Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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national GLP monitoring authority
1 Pravna redakcija
DRUGO
(National) GLP Monitoring Authority:
(Nacionalni) Nadzorni organ za DLP:
2 Pravna redakcija
DRUGO
on the permanent staff of the (national) GLP Monitoring Authority,
stalno osebje (nacionalnega) nadzornega organa za DLP,
3 Pravna redakcija
promet
CELEX: 21999A1009(01)
give their advice for the setting up of the national GLP monitoring authority,
svetovala glede ustanovitve nacionalnega nadzornega organa za DLP,
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DRUGO
the level of adherence of a test facility to the GLP principles as assessed by the (national) GLP Monitoring Authority,
stopnja zavezanosti načelom DLP v preskuševalnem laboratoriju, kakor jo oceni (nacionalni) organ za spremljanje DLP
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DRUGO
on the permanent staff of a body separate from the (national) GLP Monitoring Authority, or
stalno osebje organa, ločenega od (nacionalnega) nadzornega organa za DLP, ali
6 Pravna redakcija
DRUGO
The powers available to the (national) GLP Monitoring Authority in such cases should be defined,
Opredeliti je treba pooblastila, ki jih ima (nacionalni) nadzorni organ za DLP na voljo v takih primerih,
7 Pravna redakcija
DRUGO
The appropriate actions should be described in documents from the (national) GLP Monitoring Authority.
Ustrezni ukrepi bi se morali opisati v dokumentih (nacionalnega) nadzornega organa za DLP.
8 Pravna redakcija
DRUGO
Where no, or where only minor deviations have been found, the (national) GLP Monitoring Authority may:
Kadar se odstopanja ne odkrijejo, ali pa so le majhna, lahko (nacionalni) nadzorni organ za DLP:
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DRUGO
A mechanism should be available whereby test facilities may have their compliance with GLP principles monitored by the appropriate (national) GLP Monitoring Authority,
Vzpostavljen mora biti mehanizem, s katerim ustrezni (nacionalni) nadzorni organ za DLP spremlja skladnost preskuševalnih laboratorijev.
10 Pravna redakcija
DRUGO
a person who performs the test facility inspections and study audits on behalf of the (national) GLP Monitoring Authority,
oseba, ki izvede inšpekcijski pregled preskuševalnega laboratorija in presojo študij v imenu (nacionalnega) nadzornega organa za DLP,
11 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
(national) GLP Monitoring Authority:
(nacionalni) nadzorni organ za DLP :
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DRUGO
In such cases, it is reasonable for an inspector to report that the facility is operating in compliance with GLP principles according to the criteria established by the (national) GLP Monitoring Authority.
V takih primerih je smiselno, da ocenjevalec v svojem poročilu navede, da laboratorij deluje v skladu z načeli DLP glede na merila, ki jih je določil (nacionalni) nadzorni organ za DLP.
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DRUGO
employed on contract, or in another way, by the (national) GLP Monitoring Authority to perform test facility inspections or study audits.
zaposleni po pogodbi ali na drug način pri (nacionalnemu) nadzornemu organu za DLP za izvajanje inšpekcijskih pregledov preskuševalnih laboratorijev ali presojo študij.
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DRUGO
(National) GLP Monitoring Authorities should:
(Nacionalni) nadzorni organi za DLP bi morali:
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DRUGO
Where a study audit has been conducted at the request of a Regulatory Authority, a full report of the findings should be prepared and sent via the relevant (national) GLP Monitoring Authority.
Kadar se je presoja študije opravila na zahtevo regulativnega organa, bi se moralo pripraviti celotno poročilo o ugotovitvah in se poslati preko pristojnega (nacionalnega) nadzornega organa za DLP.
16 Pravna redakcija
promet
CELEX: 21999A1009(01)
NOTING that in the absence of a national GLP monitoring authority in Israel, there is a need for transitional arrangements during an initial period during which Israel will set up this authority,
UGOTAVLJAJOČ, da v odsotnosti nacionalnega nadzornega organa za DLP v Izraelu, obstaja potreba po prehodni ureditvi v začetnem obdobju, v katerem bo Izrael ustanovil ta organ -
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DRUGO
ensure that the (national) GLP Monitoring Authority is directly responsible for an adequate 'team' of inspectors having the necessary technical/scientific expertise or is ultimately responsible for such a team,
zagotoviti, da je (nacionalni) nadzorni organ za DLP neposredno pristojen za ustrezno "skupino" ocenjevalcev, ki imajo potrebno tehnično/strokovno znanje in izkušnje ali je na zadnji stopnji pristojen za takšno skupino,
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DRUGO
If a serious deviation from the GLP principles is identified during a test facility inspection or study audit which, in the opinion of the inspector, may have affected the validity of that study, or of other studies performed at the facility, the inspector should report back to the (national) GLP Monitoring Authority.
