Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: sl > en
51–100/101
inšpekcijski pregled laboratorija
51 Pravna redakcija
DRUGO
ob upoštevanju Direktive Sveta 88/320/EGS z dne 9. junija 1988 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) fn, kakor je bila spremenjena z Direktivo Komisije 90/18/EGS fn, in zlasti člena 7(2) Direktive,
Having regard to Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of good laboratory practice (GLP) (1) as amended by Commission Directive 90/18/EEC (2), and in particular Article 7(2) thereof,
52 Pravna redakcija
DRUGO
Kadar je treba pregledati posebne dokumente ali zapise, je priporočljivo o njih pred obiskom v naprej obvestiti preskuševalni laboratorij, tako da bodo med inšpekcijskim pregledom preskuševalnega laboratorija ti dokumenti takoj na voljo.
In cases where particular documents or records are to be examined, it may be useful to identify these to the test facility in advance of the visit so that they will be immediately available during the test facility inspection.
53 Pravna redakcija
DRUGO
začasna prekinitev inšpekcijskih pregledov preskuševalnega laboratorija ali presoj študij in, na primer kadar je to administrativno mogoče, izločitev preskuševalnega laboratorija iz (nacionalnega) programa skladnosti z DLP ali iz seznamov ali registrov preskuševalnih laboratorijev, ki se inšpekcijsko pregledujejo po načelih DLP,
suspension of test facility inspections or study audits of a test facility and, for example and where administratively possible, removal of the test facility from the (national) GLP compliance programme or from any existing list or register of test facilities subject to GLP test facility inspections,
54 Pravna redakcija
promet
CELEX: 21999A1009(01)
Obe pogodbenici lahko zahtevata nadaljnje inšpekcijske preglede preskuševalnega laboratorija ali presoje študij na ozemlju druge pogodbenice, če obstaja dokumentiran dvom o tem, da je bil preskus opravljen v skladu z dobro laboratorijsko prakso.
Each Contracting Party may request further test facility inspection or study audits on the other party's territory if there is a documented doubt as to wheter a test was conducted in accordance with good laboratory practice.
55 Pravna redakcija
promet
CELEX: 21999A1009(01)
Direktiva Sveta 88/320/EGS z dne 9. junija 1998 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) (UL L 145, 11.6.1998, str. 35), kakor je bila nazadnje spremenjena z Direktivo Komisije 1999/12/ES (UL L 77, 23.3.1999, str. 22).
Council Directive 88/320/EEC of 9 June 1998 on the inspection and verification of good laboratory practice (GLP) (OJ L 145, 11.6.1998, p. 35) as last amended by Commission Directive 1999/12/EC (OJ L 77, 23.3.1999, p. 22).
56 Pravna redakcija
promet
CELEX: 21999A1009(01)
Pogodbenici zagotovita, da so vsa poročila o inšpekcijskih pregledih preskuševalnih laboratorijev in presojah študij na voljo le nadzornim organom ter, kadar je to primerno, pregledanim preskuševalnim laboratorijem ali laboratorijem, kjer se opravijo presoje študij, in/ali naročnikom, razen če so se tržno občutljive in zaupne informacije izločile.
The Contracting Parties shall ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to regulatory authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors.
57 Pravna redakcija
DRUGO
ker je treba drugič prilagoditi Prilogo k Direktivi 88/320/EGS, da se upošteva Sklep Sveta OECD dne 9. marca 1995 in da se z objavo celotnega besedila prilog o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse pripomore k njeni enotni razlagi,
Whereas it is necessary to adapt for a second time the Annex to Directive 88/320/EEC so as to take account of the OECD Council Decision of 9 March 1995, and, by publishing the full text of the annexes on the inspection and verification of good laboratory practice, to facilitate the uniform interpretation thereof;
58 Pravna redakcija
promet
CELEX: 21999A1009(01)
Pogodbenici si takoj zagotovita informacije iz odstavka 1 o preskuševalnih laboratorijih, ki so glede na rezultate inšpekcijskih pregledov in presoj študij skladni z dobro laboratorijsko prakso vendar pa še niso bili vključeni na seznam iz navedenega odstavka.
