) suspend the licence for a period not exceeding 6 months;

(b) withdraw the licence permanently; or

(c) prohibit the licence holder from carrying on any licensed
activity until the failures or defects are remedied.

(2) The Authority shall not take any action under subsection (1) unless the
licence holder and the designated individual are given a notice to show
cause within seven days and his explanations are considered.

(3) A person aggrieved by a decision of the Authority under this section
may appeal to the Supreme Court within thirty days and the decision of the
Supreme Court shall be final.

Guidance and directions.

28H.(1) The Authority shall publish such guidance to licence holders,
designated individuals, and healthcare personnel referred to in section
28E(3)(c) as it considers necessary to ensure compliance with the Organ
Directive.

(2) The Authority shall keep the guidance published under subsection (1)
under review and prepare revised guidance when it considers necessary.
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(3) The Authority shall publish the guidance under this section in such a
way as, in its opinion, is likely to bring it to the attention of licensees.

(4) A guidance published under this section must include guidance for the
collection of relevant post-transplantation information to evaluate the
quality and safety of the organs transplanted.

(5) The Authority may give directions for any purpose for which
directions may be given under this Part.

(6) Any power under this Part to give directions–
(a) includes power to vary or revoke directions given in previous
exercise of the power; and

(b) is exercisable by instrument in writing.

(7) Directions under this Part–
(a) to a particular person, shall be given by serving notice of the
directions on the person; and

(b) in respect of any licence (including one which has ceased to
have effect) may be given−

(i) by serving notice of the directions on the person who is
(or was immediately before the cessation) the designated
individual or holder of the licence, or

(ii) if it appears to the Authority that it is not practicable to
give notice in that way, by publishing the directions in
such way as, in its opinion, is likely to bring them to the
attention of the persons to whom they are applicable.

(8) Directions under this Part which appear to the Authority to be general
directions may be given by publishing them as mentioned in subsection (7)
(b)(ii).

Records, reports and information.

28I.(1) The Authority shall−

(a) in accordance with the provisions of the Data Protection Act
2004 and any applicable European Union measure, keep a
record of activities that licence holders are carrying on, which
shall include−
(i) the aggregate number of living and deceased donors, and
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(ii) the types and quantities of organs procured and
transplanted, or otherwise disposed of;

(b) publish an annual report on the activities referred to in
paragraph (a); and

(c) establish and keep updated a record of persons who carry out a
procurement activity or a transplantation activity.

(2) The Authority shall, upon the request of the Commission or any
Member State provide information on–

(a) the requirements in Gibraltar for the authorisation of–

(i) procurement organisations;

(ii) transplantation centres; and

(b) the record of procurement organisations and transplantation
centres.

The principles of organ donation.

28J.(1) The Authority shall ensure that every donation of organs from a
deceased or a living person must be voluntary and unpaid.

(2) A living donor may be paid compensation to make good the expenses
and loss of income related to the donation which must not be such as to
become financial incentives or benefit for a potential donor.

(3) No person shall advertise the need for, or availability of, organs where
that advertisement is with a view to offering or seeking financial gain or a
comparable advantage.

(4) The Authority shall ensure that the procurement of organs is carried
out on a non-profit basis.

The quality and safety of living donation.

28K.(1) Every living donor must be selected by suitably qualified or trained
and competent professionals on the basis of an assessment of the health and
medical history of that living donor.

(2) An assessment referred to in subsection (1) may provide for the
exclusion of persons whose donation could present unacceptable health
risks.

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(3) The Authority shall keep a record or register of living donors for the
purposes of ensuring the follow up of living donors, in accordance with the
Data Protection Act 2004 and any applicable European Union measure
relating to the protection of personal data and statistical confidentiality.

(4) The Authority shall make arrangements which−
(a) ensure that reasonable endeavours are made to follow-up all
living donors for the purposes of identifying and managing any
event potentially relating to the quality and safety of the
donated organ and any serious adverse reaction in the living
donor that may result from the donation; and

(b) identify, report and manage any event or reaction identified
under paragraph (a).
(5) In subsection (4), a relevant donor means a living donor from whom
the person who has ceased to be licensed retrieved an organ.

(6) The provisions of this section shall be applied so as to ensure the
highest possible protection of living donors in order to fully guarantee the
quality and safety of organs for transplantation.

Serious adverse events and serious adverse reactions.

28L.(1) The Authority shall ensure that there is a reporting system in place
to report, investigate, register and transmit relevant and necessary
information concerning serious adverse events that may influence the
quality and safety of organs and that may be attributed to the testing,
characterisation, procurement, preservation and transport of organs, as well
as any serious adverse reaction observed during or after transplantation
which may be connected to those activities.

(2) For the purposes of subsection (1), the Authority shall ensure that there
is an operating procedure in place for the management of serious adverse
events and reactions as provided for in the framework for quality and safety.

(3) The operating procedure referred to in subsection (2) must include a
system for the notification, in due time, of−

(a) any serious adverse event and reaction to the Authority and to
the concerned procurement organisation or transplantation
centre; and

(b) the management measures with regard to serious adverse
events and reactions to the Authority.

(4) For the purposes of this section, when a licence holder reports a
serious adverse event or a serious adverse reaction to the Authority, or the
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Authority is otherwise made aware of such an event or reaction, the
Authority shall−
(a) rapidly notify that information to such persons that the
Authority considers may be affected by that information;

(b) investigate the matter where the Authority considers that an
investigation will promote the quality and safety of organs; and

(c) register that information.

(5) There shall be an interconnection between the reporting system
established under this section and the notification system established in
accordance with sections 11 and 12.

Traceability.

28M.(1) The Authority shall ensure that a traceability system is established
for the purposes of ensuring−

(a) that all organs procured, allocated and transplanted in Gibraltar
can be traced from the donor to the recipient and vice versa in
order to safeguard the health of donors and recipients; and

(b) notification of serious adverse events or reactions in
accordance with section 28L(1)(a).

(2) The Authority shall ensure–
(a) the implementation of a donor and recipient identification
system in Gibraltar that can identify each donation and each of
the organs and recipients associated with it; and

(b) that confidentiality and data security measures are in place with
regard to such a system n compliance with European Union
law and the Data Protection Act 2004.

(3) The Authority shall ensure that−

(a) any person who is licensed to carry out a procurement activity
or a transplantation activity that is involved in the chain from
donation to transplantation or disposal keeps the data needed to
ensure traceability at all stages of the chain from donation to
transplantation or disposal and the information on organ and
donor characterisation as specified in Schedule 12, in
accordance with the framework for quality and safety;

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(b) data required for full traceability is kept for a minimum of 30
years after donation and that data may be stored in electronic
form.

(4) Where any person who is licensed to carry out a procurement activity
or a transplantation activity ceases to be licensed, the Authority shall make
arrangements to ensure that the data collected by that person under the
licensing condition pursuant to section 28E (3) (e) is kept for 30 years from
the date of the retrieval of the organ.

Organs sent to another country.

28N.(1) Where an organ is sent to a Member State, the Authority shall
ensure that−
(a) information on organ and donor characterisation that is
specified in Part A of Schedule 12 is transmitted to that State;

(b) such information in Part B of the Schedule 12 that has been
collected by a registered medical practitioner or a person acting
under their supervision; and

(c) information to ensure the traceability of the organ is
transmitted to that State in conformity with procedures
established by the Commission under Article 29 of the Organ
Directive.
(2) Where an organ is sent to, or received from, a Member State, the
Authority shall ensure the reporting of serious adverse events and reactions
in conformity with procedures established by the Commission under Article
29 of the Organ Directive.

(3) The Authority shall ensure that any organs sent to, or received from,
countries which are not in the European Union can−
(a) be traced from the donor to the recipient; and

(b) meet quality and safety standards that are equivalent to those
required by this Part.
(4) For the purposes of subsection (3), the Authority may enter into
agreements with countries that are not in the European Union.

The Authority and European organ exchange organisations.

28O.(1) The Authority as defined in section 28B(1) is designated the
competent authority for the purposes of Article 17 of the Organ Directive.

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(2) The Authority shall, whenever reasonably practicable−
(a) participate in the network of competent authorities established
by the European Commission; and

(b) co-ordinate Gibraltar’s input into the activities of that network.

