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concerning centrally authorised products (human medicines) 50,000 50,500
case safety reports) dwar prodotti awtorizzati centralment (medicini ghall- bniedem)
taking into account the prac assessment report on the psur(s) for brimonidine (centrally authorised product only), the scientific conclusions of chmp are as follows:
meta jiġi kkunsidrat ir-rapport ta’ valutazzjoni tal-prac dwar il-psurs għal brimonidine (prodott awtorizzat b'mod ċentrali biss), il-konklużjonijiet xjentifiċi tas-chmp huma kif ġej:
the cvmp at their meeting on 14-16 may 2013 decided that one further renewal was required for the centrally authorised product reconcile.
is-cvmp fil-laqgħa tagħhom fl-14-16 ta’ mejju 2013 iddeċidew li hemm bżonn ta’ tiġdid wieħed addizzjonali għall-prodott awtorizzat ċentralment reconcile.
the new barriers include, for example, the requirement for all retail establishments to be centrally authorised.
ostakli ġodda jinkludu, pereżempju, ir-rekwiżit għall-istabbilimenti tal-bejgħ kollha li jridu jkunu awtorizzati ċentralment.
the agency is continuing the development of the scientific-memory database for centrally authorised veterinary medicines.
l- aġenzija qed tkompli tiżviluppa bażi tad- data ta 'memorja xjentifika għal mediċini veterinarji awtorizzati ċentralment.
fee revenues are anticipated to further increase in the coming years in line with the general increase in the number of centrally authorised products.
id-dħul mill-miżati huwa previst li jiżdied iktar fis-snin li ġejjin b'konformità maż-żieda ġenerali fin-numru tal-prodotti awtorizzati ċentralment.
as regards centrally authorised innovative products, the european medicines agency should be given certain tasks as concerns the verification of specific information.
rigward prodotti innovattivi awtorizzati b’mod ċentrali, l-aġenzija ewropea tal-mediċini għandha tingħata ċerti ħidmiet rigward il-verifika ta’ informazzjoni speċifika.
the emea receives safety reports from within the eu and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
l- emea tirċievi rapporti ta 'sigurtà minn ġewwa l- ue u minn barra dwar prodotti mediċinali awtorizzati ċentralment u tikkoordina l- azzjoni li tittieħed fir- rigward tas- sigurtà u l- kwalità tal- prodotti mediċinali.
as explained above, it can be estimated that 100 submissions for an opinion about information to patient on centrally authorised products will need to be checked by the agency in the first year.
kif spjegat hawn fuq, jista' jingħad li bħala stima 100 sottomissjoni għal opinjoni dwar informazzjoni lill-pazjenti dwar prodotti awtorizzati ċentralment jeħtieġ li jiġu vverifikati mill-aġenzija fl-ewwel sena.
on the basis of the scientific conclusions for brimonidine (centrally authorised product only) the chmp is of the opinion that the benefit-risk balance of the medicinal product(s) containing brimonidine (centrally authorised product only) is unchanged subject to the proposed changes to the product information
abbażi ta’ konklużjonijiet xjentifiċi għal brimonidine (prodott awtorizzat ċentralment biss) is-chmp huwa tal- fehma li l-bilanċ bejn il-benefiċċju u r-riskju ta’ prodott(i) mediċinali li fih/fihom brimonidine (prodott awtorizzat ċentralment biss) huwa favorevoli suġġett għall-bidliet proposti għall- informazzjoni tal-prodott.
as explained above, it can be estimated that 700 submissions about information to patients on centrally authorised products will need to be checked by the agency in the first years (2016-2021).
kif spjegat hawn fuq, jista' jingħad li bħala stima 700 sottomissjoni dwar informazzjoni lill-pazjenti dwar prodotti awtorizzati ċentralment jeħtieġ li jiġu vverifikati mill-aġenzija fl-ewwel snin (2016-2021).