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1–50/303
provisional authorisation
1 Prevajalska redakcija
izobraževanje
CELEX: 22004A0206(02)
Provisional authorisation
Začasna odobritev
2 Končna redakcija
DRUGO
Whereas the provisional authorisation of "Natrolite-phonolite" expired already on 21 April 1999;
ker je začasna dovolitev "Natrolit-fonolita" potekla že 21. aprila 1999;
3 Končna redakcija
CELEX: 32004R0278
The assessment of the application for authorisation submitted in respect of the new use of this additive shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
Proučitev vloge za dovoljenje, ki je bila predložena v zvezi z novo uporabo tega krmnega dodatka kaže, da so izpolnjeni pogoji za začasno dovoljenje, predvideni v Direktivi 70/524/EGS.
4 Končna redakcija
CELEX: 32004R0490
The assessment of the application for authorisation submitted in respect of the new use of this additive, shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
Proučitev vloge za dovoljenje, ki je bila predložena v zvezi z novo uporabo tega krmnega dodatka kaže, da so izpolnjeni pogoji za začasno dovoljenje, predvideni v Direktivi 70/524/EGS.
5 Končna redakcija
CELEX: 32004R0879
The assessment of the application for authorisation submitted in respect of the new use of this additive, shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
Ocenitev vloge za dovoljenje, ki je bila predložena za novo vrsto uporabe tega dodatka, kaže, da so izpolnjeni pogoji za izdajo začasnega dovoljenja iz Direktive 70/524/EGS.
6 Končna redakcija
CELEX: 32004R0880
The provisional authorisation of these additives was extended until 14 December 2003 by Commission Regulation (EC) No 2200/2001 of 17 October 2001(4).
Začasno dovoljenje za ta dodatka je bilo podaljšano do 14. decembra 2003 z Uredbo Komisije (ES) št. 2200/2001 z dne 17. oktobra 2001 [4].
7 Končna redakcija
CELEX: 32004R0278
Such provisional authorisation may be given for a period not exceeding four years in the case of additives referred to in Part II of Annex C to that Directive.
Tako začasno dovoljenje se lahko izda za obdobje, ki ni daljše od štirih let za krmne dodatke iz dela II Priloge C k navedeni direktivi.
8 Končna redakcija
CELEX: 32004R0879
Such provisional authorisation may be given for a period not exceeding four years in the case of additives referred to in Part II of Annex C to that Directive.
Za dodatke iz dela II Priloge C k navedeni direktivi se to začasno dovoljenje lahko da za največ štiri leta.
9 Končna redakcija
DRUGO
Such confirmation is necessary in order to permit the detailed examination of the dossier as well as to allow Member States the possibility of granting provisional authorisation for plant-protection products containing this active substance in accordance with Article 8(1) of the Directive.
Tovrstna potrditev je potrebna, saj omogoča podrobno proučitev dokumentacije in prav tako državam članicam ponuja možnost, da izdajo začasno registracijo za fitofarmacevtska sredstva, ki vsebujejo to aktivno snov, v skladu s členom 8(1) Direktive.
10 Končna redakcija
gospodarstvo
CELEX: 31999R2430
The provisional authorisations of the additives listed in Annex II to this Regulation are replaced by provisional authorisations granted to the person responsible for putting the additive into circulation, inserted in the second column of Annex II.
Začasna dovoljenja za dodatke s seznama v Prilogi II k tej uredbi se nadomestijo z začasnimi dovoljenji, danimi osebi, ki je odgovorna za dajanje dodatka v promet, vpisani v drugi stolpec Priloge II.
11 Končna redakcija
CELEX: 32004R0278
In the case of additives referred to in Part II of Annex C to Directive 70/524/EEC, which includes enzymes, provisional authorisation of a new use of an additive already authorised may be given if the conditions laid down in that Directive are satisfied, and if it is reasonable to assume, in view of the available results, that when used in animal nutrition it has one of the effects referred to in Article 2(a) of that Directive.
