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toxicological testing
1 Objavljeno
RS
DRUGO: TRANS
Toxicological testing confirmed the presence of strychnine in blood and urine, while in gastric aspirate the poison was no longer detectable.
Toksikološke preiskave so potrdile prisotnost strihnina v krvi in urinu, medtem ko ga v želodčnem izpirku ni bilo več.
2 Pravna redakcija
DRUGO
To assess the possible harmful effects of a food additive or derivatives thereof, it must be subjected to appropriate toxicological testing and evaluation.
Zaradi možnih škodljivih učinkov aditiva za živila ali njegovih derivatov ga je treba ustrezno toksikološko pregledovati in ocenjevati.
3 Pravna redakcija
finance
CELEX: 32003L0063
The testing strategy shall be such that any mechanical effects of administration or purely physico-chemical actions of the product can be distinguished from toxicological or pharmaco-dynamic ones.
Strategija preskusov je taka, da je mogoče razlikovati mehanske učinke dajanja zdravila ali samo fizikalno kemijsko delovanje zdravila od toksikološkega ali farmakodinamičnega delovanja.
4 Pravna redakcija
promet
CELEX: 22001A1029(01)
Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products and amendments thereto
Direktiva Sveta 87/19/EGS z dne 22. decembra 1986 o spremembi Direktive 75/318/EGS o približevanju zakonodaj držav članic, ki se nanašajo na analitične, farmakološko-toksikološke in klinične standarde in protokole za preskušanje lastniških zdravil, ter spremembe Direktive
5 Pravna redakcija
DRUGO
Council Directive of 22 December 1986 amending Directive 81/852/CEE on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (87/20/EEC) (OJ L 15,17.1.1987, p. 34)
Direktiva Sveta z dne 22. decembra 1986, ki spreminja Direktivo 81/852/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil za veterinarsko uporabo (87/20/EGS) (UL L 15, 17. 1. 1987, str. 34)
6 Pravna redakcija
DRUGO
Council Directive of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (87/19/EEC) (OJ L 15, 17.1.1987, p. 31)
Direktiva Sveta z dne 22. decembra 1986, ki spreminja Direktivo 75/318/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil, ki jih je moč dobiti brez recepta (87/19/EGS) (UL L 15, 17. 1. 1987, str. 31)
7 Pravna redakcija
DRUGO
products introduced by Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products;
ki so bile uvedene z Direktivo Komisije 92/18/EGS z dne 20. marca 1992 o spremembi Priloge k Direktivi Sveta 81/852/EGS o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini;
8 Pravna redakcija
DRUGO
whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (1);
ker morajo biti v tem kontekstu varnost, kakovost in uporabnost snovi preverjene po analogiji z ustreznimi metodami, določenimi v Direktivi Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaj držav članic v zvezi z analitičnimi, farmako-toksikološkimi in kliničnimi standardi in protokoli za preizkušanje lastniških zdravil fn;
9 Pravna redakcija
DRUGO
Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/85 I/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (1) and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (2);
ker je pri zdravilih za uporabo v veterini doseženo enako z direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterini fn ektivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
10 Pravna redakcija
DRUGO
Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products fn, and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products fn, as amended by Directive 87/20/EEC fn, should be taken into account;
ker je treba upoštevati predpise Skupnosti o veterinarskih zdravilih in zlasti Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o veterinarskih zdravilih fn in Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o analitskih, farmako-toksikoloških in kliničnih standardih ter protokolih o preskušanju veterinarskih zdravil fn, kakor je bila spremenjena z Direktivo 87/20/EGS fn;
11 Pravna redakcija
DRUGO
Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5);
ker je treba po znanstveni presoji, ki jo opravi Odbor za zdravila za uporabo v veterinarski medicini, sprejeti najvišje dovoljene količine zaostankov po hitrem postopku, ki zagotavlja tesno sodelovanje med Komisijo in državami članicami v odboru, ustanovljenim na podlagi Direktive Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini fn, kakor je bila nazadnje spremenjena z Direktivo 87/20/EGS fn;