(3) The Authority may conclude agreements with European organ
exchange organisations, if such organisations ensure compliance with the
requirements of this Part, delegating to those organisations−

(a) the performance of activities provided for under the framework
for quality and safety;

(b) specific tasks in relation to the exchanges of organs to and
from Gibraltar and third countries.

(4) The Authority shall supervise each organ exchange with third
countries.

(5) For the purpose of subsection (4), the Authority and the European
organ exchange organisations may conclude agreements with counterparts
in third countries.

(6) The Authority may delegate the supervision of organ exchange with
third countries to European organ exchange organisations.

(7) Organ exchange with third countries shall be allowed only where the
organs−

(a) can be traced from the donor to the recipient and vice versa;
and

(b) meet quality and safety requirements equivalent to those laid
down in the Organ Directive.

Control and audit by way of inspections.

28P.(1) The Authority shall put in place an inspection regime for the
regular inspection of procurement organisations and transplantation centres
in order to ascertain compliance with the requirements of this Part.

(2) For the purposes of subsection (1), a duly authorised person may
require a person to produce for inspection any documents relevant for
compliance with this Part.

(3) Where records or documents to which subsection (2) applies are stored
in electronic form, the power under this section includes power to require
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the records or documents to be made available for inspection in a visible
and legible form or in a form from which they can readily be produced in a
visible and legible form.

(4) A duly authorised person may inspect and take copies of any
documents produced for inspection in pursuance of a requirement under
subsection (2).

(5) For the purposes of subsection (1), the Authority may arrange for any
premises in which a licensed activity is being carried out to be inspected on
its behalf, and for a report of the inspection to be made to it, for the purpose
of ensuring compliance−
(a) with this Part;

(b) with the conditions of the licence; and

(c) by the designated individual with the duty under section
28F(9).

(6) If a justice of the peace is satisfied on sworn information that there are
reasonable grounds for believing that−

(a) an offence under this Part is being, or has been, committed on
any premises; and

(b) any of the conditions in subsection (7) is met in relation to the
premises,

he may, by a signed warrant, authorise a duly authorised person to enter the
premises, if need be by force, and search them.
(7) The conditions referred to in subsection (6) are that−

(a) entry to the premises has been, or is likely to be, refused and
notice of the intention to apply for a warrant under this section
has been given to the occupier;

(b) the premises are unoccupied;

(c) the occupier is temporarily absent; or

(d) an application for admission to the premises or the giving of
notice of the intention to apply for a warrant under this
subsection would defeat the object of entry.
(8) A warrant under this section shall continue in force until the end of the
period of 31 days beginning with the day on which it is issued.
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(9) Entry and search under a warrant under this section is unlawful if any
of subsections (10) to (12) and (14) is not complied with.

(10) Entry and search shall be at a reasonable time unless the person
exercising the warrant thinks that the purpose of the search may be
frustrated on an entry at a reasonable time.

(11) If the occupier of the premises to which the warrant relates is present
when the person executing the warrant seeks to enter them, the person
executing the warrant shall−
(a) produce the warrant to the occupier; and

(b) give the occupier−
(i) a copy of the warrant, and

(ii) an appropriate statement.
(12) If the occupier of the premises to which the warrant relates is not
present when the person executing the warrant seeks to enter them, but
some other person is present who appears to the person executing the
warrant to be in charge of the premises, the person executing the warrant
shall−
(a) produce the warrant to that other person;

(b) give that other person−
(i) a copy of the warrant,

(ii) an appropriate statement, and

(c) leave a copy of the warrant in a prominent place on the
premises.
(13) In subsections (11)(b)(ii) and (12)(b)(ii) the references to an
appropriate statement are to a statement in writing containing the
information set out section 28Q.

(14) If premises to which the warrant relates are unoccupied, the person
executing the warrant shall leave a copy of it in a prominent place on the
premises.

(15) Where the premises in relation to which a warrant under this section
is executed are unoccupied, or the occupier is temporarily absent and no
other person is present who appears to the person executing the warrant to
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be in charge of the premises, the person executing the warrant shall, when
leaving the premises, leave them as effectively secured as the person
executing the warrant found them.

Appropriate statements.

28Q. An appropriate statement for the purposes of section 28P must contain
the following information−
(a) a statement that the duly authorised person has been authorised
by the Authority for the purposes of section 28P;

(b) a statement that the duly authorised person’s rights of entry and
search are subject to that person producing evidence of
entitlement to exercise them, if required;

(c) a statement that the duly authorised person is entitled, if need
be, to enter premises by force;

(d) a description of the duly authorised person’s powers under
section 28R(2) to (4) of inspection and seizure of property;

(e) a description of the requirement under section 28R(5) for the
duly authorised person to leave a statement giving particulars
of what the duly authorised person has seized and a statement
of what has been seized;

(f) a description of the powers of the duly authorised person−

(i) under section 28R(6), to bring with the duly authorised
person such other persons and equipment as is
considered by the duly authorised person necessary, and

(ii) under section 28R(7), to inspect equipment and inspect
and take copies of records, and in the case of premises in
respect of which a licence under this Part is in force, to
observe the carrying-on of licensed activity;
(g) a description of the duly authorised person’s obligations under
section 28S(2) to prepare a written report of the search and, if
requested to do so by the appropriate person, give the
appropriate person a copy of the report; and

(h) a statement that a person commits an offence under section
28U if that person fails without reasonable excuse to comply
with requirements under section 28R(8).

Seizure in the course of inspection or search.
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28R.(1) A duly authorised person entering and inspecting premises under
this Part may seize anything on the premises which the duly authorised
person has reasonable grounds to believe may be required for purposes of
the Authority’s functions relating to the grant, revocation, variation and
suspension of licences under this Part and to the investigation of serious
adverse events and serious adverse reactions.

(2) A duly authorised person entering and searching premises under a
warrant under section 28P may seize anything on the premises which he has
reasonable grounds to believe may be required for the purpose of being used
in evidence in any proceedings for an offence under this Part.

(3) Where a person has power under subsection (1) or (2) to seize
anything, that person may take such steps as appear to be necessary for
preserving the thing or preventing interference with it.

(4) The power under subsection (1) or (2) includes a power to retain
anything seized in the exercise of the power for so long as it may be
required for the purpose for which it was seized.
(5) Where by virtue of subsection (1) or (2) a person seizes anything, that
person shall leave on the premises from which the thing was seized a
statement giving particulars of what has been seized and stating the name of
the person who has seized it.

(6) Any power under this Part to enter and inspect or search any premises
includes a power to take such other persons and equipment as the person
exercising the power reasonably considers necessary.

(7) Any power under section 28P or 28Q to inspect or search any premises
includes, in particular−
(a) power to inspect any equipment found on the premises;

(b) power to inspect and take copies of any records found on the
premises; and

(c) in the case of premises in respect of which a licence under
section 28E is in force, power to observe the carrying-on on the
premises of the licensed activity.

(8) Any power under this Part to enter, inspect or search premises includes
power to require any person to afford such facilities and assistance with
respect to matters under that person’s control as are necessary to enable the
power of entry, inspection or search to be exercised.

Requirements when exercising power of inspection or search.
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28S.(1) A person’s right to exercise a power under this Part is subject to
that person producing evidence of their entitlement to exercise it, if
required.

(2) As soon as reasonably practicable after having exercised a power
under this Part to inspect or search premises, the duly authorised person
shall−

(a) prepare a written report of the inspection or search; and

(b) if requested to do so by the appropriate person, give the
appropriate person a copy of the report.

(3) In subsection (2), the “appropriate person”, in relation to premises
where a licensed activity is being carried out, means the designated
individual or the licence holder.

Protection of personal data, confidentiality and security of processing.
28T.(1) The holder of a licence issued under this Part shall ensure that the
fundamental right to protection of personal data is fully and effectively
protected in all organ donation and transplantation activities, in accordance
with sections 8(2)(h), 11 and 12 of the Data Protection Act 2004.

(2) The holder of a licence issued under this Part shall take all necessary
measures to ensure that-
(a) the data processed are kept confidential and secure in
accordance with sections 11 and 12 of the Data Protection Act
2004;
(b) donors and recipients whose data are processed within the
scope of this Part are not identifiable, except as permitted by
section 8(2) of the Data Protection Act 2004; and

(c) the principles relating to data quality, as set out in section 6 of
the Data Protection Act 2004 are met.
Offences and penalties.

