Annex I

The Annexes to Directive 2006/86/EC are amended as follows:

1. (1)

   Annex II, Part E, is amended as follows:

   1. (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’;

   2. (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.’;

   3. (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. (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. (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