Če se pri inšpekcijskem pregledu preskusnega laboratorija ali presoji študije ugotovijo znatna odstopanja od načel DLP, ki bi po mnenju ocenjevalca lahko vplivala na veljavnost navedene študije ali drugih študij, opravljenih v tem laboratoriju, bi moral ocenjevalec o tem poročati (nacionalnemu) nadzornemu organu za DLP.
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DRUGO
In the latter two cases, the (national) GLP Monitoring Authority should have ultimate responsibility for determining the GLP compliance status of test facilities and the quality/acceptability of a study audit, and for taking any action based on the results of test facility inspections or study audits which may be necessary.
V zadnjih dveh primerih bi moral biti (nacionalni) nadzorni organ za DLP na zadnji stopnji pristojen za ugotavljanje stanja skladnosti preskuševalnega laboratorija z DLP in kakovosti / sprejemljivosti presoje študij ter za ukrepanje na podlagi rezultatov inšpekcijskih pregledov preskuševalnih laboratorijev ali presoj študij, ki so morda potrebni.
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DRUGO
Such statements may be used to provide information to (national) GLP Monitoring Authorities in other OECD member countries,
Takšne izjave se lahko uporabljajo kot informacija (nacionalnim) nadzornim organom za DLP v drugih državah članicah OECD,
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DRUGO
Where serious deviations are found, the action taken by (national) GLP Monitoring Authorities will depend on the particular circumstances of each case and the legal or administrative provisions under which GLP compliance monitoring has been established within their countries.
Kadar se ugotovijo znatna odstopanja, bodo ukrepi (nacionalnih) nadzornih organov za DLP odvisni od posebnih okoliščin vsakega primera in od pravnih ali upravnih določb, s katerimi je bilo vzpostavljeno spremljanje skladnosti z DLP v njihovih državah.
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DRUGO
encourage consultations, including joint training activities where necessary, with the staff of (national) GLP Monitoring Authorities in other OECD member countries in order to promote international harmonisation in the interpretation and application of GLP principles, and in the monitoring of compliance with such principles,
vzpodbujati posvetovanja, vključno s skupnim usposabljanjem, kadar je to primerno, z osebjem (nacionalnih) organov za spremljanje DLP v drugih državah članicah OECD, da se pospeši mednarodno usklajevanje razlag in uporabe načel DLP, ter nadzor skladnosti s temi načeli,
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DRUGO
(National) GLP Monitoring Authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a test facility or refer to them in detail in their reports.
(Nacionalni) nadzorni organ za DLP bo imel dostop do podatkov s komercialno vrednostjo, včasih pa bo morda celo odnesel komercialno občutljive dokumente iz preskuševalnega laboratorija ali se nanje podrobno skliceval v svojih poročilih.
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izobraževanje
CELEX: 32002D0227
The additional information requested by the Services of the Commission was provided timely by the Israel Laboratory Accreditation Authority (ISRAC) acting as the national GLP monitoring authority.
Dodatne podatke, zahtevane s strani služb Komisije, so pravočasno zagotovili v Israel Laboratory Accreditation Authority (ISRAC), ki deluje kot nacionalni nadzorni organ DLP.
25 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
ensure that the (national) GLP Monitoring Authority is directly responsible for an adequate "team" of inspectors having the necessary technical/scientific expertise or is ultimately responsible for such a team,
zagotoviti, da je (nacionalni) nadzorni organ za DLP neposredno pristojen za ustrezno "skupino" ocenjevalcev, ki imajo potrebno tehnično/strokovno znanje in izkušnje, ali je na zadnji stopnji pristojen za takšno skupino,
26 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Member States shall ensure that commercially sensitive and other confidential information to which they gain access as a result of GLP compliance monitoring activities is made available only to the Commission, to national regulatory and designated authorities and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.
Države članice zagotovijo, da so komercialno občutljive in druge zaupne informacije, do katerih imajo dostop zaradi dejavnosti nadzora skladnosti z DLP, na voljo samo Komisiji, nacionalnim nadzornim organom in imenovanim organom, laboratoriju ter naročniku študije, ki jih inšpekcijski pregled ali pregled študije neposredno zadeva.
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national GLP monitoring authority