28U.(1) A person who contravenes section 28D, commits an offence and is
liable−
(a) on summary conviction to a fine not exceeding level 5 on the
standard scale; or

(b) on conviction on indictment−

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(i) to imprisonment for a term not exceeding 2 years,

(ii) to a fine, or

(iii) to both.
(2) A person commits an offence if that person-

(a) fails without reasonable excuse to comply with a requirement
under section 28P(2); or

(b) intentionally obstructs the exercise of any right or powers
under sections 28P or 28R.

(3) A person guilty of an offence under subsection (2) is liable on
summary conviction to a fine not exceeding level 4 on the standard scale.
(4) A person commits an offence if that person in contravention of section
28T−

(a) accesses any data or systems that makes identification of donor
or recipients possible; or

(b) uses any system or data that makes the identification of donors
or recipients possible with a view to tracing donors or
recipients other than for the purposes permitted by section 8(2)
of the Data Protection Act 2004.

(5) A person who commits an offence under subsection (4) is liable–

(a) on summary conviction, to a fine not exceeding level 4 on the
standard scale; or

(b) on conviction on indictment to a fine not exceeding level 5 on
the standard scale.

(6) Where a person is convicted of an offence under subsection (4), the
court may order any data material which appears to the court to be
connected with the commission of the offence to be forfeited or destroyed
and any relevant data to be erased.

(7) The court shall not make an order under subsection (6) in relation to
data material or data where it considers that some person other than the
person convicted of the offence may be the owner of, or otherwise interested
in, the data unless such steps as are reasonably practicable have been taken
for notifying that person and giving him an opportunity to show cause why
the order should not be made.

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Offences by bodies corporate.

28V.(1) Where an offence under this Part is committed by a body corporate
and is proved to have been committed with the consent or connivance of or
to be attributable to any neglect on the part of−
(a) any director, manager, secretary or other similar officer of the
body corporate; or

(b) any person who was purporting to act in any such capacity,

that person (as well as the body corporate) commits the offence and shall
be liable to be proceeded against and punished accordingly.
(2) Where the affairs of a body corporate are managed by its members,
subsection (1) applies in relation to the acts and defaults of a member in
connection with that member’s functions of management as if that member
were a director of the body corporate.

Reports to the Commission.

28W. The Authority shall ensure that a report is sent to the Commission
before 27 August 2013 and every three years thereafter on the activities
undertaken in relation to the provisions of the Organ Directive, and on
experience gained in implementing it.

Regulations.

29.(1) The Minister may make Regulations–

(a) prescribing fees to be paid under this Part;

(b) giving effect to or implementing any International Convention,
Protocol or Agreement or any European Union Directive or
Regulation that relate to the subject-matter of this Part; or

(c) providing for generally carrying out the purposes of this Part.

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SCHEDULE 1

Section 13(2) (a) and 13 (7)

SELECTION CRITERIA FOR DONORS OF TISSUES OR CELLS
OR BOTH (EXCEPT DONORS OF REPRODUCTIVE CELLS).

Selection criteria for donors are based on an analysis of risks related to the
application of the specific cells/tissues. Indicators of these risks must be
identified by physical examination, review of the medical and behavioural
history, biological testing, post-mortem examination (for deceased donors)
and any other appropriate investigation. Unless justified on the basis of a
documented risk assessment approved by the responsible person as defined
in section 2(1), donors must be excluded from donation if any of the
following criteria applies:

1. Deceased Donors.

1.1. General criteria for exclusion

1.1.1. Cause of death unknown, unless autopsy provides information on the
cause of death after procurement and none of the general criteria for
exclusion set out in the present section applies.

1.1.2. History of a disease of unknown aetiology.

1.1.3. Presence, or previous history, of malignant disease, except for
primary basal cell carcinoma, carcinoma in situ of the uterine cervix, and
some primary tumours of the central nervous system that have to be
evaluated according to scientific evidence. Donors with malignant diseases
can be evaluated and considered for cornea donation, except for those with
retinoblastoma, haematological neoplasm, and malignant tumours of the
anterior segment of the eye.

1.1.4. Risk of transmission of diseases caused by prions. This risk applies,
for example, to

(a) people diagnosed with Creutzfeldt-Jakob Disease, or variant
Creutzfeld-Jakob Disease, or having a family history of non-
iatrogenic Creutzfeldt-Jakob disease.

(b) People with a history of rapid progressive dementia or
degenerative neurological disease, including those of unknown
origin;

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(c) Recipients of hormones derived from the human pituitary
gland (such as growth hormones) and recipients of grafts of
cornea, sclera and dura mater, and persons that have undergone
undocumented neurosurgery (where dura mater may have been
used).

For variant Creutzfeld-Jakob Disease, further precautionary measures may
be recommended.

1.1.5. Systemic infection which is not controlled at the time of donation,
including bacterial diseases, systemic viral, fungal or parasitic infections, or
significant local infection in the tissue and cells to be donated. Donors with
bacterial septicaemia may be evaluated and considered for eye donation, but
only where the corneas are to be stored by organ culture to allow detection
of any bacterial contamination of the tissue.

1.1.6. History, clinical evidence, or laboratory evidence of HIV, acute or
chronic hepatitis B (except in the case of persons with a proven immune
status) hepatitis C and HTLV I/II, transmission risk or evidence of risk
factors for these infections.

1.1.7. History of chronic, systemic autoimmune disease that could have a
detrimental effect on the quality of the tissue to be retrieved.

1.1.8. Indications that test results of donor blood samples will be invalid
due to: (a) the occurrence of haemodilution, according to the specifications
in section 2 of Schedule 2, where a pre-transfusion sample is not available;
or (b) treatment with immunosuppressive agents.

1.1.9. Evidence of any other risk factors for transmissible diseases on the
basis of a risk assessment, taking into consideration donor travel and
exposure history and local infectious disease prevalence.

1.1.10. Presence on the donor’s body of physical signs implying a risk of
transmissible disease(s) as described in point 1.2.3 of Schedule 4.

1.1.11. Ingestion of, or exposure to, a substance (such as cyanide, lead,
mercury, gold) that may be transmitted to recipients in a dose that could
endanger their health.

1.1.1 Recent history of vaccination with a live attenuated virus where a
risk of transmission is considered to exist.

1.1.13. Transplantation with xenografts.

1.2. Additional exclusion criteria for deceased child donors.

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1.2.1. Any children born from mothers with HIV infection or that meet any
of the exclusion criteria described in section 1.1 must be excluded as donors
until the risk of transmission of infection can be definitely ruled out.

(a) Children aged less than 18 months born from mothers with
HIV, hepatitis B, hepatitis C or HTLV infection or at risk of
such infection, and who have been breastfed by their mothers
during the previous 12 months, cannot be considered as donors
regardless of the results of the analytical tests;

(b) Children of mothers with HIV, hepatitis B, hepatitis C or
HTLV infection or at risk of such infection, and who have not
been breastfed by their mothers during the previous 12 months
and for whom analytical tests, physical examinations and
reviews of medical records do not provide evidence of HIV,
hepatitis B, hepatitis C or HTLV infection, can be accepted as
donors.

2. Living Donors.

2.1. Autologous Living Donor

2.1.1. If the removed tissues and cells are to be stored or cultured, the same
minimum set of biological testing requirements must apply as for an
allogeneic living donor. Positive test results will not necessarily prevent the
tissues or cells or any product derived from them being stored, processed
and re-implanted, if appropriate isolated storage facilities are available to
ensure no risk of cross-contamination with other grafts or no risk of
contamination with adventitious agents or mix-ups or both.

2.2. Allogeneic Living Donor

2.2.1. Allogeneic living donors must be selected on the basis of their health
and medical history, provided on a questionnaire and through an interview
performed by a qualified and trained healthcare professional with the donor,
in compliance with point 2.2.2. This assessment must include relevant
factors that may assist in identifying and screening our persons whose
donation could present a health risk to others, such as the possibility of
transmitting diseases or health risks to themselves. For any donation, the
collection process must not interfere with or compromise the health or care
of the donor. In the case of cord blood or amniotic membrane donation, this
applies to both mother and baby.

