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101–104/104
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101 Prevajalska redakcija
izobraževanje
CELEX: 31996D1692
ker morajo države članice pri izvajanju projektov v skupnem interesu upoštevati varstvo okolja z izvajanjem študij o okoljskem vplivu v skladu z Direktivo Sveta 85/337/EGS z dne 27. junija 1985 o presoji učinkov nekaterih javnih in zasebnih projektov na okolje [5] in z uporabo Direktive Sveta 92/43/EGS z dne 21. maja 1992 o ohranjanju naravnih habitatov ter prosto živečih živalskih in rastlinskih vrst [6];
Whereas Member States need to take account of environmental protection when implementing projects of common interest by carrying out environmental impact studies pursuant to Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (5) and by applying Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (6);
102 Prevajalska redakcija
izobraževanje
"overjanje" je spremljanje skladnosti preskusnega laboratorija z načeli DLP s postopki, kakršni so presoje študij in kontrole, ki so določeni v zakonih, predpisih in upravnih določbah vsake pogodbenice, navedenih v oddelku III dela B te sektorske priloge, in so v skladu s Sklepom - Priporočilom Sveta OECD z dne 2. oktobra 1989 (C(89) 87(dokončen)), zlasti z njegovima prilogama I in II, kakor je bil spremenjen s Sklepom Sveta OECD z dne 9. marca 1995 (C(95)8(dokončen)).
"verification" means the monitoring of the compliance of a test facility with the principles of GLP by procedures such as study audits and inspections that are set out in the laws, regulations and administrative provisions of each party specified in Section III of Part B of this Sectoral Annex and that are consistent with the OECD Council Decision - Recommendation of 2 October 1989 (C(89) 87(final)), and in particular its Annexes I and II, as amended by the OECD Council Decision of 9 March 1995 (C(95)8(final)).
103 Prevajalska redakcija
izobraževanje
CELEX: 32002R1490
za vsako točko v Prilogi III k Direktivi 91/414/EGS povzetke in rezultate študij in poskusov, ime osebe ali inštituta, ki je izvedel poskuse, relevantne za presojo kriterijev iz člena 5 Direktive 91/414/EGS za enega ali več pripravkov, ki so reprezentativni za uporabe iz pododstavka (b) ob upoštevanju dejstva, da podatkovne vrzeli v informacijah v dokumentaciji po Prilogi II, ki so rezultat predlaganega omejenega števila reprezentativnih uporab aktivne snovi, lahko privedejo do omejitev pri vključevanju v Prilogo I Direktive 91/414/EGS;
for each point of Annex III to Directive 91/414/EEC the summaries and results of studies and trials, the name of the person or institute that has carried out the trials, relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion into Annex I to Directive 91/414/EEC;
104 Prevajalska redakcija
izobraževanje
CELEX: 32004L0009
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 in 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 in 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)).
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101–104/104
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