12 Pravna redakcija
DRUGO
Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products (6), and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (7);
ker so pri zdravilih za ljudi merila kakovosti, varnosti in učinkovitosti v znatni meri usklajena z direktivo Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov, ki se nanašajo na zdravila fn ugo direktivo Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov, ki se nanašajo na lastniška zdravila fn rektivo Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
13 Pravna redakcija
DRUGO
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (3), Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (5), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (6) have been frequently and substantially amended;
Direktiva Sveta 81/851/EGS z dne 28. septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini( fn ), Direktiva Sveta 81/852/EGS z dne 28. Septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na analitske, farmakološko-toksikološke in klinične standarde ter protokole v zvezi s preskušanjem zdravil za uporabo v veterinarski medicini( fn ), Direktiva Sveta 90/677/EGS z dne 13. decembra 1990 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini in o določitvi dodatnih določb za imunološka zdravila za uporabo v veterinarski medicini( fn ), in Direktiva Sveta 92/74/EGS z dne 22. septembra 1992 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonov in drugih predpisov, ki se nanašajo na zdravila za uporabo v veterinarski medicini in ki določa dodatne predpise za homeopatska zdravila za uporabo v veterinarski medicini( fn ), so bile pogosto in znatno spremenjene;
14 Prevajalska redakcija
izobraževanje
CELEX: 31994L0040
where such products are not generally considered a normal part of the diet used, some toxicological testing may be required.
kadar taki proizvodi na splošno ne veljajo za običajni del prehrane, se lahko zahteva nekaj toksikoloških preskusov.
15 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment.
Študije, v katerih se uporabljajo aktivne snovi, proizvedene v laboratoriju ali v poskusni proizvodnji, je treba ponoviti z aktivno snovjo iz proizvodnje, razen kadar je mogoče utemeljiti, da je uporabljena testirana snov s stališča toksikološkega testa in ocene enaka.
16 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
The testing strategy shall be such that any mechanical effects of administration or purely physico-chemical actions of the product can be distinguished from toxicological or pharmacodynamic ones.
Strategija preskusov mora biti taka, da je mogoče razlikovati mehanske učinke dajanja zdravila ali samo fizikalno-kemijsko delovanje zdravila od toksikološkega ali farmakodinamičnega delovanja.
17 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products(4),
Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi ter protokoli, ki se nanašajo na preskušanje lastniških zdravil [4],
18 Prevajalska redakcija
izobraževanje
CELEX: 32000L0070
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ L 147, 9.6.1975, p. 1).
Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analitskimi, farmakotoksikološkimi in kliničnimi standardi ter protokoli v zvezi s preskušanjem zdravil (UL L 147, 9.6.1975, str. 1).
19 Prevajalska redakcija
izobraževanje
CELEX: 31994D0358
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ No L 147, 9.6.1975, p. 1).
2 Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic, ki se nanaša na analizne, farmakološko-toksikološke in klinične standarde ter protokole v zvezi s preskušanjem lastniških zdravil (UL L 147, 9.6.1975, str. 1).
20 Prevajalska redakcija
izobraževanje
CELEX: 31994D0358
Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ No L 317, 6.11.1981, p. 16).
3 Direktiva Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic, ki se nanaša na analizne, farmakološko-toksikološke in klinične standarde ter protokole v zvezi s preskušanjem veterinarskih zdravil (UL L 317, 6.11.1981, str. 16).
21 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products(5) lays down uniform rules on the compilation of dossiers including their presentation.
Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil [5] določa enotna pravila o sestavi dokumentacije, vključno z njeno obliko.
