# Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance), Annex I

Extent: E+W+S+N.I.

The Annexes to Directive 2006/86/EC are amended as follows:
(1) Annex II, Part E, is amended as follows:
(a) in point 1 the following point (g) is added:
‘(g)
Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application’;
(b) the second subparagraph of point 1 is replaced by the following:
‘If any of the information under points (d), (e) and (g) 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.’;
(c) in point 2, the following point (j) is added:
‘(j)
for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country)’.
(2) Annexes III and IV are replaced by the following:
ANNEX III
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
ANNEX IV
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)
(3) Annexes VI and VII are replaced by the following:
ANNEX VI
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
B.
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)
ANNEX VII
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

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Source: https://www.legislation.gov.uk/eudr/2015/565/annex/I (the official version)
Page: https://openlegislation.uk/eu-directive-2015-565/annex-I
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.