2.2.2. Selection criteria for allogeneic living donors must be established
and documented by the tissue establishment (and the transplanting clinician
in the case of direct distribution to the recipient) based on the specific tissue
or cells to be donated, together with the donor’s physical status and medical
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and behavioural history and the results of clinical investigations and
laboratory tests establishing the donor’s state of health.

2.2.3. The same exclusion criteria must be applied as for deceased donors
with the exception of point 1.1.1 Depending on the tissue or cell to be
donated, other specific exclusion criteria may need to be added, such as:

(a) pregnancy (except for donors of umbilical cord blood cells and
amniotic membrane and sibling donors of haematopoietic
progenitors);

(b) breastfeeding;

(c) in the case of haematopoietic progenitor cells, the potential for
transmission of inherited conditions.

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SCHEDULE 2

Section 13(1)(a) and (b)

LABORATORY TESTS REQUIRED FOR DONORS (EXCEPT
DONORS OF REPRODUCTIVE CELLS).

1. Biological tests required for donors.

1.1. The following biological tests must be performed for all donors as a
minimum requirement;

HIV 1 and 2 Anti-HIV-1,2
Hepatitis B HbsAg
Anti HBc
Hepatitis C Anti- HCV- Ab
Syphilis See 1.4 (below)

1.2. HTLV-I antibody testing must be performed for donors living in, or
originating from, high-prevalence areas or with sexual partners originating
from those areas or where the donor’s parents originate from those areas.

1.3. When anti-HBc is positive and HbsAg is negative, further
investigations are necessary with a risk assessment to determine eligibility
for clinical use.

1.4. A validated testing algorithm must be applied to exclude the
presence of active infection with Treponema pallidum. A non-reactive test,
specific or non-specific, can allow tissues and cells to be released. When a
non-specific test is performed, a reactive result will not prevent procurement
or release if a specific Treponema confirmatory test is non-reactive. A donor
whose specimen tests reactive on a Treponema-specific test will require a
thorough risk assessment to determine eligibility for clinical use.

1.5. In certain circumstances, additional testing may be required
depending on the donor’s history and the characteristics of the tissue or cells
donated (e.g. RhD, HLA, malaria, CMV, toxoplasma, EBV, Trypanosoma
cruzi).

1.6. For autologous donors, point 2.1.1. in Schedule 1 applies.

2. General requirements to be met for determining biological markers.

2.1. The tests must be carried out by a qualified laboratory, authorised as
a testing centre by the competent authority, using CE marked testing kits
where appropriate. The type of test used must be validated for the purpose
in accordance with current scientific knowledge.

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2.2. The biological tests will be carried out on the donor’s serum or
plasma; they must not be performed on other fluids or secretions such as the
aqueous or vitreous humour unless specifically justified clinically using a
validated test for such a fluid.

2.3. When potential donors have lost blood and have recently received
donated blood, blood components, colloids or crystalloids, blood testing
may not be valid due to haemodilution of the sample. An algorithm must be
applied to assess the degree of haemodilution in the following
circumstances

(a) ante-mortem blood sampling: if blood, blood components or
colloids were infused in the 48 hours preceding blood sampling
or if crystalloids were infused in the hour preceding blood
sampling;

(b) post-mortem blood sampling: if blood, blood components or
colloids were infused in the 48 hours preceding death or if
crystalloids were infused in the hour preceding death.

Tissue establishments may accept tissues and cells from donors with plasma
dilution of more than 50% only if the testing procedures used are validated
for such plasma or if a pre-transfusion sample is available.

2.4. In the case of a deceased donor, blood samples must have been
obtained just prior to death, or if not possible, the time of sampling must be
as soon as possible after death and in any case within 24 hours after death.

2.5.
(a) In the case of living donors (except allogeneic bone marrow
stem-cell and peripheral blood stem-cell donors, for practical
reasons), blood samples must be obtained at the time of
donation or if not possible, within 7 days post donation (this is
the ‘donation sample’).

(b) Where tissues and cells of allogeneic living donors can be
stored for long periods, repeat sampling and testing is required
after an interval of 180 days. In these circumstances of repeat
testing, the donation sample can be taken up to 30 days prior to
and 7 days post donation.

(c) Where tissues and cells of allergenic living donors cannot be
stored for long periods and repeat sampling is therefore not
possible, paragraph 2.5(a) above applies.

2.6. If, in a living donor (except bone marrow stem-cell and peripheral
blood stem-cell donors) the ‘donation sample’ as defined in paragraph
2.5(a) above, is additionally tested by the nucleic acid amplification
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technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample
is not required. Retesting is also not required if the processing includes an
inactivation step that has been validated for the viruses concerned.

2.7. In the case of bone marrow and peripheral blood stem-cell
collection, blood samples must be taken for testing within 30 days prior to
donation.

2.8. In the case of neonatal donors, the biological tests may be carried
out on the donor’s mother to avoid medically unnecessary procedures upon
the infant.

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SCHEDULE 3

Section 13(1)(c) and (d) and 13(2)(b)

SELECTION CRITERIA AND LABORATORY TESTS REQUIRED
FOR DONORS OF REPRODUCTIVE CELLS

1. Partner donation for direct use.

Donor selection criteria and laboratory testing do not need to be applied in
the case of partner donation of reproductive cells for direct use.

2. Partner donation (not direct use).

Reproductive cells that are processed or stored or both and reproductive
cells that will result in the cryopreservation of embryos must meet the
following criteria

2.1. The clinician responsible for the donor must determine and
document, based on the patient’s medical history and
therapeutic indications, the justification for the donation and its
safety for the recipient and any child(ren) that might result.

2.2. The following biological tests must be carried out to assess the
risk of cross contamination

HIV 1 and 2 Anti-HIV-1,2
Hepatitis B HbsAg
Anti HBc
Hepatitis C Anti- HCV- Ab

In case of sperm processed for intrauterine insemination, not to be stored
and if the tissue establishment can demonstrate that the risk of cross
contamination and staff exposure has been addressed through the use of
validated processes, the biological testing may not be required.

2.3. Where HIV 1 and 2, hepatitis B or hepatitis C test results are
positive or unavailable, or where the donor is known to be a source of
infection risk, a system of separate storage must be devised.

2.4. HTLV-I antibody testing must be performed for donors living in, or
originating from, high-prevalence areas or with sexual partners originating
from those areas or where the donor’s parents originate from those areas;

2.5. In certain circumstances, additional testing may be required
depending on the donor’s travel and exposure history and the characteristics
of the tissue or cells donated (e.g. RhD, malaria, CMV, T cruzi).

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2.6. Positive results will not necessarily prevent partner donation in
accordance with national rules.

3. Donations other than by partners.

The use of reproductive cells other than for partner donation must meet the
following criteria

3.1. Donors must be selected on the basis of their age, health and medical
history, provided on a questionnaire and through a personal interview
performed by a qualified and trained healthcare professional. This
assessment must include relevant factors that may assist in identifying and
screening out persons whose donation could present a health risk to others,
such as the possibility of transmitting diseases (such as sexually transmitted
infections), or health risks to themselves (e.g; superovulation, sedation or
the risks associated with the egg collection procedure or the psychological
consequences of being a donor).

3.2. The donors must be negative for HIV 1 and 2, HCV, HBV and
syphilis on a serum or plasma sample, tested in accordance with point 1.1 of
Schedule 2 and sperm donors must additionally be negative for Chlamydia
on a urine sample tested by the nucleic acid amplification technique (NAT).

3.3. HTLV-I antibody testing must be performed for donors living in, or
originating from, high-prevalence areas or with sexual partners originating
from those areas or where the donor’s parents originate from those areas;

3.4. In certain circumstances, additional testing may be required
depending on the donor’s history and the characteristics of the tissue or cells
donated (e.g. RhD, malaria, CamV, T.cruzi).

3.5. For autologous donors, point 2.1.1 in Schedule 1 applies.

3.6. Genetic screening for autosomal recessive genes known to be
prevalent, according to international scientific evidence, in the donor’s
ethnic background and an assessment of the risk of transmission of inherited
conditions known to be present in the family must be carried out, after
consent is obtained. Complete information must be provided, in accordance
with the requirements in this Act. Complete information on the associated
risk and on the measures undertaken for its mitigation must be
communicated and clearly explained to the recipient.