22 Prevajalska redakcija
izobraževanje
CELEX: 31992R0762
Whereas it is necessary to amend Annex V to Regulation (EEC) No 2377/90 to take account of the changes to the requirements for the testing of veterinary medicinal products introduced by Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products;
ker je treba spremeniti Prilogo V k Uredbi (EGS) št. 2377/90, tako da bo upoštevala spremembe zahtev za preskušanje zdravil za uporabo v veterinarski medicini, ki so bile uvedene z Direktivo Komisije 92/18/EGS z dne 20. marca 1992 o spremembi Priloge k Direktivi Sveta 81/852/EGS o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini;
23 Prevajalska redakcija
izobraževanje
CELEX: 31993L0042
whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (5);
ker morajo biti v tem kontekstu varnost, kakovost in uporabnost snovi preverjene po analogiji z ustreznimi metodami, določenimi v Direktivi Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaj držav članic v zvezi z analitičnimi, farmako-toksikološkimi in kliničnimi standardi in protokoli za preizkušanje lastniških zdravil 5;
24 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3), Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products(4),
Direktiva Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov o lastniških zdravilih [3], Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi ter protokoli, ki se nanašajo na preskušanje lastniških zdravil [4],
25 Prevajalska redakcija
izobraževanje
CELEX: 31993R2309
Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (7) and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (8);
ker je pri zdravilih za uporabo v veterinarski medicini doseženo enako z Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterini 4 in z Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini 5;
26 Prevajalska redakcija
izobraževanje
CELEX: 31990L0167
Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products (4), and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (5), as amended by Directive 87/20/EEC (6), should be taken into account;
ker je treba upoštevati predpise Skupnosti o veterinarskih zdravilih in zlasti Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o veterinarskih zdravilih [4] in Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o analitskih, farmako-toksikoloških in kliničnih standardih ter protokolih o preskušanju veterinarskih zdravil [5], kakor je bila spremenjena z Direktivo 87/20/EGS [6];
27 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
Whereas the principles and guidelines envisaged by this Directive are in conformity with the opinion of the Committee for Adaptation of Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector created by Article 2b of Directive 81/852/EEC of 28 September 1981 concerning the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5),
ker so načela in smernice, predvidene s to direktivo, v skladu z mnenjem Odbora za prilagoditev tehničnega napredka direktiv o odstranitvi tehničnih ovir v trgovini v sektorju zdravil za uporabo v veterinarski medicini, ustanovljenega s členom 2b Direktive 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic v zvezi z analitskimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli pri testiranju zdravil za uporabo v veterinarski medicini [4], kakor je bila nazadnje spremenjena z Direktivo 87/20/EGS [5],
28 Prevajalska redakcija
izobraževanje
CELEX: 31993R2309
Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products (6), and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (6);
ker so pri zdravilih za uporabo v humani medicini merila kakovosti, varnosti in učinkovitosti v znatni meri usklajena z Direktivo Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov, ki se nanašajo na zdravila 1, in z drugo Direktivo Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov, ki se nanašajo na lastniška zdravila 2, in z Direktivo Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini 3,
29 Prevajalska redakcija
izobraževanje
CELEX: 31999R1308
since the adoption of Council Regulation (EEC) No 2377/90(4), the regulatory environment for veterinary medicinal products has altered radically, in particular as a result of the entry into force of Council Regulation (EC) No 2309/93 of 22 July laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) and of the amendments made by Directive 93/40/EEC(6) to Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(7), and to Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(8);
Od sprejetja Uredbe Sveta (EGS) št. 2377/90 [4] se je zakonodajno okolje za zdravila za uporabo v veterinarska medicini temeljito spremenilo, zlasti zaradi začetka veljavnosti Uredbe Sveta (ES) št. 2309/93 z dne 22. julija o določitvi postopkov Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za uporabo v humani medicini in zdravil za uporabo v veterinarski medicini in o ustanovitvi Evropske agencije za zdravila [5] ter sprememb, ki jih prinaša Direktiva 93/40/EGS [6] za Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic glede zdravil za uporabo v veterinarski medicini [7] in za Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje glede analitičnih, farmako-toksikoloških in kliničnih standardov in protokolov v zvezi s preskušanjem zdravil za uporabo v veterinarski medicini [8].
Prevodi: en > sl
1–29/29
toxicological testing