Focusing on the provisions of the Regulation, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by rejecting the proposed transferable exclusivity vouchers for novel antimicrobials.
CAP
Czech association of pharmaceutical companies
Industry association · Czechia
2
positions filed
in the 665 files tracked
1
legislative file
of 665 tracked
0
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,800 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
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Their record over time
Czech association of pharmaceutical companies filed 2 positions on 8 Nov 2023, across 1 of the 665 legislative files tracked here.
What they argued
Focusing on the Directive, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by: a) clarifying the Bolar provision to allow immediate day-1 competition after IP expiry, through the inclusion of the supply of EU produced APIs for obtaining marketing authorisations (API supply, offer, export, manufacturing) and all…
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