GAPP  is a 45 month Joint Action funded by the EU Health programme aiming at facilitating the development of a common and optimal approach to assess and authorize preparation processes in blood and tissues establishments (BEs and TEs), adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC .
 

This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted ;

Since the directives for these fields were adopted, significant technical developments have taken place and the complexity of preparation processes has greatly increased. Increasing complexity of processing can bring significant quality and functionality improvements for patients, and/or more efficient use of donations, but it can also bring increased risk, particularly as the level of complexity brings the final product towards the borderline with medicinal products.

GAPP will ensure that any possible advantage or outcome is taken into account from two ongoing Public Health Programme projects focused on tissues and cells (EuroGTP II and ECCTR) incorporating a need for clinical follow-up data as part of a comprehensive process authorization.

GAPP durable output is that a concept of a knowledge sharing platform on PPAs will be developed and fed in order to facilitate sharing of information among European Union, Competent Authorities and all EU CA inspectors and assessors will be trained specifically to assess and authorize preparation processes of tissues, cells, reproductive cells and blood products.

Please visit GAPP website to download available documents.