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S.I. No. 598/2007 - European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007
Table of Provisions (23)
Statutory Text (23 Articles)
1. The primary tissue / cell container must provide
(
a
) type of tissues and cells, identification number or code of the tissue / 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 paragraphs (
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 / 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 / reconstitution;
(
g
) expiry dates after opening / manipulation;
(
h
) instructions for reporting serious adverse reactions and / or events as set out in Regulations 7 to 15;
(
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 tissue / 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 / method of cooling (when applicable).
SCHEDULE 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)
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
Clinicial outcome (if known)— Complete recovery— Minor sequelae— Serious sequelae— Death
Outcome of the investigation and final conclusions
Recommendations for preventive and corrective actions
SCHEDULE 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)
Specification
Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in
Tissues and cells defect
Equipment Failure
Human Error
Other (specify)
Procurement
Testing
Transport
Processing
Storage
Distribution
Materials
Others (specify)
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)
SCHEDULE 5 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 tissues and cells)
Type of tissue / cell (or product in contact with 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 / cells distributed (including type of tissue and cell for which no serious adverse reactions were reported)
Number of recipients affected (total number of recipients)
Nature of the serious adverse reactions reported
Total number of serious adverse reaction(s)
Transmitted bacterial infection
Transmitted viral infection
HBV
HCV
HIV-1/2
Other (specify)
Transmitted parasitical infection
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
Specification
Total number of serious adverse events, which may have affected quality and safety of tissues and cells due to a deviation in
Tissues and cells defect (specify)
Equipment Failure (specify)
Human Error (specify)
Other (specify)
Procurement
Testing
Transport
Processing
Storage
Distribution
Materials
Others (specify)
SCHEDULE 6 INFORMATION ON THE MINIMUM DONOR / RECIPIENT DATA SET TO BE KEPT AS REQUIRED IN REGULATION 21.
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 / 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 and / or safety.
—Identification of the facility issuing the final label
Human application identification that will include at least
—Date of distribution / disposal
—Identification of the clinician or end user / facility
B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
(
a
) Identification of the supplier tissue establishment
(
b
) Identification of the clinician or end user / facility
(
c
) Type of tissues and cells
(
d
) Product identification
(
e
) Identification of the recipient
(
f
) Date of application
SCHEDULE 7
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
GIVEN under my Official Seal,
31 August 2007
MARY HARNEY
Minister for Health and Children.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation)
These Regulations give effect to Commission Directive 2006/86/EC of 24th October 2006. The Regulations may be cited as the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007.
The Regulations set down standards for the quality and safety of human tissues and cells during coding, processing, preservation, storage and distribution to the healthcare establishment where they will be applied to the human body. The Regulations do not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos). The provisions in the Regulations concerning traceability and the reporting of serious adverse reactions and events also apply to the donation, procurement and testing of human tissues and cells.
1 OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
2 OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No. 1882/2003.
3. Where distribution is carried out by a contracted third party, 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.
E. FINAL LABELLING FOR DISTRIBUTION
9. 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
10. Each tissue establishment shall
(
a
) notify the Irish Medicines Board of the actions taken with respect to other implicated tissues and cells that have been distributed for human applications;
(
b
) notify the Irish Medicines Board of the conclusion of the investigation, supplying at least the information set out in Part B of Schedule 3.
Notification of serious adverse events
11. (
a
) Each procurement organisation and tissue establishment shall 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 and/or safety of human tissues and cells;
(
b
) Each organisation responsible for human application of tissues and cells shall 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;
(
c
) Each tissue establishment shall 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.
12. 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 responsible for human application performing assisted reproduction shall report such events to the supplying tissue establishments for investigation and notification to the Irish Medicines Board.
13. Each tissue establishment shall
(
a
) have procedures in place to communicate to the Irish Medicines Board without delay all relevant available information about suspected serious adverse events as referred to in paragraph 11(
a
) and (
b
);
(
b
) have procedures in place to communicate to the Irish Medicines Board without delay the conclusion of the investigation to analyse the cause and the ensuing outcome.
14. The responsible person designated for each tissue establishment shall notify the Irish Medicines Board of the information included in the notification set out in Part A of Schedule 4.
15. Each tissue establishment shall
(
a
) evaluate serious adverse events to identify preventable causes within the process;
(
b
) notify the Irish Medicines Board of the conclusion of the investigation, supplying at least the information set out in Part B of Schedule 4.
Annual reports
16. The Irish Medicines Board shall submit to the European Commission an annual report by 30th June of the following year, on the notification of serious adverse reactions and events received by it.
17. The Irish Medicine Board shall make available to tissue establishments the report it receives from the European Commission summarising the report the Commission received from competent authorities of Member States.
18. Data transmission shall comply with the data exchange format specifications as set out in Part A and B of Schedule 5 and shall provide all the information necessary to identify the sender and maintain its reference data.
Communication of information between competent authorities and to the Commission
19. The Irish Medicines Board shall communicate to the competent authorities of other Member States and to the Commission such information as is appropriate with regard to serious adverse reactions and events, in order to guarantee that adequate actions are taken.
Traceability
20. Each tissue establishment shall have effective and accurate systems to uniquely identify and label cells/tissues received and distributed.
21. Each tissue establishment and each organisation responsible for human application shall retain the data set out in the Schedule 6 for at least 30 years, in an appropriate and readable storage medium.
European coding system
22. (
a
) Each tissue establishment shall allocate a single European identifying code to all donated material, to ensure proper identification of the donor and the traceability of all donated material and to provide information on the main characteristics and properties of tissues and cells. The code shall incorporate at least the information set out in Schedule 7.
(
b
) Paragraph (
a
) shall not apply to partner donation of reproductive cells.
SCHEDULE 1 Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Regulation 5
A. ORGANISATION AND MANAGEMENT
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of
4
th September
, 2007.
I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by
section 3
of the
European Communities Act 1972
(No. 27 of 1972) and for the purpose of giving effect to Directive 2006/86/EC of the European Commission 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, do hereby make the following Regulations