The Contracting Parties shall provide each other promptly with the information referred to in paragraph 1 about test facilities that in the light of the results of the inspections and study audits conform to good laboratory practice but have yet not been included in the list referred to in that paragraph.
59 Pravna redakcija
DRUGO
V času inšpekcijskih pregledov se preverijo upravljavske strukture in operativni postopki preskuševalnega laboratorija, opravijo se pogovori s ključnim tehničnim osebjem, oceni se kakovost in celovitost podatkov, ki jih laboratorij pridobiva, ter se o njih poroča,
During inspections, the management structures and operational procedures of the test facility are examined, key technical personnel are interviewed, and the quality and integrity of data generated by the facility are assessed and reported,
60 Pravna redakcija
DRUGO
zagotoviti, da so poročila o pregledih preskuševalnih laboratorijev in presojah študij na voljo le regulativnim organom in, kadar je to primerno, inšpekcijsko pregledanim preskuševalnim laboratorijem ali preskuševalnim laboratorijem, kjer se izvaja presoja študij in/ali naročnikom študij, razen če so bili iz njih odstranjeni vsi komercialno občutljivi in zaupni podatki.
ensure that, unless all commercially sensitive and confidential information has been excised, reports of test facility inspections and study audits are made available only to Regulatory Authorities and, where appropriate, to the test facilities inspected or concerned with study audits and/or to study sponsors.
61 Pravna redakcija
finance
CELEX: 32003L0063
(9) Neklinične (farmokološko-toksikološke) študije se izvajajo v skladu z določbami o dobri laboratorijski praksi iz Direktive Sveta 87/18/EGS o uskladitvi predpisov in administrativnih določb o uporabi načel dobre laboratorijske prakse in preverjanju uporabe načel za preskuse kemičnih snovi fn, ter 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) fn.
(9) Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances(4) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP)(5).
62 Pravna redakcija
DRUGO
Zagotoviti bi bilo treba postopek, po katerem lahko preskuševalni laboratorij poda svoja stališča v zvezi z izidom inšpekcijskega pregleda preskuševalnega laboratorija ali presoje študije za spremljanje skladnosti z DLP in /ali v zvezi z ukrepi, ki jih v ta namen predlaga nadzorni organ za DLP.
A procedure should exist whereby a test facility may make representations relating to the outcome of a test facility inspection or study audit for GLP compliance monitoring and/or relating to the action the GLP Monitoring Authority proposes to take thereon.
63 Pravna redakcija
DRUGO
opisati dokumentacijo, ki bo potrebna za inšpekcijski pregled preskuševalnega laboratorija, kot npr. sezname študij v teku in končanih študij, načrte študij, standardne operativne postopke, poročila o študijah, itd. Hkrati se dogovorijo o dostopu do dokumentov in, po potrebi, kopiranju pomembnih dokumentov,
describe the documentation which will be required for the test facility inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc. Access to and, if necessary, arrangements for the copying of relevant documents should be agreed on at this time,
64 Pravna redakcija
promet
CELEX: 21999A1009(01)
- določbe o inšpekcijskih pregledih preskuševalnih laboratorijev in presojah študij so skladne z določbami, ki jih je sprejel Svet OECD v Prilogah I do III k Sklepu-Priporočilu (C(89)87(final)) iz leta 1989, spremenjenem z njegovim Sklepom-Priporočilom z 9. marca 1995 (C(95)8(final)), in vseh njegovih spremembah,
- the provisions regarding test facility inspection and study audits shall be in conformity with those adopted by the Council of the OECD in Annexes I to III to the 1989 Decision-Recommendation (C(89)87(final)), that has been modified by its Decision-Recommendation of 9 March 1995 (C(95)8(final)), and all amendments made thereto,
65 Pravna redakcija
DRUGO
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.
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.
66 Pravna redakcija
DRUGO
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.
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.
