VIGILANCE GUIDANCE DOCUMENTS

Facilitating the Authotisation of Preparation Process for blood, tissues and cells (GAPP)

This document is part of the joint action ‘785269/GAPP’, which has received funding from the European Union’s Health Programme (2014-2020). 
The main scope of the guideline is to define how a PPA programme should or could be organised. This document provides recommendations to Competent Authorities to have a common approach for a Preparation Process Authorisation (PPA). For that, different steps are described throughout the guideline to assess the PPA.

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