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vhodna snov
starting material
Last Update: 2014-11-21
Usage Frequency: 1
Quality:
z uporabo metode predelave 1 (sterilizacija pod pritiskom), kadar se kot vhodna snov uporabi snov kategorije 2;
applying processing method 1 (pressure sterilisation), when category 2 material is used as starting material;
Če vhodna snov ni opisana v evropski farmakopeji ali v farmakopeji države članice, je sprejemljiva skladnost z monografijo farmakopeje tretje države;
in cases where a starting material is described neither in the european pharmacopoeia nor in the pharmacopoeia of a member state, compliance with the monograph of a third country pharmacopoeia can be accepted;
Če se uporabljajo še drugi preskusi, ki so navedeni v farmakopeji, je treba predložiti dokaze, da vhodna snov ustreza zahtevam glede kakovosti iz zadevne farmakopeje.
if tests other than those mentioned in the pharmacopoeia are used, proof must be supplied that the starting materials meet the quality requirements of that pharmacopoeia.
pregled reproduktivnga delovanja je treba izvesti takrat, kadar podatki nakazujejo, da bi lahko vhodna snov iz katere se zdravilo izdeluje, lahko predstavljala rizični faktor.
examination of reproductive performance shall be considered when data suggest that the starting material from which the product is derived may be a potential risk factor.
kakšna je bila za posamezno vrsto odpadkov skupna količina emisij fosilnega co2 iz odpadkov, uporabljenih kot gorivo ali vhodna snov, kot so jo sporočili upravljavci v svojih preverjenih poročilih o emisijah?
what was for each waste type the total quantity of fossil co2 emissions from waste used as fuel or input material, as reported by operators in their verified emissions report?
z uporabo katere koli metode predelave od 1 do 7, določene v poglavju iii priloge iv, kadar se kot vhodna snov uporabi snov kategorije 3, ki se ne uporablja za proizvodnjo predelanih živalskih beljakovin.
by applying any of the processing methods 1 to 7, as set out in chapter iii of annex iv, when category 3 material is used as starting material which is not used for the production of processed animal protein.
kadar je vhodna snov v evropski farmakopeji ali v farmakopeji države članice pripravljena po postopku, pri katerem bi lahko nastale nečistote, ki niso nadzorovane z monografijo farmakopeje, je treba navesti nečistote in njihove najvišje dopustne meje vsebnosti ter opisati ustrezen postopek preskušanja.
however, where a starting material in the european pharmacopoeia or in the pharmacopoeia of a member state has been prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits must be declared and a suitable test procedure must be described.
vendar pa, če je bila vhodna snov pripravljena po evropski farmakopeji ali po farmakopeji države članice po postopku, pri katerem bo lahko nastale nečistoče, ki jih farmakopeja ne kontrolira, je treba te nečistoče ter njihove najvišje dopustne meje vsebnosti navesti ter opisati ustrezni postopek preskušanja.
however, where a starting material in the european pharmacopoeia or in the pharmacopoeia of a member state has been prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits must be declared and a suitable test procedure must be described.
kadar vhodna snov ni opisana niti v evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme skladnost z monografijo farmakopeje tretje države; v takih primerih predlagatelj predloži kopijo monografije, po potrebi potrditev postopkov preskušanj, ki jih monografija navaja, ter, kadar je to potrebno, prevod.
in cases where a starting material is described neither in the european pharmacopoeia nor in the pharmacopoeia of a member state, compliance with the monograph of a third country pharmacopoeia can be accepted; in such cases, the applicant shall submit a copy of the monograph accompanied where necessary by the validation of the test procedures contained in the monograph and by a translation where appropriate.