4. General requirements to be met for determining biological markers.

4.1. The tests must be carried out in accordance with points 2.1 and 2.2
of Schedule 2.

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4.2. For donations other than by partners, blood samples must be obtained at
the time of each donation.

For donation by partners (not for direct use), blood samples must be
obtained within three months before the first donation. For further partner
donations by the same donor, further blood samples must be obtained
according to national legislation, but no later than 24 months from the
previous sampling.

4.3. Sperm donations other than by partners will be quarantined for a
minimum of 180 days, after which repeat testing is required. If the blood
donation sample is additionally tested by the nucleic acid amplification
technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample
is not required. Retesting is also not required if the processing includes an
inactivation step that has been validated for the viruses concerned.

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SCHEDULE 4
Sections 9, 10 and 14

CELL OR TISSUE OR BOTH DONATION AND PROCUREMENT
PROCEDURES AND RECEPTION AT THE TISSUE
ESTABLISHMENT

1. Donation and procurement procedures.

1.1. Consent and donor identification

1.1.1. Before the procurement of tissues and cells proceeds, an authorised
person must confirm and record

(a) that consent for the procurement has been obtained in
accordance with section 13; and

(b) how and by whom the donor has been reliably identified.

1.1.2. In the case of living donors, the health professional responsible for
obtaining the health history must ensure that the donor has
(a) understood the information provide,

(b) had an opportunity to ask questions and been provided with
satisfactory responses;

(c) confirmed that all the information provided is true to the best
of his/her knowledge.

1.2. Donor evaluation (this paragraph does not apply to partner
donation of reproductive cells or to autologous donors)

1.2.1. An authorised person must collect and record the donor’s relevant
medical and behavioural information according to the requirements
described in point 1.4

1.2.2. In order to acquire the appropriate information, different relevant
sources must be used, including at least an interview with the donor, for
living donors, and the following when appropriate:

(a) the medical records of the donor;

(b) an interview with a person who knew the donor well, for
deceased donors;

(c) an interview with the treating physician;

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(d) an interview with the general practitioner;

(e) the autopsy report.

1.2.3. In addition, in the case of a deceased donor, and in the case of a
living donor when justified, a physical examination of the body must be
performed to detect any signs that may be sufficient in themselves to
exclude the donor or which must be assessed in the light of the donor’s
medical and personal history.

1.2.4. The complete donor records must be reviewed and assessed for
suitability and signed by a qualified health professional.

1.3. Procurement procedures for tissues and cells

1.3.1. The procurement procedures must be appropriate for the type of
donor and the type of tissue/cells donated. There must be procedures in
place to protect the safety of the living donor.

1.3.2. The procurement procedures must protect those properties of the
tissues/cells that are required for their ultimate clinical use, and at the same
time minimise the risk of microbiological contamination during the process,
particularly when tissues and cells cannot subsequently be sterilised.

1.3.3. For deceased donation, the area of access must be restricted. A local
sterile field using sterile drapes must be used. Staff conducting procurement
must be clothed appropriately for the type of procurement. Usually, this will
extend to being scrubbed, gowned in sterile clothing and wearing sterile
gloves, face shields and protective masks.

1.3.4. In the case of a deceased donor, the place of procurement must be
recorded and the time interval from death to procurement must be specified
so as to ensure that the required biological or physical properties of the
tissues/cells are retained.

1.3.5. Once the tissues and cells have been retrieved from a deceased donor
body, it must be reconstructed so that it is as similar as possible to its
original anatomical appearance.

1.3.6. Any adverse event occurring during procurement that has or may
have resulted in harm to a living donor and the outcome of any investigation
to determine the cause must be recorded and reviewed.

1.3.7. Policies and procedures must be in place to minimise the risk of
tissue or cell contamination by staff who might be infected with
transmissible diseases.

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1.3.8. Sterile instruments and devices must be used for tissue and cell
procurement. Instruments or devices must be of good quality, validated or
specifically certified and regularly maintained for the procurement of tissues
and cells.

1.3.9. When reusable instruments must be used, a validated cleaning and
sterilisation procedure for removal of infectious agents has to be in place.

1.3.10. Wherever possible, only CE marked medical devices must be used
and all concerned staff must have received appropriate training on the use of
such devices.

1.4. Donor documentation

1.4.1. For each donor, there must be a record containing

(a) the donor identification (first name, family name and date of
birth – if a mother and child are involved in the donation, both
the name and date of birth of the mother and the name, if
known, and date of birth of the child);

(b) age, sex, medical and behavioural history (the information
collected must be sufficient to allow application of the
exclusion criteria, where required);

(c) outcome of body examination, where applicable;

(d) haemodilution formula, where applicable;

(e) the consent/authorisation form, where applicable;

(f) clinical data, laboratory test results, and the results of other
tests carried out;

(g) if an autopsy was performed, the results must be included in
the record (for tissues and cells that cannot be stored for
extended periods, a preliminary verbal report of the autopsy
must be recorded);

(h) for haematopoietic progenitor cell donors, the donor’s
suitability for the chosen recipient must be documented. For
unrelated donations, when the organisation responsible for
procurement has limited access to recipient data, the
transplanting organisation must be provided with donor data
relevant for confirming suitability.

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1.4.2. The organisation performing the procurement must produce a
procurement report, which is passed on to the tissue establishment. This
report must contain at least:

(a) the identification, name and address of the tissue establishment
to receive the cells/tissues;

(b) donor identification data (including how and by whom the
donor was identified);

(c) description and identification of procured tissues and cells
(including samples for testing);

(d) identification of the person who is responsible for the
procurement session, including signing;

(e) date, time(where relevant, start and end) and location of
procurement and procedure (SOP) used, including any
incidents that occurred; where relevant, environmental
conditions at the procurement facility (description of the
physical area where procurement took place);

(f) for deceased donors, conditions under which the cadaver is
kept: refrigerated (or not), time of start and end of
refrigeration;

(g) ID/batch numbers of reagents and transport solutions used.

The report must also contain the date and time of death where possible.

Where sperm is procured at home, the procurement report must state this
and must contain only

(a) the name and address of the tissue establishment to receive the
cells/tissues;

(b) the donor identification. The date and time of procurement may
be included, where possible.

1.4.3. All the records must be clear and readable, protected from
unauthorised amendment and retained and readily retrieved in this condition
throughout their specified retention period in compliance with data
protection legislation.

1.4.4. Donor records, required for full traceability must be kept for a
minimum of 30 years after clinical use, or the expiry date, in an appropriate
archive acceptable to the competent authority.

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1.5. Packaging

1.5.1. Following procurement, all recovered tissues and cells must be
packaged in a manner which minimises the risk of contamination and must
be stored at temperature that preserve the required characteristics and
biological function of the cells/tissues. The packaging must also prevent
contamination of those responsible for packaging and transportation of the
tissues or cells.

1.5.2. The packaged cells/tissues must be shipped in a container which is
suitable for the transport of biological materials and which maintains the
safety and quality of the contained tissue or cells.

1.5.3. Any accompanying tissue or blood samples for testing must be
accurately labelled to ensure identification with the donor, and must include
a record of the time and place the specimen was taken.

1.6. Labelling of the procured tissues or cells or both

At the time of procurement, every package containing tissues and cells must
be labelled. The primary tissue/cell container must indicate the donation
identification or code and the type of tissues and cells. Where the size of the
package permits, the following information must also be provided

(a) date (and time where possible) of donation;

(b) hazard warnings;

(c) nature of any additives (if used);

(d) in the case of autologous donations, the label must state ‘for
autologous use only’;

(e) in the case of directed donations, the label must identify the
intended recipient.

If any of the information under points (a) to (e) above cannot be included on
the primary package label, it must be provided on a separate sheet
accompanying the primary package.

