Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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1–6/6
smernice Evropske farmakopeje
1 Pravna redakcija
finance
CELEX: 32003L0063
(10) Za prisotnost naključnih snovi se predložijo podatki, ki ocenjujejo tveganje glede na možno onesnaženje z naključnimi snovmi, če so nevirusne ali virusne, kakor je določeno v ustreznih smernicah kot tudi ustrezni splošni monografiji in splošnem poglavju Evropske farmakopeje.
(10) For adventitious agents, information assessing the risk with respect to potential contamination with adventitious agents, whether they are non-viral or viral, as laid down in relevant guidelines as well as in relevant general monograph and general chapter of the European Pharmacopoeia, shall be provided.
2 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Pri vseh kontrolah bioloških zdravil, kot so imunološka zdravila ter zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedene v Evropski farmakopeji ali v nacionalni farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
For all controls of biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, which are not specified in the European Pharmacopoeia, or failing this, in the national pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the World Health Organization (Requirements for Biological Substances) shall serve as guidelines.
3 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Pri bioloških zdravilih, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, se kot smernice za vse nadzore faz proizvodnje, ki niso navedene v Evropski farmakopeji ali farmakopeji države članice, upoštevajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
For biological medicinal products, such as immunological medicinal products and medicinal products derived from human blood or plasma, the procedures and the criteria of acceptability published as recommendations of the WHO (Requirements for Biological Substances) shall serve as guidelines for all controls of production stages which are not specified in the European Pharmacopoeia, or falling this, in the national pharmacopoeia of a Member State.
4 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Za vse kontrole bioloških zdravil, kot so imunološka zdravila in zdravila, pridobljena iz človeške krvi ali plazme, ki niso navedena v Evropski farmakopeji ali, če jih ta ne vsebuje, v farmakopeji države članice, se kot smernice uporabljajo postopki in merila sprejemljivosti, objavljeni kot priporočila WHO (Zahteve za biološke snovi).
For all controls of biological medicinal products such as immunological medicinal products and medicinal products derived from human blood or plasma which are not specified in the European Pharmacopoeia or failing this, in the pharmacopoeia of a Member State, the procedures and the criteria of acceptability published as recommendations in the WHO (Requirements for Biological Substances) shall serve as guidelines.
5 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
Za prisotnost naključnih snovi se predložijo podatki, ki ocenjujejo tveganje glede na možno onesnaženje z naključnimi snovmi, če so nevirusne ali virusne, kakor je določeno v ustreznih smernicah kot tudi ustrezni splošni monografiji in splošnem poglavju Evropske farmakopeje.
For adventitious agents, information assessing the risk with respect to potential contamination with adventitious agents, whether they are non-viral or viral, as laid down in relevant guidelines as well as in relevant general monograph and general chapter of the European Pharmacopoeia, shall be provided.
6 Prevajalska redakcija
RS
EMEA
Proizvodnja in testiranje cepiva Bovilis BVD potekata v skladu z ustreznimi zahtevami Direktive 2001/ 82/ ES, ustreznimi smernicami EU in ustreznimi monografijami Evropske farmakopeje. Odbor za zdravila za uporabo v veterinarski medicini je zaključil, da je proizvodnja cepiva Bovilis BVD v skladu z načeli dobre proizvodne prakse, da se testiranja surovin na tuje snovi izvajajo v skladu z ustreznimi zahtevami ter da testiranja zaključenih serij zdravila Bovilis BVD na virus slinavke in parkljevke (FMDV), virus goveje levkemije (BLV), virus bolezni modrikastega jezika (BTV) in virusov za infekciozni goveji rinotraheitis (IBRV) niso potrebna za ustrezne monografije.
The CVMP concluded that the production of Bovilis BVD vaccine is in compliance with GMP requirements, that extraneous agent testing of raw materials are carried out according to the relevant requirements and that extraneous agent testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs.
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1–6/6
smernice Evropske farmakopeje