This task is being led by CNT. A working group including 5 partners in the project (Italy, Austria, France – both ABM and AFSSAPS - and Slovakia) were involved in the development of practical guidelines on the conduct of inspections in tissue and cell establishments.

EDITION I: A number of existing guidance documents were consulted for developing the first edition of the guidelines. All partners participated by ensuring that stakeholders in their MS and their professional groups were aware of the drafts and submit comments. This first edition of guidelines for the inspection of tissue and cells procurement and tissue establishments in the EU was released at the beginning of Octoer 2007 and is available for use. This edition is largely based on guidance already existing in some EU Member States (MS), and some countries outside the EU, and in fields related to tissue and cell inspection such as pharmaceutical and blood inspection. It is hoped that many EU Competent Authorities will apply part of all of these guidelines and feedback to the project whether they have been useful and how they could be improved. The guidelines included proposed standard forms for the provision of information by tissue establishments to inspectorates prior to inspection and for inspection reporting. 

EDITION II: The second edition was developed from Edition I, with the addition of a number of annexes and additional text that reflects the outcome of various project activities.  Edition II was launched for open consultation on March 9th 2008.  The Commission supported the consultation process by giving an announcement on their website together with a link to the EUSTITE website. Comments were received from many Competent Authorities and a final version of Edition II was submitted to the European Commission on May 23rd.  This version is now available to EU Competent Authorities and has been supplied in a printed booklet form.  The final version can be downloaded here as a .pdf file and printed copies can be requested by email at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

          Inspection Guidelines - Final Edition