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Commission Directive 2006/86/ECShow full title

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 (Text with EEA relevance)

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D.DISTRIBUTION AND RECALLU.K.

When the activities for which the accreditation/designation/authorisation/licensing is sought include distribution of tissues and cells, the authorised tissue establishment procedures must comply with the following criteria:

1.

Critical transport conditions, such as temperature and time limit must be defined to maintain the required tissue and cell properties.

2.

The container/package must be secure and ensure that the tissue and cells are maintained in the specified conditions. All containers and packages need to be validated as fit for purpose.

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.

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