Za dodatke iz dela II Priloge C k Direktivi 70/524/EGS, ki vključujejo encime, se lahko izda začasno dovoljenje nove uporabe že dovoljenega krmnega dodatka, če so izpolnjeni pogoji, določeni v navedeni direktivi, in če je z vidika rezultatov, ki so na voljo, utemeljeno predvidevati, da ima, če se uporabi v prehrani živali, enega od učinkov iz člena 2(a) navedene direktive.
12 Končna redakcija
CELEX: 32004R0879
In the case of additives referred to in Part II of Annex C to Directive 70/524, which includes micro-organisms, provisional authorisation of a new use of an additive already authorised may be given if the conditions laid down in that Directive are satisfied, and if it is reasonable to assume, in view of the available results, that when used in animal nutrition it has one of the effects referred to in Article 2(a) of that Directive.
Za dodatke iz dela II Priloge C k Direktivi 70/524, ki zajema mikroorganizme, se lahko da začasno dovoljenje za novo uporabo že dovoljenega dodatka, če so izpolnjeni pogoji iz navedene direktive in če se lahko glede na dostopne rezultate razumno predvideva, da bodo pri uporabi v prehrani živali učinkovali tako, kakor je določeno v členu 2(a) navedene direktive.
13 Končna redakcija
DRUGO
Such confirmation is necessary to permit a detailed examination of the dossier and to allow Member States to grant provisional authorisation for plant protection products containing the active substance concerned while complying with the conditions laid down in Article 8(1) of the Directive and, in particular, the condition relating to the detailed assessment of the active substance and the plant protection product in the light of the requirements laid down by the Directive.
Taka potrditev je potrebna, da se omogoči podroben pregled dokumentacije in da se državam članicam omogoči odobritev začasnih registracij za fitofarmacevtska sredstva, ki vsebujejo zadevno aktivno snov, ob upoštevanju pogojev iz člena 8(1) Direktive in zlasti pogoja v zvezi s podrobno oceno aktivne snovi in fitofarmacevtskega sredstva glede na zahteve, ki jih je določila Direktiva.
14 Končna redakcija
gospodarstvo
CELEX: 31999R2430
The provisional authorisations of the additives listed in Annex I to this Regulation are replaced by authorisations granted to the person responsible for putting the additive in circulation, inserted in the second column of Annex I.
Začasna dovoljenja za dodatke s seznama v Prilogi I k tej uredbi se nadomestijo z začasnimi dovoljenji, danimi osebi, ki je odgovorna za dajanje dodatka v promet, vpisani v drugi stolpec Priloge I.
15 Končna redakcija
DRUGO
Such confirmation is necessary in order to pursue the detailed examination of the dossier as well as in order to open to Member States the possibility of granting provisional authorisation for plant-protection products containing this active substance in due respect of the conditions laid down in Article 8(1) of the Directive, and in particular the condition to make a detailed assessment of the active substances and the plant-protection products with regard to the requirements of the Directive.
Taka potrditev je potrebna zato, da se omogoči podroben pregled dokumentacije ter da imajo države članice možnost odobriti začasne registracije za fitofarmacevtska sredstva, ki vsebujejo zadevno aktivno snov, ob ustreznem upoštevanju pogojev iz člena 8(1) Direktive in zlasti pogoja, da se naredi podrobna ocena aktivnih snovi in fitofarmacevtskih sredstev glede na zahteve Direktive.
16 Končna redakcija
DRUGO
Whereas a provisional authorisation of new additives or uses of additives may be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock product, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs;
ker se lahko začasno dovolijo novi dodatki ali uporaba dodatkov, če dodatek pri dovoljeni vsebnosti v krmi nima škodljivih vplivov na zdravje ljudi ali živali ali na okolje niti ne škoduje potrošniku zaradi spremenjenih značilnosti izdelkov iz rejnih živali, če ga je mogoče nadzorovati v krmi in če se upravičeno domneva, glede na razpoložljive rezultate, da ugodno vpliva na značilnosti omenjene krme ali na proizvodnjo rejnih živali, kadar je vključen v omenjeno krmo;
17 Končna redakcija
gospodarstvo
CELEX: 31999R2430
in particular Article 9i of Directive 70/524/EEC provides for the replacement of the provisional authorisations of additives included in Annex II before 1 April 1998 and belonging to the group of coccidiostats and other medicinal substances and transferred to Chapter III of Annex B by provisional authorisations linked to the person responsible for putting them into circulation;
Zlasti člen 9i Direktive 70/524/EGS predvideva nadomestitev začasnih dovoljenj za dodatke, vključene v Prilogo II pred 1. aprilom 1987, ki spadajo v skupino kokcidiostatikov in drugih zdravil in so preneseni v poglavje III Priloge B, z začasnimi dovoljenji, povezanimi z osebo, ki je odgovorna za njihovo dajanje v promet.
