S.I. No. 32/2019 - European Communities (Human Tissues And Cells Traceability Requirements, Notification Of Serious Adverse Reactions And Events And Certain Technical Requirements) (Amendment) Regulations 2019

1. Name of the authorising, accrediting, designating or licensing competent authority or authorities

2. Name of the national competent authority or authorities responsible for maintenance of the EU Tissue Establishment Compendium

3. Name of the authorisation, accreditation, designation or licence holder (if applicable)

4. Tissues and cells for which the authorisation, accreditation, designation or license was granted

5. Activities actually carried out for which the authorisation, accreditation, designation or licence was granted

6. Status of the authorisation, accreditation, designation or license (authorised, suspended, revoked, in part or in full, voluntary cessation of activities)

7. Details of any conditions and exemptions added to the authorisation (if applicable).’

GIVEN under my Official Seal,

5 February 2019

SIMON HARRIS,

Minister for Health.

Explanatory Note

(This note is not part of the instrument and does not purport to be a legal interpretation)

These Regulations give effect to Commission Directive (EU) 2015/565 of 08 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.

The Regulations provide procedures for ensuring the traceability of human tissues and cells from the donor to the recipient and vice versa. The Regulations provide that a unique identifier known as the Single European Code should be applied to all tissues and cells distributed for human application. The Regulations further provide that the Health Products Regulatory Authority will assign a unique tissue establishment number to all authorised, accredited, designated or licensed tissue establishments and importing tissue establishments.

The Regulations amend the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007 (

S.I. No. 598 of 2007

).

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) (Amendment) Regulations 2019.

1 OJ No. L 93, 9.4.2015, p. 43.

8. The Regulations of 2006 are amended -

(

a

) in Regulation 2(1) -

(i) in the definition of “inspection”, by the substitution of “these Regulations and the Regulations of 2007” for “these Regulations”, and

(ii) by the insertion of the following definition

“‘Regulations of 2007’ means the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007 (

S.I. No. 598 of 2007

) (amended by the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) (Amendment) Regulations 2019 (

S.I. No. 32 of 2019

));”, and

(

b

) in Regulation 19, by the substitution of “these Regulations and the Regulations of 2007” for “these Regulations” in each place that it occurs.

Schedule 1

NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A

Rapid notification for suspected serious adverse reactions

Tissue establishment

EU tissue establishment code (if applicable)

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

Single European Code of tissues or cells involved in the suspected serious adverse reaction (if applicable)

Type of suspected serious adverse reaction(s)

PART B

Conclusions of Serious Adverse Reactions Investigation

Tissue establishment

EU tissue establishment code (if applicable)

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)

Single European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)

Change of type of serious adverse reaction (Yes/No) If YES, specify

Clinical outcome (if known)

— Complete recovery

— Minor sequelae

— Serious sequelae

— Death

Outcome of the investigation and final conclusions

Recommendations for preventive and corrective actions

Schedule 2

NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A

Rapid notification for suspected serious adverse events

Tissue establishment

EU tissue establishment code (if applicable)

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)

PART B

Conclusions of Serious Adverse Events investigation

Tissue establishment

EU tissue establishment code (if applicable)

Report identification

Confirmation date (year/month/day)

Date of serious adverse event (year/month/day)

Root cause analysis (details)

Corrective measures taken (details)’

Schedule 3

Minimum data to be kept in accordance with Article 9(2)

A. BY TISSUE ESTABLISHMENTS

(1) Donor identification

(2) Donation identification that will include at least

– Identification of the procurement organisation (including contact details) or the tissue establishment

– Unique donation number

– Date of procurement

– Place of procurement

– Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)

(3) Product identification that will include at least

– Identification of the tissue establishment

– Type of tissue and cell/product (basic nomenclature)

– Pool number (in case of pooling)

– Split number (if applicable)

– Expiry date (if applicable)

– 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

(4) Single European Code (if applicable)

(5) Human application identification that will include at least

– Date of distribution/disposal

– Identification of the clinician or end-user/facility

A. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION

(1) Identification of the supplier tissue establishment

(2) Identification of the clinician or end-user/facility

(3) Type of tissues and cells

(4) Product identification

(5) Identification of the recipient

(6) Date of application

(7) Single European Code (if applicable)

Schedule 4

THE STRUCTURE OF THE SINGLE EUROPEAN CODE

DONATION IDENTIFICATION SEQUENCE

PRODUCT IDENTIFICATION SEQUENCE

EU TISSUE ESTABLISHMENT CODE

UNIQUE DONATION NUMBER

PRODUCT CODE

SPLIT NUMBER

EXPIRY DATE (YYYYMMDD)

ISO country code

Tissue establishment number

Product Coding System identifier

Product number

2 alphabetic characters

6 alpha-numeric characters

13 alpha-numeric characters

1 alphabetic character

7 alpha-numeric characters

3 alpha-numeric characters

8 numeric characters’

Schedule 5

Data to be recorded in the EU Tissue Establishment Compendium

A. Tissue establishment information

23. (1) The Single European Code shall -

(

a

) comply with this Regulation and Schedule 8,

(

b

) be in eye-readable format,

(

c

) be preceded by the acronym ‘SEC’, and

(

d

) be printed with the donation identification sequence and product identification sequence separated by a single space or as 2 successive lines.

(2) Nothing in these Regulations shall be construed as prohibiting the parallel use of other labelling and traceability systems in accordance with the Single European Code.