67 Pravna redakcija
promet
CELEX: 21999A1009(01)
Če v izjemnih primerih dvom ostaja in pogodbenica prosilka lahko upraviči posebno skrb, ter v soglasju z zadevnim preskuševalnim laboratorijem, lahko ta pogodbenica imenuje enega ali več strokovnjakov iz njenih organov, da sodelujejo pri inšpekcijskem pregledu preskuševalnega laboratorija ali presoji študije, ki ju opravijo organi druge pogodbenice.
If in exceptional cases doubts persist and the requesting party can justify a special concern, and with the consent of the test facility concerned, it may designate one or more expets of its authorities to participate in a test facility inspection or the audit of a study conducted by the authorities of the other party.
68 Pravna redakcija
promet
CELEX: 32002D0228
(1) Po inšpekcijskih pregledih, ki so jih med 28. marcem 1996 in 1. januarjem 2000 v skladu s členom 12 Sporazuma o vzajemnem priznavanju načel OECD za dobro laboratorijsko prakso (DLP) in o programih nadzora skladnosti med Evropsko skupnostjo in Državo Izrael opravili pristojni inšpektorji ES, se je izkazalo, da pet izraelskih preskusnih laboratorijev na svojem strokovnem področju izpolnjuje zahteve DLP.
(1) Following inspections carried out by designated EC inspectors between 28 March 1996 and 1 January 2000, in accordance with Article 12 of the Agreement on mutual recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes between the European Community and the State of Israel, five Israeli test facilities were found to be in compliance with GLP requirements in their respective areas of expertise.
69 Pravna redakcija
DRUGO
Določbe za inšpekcijsko pregledovanje in preverjanje DLP, ki jih vsebujeta del A in B, so enaka tistim iz prilog I (Vodila za postopke nadzora skladnosti za dobro laboratorijsko prakso) in II (Navodila za izvajanje inšpekcij laboratorijev in presoj študij) Sklepa - Priporočila Sveta OECD o skladnosti z načeli dobre laboratorijske prakse C(89)87(dokončen) z dne 2. oktobra 1989, kakor je bil popravljen s Sklepom Sveta OECD o spremembi prilog k Sklepu - Priporočilu Sveta o skladnosti z načeli dobre laboratorijske prakse z dne 9. marca 1995 C(95)8(dokončen).
The provisions for the inspection and verification of GLP which are contained in parts A and B are those contained in Annexes I (Guides for compliance monitoring procedures for good laboratory practice) and II (Guidance for the conduct of test facility inspections and study audits) respectively of the OECD Council Decision-Recommendation on compliance with principles of good laboratory practice [C(89)87(Final)] of 2 October 1989 as revised by the OECD Council Decision amending the Annexes to the Council Decision-Recommendation on compliance with principles of good laboratory practice of 9 March 1995 [C(95)8(Final)].
70 Pravna redakcija
DRUGO
uradno pregledan na poljih med rastjo glede simptomov rjave gnilobe na krompirju, ki jo povzroča krompirjeva rjava gniloba Pseudomonas solanacearum (Smith) Smith, in za katerega je v teh inšpekcijskih pregledih ugotovljeno, da nima simptomov te bolezni; kot vzorce se vzame 500 gomoljev na 5 fedanov (= 5 akrov) ali 200 gomoljev na 1 fedan (= 1 aker) ali en del tega za krompirjeva polja, ki merijo manj akrov, vzorce se vzame čim bliže času spravila; na vzorcih se opravi laboratorijski pregled vključno s testom inkubacije, in vizualnimi inšpekcijskimi pregledi prerezanih gomoljev za ugotavljanje simptomov krompirjeve krave gnilobe, ki jo povzroča krompirjeva rjava gniloba Pseudomonas solanacearum (Smith) Smith;
officially inspected in the field during the growing season for symptoms of potato brown rot caused by Pseudomonas solanacearum (Smith) Smith and found free from auch symptoms in these inspections and a sample taken of 500 tubers per five feddans (=5 acres) or 200 tubers per feddan (= 1 acre) or part thereof for smaller acreages of potatoes as close as possible to harvest for laboratory examination including an incubation test and visual inspection on cutting of the tubers for symptoms of potato brown rot caused by Pseudomonas solanacearum (Smith) Smith and found free from such symptoms in these inspections,
71 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Ko je inšpekcijski pregled laboratorija ali presoja študije dokončana, bi moral biti ocenjevalec pripravljen na razpravo o svojih ugotovitvah s predstavniki preskusnega laboratorija na zaključnem sestanku ter pripraviti pisno poročilo, tj. poročilo o inšpekcijskem pregledu.