18 Končna redakcija
CELEX: 32004L0060
After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing quinoxyfen and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi je treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo kvinoksifen, in zlasti da ponovno pregledajo obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka roka spremenijo v stalne registracije, jih dopolnijo ali umaknejo.
19 Končna redakcija
CELEX: 32004L0062
After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing mepanipyrim and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi bi bilo treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo mepanipirim, in zlasti da ponovno pregledajo obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka roka spremenijo v stalne registracije, dopolnijo ali umaknejo.
20 Končna redakcija
CELEX: 32004L0071
After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing Pseudomonas chlororaphis and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi bi bilo treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo Pseudomonas chlororaphis, in zlasti pregledati obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka roka spremeniti v stalne registracije, dopolniti ali umakniti.
21 Končna redakcija
CELEX: 32004L0030
After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing benzoic acid, flazasulfuron or pyraclostrobin and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi je treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo benzojsko kislino, flazasulfuron ali piraklostrobin, in zlasti pregledati obstoječa začasna dovoljenja, ta pa skladno z določbami Direktive 91/141/EGS najpozneje do poteka roka pretvoriti v stalna dovoljenja, jih spremeniti ali umakniti.
22 Končna redakcija
CELEX: 32004L0063
After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi nove aktivne snovi bi bilo treba državam članicam omogočiti primeren čas za izvedbo določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo to aktivno snov, in zlasti da ponovno pregledajo obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka tega roka spremenijo v stalne registracije, jih dopolnijo ali prekličejo.
23 Končna redakcija
CELEX: 32004L0064
After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi nove aktivne snovi bi bilo treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo to aktivno snov, in zlasti da ponovno pregledajo obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka tega roka spremenijo v stalne registracije, jih dopolnijo ali umaknejo.
24 Končna redakcija
CELEX: 32004L0065
After inclusion of a new active substance, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing this active substance and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.
Po vključitvi nove aktivne snovi je treba državam članicam omogočiti primeren rok za izvajanje določb Direktive 91/414/EGS glede fitofarmacevtskih sredstev, ki vsebujejo to aktivno snov, in zlasti da ponovno pregledajo obstoječe začasne registracije ter jih skladno z določbami Direktive 91/141/EGS najpozneje do poteka tega roka spremenijo v stalne registracije, jih dopolnijo ali prekličejo.
25 Končna redakcija
gospodarstvo
CELEX: 31999R2430
in particular Article 9h of Directive 70/524/EEC provides for the replacement of the provisional authorisations of additives included in Annex I after 31 December 1987 and belonging to the group of coccidiostats and other medicinal substances and transferred to Chapter II of Annex B by authorisations linked to the person responsible for putting them into circulation for a period of 10 years;
Zlasti člen 9h Direktive 70/524/EGS predvideva nadomestitev začasnih dovoljenj za dodatke, vključene v Prilogo I po 31. decembru 1987, ki spadajo v skupino kokcidiostatikov in drugih zdravil ter so preneseni v poglavje II Priloge B, z dovoljenji, povezanimi z osebo, ki je odgovorna za njihovo dajanje v promet za obdobje 10 let.
26 Končna redakcija
CELEX: 32004L0028
In the event of serious epizootic diseases, Member States may provisionally allow the use of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.
V primeru resnih epizootij lahko države članice začasno dovolijo uporabo imunoloških zdravil za uporabo v veterinarski medicini, ki nimajo dovoljenja za promet, če ni na voljo ustreznega zdravila, pri čemer morajo Komisijo predhodno obvestiti o podrobnih pogojih uporabe.
