您搜索了: psur (英语 - 马耳他语)

psur
psur

(psur).
sigurta` (psur) li jmiss, skond ir- regolament tas- chmp dwar sistemi għal- maniġġjar ta ’ riskji għal - prodotti mediċinali għall- użu fil- bniedem. ot

with psur
b’psur

first psur
l-ewwel psur

psur assessment worksharing
il-valutazzjoni dwar il-qsim tax-xogħol tal-psur

standard psur timings.
il- ħinijiet standard stipulati tal - psur.

27 june 2009 psur 3:
27 ta ’ Ġunju 2009 psur 3:

27 december 2008 psur 2:
27 ta ’ diċembru 2008 psur 2:

format of the simplified psur
format tar-rapport ta’ aġġornament dwar is-sigurtà simplifikat

format of the simplified psur:
format tal-psur issimplifikat:

interim study reports - with each psur
rapporti ta’ studju interim – b’kull psur

submission of study protocol with first psur
sottomissjoni tal-protokoll ta’ studju mal- ewwel psur

psur submission during the influenza pandemic:
sottomissjoni tal- psur (rapporti perjodiċi dwar l- aġġornament tas- sigurtà) matul l- influwenza pandemika:

have to be provided in the (simplified) psur
riżultati, inkluż kull analiżi preliminari għandhom jiġu pprovduti fil-psur (simplifikat)

psurs psur submission during the influenza pandemic:
psurs is- sottomissjoni ta ’ psur waqt l- influwenza pandemika:

the marketing authorisation holder will provide the psur annually.
id- detentur ta ’ l- awtorizzazzjoni g at- tqeg id fis- suq se jipprovdi l- psur kull sena.

the marketing authorisation holder will submit yearly psur’ s
id- detentur ta 'l- awtorizzazzjoni tal - manifattura se jissottometti psurs ta' kull sena

psur: the marketing authorisation holder will submit yearly psurs.
psur: id-detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq se jissottometti psurs kull sena.

the psur submission schedule should follow the psur schedule for the reference medicinal product.
l-iskeda tas-sottomissjoni tal-psur għandha ssegwi l-iskeda tal-psur tal-prodott ta’ riferiment.

the psur submission schedule should follow the psur submission schedule for the reference medicinal product.
is-sottomissjoni tal-psur skedata għandha ssegwi s-sottomissjoni skedata għall-prodott mediċinali ta’ referenza.