Allocation of Single European Code

24. (1) A tissue establishment –

(

a

) shall allocate a Single European Code to all tissues and cells requiring application of this code before their distribution for human application,

(

b

) shall allocate a donation identification sequence after procuring the tissues and cells, or when receiving them from a procurement organisation, or when importing tissues and cells from a third country supplier,

(

c

) shall not alter the donation identification sequence once it is allocated to tissues and cells released for circulation unless the alteration is necessary to correct an encoding error, and where such an error is corrected, the tissue establishment shall maintain a record of the correction,

(

d

) shall use one of the permitted product coding systems and the corresponding tissue and cell product numbers included in the EU Tissue and Cell Product Compendium at the latest before the distribution for human application, and

(

e

) shall use an appropriate split number and expiry date for tissues and cells and where no expiry date is defined the expiry date shall be 00000000 at the latest before their distribution for human application.

(2) A donation identification sequence shall include -

(

a

) the EU tissue establishment code as established in the EU Tissue Establishment Compendium, and

(

b

) a unique donation number allocated by the tissue establishment unless the number is a globally unique number as used by the ISBT128 coding system.

(3) Where the pooling of tissues and cells is permitted -

(

a

) a new donation identification number shall be allocated to the final product, and

(

b

) the tissue establishment in which the pooling is carried out shall ensure the traceability of individual donations.

(4) A tissue establishment shall apply the Single European Code on the label of the product concerned in an indelible and permanent manner and specify that code in the relevant accompanying documentation prior to the distribution for human application.

(5) Where the label size does not allow the application of the Single European Code on the label, the code shall be clearly linked to tissues and cells packaged with such a label through the accompanying documents.

(6) A tissue establishment shall take the necessary measures in consultation with the Health Products Regulatory Authority in the case of incorrect application of the Single European Code on the label.

(7) A tissue establishment may entrust a third party to apply the Single European Code in accordance with paragraph (4), provided that the establishment ensures that the third party complies with these Regulations, in particular in terms of uniqueness of the code.

(8) A tissue establishment shall notify the Health Products Regulatory Authority when -

(

a

) information contained in the EU Tissue Establishment Compendium requires an update or correction,

(

b

) the EU Tissue and Cell Product Compendium requires an update, and

(

c

) that establishment observes a situation of significant non-compliance with the requirements relating to the Single European Code concerning tissues and cells received from other EU tissue establishments.

Allocation of tissue establishment number

25. (1) The Health Products Regulatory Authority shall allocate a unique tissue establishment number to all tissue establishments authorised in the State.

(2) Where a tissue establishment has different physical locations in the State, but has one system for allocating unique donation numbers, it may be deemed to be one and the same tissue establishment.

(3) Where a tissue establishment uses 2 or more systems for allocating unique donation numbers, such an establishment shall be allocated separate tissue establishment numbers corresponding to the number of allocation systems used.

EU Tissue Establishment Compendium

26. (1) The Health Products Regulatory Authority shall validate the data on the tissue establishments established in the State that are contained in the EU Tissue Establishment Compendium.

(2) The Health Products Regulatory Authority shall, as soon as practicable, update the EU Tissue Establishment Compendium in relation to the following

(

a

) the authorisation of a new tissue establishment;

(

b

) when information relating to a tissue establishment changes or is not recorded correctly in the EU Tissue Establishment Compendium;

(

c

) when the particulars of an authorisation of a tissue establishment listed in Schedule 8 changes, including -

(i) authorisation for a new tissue or cell type,

(ii) authorisation for a new prescribed activity or a new importing activity,

(iii) details of any conditions and or exemptions added to an authorisation,

(iv) suspension of an authorisation for a tissue establishment whether in part or in full,

(v) revocation of an authorisation for a tissue establishment whether in part or in full, and

(vi) where a tissue establishment voluntarily ceases the activity or activities for which it is authorised whether in part or in full.

(3) In this Regulation, “as soon as practicable” means, in relation to any changes substantially affecting the authorisation of the tissue establishment concerned, not later than 10 working days.

Alerts

27. The Health Products Regulatory Authority shall alert -

(

a

) the competent authority of a Member State when it observes -

(i) incorrect information in the EU Tissue Establishment Compendium relating to that Member State, or

(ii) a situation of significant non-compliance with the provisions relating to the Single European Code relating to that Member State, and

(

b

) the Commission and competent authorities of Member States when, in the assessment of the Health Product Regulatory Authority, the Compendium requires an update.

Transitional provisions

28. (1) Regulation 20 and Regulations 22 to 27 shall not apply to tissues and cells in storage on or before 29 October 2016 if such tissues and cells are released for circulation in the European Union on or before 29 October 2021 and full traceability is ensured by alternative means.

(2) Where -

(

a

) tissues and cells remain in storage and are released for circulation after 29 October 2021, and

(

b

) the Single European Code cannot be applied, in particular because the tissues and cells are stored under deep-freeze conditions,

a tissue establishment shall use the procedures applicable to products with small labels in accordance with Regulation 24(4), (5) and (7).”.

Amendments to Schedules to Principal Regulations

Notice of the making of this Statutory Instrument was published in

“Iris Oifigúil” of

12

th February,

2019

I, Simon Harris, Minister for Health, in exercise of the powers conferred on me by

section 3

of the

European Communities Act 1972

(No. 27 of 1972) and for the purpose of giving effect to Commission Directive (EU) 2015/565 of 8 April 2015

1

amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells, hereby make the following regulations

Citation