When a test facility inspection or study audit has been completed, the inspector should be prepared to discuss his findings with representatives of the test facility at a closing conference and should prepare a written report, i.e., the inspection report.
72 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
inšpekcijski pregled preskuševalnih laboratorijev :
test facility inspection:
73 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Poročilo vsebuje seznam inšpekcijsko pregledanih laboratorijev, datume opravljenih inšpekcijskih pregledov in kratke povzetke zaključkov inšpekcijskih pregledov.
This report shall contain a list of laboratories inspected, the date on which such inspection was carried out and a brief summary of the conclusions of the inspections.
74 Prevajalska redakcija
izobraževanje
CELEX: 32003L0085
inšpekcijskem pregledu, ki ga izvede uradni veterinar, in laboratorijskih preskusih, kakor so predvideni v Prilogi XIII.
inspection by an official veterinarian and laboratory tests as provided for in Annex XIII.
75 Prevajalska redakcija
izobraževanje
CELEX: 32003R1882
Direktiva Sveta 88/320/EGS z dne 7. junija 1988 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [18].
Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP)(18).
76 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Organi iz odstavka 1 izvajajo inšpekcijske preglede v laboratorijih ter presoje študij v skladu z določbami, navedenimi v Prilogi I.
The authorities referred to in paragraph 1 shall inspect the laboratory and audit the studies in accordance with the provisions laid down in Annex I.
77 Prevajalska redakcija
izobraževanje
CELEX: 32003L0116
To je treba potrditi z vizualnimi inšpekcijskimi pregledi v ustreznem času in laboratorijskimi preskusi, da bi ugotovili morebitne latentne okužbe.
This should be confirmed by visual inspections carried out at appropriate times and laboratory tests for the possible detection of latent infections.
78 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Direktiva 2004/9/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP)
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)
79 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Za ocenitev skladnosti z DLP države članice imenujejo organe, odgovorne za inšpekcijske preglede laboratorijev in za preglede študij, izvedenih v laboratorijih, na svojem ozemlju.
Member States shall designate the authorities responsible for the inspection of laboratories within their territories and for the audit of studies carried out by laboratories to assess compliance with GLP.
80 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Imena laboratorijev, ki jih imenovani organ inšpekcijsko pregleda, njihovo stanje skladnosti z DLP ter datumi opravljenih inšpekcijskih pregledov laboratorijev ali pregledov študij, se ne štejejo kot zaupni.
The names of laboratories subject to inspection by a designated authority, their GLP compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential.
81 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Brez poseganja v člen 6 so rezultati inšpekcijskih pregledov laboratorijev ter pregledov študij o skladnosti z DLP, ki jih izvede država članica, zavezujoči za druge države članice.
Without prejudice to Article 6, the results of laboratory inspections and study audits on GLP compliance carried out by a Member State shall be binding on the other Member States.
82 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Direktiva Sveta 88/320/EGS z dne 7. junija 1988 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [3] je bila večkrat bistveno spremenjena.
Council Directive 88/320/EEC of 7 June 1988 on the inspection and verification of Good Laboratory Practice (GLP)(3) has been significantly amended several times.
83 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
inšpekcijski pregled proizvodnih ali poslovnih zgradb in laboratorijev, ki jim je imetnik dovoljenja za proizvodnjo zaupal nalogo izvajanja nadzora v skladu s členom 20;
inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20;
84 Prevajalska redakcija
izobraževanje
CELEX: 32003L0085
Laboratoriji in ustanove, ki ravnajo z živim virusom slinavke in parkljevke, morajo biti vsaj dvakrat inšpekcijsko pregledani v petih letih, od tega enkrat nenapovedano.
The laboratories and establishments handling live foot-and-mouth disease virus must be subject to at least two inspections within five years, with one of the inspections being carried out unannounced.
