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1–11/11
UIS
1 Pravna redakcija
DRUGO
UIS lahko ta rok preveri in po potrebi spremeni.
this date can be checked and if necessary reviewed by the CCI.
2 Pravna redakcija
DRUGO
UIS preverja učinkovitost cepiva, pripravljenega iz koncentriranega antigena.
potency of the vaccines prepared from the concentrated antigen will be tested by the CCI.
3 Pravna redakcija
DRUGO
UIS ob prejemu preizkusi vsako serijo koncentriranega inaktiviranega antigena glede prisotnosti infektivnega virusa z metodo in vitro, pri govedu pa z metodo, ki jo za cepivo predpisuje evropska farmakopeja;
On receipt, each batch of concentrated inactivated antigen will be checked by the CCI for possible residual infective virus in vitro and in cattle using the method prescribed for vaccine in the European Pharmacopoeia;
4 Pravna redakcija
DRUGO
sodelovanje z UIS pri:
to liaise with the CCI for the purposes of:
5 Pravna redakcija
DRUGO
Koncentracija in kakovost sestavin za cepivo se določi v dogovoru z UIS.
The concentration and quality of the vaccine adjuvants will be agreed with the CCI.
6 Pravna redakcija
DRUGO
Usklajevalni inštitut Skupnosti za cepivo proti slinavki in parkljevki (UIS):
Community Coordinating Institute for foot-and-mouth disease vaccine (CCI):
7 Pravna redakcija
DRUGO
proizvajalec mora UIS-u posredovati v presojo vse pomembne podatke o antigenu in pripravi iz njega cepivo.
the producer must provide relevant information about the antigen and its formulation into vaccine for consideration by the CCI.
8 Pravna redakcija
DRUGO
glavnina inaktiviranega antigena se dobavlja v posodah, primernih za shranjevanje v tekočem dušiku v količinah, za kakršne se dogovorita proizvajalec in UIS.
the main bulk of the inactivated antigen should be supplied in containers suitable for storage over liquid nitrogen and divided into volumes to be agreed between the producer and the CCI.
9 Pravna redakcija
DRUGO
Po posvetu z UIS in pod njegovim nadzorom mora proizvajalec priskrbeti tudi 20 reprezentančnih vzorcev, ki vsebujejo vsaj po 1 mg koncentriranega antigena 146S za redno preizkušanje in vitro in in vivo;
In consultation with, and under the supervision of, the CCI, the producer must also provide 20 representative samples containing at least 1 mg each of concentrated 146S antigen for periodic in vitro and in vivo tests;
10 Pravna redakcija
DRUGO
Antigenske banke, ustanove, ki oskrbujejo z antigenom, in ustanove, ki pripravljajo in stekleničijo cepivo, delujejo pod najstrožjimi higienskimi in varnostnimi pogoji v skladu s splošno sprejetimi standardi dobre proizvodne prakse v Evropi, ki jih nadzoruje UIS.
The antigen banks, the establishments supplying the antigen and the establishments carrying out formulation and bottling shall operate under strict conditions of hygiene and safety, in accordance with the generally accepted standards for good manufacturing practice in Europe, which shall be monitored by the CCI.
11 Prevajalska redakcija
izobraževanje
CELEX: 31991D0666
Usklajevalni inštitut Skupnosti za cepivo proti slinavki in parkljevki (UIS): inštitut, imenovan z Odločbo 91/665/EGS.
Community Coordinating Institute for foot-andmouth disease vaccine (CCI): the institute designated by Decision 91/665/EEC.
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1–11/11
UIS