Results for psur translation from Slovenian to English

psur
psurs

psur:
official batch release: in accordance with article 114 of directive 2001/ 83/ ec as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose psur:

psur-ji
psurs

psur-om.
psur

cikel psur
psur cycle

struktura poenostavljenega psur
format of the simplified psur

rok: standardni roki za psur.
standard psur timings.

oblika poenostavljenih poročil psur
format of the simplified psur

psur/letna ponovna ocena
psur/ annual reassessment

format za poenostavljeno poročilo psur:
format of the simplified psur:

periodična poročila o varnosti (psur):
psur:

letne varnostne posodobitve s psur-i.
annual safety updates with

letna poročila bodo predložena hkrati s psur.
annual reports will be submitted with the psur.

periodično poročilo o varnosti zdravila (psur):
psur:

11 periodična poročila o varnosti zdravila (psur)
11 outside of the pandemic period, the normal psur periodicity and format will be maintained.

imetnik dovoljenja za promet bo predajal psur na 3 leta.
the marketing authorisation holder will provide the psur at 3-yearly intervals.

redna posodobljena poročila o varnosti (psur- ji)
psurs

rednem posodobljenem poročilu o varnosti zdravila (psur).
progress on enrolment will be submitted

imetnik dovoljenja za promet bo nadalje predajal letne psur-je.
the marketing authorisation holder will continue to submit yearly psurs.

redno poročilo o neželjenih, škodljivih učinkih zdravila (psur’ s):
periodic safety update reports (psur’ s):