GAPP Joint Action

HemAffairs Blood tubes

Joint Actions are projects designed and financed by Member State Authorities and the EU to address specific priorities under the EU Health Program. They have a clear added value as they are expected to contribute to solving problems at the European level, and to have a greater impact than single national activities, especially at policy-making level.

GAPP is the acronym (FacilitatinG the Authorisation of Preparation Process for blood, tissues and cells) of a new Joint Action which launched in May 2018 with a 36-month duration. The main aim of GAPP is to facilitate the development of a common and optimal approach to assess and authorize preparation processes in Blood and Tissues Establishments, adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC. GAPP will give particular attention to innovative processes under development and/or previously described in relevant EU Joint Actions.

The main objectives of GAPP are:

  1. To increase the consistency and efficacy of Competent Authority (CA) regulatory activities through the harmonization of EU-level tools for authorization procedures for preparation processes at blood and tissues establishments;
  2. To develop a concept model for a European knowledge-sharing platform that can support CAs in the assessment and evaluation of novel preparation processes of products;
  3. To develop an international network of experts that can support CAs in the assessment and evaluation of preparation processes of products, trained by the Joint Action.

GAPP is coordinated by the Italian National Institute of Health, National Transplant Centre and National Blood Centre and includes 17 European countries and more than 40 partners.

EHA supports the project as a Collaborating Stakeholder, contributing expertise and contacts as well as assistance on communication and dissemination. Support for GAPP fits in with EHA’s strategy of promoting collaboration between stakeholders at the European level and involving hematologists in the drafting, evaluation and – as in this case – the implementation of EU legislation.

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Last Updated on Monday 18 March 2019.