The labeling of the primary packaging (vial) of radiopharmaceuticals is a practice that involves investigative procedures for the manufacturer, with onerous repercussions (procedural and structural). We know that for radiation protection issues, the vial containing radiopharmaceutical cannot be handled so the label on the vial cannot be read by practitioners in Nuclear Medicine, at least as long as it is…
ISC
IRCCS Sacro Cuore - Istituto Don Calabria
Academic / research · Italy
3
positions filed
in the 665 files tracked
1
legislative file
of 665 tracked
1
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
IRCCS Sacro Cuore - Istituto Don Calabria filed 3 positions between 30 Oct 2023 and 8 Nov 2023, across 1 of the 665 legislative files tracked here, attaching a full position paper 1 time.
What they argued
The labeling of the primary packaging (vial) of radiopharmaceuticals is a practice that involves investigative procedures for the manufacturer, with onerous repercussions (procedural and structural). We know that for radiation protection issues, the vial containing radiopharmaceutical cannot be handled so the label on the vial cannot be read by practitioners in Nuclear Medicine, at least as long as it is…
Comment on Article 68 The labelling of the immediate packaging of radiopharmaceuticals (in particular those used in PET) is a practice which increases the risks and does not bring any clinical or safety benefit to the user.
Filed in Italian · English published by the European Commission
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