1.7. Labelling of the shipping container

When tissues/cells are shipped by an intermediary, every shipping container
must be labelled at least with

(a) TISSUES AND CELLS and HANDLE WITH CARE;

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(b) The identification of the establishment from which the package
is being transported (address and phone number) and the
contact person in the event of problems;

(c) the identification of the tissue establishment of destination
(address and phone number) and the person to be contacted to
take delivery of the container;

(d) the date and time of the start of transportation;

(e) specifications concerning conditions of transport relevant to the
quality and safety of the tissues and cells;

(f) in the case of all cellular products, the following indication:
DO NOT IRRADIATE;

(g) when a product is known to be positive for relevant infectious
disease marker, the following indication: BIOLOGICAL
HAZARD;

(h) in the case of autologous donors, the following indication:
FOR AUTOLOGOUS USE ONLY.

(i) specifications concerning storage conditions (such as DO NOT
FREEZE).

2. Receipt of the tissue/cells at the tissue establishment.

2.1. When the retrieved tissues/cells arrive at the tissue establishment,
there must be documented verification that the consignment, including the
transport conditions, packaging, labelling and associated documentation and
samples, meet the requirements of this Schedule and the specifications of
the receiving establishment.

2.2. Each establishment must ensure that the tissue and cells received are
quarantined until they, along with the associated documentation, have been
inspected or otherwise verified as conforming to requirements. The review
of relevant donor/procurement information and thus acceptance of the
donation needs to be carried out by specified/authorised persons.

2.3. Each tissue establishment must have a documented policy and
specifications against which each consignment of tissues and cells,
including samples, are verified. These must include the technical
requirements and other criteria considered by the tissue establishment to be
essential for the maintenance of acceptable quality. The tissue establishment
must have documented procedures for the management and segregation of
non-conforming consignments, or those with incomplete test results, to
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ensure that there is no risk of contamination of other tissues and cells being
processed, preserved or stored.

2.4. The data that must be registered at the tissue establishment (except
for donors of reproductive cells intended for partner donation) include

(a) consent/authorisation; including the purpose(s) for which the
tissues and cells may be used (i.e. therapeutic or research, or
both therapeutic use and research) and any specific instructions
for disposal if the tissue or cells are not used for the purpose
for which consent was obtained;

(b) all required records relating to the procurement and the taking
of the donor history, as described in the donor documentation
section;

(c) results of physical examination, of laboratory tests and of other
tests (such as the autopsy report, if used in accordance with
point 1.2.2.);

(d) for allogeneic donors, a properly documented review of the
complete donor evaluation against the selection criteria by an
authorised and trained person;

(e) in the case of cell cultures intended for autologous use,
documentation of the possibility of medicinal allergies (such as
to antibiotics) of the recipient.

2.5. In the case of reproductive cells intended for partner donation, the
data to be registered at the tissue establishment include

(a) consent; including the purpose(s) for which the tissues and
cells may be used (such as reproductive only or for research or
both) and any specific instructions for disposal if the tissue or
cells are not used for the purpose for which consent was
obtained;

(b) donor identification and characteristics: type of donor, age, sex
and presence of risk factors and, in the case of a deceased
donor, the cause of death;

(c) partner identification;

(d) place of procurement;

(e) tissues and cells obtained and relevant characteristics.
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SCHEDULE 5
Section 5(2)

Requirements for authorisation of tissue establishments

A. ORGANISATION AND MANAGEMENT

1. A responsible person must be appointed having qualifications and
responsibilities as provided in section 8 of this Part.

2. A tissue establishment must have an organisational structure and
operational procedures appropriate to the activities for which authorisation
is sought; there must be an organisational chart which clearly defines
accountability and reporting relationships.

3. Every tissue establishment must have access to a nominated medical
registered practitioner to advise on and oversee the establishment’s medical
activities such as donor selection, review of clinical outcomes of applied
tissues and cells or interaction as appropriate with clinical users.

4. There must be a documented quality management system applied to
the activities for which authorisation is sought, in accordance with the
standards laid down in this Part

5. It must be ensured that the risks inherent in the use and handling of
biological material are identified and minimised, consistent with
maintaining adequate quality and safety for the intended purpose of the
tissues and cells. The risks include those relating in particular to the
procedures, environment, and staff health status specific to the tissue
establishment.

6. Agreements between tissue establishments and third parties must
comply with section 18 of this Part. Third party agreements must specify the
terms of the relationship and responsibilities as well as the protocols to be
followed to meet the required performance specification.

7. There must be a documented system in place, supervised by the
responsible person, for ratifying that tissues or cells or both meet
appropriate specifications for safety and quality for release and for their
distribution.

8. In the event of termination of activities the agreements concluded
and the procedures adopted in accordance with section 14(9) of this Part
shall include traceability data and material concerning the quality and safety
of tissues and cells.

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9. There must be a documented system in place that ensures the
identification of every unit of tissue or cells at all stages of the activities for
which authorisation is sought.

B. PERSONNEL

1. The personnel in tissue establishments must be available in
sufficient number and be qualified for the tasks they perform. The
competency of the personnel must be evaluated at appropriate intervals
specified in the quality system.

2. All personnel should have clear, documented and up-to-date job
descriptions. Their tasks, responsibilities and accountability must be clearly
documented and understood.

3. Personnel must be provided with initial or basic training, updated
training as required when procedures change or scientific knowledge
develops and adequate opportunities for relevant professional development.
The training programme must ensure and document that each individual

(a) has demonstrated competence in the performance of their
designated tasks;

(b) has an adequate knowledge and understanding of the scientific
or technical processes and principles relevant to their
designated tasks;

(c) understands the organisational framework, quality system and
health and safety rules of the establishment in which they
work; and

(d) is adequately informed of the broader ethical, legal and
regulatory context of their work.

C. EQUIPMENT AND MATERIALS

1. All equipment and material must be designed and maintained to suit
its intended purpose and must minimise any hazard to recipients or staff or
to both.

2. All critical equipment and technical devices must be identified and
validated, regularly inspected and preventively maintained in accordance
with the manufacturers' instructions. Where equipment or materials affect
critical processing or storage parameters (e.g. temperature, pressure, particle
counts, microbial contamination levels), they must be identified and must be
the subject of appropriate monitoring, alerts, alarms and corrective action, as
required, to detect malfunctions and defects and to ensure that the critical
parameters are maintained within acceptable limits at all times. All
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equipment with a critical measuring function must be calibrated against a
traceable standard if available.

3. New and repaired equipment must be tested when installed and must
be validated before use. Test results must be documented.

4. Maintenance, servicing, cleaning, disinfection and sanitation of all
critical equipment must be performed regularly and recorded accordingly.

5. Procedures for the operation of each piece of critical equipment,
detailing the action to be taken in the event of malfunctions or failure, must
be available.

6. The procedures for the activities for which authorisation is sought,
must detail the specifications for all critical materials and reagents. In
particular, specifications for additives (e.g. solutions) and packaging
materials must be defined. Critical reagents and materials must meet
documented requirements and specifications.

D. FACILITIES OR PREMISES

1. A tissue establishment must have suitable facilities to carry out the
activities for which authorisation is sought, in accordance with the standards
laid down in this Part.

2. When these activities include processing of tissues and cells while
exposed to the environment, this must take place in an environment with
specified air quality and cleanliness in order to minimise the risk of
contamination, including cross-contamination between donations. The
effectiveness of these measures must be validated and monitored.

3.Unless otherwise specified in point 4, where tissues and cells are exposed
to the environment during processing, without a subsequent microbial
inactivation process, an air quality with particle counts and microbial colony
counts equivalent to those of Grade A as defined in the current European
Guide to Good Manufacturing Practice (GMP), Annex 1 and Directive
2003/94/EC is required with a background environment appropriate for the
processing of the tissue/cell concerned but at least equivalent to GMP Grade
D in terms of particles and microbial counts.

4. A less stringent environment than specified in point 3 may be
acceptable where

(a) a validated microbial inactivation or validated terminal
sterilisation process is applied;

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(b) or, where it is demonstrated that exposure in a Grade A
environment has a detrimental effect on the required properties
of the tissue or cell concerned;

(c) or, where it is demonstrated that the mode and route of
application of the tissue or cell to the recipient implies a
significantly lower risk of transmitting bacterial or fungal
infection to the recipient than with cell and tissue
transplantation;

(d) or, where it is not technically possible to carry out the required
process in a Grade A environment (for example, due to
requirements for specific equipment in the processing area that
is not fully compatible with Grade A).