85 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Namen tega dela priloge je podati napotke za izvajanje inšpekcijskih pregledov preskuševalnih laboratorijev in presoj študij, ki bi bili vzajemno sprejemljivi za države članice OECD.
The purpose of this part of this Annex is to provide guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries.
86 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
poseben sistem, ki ga z inšpekcijskimi pregledi in presojami študij vzpostavi država članica za spremljanje skladnosti preskuševalnih laboratorijev na njenem ozemlju, z dobro laboratorijsko prakso,
the particular scheme established by a Member State to monitor GLP compliance by test facilities within its territories, by means of inspections and study audits,
87 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
Pristojni organ zadevne države članice s ponavljajočimi inšpekcijskimi pregledi in, če je potrebno, z nenapovedanimi pregledi, ter s prošnjo za testiranje vzorcev, naslovljeno na Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, pooblaščen za ta namen, zagotovi, da se pravne zahteve, ki urejajo področje zdravil, izpolnjujejo.
The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with.
88 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
opisati dokumentacijo, ki bo potrebna za inšpekcijski pregled preskuševalnega laboratorija, kot npr, sezname potekajočih študij in končanih študij, načrte študij, standardne operativne postopke, poročila o študijah, itd.
describe the documentation which will be required for the test facility inspection, such as lists of on-going and completed studies, study plans, standard operating procedures, study reports, etc.
89 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Za zagotovitev, da preskusne podatke, pridobljene v laboratoriju ene države članice, priznajo tudi druge države članice, je treba predvideti usklajen sistem pregledov študij in inšpekcijskih pregledov laboratorijev, ki bo zagotovil, da laboratoriji delujejo pod pogoji DLP.
However, in order to ensure that test data generated by laboratories in one Member State are also recognised by other Member States, it is necessary to provide for a harmonised system for study audit and inspection of laboratories to ensure that they are working under GLP conditions.
90 Prevajalska redakcija
izobraževanje
CELEX: 22000D0019
Direktiva Komisije 1999/12/ES z dne 8. marca 1999 o drugi prilagoditvi tehničnemu napredku Priloge k Direktivi Sveta 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [3] mora biti vključena v Sporazum.
Commission Directive 1999/12/EC of 8 March 1999 adapting to technical progress for the second time the Annex to Council Directive 88/320/EEC on the inspection and verification of good laboratory practice (GLP)(3) is to be incorporated into the Agreement.
91 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
inšpekcijski pregled proizvodnih ali poslovnih zgradb izdelovalcev zdravil ali zdravilnih učinkovin, uporabljenih kot vhodne snovi, in vseh laboratorijev, ki jih imetnik dovoljenja za izdelavo uporablja za izvajanje kontrole v skladu s členom 20;
inspect the manufacturing or commercial establishments of manufacturers of medicinal products or of active substances used as starting materials, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20;
92 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
Pristojni organ zadevne države članice s ponavljajočimi in če je potrebno, z nenajavljenimi inšpekcijskimi pregledi ter, kadar je to primerno, z zahtevo, da uradni državni laboratorij ali laboratorij, pooblaščen za ta namen, opravi preskuse na vzorcih, zagotovi, da se izpolnjujejo pravne zahteve glede zdravil za uporabo v veterinarski medicini.
The competent authority of the Member State concerned shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products are complied with.
93 Prevajalska redakcija
izobraževanje
CELEX: 31989D0569
ker Skupnost s sprejetjem Direktive Sveta 87/18/EGS z dne 18. decembra 1986 o usklajevanju zakonov in drugih predpisov o uporabo načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih na kemičnih snoveh [1] ter Direktive Sveta 88/320/EGS z dne 7. junija 1988 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [2], že izvaja postopke za uporabo in preverjanje dobre laboratorijske prakse v skladu z zadevno odločbo/priporočilom OECD;
Whereas, in adopting Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (1) and Council Directive 88/320/EEC of 7 June 1988 on the inspection and verification of good laboratory practice (GLP) (2), the Community has already implemented procedures for the application and verification of good laboratory practice in accordance with the OECD decision/recommendation in question;
94 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
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.
