9.4.2015 |
EN |
Official Journal of the European Union |
L 93/43 |
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 (1) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, and in particular Article 28 thereof,
Whereas:
(1) |
Directive 2004/23/EC requires that Member States ensure the traceability of human tissues and cells from the donor to the recipient and vice versa. |
(2) |
In order to facilitate traceability it is necessary to establish a unique identifier applied to tissues and cells distributed in the Union (Single European Code) providing information on the main characteristics and properties of those tissues and cells. |
(3) |
In order to ensure a uniform implementation of the Single European Code throughout the Union, obligations of the Member States competent authorities and of the tissue establishments for the application of the Single European Code should be set out. Only this approach will guarantee a consistent and coherent application of the code in the Union. |
(4) |
Traceability from donor to recipient and vice versa should be ensured through coding of tissues and cells and through accompanying documentation. At the recipient end, the Single European Code provides information on the donation and on the tissue establishment responsible for the procurement of tissues and cells. At the donor end, the tissue establishment responsible for the procurement of tissues and cells may track the tissues and cells distributed for human application by requesting the next operators in the chain to provide data related to the use of the tissues and cells based on the donation identification elements of the Single European Code as contained in the accompanying documentation. |
(5) |
The format of the Single European Code should be harmonised in order to facilitate its application by small and large establishments, whilst allowing some flexibility for establishments to continue using existing codes. |
(6) |
A Single European Code allowing for donation and product identification should be allocated to all tissues and cells distributed for human application, including those imported from third countries. Member States may allow certain exemptions from the application of the code. |
(7) |
Where tissues and cells are excluded or exempted from the application of the Single European Code, the Member States should ensure that appropriate traceability of these tissues and cells is guaranteed throughout the entire chain from donation and procurement to human application. |
(8) |
In situations where tissues and cells are released for circulation, other than for distribution (such as transfer to another operator for further processing with or without return), as a minimum the donation identification sequence should be applied at least in the accompanying documentation. Where tissues and cells are transferred from a tissue establishment to another operator just for storage and/or for further distribution, the tissue establishment may already apply the Single European Code on their final label in addition to the donation identification sequence which should be applied at least in the accompanying documentation. |
(9) |
In the case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across procurements. This may be ensured by developing a central system for the allocation of the unique donation numbers for each donation event recorded at national level, or by requiring all tissue establishments to ensure robust traceability links between the donation identification numbers allocated by each tissue establishment procuring or receiving tissue and cells originating from the same deceased donor. |
(10) |
The Commission should ensure the implementation of the Single European Code by providing the appropriate tools to the Member States competent authorities and tissue establishments. The Member States competent authorities should update the register for tissue establishments, reflecting any changes in tissue establishment accreditations, designations, authorisations, or licences and the Commission should ensure the update of the register of the tissues and cells whenever new products need to be included. For this the Commission should consult a group of experts, in particular experts nominated by the Member States competent authorities. |
(11) |
For the donation identification sequence in the Single European Code, the importing tissue establishment should use the tissue establishment code allocated to it in the EU Tissue Establishment Compendium and should allocate a unique donation number if the donation number on the imported product is not globally unique. |
(12) |
Pooling of tissues or cells is allowed in some Member States. Therefore, the application of the Single European Code in case of pooling is also addressed by this Directive. |
(13) |
A transitional regime for tissues and cells already in storage at the end of the transposition period should be introduced. |
(14) |
This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to coding of tissues and cells, provided that the provisions of the Treaty are met. |
(15) |
The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 29 of Directive 2004/23/EC, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Commission Directive 2006/86/EC (2) is hereby amended as follows:
(1) |
In Article 2, the following points (k) to (y) are added:
|
(2) |
Article 9 is replaced by the following: ‘Article 9 Traceability 1. Member States shall ensure that tissues and cells shall be traceable in particular through documentation and the use of the Single European Code from procurement to human application or disposal and vice versa. Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer. 2. Member States shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, using an appropriate and readable storage medium. 3. In case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across the procurements.’ |
(3) |
Article 10 is replaced by the following: ‘Article 10 European coding system 1. Without prejudice to paragraphs 2 or 3 of this Article, a Single European Code shall be applied to all tissues and cells distributed for human application. For the other situations where tissues and cells are released for circulation, as a minimum the donation identification sequence shall be applied at least in the accompanying documentation. 2. Paragraph 1 shall not apply to:
3. Member States may also allow exemptions from the requirement provided for in paragraph 1 for:
|
(4) |
The following Articles are inserted: ‘Article 10a Format of the Single European Code 1. The Single European Code referred to in Article 10(1) shall comply with the specifications set out in this Article and in Annex VII. 2. The Single European Code shall be in eye-readable format and shall be preceded by the acronym “SEC”. The parallel use of other labelling and traceability systems is possible. 3. The Single European Code shall be printed with the Donation Identification Sequence and Product Identification Sequence separated by a single space or as two successive lines. Article 10b Requirements related to the application of the Single European Code 1. Member States shall ensure that the following minimum requirements are complied with by tissue establishments, including importing tissue establishments as defined by Commission Directive (EU) 2015/566 (*1):
2. Member States shall ensure that the following minimum requirements are applied by all competent authorities:
3. The application of the Single European Code does not preclude the additional application of other codes in accordance with Member States' national requirements. Article 10c Accessibility and maintenance of the European coding system 1. The Commission shall host and maintain an IT platform (“EU Coding Platform”) which contains:
2. The Commission shall ensure that the information contained in the EU Coding Platform is publicly available before 29 October 2016. 3. The Commission shall update when needed the EUTC and ensure the overall update of the EU Tissue and Cell Product Compendium. The Commission considers that it is necessary that agreements are established with the organisations managing ISBT128 and Eurocode to ensure that updated product codes are regularly made available to the Commission for inclusion in the EU Tissue and Cell Product Compendium. If such organisations do not comply with the terms of the memoranda of understanding, the Commission may suspend, partially or in full, the future use of their respective product codes, having considered the sufficient supply of the concerned type of products in the Member States including a transitional period and having consulted the Member State experts through the Competent Authorities on Substances of Human Origin Expert Group. Article 10d Transitional period Tissues and cells already in storage on 29 October 2016 shall be exempted from the obligations relating to the Single European Code, provided the tissues and cells are released for circulation in the Union within five years following that date and under the condition that full traceability is ensured by alternative means. For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in Article 10b paragraph 1(f). (*1) Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissue (OJ L 93, 9.4.2015, p. 56).’ " |
(5) |
The Annexes are amended in accordance with Annex I to this Directive. |
(6) |
A new Annex VIII is added, the text of which is set out in Annex II to this Directive. |
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 October 2016 at the latest. They shall forthwith communicate to the Commission the text of those provisions. They shall apply the legislation from 29 April 2017.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 8 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 102, 7.4.2004, p. 48.
(2) 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 (OJ L 294, 25.10.2006, p. 32).
ANNEX I
The Annexes to Directive 2006/86/EC are amended as follows:
(1) |
Annex II, Part E, is amended as follows:
|
(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)
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
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
B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
‘ANNEX VII THE STRUCTURE OF THE SINGLE EUROPEAN CODE
|
ANNEX II
‘ANNEX VIII
Data to be recorded in the EU Tissue Establishment Compendium
A. Tissue establishment information
1. |
Name of the tissue establishment |
2. |
National or international code of tissue establishment |
3. |
Name of the organisation in which the tissue establishment is located (if applicable) |
4. |
Address of the tissue establishment |
5. |
Publishable contact details: functional e-mail address, phone and fax |
B. Details on the authorisation, accreditation, designation, or license of the tissue establishment
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).’ |
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