27 Končna redakcija
izobraževanje
CELEX: 32002R1605
If, for a given chapter, the authorisation of two or more provisional twelfths granted in the circumstances and under the procedures provided for in paragraph 3 is not sufficient to cover the expenditure necessary to avoid a break in continuity of the Communities' activity in the area covered by the chapter in question, authorisation may exceptionally be given to exceed the amount of the appropriations entered in the corresponding chapter of the budget of the preceding financial year.
Če za dani program odobritev dveh ali več začasnih dvanajstin v okoliščinah in po postopkih iz odstavka 3 ne zadostuje za pokrivanje izdatkov, potrebnih za preprečitev prekinitve kontinuitete delovanja Skupnosti na področju porabe, ki ga pokriva zadevni program, se lahko izjemoma dovoli prekoračitev sredstev, odobrenih za ustrezni program proračuna v preteklem proračunskem letu.
28 Končna redakcija
CELEX: 32004R0726
A number of provisions need to be introduced to put in place stringent and efficient pharmacovigilance procedures, to allow the competent authority to take provisional emergency measures, including the introduction of amendments to the marketing authorisation and, finally, to permit a reassessment to be made at any time of the risk-benefit balance of a medicinal product.
Uvesti je treba številne določbe za stroge in učinkovite postopke farmakovigilance, da pristojni organ lahko sprejme začasne izredne ukrepe, vključno z uvedbo sprememb v dovoljenje za promet in nazadnje, da v vsakem trenutku dovoli ponovno oceno razmerja med tveganjem in koristmi zdravila.
29 Pravna redakcija
gospodarstvo
CELEX: 32003R1801
Such provisional authorisation may be given for a period not exceeding four years.
Tako začasno dovoljenje se lahko izda za obdobje, ki ni daljše od štirih let.
30 Pravna redakcija
gospodarstvo
CELEX: 32001R2013
concerning the provisional authorisation of a new additive use and the permanent authorisation of an additive in feedingstuffs
o začasnem dovoljenju uporabe novega dodatka in trajnem dovoljenju dodatka v krmi
31 Pravna redakcija
DRUGO
The possibility of granting provisional authorisation for fluazolat should therefore be withdrawn.
Zato se možnost izdaje začasne registracije za fluazolat prekliče.
32 Pravna redakcija
gospodarstvo
CELEX: 32003R1847
concerning the provisional authorisation of a new use of an additive and the permanent authorisation of an additive already authorised in feedingstuffs
o začasnem dovoljenju za novo uporabo dodatka in dovoljenju za neomejen čas za dodatek v krmi, ki je že bil odobren
33 Pravna redakcija
gospodarstvo
CELEX: 32004R0278
concerning the provisional authorisation of a new use of an additive already authorised in feedingstuffs
o začasnem dovoljenju nove uporabe krmnega dodatka, ki je že dovoljen v krmi
34 Pravna redakcija
DRUGO
Commission Regulation (EC) No 256/2002 of 12 February 2002 concerning the provisional authorisation of new additives, the prolongation of provisional authorisation of an additive and the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance)
UREDBA KOMISIJE (ES) št. 256/2002 z dne 12. februarja 2002 o začasnem dovoljenju za nove dodatke, podaljšanju začasnega dovoljenja za dodatek in trajnem dovoljenju za dodatek v krmi (Besedilo velja za EGP)
35 Pravna redakcija
DRUGO
(Provisional residence authorisation)
(Dovoljenje za začasno prebivanje)
36 Pravna redakcija
gospodarstvo
CELEX: 32003R1847
The provisional authorisation of the micro-organism was extended until 30 June 2004 by Regulation (EC) No 2200/2001.
Začasno dovoljenje za mikroorganizem je bilo z Uredbo Komisije (ES) št. 2200/2001 podaljšano do 30. junija 2004.
37 Pravna redakcija
gospodarstvo
CELEX: 32000R2437
COMMISSION REGULATION (EC) No 2437/2000 of 3 November 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives in feedingstuffs
UREDBA KOMISIJE (ES) št. 2437/2000 z dne 3. novembra 2000 o stalnem dovoljenju za dodatek in začasnem dovoljenju za nove dodatke v krmi
38 Pravna redakcija
gospodarstvo
CELEX: 32003R1847
The provisional authorisation of that additive was extended until 30 June 2004 by Commission Regulation (EC) No 2200/2001( 4 ).