5. In point 4(a), (b), (c) and (d), an environment must be specified. It
must be demonstrated and documented that the chosen environment
achieves the quality and safety required, at least taking into account the
intended purpose, mode of application and immune status of the recipient.
Appropriate garments and equipment for personal protection and hygiene
must be provided in each relevant department of the tissue establishment
along with written hygiene and gowning instructions.

6. When the activities for which authorisation is sought involve storage
of tissues and cells, the storage conditions necessary to maintain the
required tissue and cell properties, including relevant parameters such as
temperature, humidity or air quality must be defined.

7. Critical parameters (e.g. temperature, humidity, air quality) must be
controlled, monitored, and recorded to demonstrate compliance with the
specified storage conditions.

8. Storage facilities must be provided that clearly separate and
distinguish tissues and cells prior to release in quarantine from those that are
released and from those that are rejected, in order to prevent mix-up and
cross-contamination between them. Physically separate areas or storage
devices or secured segregation within the device must be allocated in both
quarantine and released storage locations for holding certain tissue and cells
collected in compliance with special criteria.

9. The tissue establishment must have written policies and procedures
for controlled access, cleaning and maintenance, waste disposal and for the
re-provision of services in an emergency situation.

E. DOCUMENTATION AND RECORDS

1. There must be a system in place that results in clearly defined and
effective documentation, correct records and registers and authorised
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Standard Operating Procedures (SOPs), for the activities for which
authorisation is sought. Documents must be regularly reviewed and must
conform to the standards laid down in this Part. The system must ensure that
work performed is standardised, and that all steps are traceable; i.e. coding,
donor eligibility, procurement, processing, preservation, storage, transport,
distribution or disposal, including aspects relating to quality control and
quality assurance.

2. For every critical activity, the materials, equipment and personnel
involved must be identified and documented.

3. In the tissue establishments all changes to documents must be
reviewed, dated, approved, documented and implemented promptly by
authorised personnel.

4. A document control procedure must be established to provide for the
history of document reviews and changes and to ensure that only current
versions of documents are in use.

5. Records must be shown to be reliable and a true representation of the
results.

6. Records must be legible and indelible and may be handwritten or
transferred to another validated system, such as a computer or microfilm.

7. Without prejudice to section 16(8) of this Part, all records, including
raw data, which are critical to the safety and quality of the tissues and cells
shall be kept so as to ensure access to these data for at least 10 years after
expiry date, clinical use or disposal.

8. Records must meet the confidentiality requirements laid down in
section 20. Access to registers and data must be restricted to persons
authorised by the responsible person, and to the competent authority for the
purpose of inspection and control measures.

F. QUALITY REVIEW

1. An audit system must be in place for the activities for which
authorisation is sought. Trained and competent persons must conduct the
audit in an independent way, at least every two years, in order to verify
compliance with the approved protocols and the regulatory requirements.
Findings and corrective actions must be documented.

2. Deviations from the required standards of quality and safety must
lead to documented investigations, which include a decision on possible
corrective and preventive actions. The fate of non-conforming tissues and
cells must be decided in accordance with written procedures supervised by
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the responsible person and recorded. All affected tissues and cells must be
identified and accounted for.

3. Corrective actions must be documented, initiated and completed in a
timely and effective manner. Preventive and corrective actions should be
assessed for effectiveness after implementation.

4. The tissue establishment should have processes in place for review
of the performance of the quality management system to ensure continuous
and systematic improvement.
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SCHEDULE 6
Section 9(1)(c)

Requirements for the authorisation of tissue and cell preparation
processes at the tissue establishments

The competent authority shall authorise each tissue and cell preparation
process after evaluation of the donor selection criteria and procurement
procedures, the protocols for each step of the process, the quality
management criteria, and the final quantitative and qualitative criteria for
tissues and cells. This evaluation must comply at least with the requirements
set out in this Schedule.

A. RECEPTION AT THE TISSUE ESTABLISHMENT

Upon reception of procured tissues and cells at the tissue establishment, the
tissues and cells must comply with the requirements defined in this Part.

B. PROCESSING

When the activities for which the authorisation is sought include processing
of tissues and cells, the tissue establishment procedures must comply with
the following criteria

1. The critical processing procedures must be validated and must
not render the tissues or cells clinically ineffective or harmful
to the recipient. This validation may be based on studies
performed by the establishment itself, or on data from
published studies or, for well-established processing
procedures, by retrospective evaluation of the clinical results
for tissues supplied by the establishment.

2. It has to be demonstrated that the validated process can be
carried out consistently and effectively in the tissue
establishment environment by the staff.

3. The procedures must be documented in SOPs which must
conform to the validated method and to the standards laid
down in this Part accordingly with Schedule 1 (E), points 1 to
4.

4. It must be ensured that all processes are conducted in
accordance with the approved SOPs.

5. Where a microbial inactivation procedure is applied to the
tissue or cells it must be specified, documented, and validated.

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6. Before implementing any significant change in processing, the
modified process must be validated and documented.

7. The processing procedures must undergo regular critical
evaluation to ensure that they continue to achieve the intended
results.

8. Procedures for discarding tissues and cells must prevent the
contamination of other donations and products, the processing
environment or personnel. These procedures must comply with
national regulations.

C. STORAGE AND RELEASE OF PRODUCTS

When the activities for which the authorisation is sought include storage and
release of tissues and cells, the authorised tissue establishment procedures
must comply with the following criteria

1. Maximum storage time must be specified for each type of
storage condition. The selected period must reflect among
others possible deterioration of the required tissue and cell
properties.

2. There must be a system of inventory hold for tissues and cells
to ensure that they cannot be released until all requirements
laid down in this Part have been satisfied. There must be a
standard operating procedure that details the circumstances,
responsibilities and procedures for the release of tissues and
cells for distribution.

3. A system for identification of tissues and cells throughout any
phase of processing in the tissue establishment must clearly
distinguish released from non-released (quarantined) and
discarded products.

4. Records must demonstrate that before tissues and cells are
released all appropriate specifications are met, in particular all
current declaration forms, relevant medical records, processing
records and test results have been verified according to a
written procedure by a person authorised for this task by the
responsible person as specified in section 8 of this Part. If a
computer is used to release results from the laboratory, an audit
trail should indicate who was responsible for their release.

5. A documented risk assessment approved by the responsible
person as defined in section 8 of this Part must be undertaken
to determine the fate of all stored tissues and cells following
the introduction of any new donor selection or testing criterion
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or any significantly modified processing step that enhances
safety or quality.

D. DISTRIBUTION AND RECALL

When the activities for which the authorisation is sought include distribution
of tissues and cells, the authorised tissue establishment procedures must
comply with the following criteria

1. Critical transport conditions, such as temperature and time
limit must be defined to maintain the required tissue and cell
properties.

2. The container and the package must be secure and ensure that
the tissue and tissues and cells are maintained in the specified
conditions. All containers and packages need to be validated as
fit for purpose.

3. Where a contracted third party carries out distribution, a
documented agreement must be in place to ensure that the
required conditions are maintained.

4. There must be personnel authorised within the tissue
establishment to assess the need for recall and to initiate and
coordinate the necessary actions.

5. An effective recall procedure must be in place, including a
description of the responsibilities and actions to be taken. This
must include notification to the competent authority.

6. Actions must be taken within pre-defined periods of time and
must include tracing all relevant tissues and cells and, where
applicable, must include trace-back. The purpose of the
investigation is to identify any donor who might have
contributed to causing the reaction in the recipient and to
retrieve available tissues and cells from that donor, as well as
to notify consignees and recipients of tissues and cells procured
from the same donor in the event that they might have been put
at risk.

7. Procedures must be in place for the handling of requests for
tissues and cells. The rules for allocation of tissues and cells to
certain patients or health care institutions must be documented
and made available to these parties upon request.

8. A documented system must be in place for the handling of
returned products including criteria for their acceptance into
the inventory, if applicable.
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E. FINAL LABELLING FOR DISTRIBUTION

The primary tissue or cell container must provide

(a) type of tissues and cells, identification number or code of the
tissue or cells, and lot or batch number where applicable;

(b) identification of the tissue establishment;

(c) expiry date;

(d) in the case of autologous donation, this has to be specified (for
autologous use only) and the donor/recipient has to be
identified;

(e) in the case of directed donations - the label must identify the
intended recipient;

(f) when tissues and cells are known to be positive for a relevant
infectious disease marker, it must be marked as:

BIOLOGICAL HAZARD.

