Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Enter Title Minimize

9. CONTINUITY PLANS

 

 

1.     TEs shall have in place a continuity plan (with adopted procedures and concluded agreements) to ensure that, in the event of termination of their banking/servicing activities (partly, temporarily or permanently) for whatever reason, the tissues in their management shall be transferred to other TEs.

2.     This continuity plan should not undermine legitimate public health interests and should not be guided by financial considerations (profit-maximizing practices).

3.     When the continuity plan implies that tissue could be exported (transferred to a country outside the EU), the export should comply with the requirements in section B.4.3.3. Import and export.

4.     The accepting TEs need to be accredited, designated, authorized or licensed for the purpose of the activities they will need to assume when accepting the tissue.

5.     The accepting TEs need to be able to handle the anticipated amounts of transferred tissue (e.g. sufficient stocking capacity).

6.     The transferred tissue needs to be accompanied by its relevant documentation (including traceability data) and material concerning the quality and safety of the tissue (including retain samples).

7.     The transport conditions should maintain the quality and safety of the tissues.

8.     The transfer of tissues, documentation and material are done under the responsibility of the Responsible Persons of the ceasing and the accepting TEs.

9.     The accepting TEs should have in place procedures for verifying the compliance of the tissues to the ethical and legal requirements.

10.  The terms and conditions of the transfer of tissues shall be described in an agreement (service level agreement or convention) detailing at least:

a.     The responsibilities and commitments of each party.

b.     The type and anticipated quantities of tissues that will be transferred.

c.     The type and anticipated quantities of documentation that will be transferred.

d.     The type and amount anticipated quantities of material (e.g. retain samples) that will be transferred.

e.     The transport conditions for tissue, documentation and material.

11.  It is however possible that a meaningful transfer of tissues can not be agreed upon (or is impossible). In this case the CA shall determine the fate of the tissues.

Print  
A3f Engine ::Terms Of Use::Privacy Statement