Document R2jYvVNNR2M0ygQMnr9a9YLKv
I se como. toca
Meeting with EFPIA 23.01.2023 Participants:
European Federation of Pharmaceutical Industries and Associations (EEPIA, Transition
-- Register 1D 38526121292-85) and European Fine Chemicals Group (EFCG ei-Lily
| I son & Johnson Eurgnean CommRisOsWionF:1)
ext GROW F1) os env. 2)
Items presented by EFPIA: 1. Limitations of the current authorisation process 2. Key substance studies on several substances 3. Influence of the essential use concept (EUC) on the authorisation reform
EFPIA gave the presentation attached to this document. At the beginning, COM pointed out, that the presentation of the consultant during the essential use concept (EUC) workshop does not represent the position of the COM, it is an input that needs to be further considered and that the EUC concept is still underdiscussion within the COM. EFPIA informed that, based on the consultant's presentation in CARACAL, they carried out case studies looking at the impact of the essential use concept (EUC) for the substitution of several substances. EFPIA explained that essentiality would be complex to assessfor their products,for the reasons expressed in their presentation. COM explained that at this stage, discussions on the implementation of the essential uses in REACH were still ongoing.