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täpsustamine ei too siiski liikmesriikidele ega lubade valdajatele kaasa uusi kohustusi, võrreldes i lisa muutmiseks seni vastu võetud direktiividega.
however, this clarification does not impose any new obligations on member states or holders of authorisations compared to the directives which have been adopted until now amending annex i.
Last Update: 2010-09-10
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[6] teiste direktiivi 91/414/emÜ i lisasse kantud ainetega sarnaselt võidakse varfariini staatus kõnealuse direktiivi artikli 5 lõike 5 alusel uuesti läbi vaadata, pidades silmas kõiki uusi kättesaadavaid andmeid, mis on saadud eelkõige samalaadsete ainete hindamisel või varfariini enda hindamisel direktiivi 98/8/eÜ alusel.
as with all substances included in annex i to directive 91/414/eec, the status of warfarin could be reviewed under article 5(5) of that directive in the light of any new data becoming available, in particular from the assessment of similar substances or from the assessment of warfarin itself under directive 98/8/ec.
Last Update: 2010-09-10
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