Page 5 - INTERIM NEWSLETTER FINAL

performed with the main aim of assessing how the EU legislation improved the quality and safety
issues, whether it achieved its original objectives and whether it is still fit for purpose.

The evaluation was expected to provide a sound evidence base which will be used to consider

the need for any changes to the legislation.

4

INTERIM OVERVIEW ON TECHNICAL WP’s

WP5 - Development of Overall Guidance on organisation of PPA

system (Gerard Sheridan, HPRA, Ireland; Ruth Barrio, CatSalut,

Spain)

Deliverable 5.1 aims at extending the Outputs of Previous Projects – VISTART, GTPII etc. to the
Blood field. It will be finalised in April 2020 after the second multi-country workshop. So far WP5
have reviewed a Blood risk assessment and compared it with EUROGTP tool, the future discussion

to be brought to the second workshop will be mostly focused on how to enlarge the EUROGTP II
risk assessment tool also to the Blood group.

The preparation of D5.2 is ongoing and will describe the outcome of the Survey circulated in April
2019 (structured in three parts and issued to Competent Authorities in Blood, Tissues and Cells)
and the desk-based review of PPA in other fields. The final Deliverable of WP5 will be the D5.3
Good Practice Guideline on the authorisation of preparation processes in Blood, Tissues and Cells
(BTC) to be delivered at the end of the Action.

WP6 - Technical Annex 1 to overall guidance: authorisation of

changes in donation, procurement and collection, processing,

preservation, storage and distribution (Samuel Arrabal, Katia

Bruneau, ABM, France)

The aim of WP6 is to prepare the first annex of the guideline, focusing on the authorisation of
changes in donation, procurement and collection, processing, preservation, storage and
distribution (including labeling and package inserts), taking into account that the quality of the
preparation of BTC has an impact on patients and will condition the authorisation of preparation

process steps. Within this WP there is the need to establish clear quality criteria for different
blood components and tissues and cells.

The final deliverable should be ready by September 2020.

This report is part of the project/joint action ‘785269/GAPP’ which has received funding from the European Union’s Health Programme (2014-2020). The content of this report represents the views of
the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any
other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.
GAPP JA | Deliverable 0.0