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.
95 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
Neklinične (farmokološko-toksikološke) študije se izvajajo v skladu z določbami o dobri laboratorijski praksi iz Direktive Sveta 87/18/EGS o uskladitvi predpisov in administrativnih določb o uporabi načel dobre laboratorijske prakse in preverjanju uporabe načel za preskuse kemičnih snovi [6], ter 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [7].
Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances(4) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP)(5).
96 Prevajalska redakcija
izobraževanje
CELEX: 32002L0089
v odstavku 5, v drugem pododstavku, se za tretjim stavkom doda naslednji stavek: "Ta določba se ne uporablja za izdatke, ki so rezultat naslednjih vrst zahtev, postavljenih ob sodelovanju imenovanih strokovnjakov pri inšpekcijskih pregledih ob uvozu držav članic: laboratorijsko testiranje in vzorčenje za vizualne preglede ali za laboratorijsko testiranje, ki so že pokriti s pristojbinami iz člena 13d.";
in paragraph 5, in the second subparagraph, the following sentence shall be added after the third sentence:"This provision shall not apply to expenses resulting from the following types of requests made on the occasion of the participation of the said experts in the Member States' import inspections: laboratory testing and sampling for visual inspection or for laboratory testing, and already covered by the fees referred to in Article 13d.";
97 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Kadar ima država članica zadosten razlog za domnevo, da laboratorij iz druge države članice, ki trdi, da je skladen z DLP, preskusa ni izvedel skladno z DLP, lahko od te države članice zahteva nadaljnje informacije ter še zlasti pregled študije, po možnosti v povezavi s ponovnim inšpekcijskim pregledom.
Where a Member State has sufficient reason to believe that a laboratory in another Member State claiming GLP compliance has not carried out a test in accordance with GLP, it may request further information from that Member State and in particular may request a study audit, possibly in conjunction with a new inspection.
98 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Kadar so izpolnjene določbe odstavka 1 in so rezultati inšpekcijskega pregleda in preverjanja zadovoljivi, lahko zadevna država članica potrdi izjavo laboratorija, da so laboratorij sam in preskusi, ki jih izvaja, v skladu z zahtevami DLP, z besedami "Ocena skladnosti z DLP v skladu z Direktivo 2004/9/ES z dne … (datum)".
Where the provisions of paragraph 1 have been complied with, and the results of the inspection and verification are satisfactory, the Member State in question may provide endorsement of a claim by a laboratory that it and the tests that it carries out comply with GLP, using the formula "Assessment of conformity with GLP according to Directive 2004/9/EC on... (date)".
99 Prevajalska redakcija
izobraževanje
CELEX: 32001R0883
Dokumenti V I 1, ki jih sestavijo proizvajalci vina v tretjih državah iz Priloge IX, ki so ponudile posebna jamstva, sprejeta v Skupnosti, veljajo za potrdila ali analizne izvide, ki jih sestavijo agencije in laboratoriji, vključeni v seznam iz člena 29, kolikor so proizvajalci prejeli posamično odobritev ustreznih uradnih organov v tistih tretjih državah in so predmet inšpekcijskega pregleda teh uradnih organov.
V I 1 documents drawn up by wine producers in the third countries listed in Annex IX which have offered special guarantees accepted by the Community shall be considered as certificates or analysis reports drawn up by agencies and laboratories included in the list referred to in Article 29 provided that the producers have received individual approval from the competent authorities of those third countries and are subject to inspection by the latter.
100 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
Ta direktiva se nanaša za inšpekcijske preglede in preverjanje organizacijskih postopkov in pogojev, pod katerimi se za vse kemikalije (npr. kozmetične izdelke, industrijske kemikalije, zdravila, aditive za živila, dodatke h krmi, pesticide) v skladu s pravili in predpisi načrtujejo, izvajajo, zaznamujejo ter sporočajo rezultati laboratorijskih raziskav za neklinično preskuse, da se oceni učinek teh proizvodov na ljudi, živali in okolje.
This Directive shall apply to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.
Prevodi: sl > en
51–100/101
inšpekcijski pregled laboratorija