If any of the information under points (d) and (e) above cannot be included
on the primary container label, it must be provided on a separate sheet
accompanying the primary container. This sheet must be packaged with the
primary container in a manner that ensures that they remain together.

2. The following information must be provided either on the label or in
accompanying documentation

(a) description (definition) and, if relevant, dimensions of the
tissue or cell product;

(b) morphology and functional data where relevant;

(c) date of distribution of the tissue or cells;

(d) biological determinations carried out on the donor and results;

(e) storage recommendations;

(f) instructions for opening the container, package, and any
required manipulation or reconstitution;

(g) expiry dates after opening or manipulation;

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(h) instructions for reporting serious adverse reactions or events or
both as set out in sections 11 and 12 of this Part;

(i) presence of potential harmful residues (e.g. antibiotics,
ethylene oxide etc).

F. EXTERNAL LABELLING OF THE SHIPPING CONTAINER

For transport, the primary container must be placed in a shipping container
that must be labelled with at least the following information

(a) identification of the originating tissue establishment, including
an address and phone number;

(b) identification of the organisation responsible for human
application of destination, including address and phone
number;

(c) a statement that the package contains human tissues or cells
and HANDLE WITH CARE;

(d) where living cells are required for the function of the graft,
such as stem cells gametes and embryos, the following must be
added: ‘DO NOT IRRADIATE’;

(e) recommended transport conditions (e.g. keep cool, in upright
position, etc.);

(f) safety instructions or method of cooling (when applicable).

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SCHEDULE 7
Section 11(3)

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A
Rapid notification for suspected serious adverse reactions



Tissue establishment


Report identification


Reporting date (year/month/day)


Individual affected (recipient or donor)


Date and place of procurement or human application
(year/month/day)


Unique Donation identification number


Date of suspected serious adverse reaction (year/month/day)


Type of tissues and cells involved in the suspected serious
adverse reaction

Type of suspected serious adverse reaction(s)

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PART B

Conclusions of serious adverse reactions investigation


Tissue establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Unique donation identification number

Confirmation of serious adverse reaction (Yes/No)

Change of type of serious adverse reaction (Yes/No)

If Yes, Specify

Critical outcome (if known)

-Complete recovery

-Minor sequelae

-Death

Outcome of the investigation and final conclusions


Recommendations for preventive and corrective actions


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SCHEDULE 8
Section 12(4)

NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A
Rapid notification for suspected serious adverse events



Tissue establishment

Report identification

Reporting date (year/month/day)

Date of serious adverse event (year/month/day)

Serious adverse event, which
may affect quality and safety
of tissues and cells due to a
deviation in:

Specification
Tissues
and cells
defect

Equipment
failure

Human
error

Other
(specify)

Procurement


Testing


Transport


Processing


Storage


Distribution


Materials


Others (specify)



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PART B

Conclusions of Serious Adverse Events investigation



Tissue establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse event (year/month/day)

Root cause analysis (details)

Corrective measures taken (details)






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SCHEDULE 9
Section 28(3)

ANNUAL NOTIFICATION FORMAT

PART A
Annual notification format for serious adverse reactions


Reporting country


Reporting date 1 January-31
December (year)


Number of serious adverse reaction(s) per type of tissue and cell
(or product in contact with the tissues and cells)

Type of tissue/cell
(or product in
contact with the
tissues and cells)
Number of serious
adverse
reaction(s)
Total number of
tissues/cells of
this type
distributed (if
available)
1
2
3
4

Total

Total number of tissues and cells distributed (including type of
tissue and cell for which no serious adverse reactions were
reported):

Number of recipients affected (total number of recipients):

Number of serious adverse
reactions reported
Total number of serious
adverse reaction(s)

Transmitted bacterial infection


Transmitted
viral
Infection

HBV


HCV


HIV-1/2


Other
(Specify)

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Transmitted
parasitical

Malaria


Other
(Specify)


Transmitted malignant diseases


Other disease transmissions


Other serious reactions
(Specify)



PART B
Annual notification format for serious adverse events



Reporting country

Reporting date 1 January-31 December (year)

Total number of tissues and cells processed

Total number of serious
adverse events, which may
have affected quality and
safety of tissues and cells due
to a deviation in:

Specification
Tissues
and
cells
defect
(specify)
Equipment
failure
(Specify)
Human
error
Other
(specify)

Procurement


Testing


Processing


Storage


Distribution


Materials


Others (specify)


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SCHEDULE 10
Section 16(8)

Information on the minimum donor or recipient or both data set to be
kept

A. BY TISSUE ESTABLISHMENTS

Donor identification

Donation identification that will include at least

— Identification of the procurement organisation or Tissue
establishment

— Unique Donation ID number

— Date of procurement

— Place of procurement

— Type of donation (e.g. single v multi-tissue; autologous v
allogenic; living v deceased)

Product identification that will include at least

— Identification of the tissue establishment

— Type of tissue and cell or product (basic nomenclature)

— Pool number (if applicable)

— Split number (if applicable)

— Expiry date

— Tissue/cell status (i.e. quarantined, suitable for use etc.)

— Description and origin of the products, processing steps
applied, materials and additives coming into contact with
tissues and cells and having an effect on their quality or safety
or both.

— Identification of the facility issuing the final label
Human application identification that will include at least:

— Date of distribution or disposal

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— Identification of the clinician or end user or facility

B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN
APPLICATION
(a) Identification of the supplier tissue establishment

(b) Identification of the clinician or end user or facility

(c) Type of tissues and cells

(d) Product identification

(e) Identification of the recipient

(f) Date of application

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SCHEDULE 11
Section 16(3)

Information contained in the European Coding System
(a) Donation identification

— Unique ID number

— Identification of the tissue establishment

(b) Product identification

— Product code (basic nomenclature)

— Split number (if applicable)

— Expiry date.

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SCHEDULE 12
Sections 28E and 28M

ORGAN AND DONOR CHARACTERISATION
PART A

Minimum data set

Minimum data – information for the characterisation of organs and donors
which has to be collected for each donation in accordance with the second
subparagraph of Article 7(1) of the Organ Directive and without prejudice
to Article 7(2) of the Organ Directive.

Minimum data set

The establishment where the procurement takes place and other general data

Type of donor

Blood group

Gender

Cause of death

Date of death

Date of birth or estimated age

Weight

Height

Past or present history of IV drug abuse

Past or present history of malignant neoplasia

Present history of other transmissible disease

HIV; HCV; HBV tests

Basic information to evaluate the function of the donated organ

PART B

Complementary data set

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Complementary data – information for the characterisation of organs and
donors to be collected in addition to minimum data specified in Part A,
based on the decision of the medical team, taking into account the
availability of such information and the particular circumstances of the case,
in accordance with the second subparagraph of Article 7(1) of the Organ
Directive .

Complementary data set

General data

Contact details of the procurement organisation/the establishment where the
procurement takes place necessary for coordination, allocation and
traceability of the organs from donors to recipients and vice versa.

Donor data

Demographic and anthropometrical data required in order to guarantee an
appropriate matching between the donor/organ and the recipient.


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Donor medical history

Medical history of the donor, in particular the conditions which might affect
the suitability of the organs for transplantation and imply the risk of disease
transmission.

Physical and clinical data

Data from clinical examination which are necessary for the evaluation of the
physiological maintenance of the potential donor as well as any finding
revealing conditions which remained undetected during the examination of
the donor’s medical history and which might affect the suitability of organs
for transplantation or might imply the risk of disease transmission.

Laboratory parameters

Data needed for the assessment of the functional characterisation of the
organs and for the detection of potentially transmissible diseases and of
possible contraindications with respect to organ donation.

Image tests

Image explorations necessary for the assessment of the anatomical status of
the organs for transplantation.

Therapy

Treatments administered to the donor and relevant for the assessment of the
functional status of the organs and the suitability for organ donation, in
particular the use of antibiotics, inotropic support or transfusion therapy.