Začasno dovoljenje za naveden dodatek je bilo z Uredbo Komisije (ES) št. 2200/2001( fn ) podaljšano do 30. junija 2004.
39 Pravna redakcija
gospodarstvo
CELEX: 32003R1847
(5) The assessment of the application for authorisation submitted in respect of the new use of the enzyme shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
(5) Ocena vloge za izdajo dovoljenja, ki je bila predložena v zvezi z novo uporabo encima, pokaže, da so izpolnjeni pogoji za izdajo začasnega dovoljenja, ki so predvideni v Direktivi 70/524/EGS.
40 Pravna redakcija
gospodarstvo
CELEX: 32004R0278
(5) The assessment of the application for authorisation submitted in respect of the new use of this additive shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
(5) Proučitev vloge za dovoljenje, ki je bila predložena v zvezi z novo uporabo tega krmnega dodatka kaže, da so izpolnjeni pogoji za začasno dovoljenje, predvideni v Direktivi 70/524/EGS.
41 Pravna redakcija
gospodarstvo
CELEX: 32004R0490
(5) The assessment of the application for authorisation submitted in respect of the new use of this additive, shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.
(5) Proučitev vloge za dovoljenje, ki je bila predložena v zvezi z novo uporabo tega krmnega dodatka kaže, da so izpolnjeni pogoji za začasno dovoljenje, predvideni v Direktivi 70/524/EGS.
42 Pravna redakcija
DRUGO
Commission Regulation (EC) No 1887/2000 of 6 September 2000 on the provisional authorisation of a new additive in feedingstuffs (Text with EEA relevance)
UREDBA KOMISIJE (ES) št. 1887/2000 z dne 6. septembra 2000 o začasnem dovoljenju novega dodatka v krmi (Besedilo velja za EGP)
43 Pravna redakcija
gospodarstvo
CELEX: 32004R0278
Such provisional authorisation may be given for a period not exceeding four years in the case of additives referred to in Part II of Annex C to that Directive.
Tako začasno dovoljenje se lahko izda za obdobje, ki ni daljše od štirih let za dodatke iz dela II Priloge C k navedeni direktivi.
44 Pravna redakcija
promet
CELEX: 22003D0002
Commission Regulation (EC) No 1041/2002 of 14 June 2002 concerning the provisional authorisation of a new additive in feedingstuffs (OJ L 157, 15.6.2002, p. 41).
Uredba Komisije (ES) št. 1041/2002 z dne 14. junija 2002 o začasnem dovoljenju za nov dodatek v krmi (UL L 157, 15.6.2002, str. 41).
45 Pravna redakcija
promet
CELEX: 22003D0002
Commission Regulation (EC) No 1252/2002 of 11 July 2002 concerning the provisional authorisation of a new additive in feedingstuffs (OJ L 183, 12.7.2002, p. 10)."
Uredba Komisije (ES) št. 1252/2002 z dne 11. julija 2002 o začasnem dovoljenju za nov dodatek v krmi (UL L 183, 12.7.2002, str. 10).'
46 Pravna redakcija
DRUGO
Commission Regulation (EC) No 1353/2000 of 26 June 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives, new additive uses and new preparations in feedingstuffs (Text with EEA relevance)
UREDBA KOMISIJE (ES) št. 1353/2000 z dne 26. junija 2000 o stalnem dovoljenju za dodatek in začasnem dovoljenju za nove dodatke, za nove načine uporabe dodatkov in nove pripravke v krmi
47 Pravna redakcija
promet
CELEX: 22002A0130(01)
Within the period of provisional authorisation, the Parties shall examine the health and technological aspects of these limits with a view to taking a final decision.
V obdobju začasne odobritve pogodbenici preverjata zdravstvene in tehnološke vidike teh omejitev za sprejetje končne odločitve.
Prevodi: en > sl
1–50/303
provisional authorisation