natgillin/translations-raw huggingface dataset:
In Czech Snížení cla stanovené nařízením (ES) č.
v češčini Snížení cla stanovené nařízením (ES) č.
In Slovak Zníženie cla v zmysle nariadenia (ES) č.
v slovaščini Zníženie cla v zmysle nariadenia (ES) č.
Commission Regulation (EC) No 2041/2005
Uredba Komisije (ES) št. 2041/2005
laying down, for the 2005/06 marketing year, the revised production estimate for unginned cotton and the resulting new provisional reduction in the guide price
o določitvi predvidene proizvodnje neprečiščenega bombaža in novega začasnega znižanja normirane cene, ki izhaja iz nje, za tržno leto 2005/2006
Having regard to Council Regulation (EC) No 1051/2001 of 22 May 2001 on production aid for cotton [2], and in particular the second indent of Article 19(2) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1051/2001 z dne 22. maja 2001 o proizvodni pomoči za bombaž [2], in zlasti druge alinee člena 19(2) Uredbe,
That revised estimate should therefore be fixed on the basis of data available for the 2005/06 marketing year.
Zato je treba določiti omenjeno predvideno proizvodnjo na osnovi podatkov za tržno leto 2005/2006.
In view of the most recent figures on quantities placed in supervised storage notified by the Member States in accordance with Article 15(4)(c)(i) of Regulation (EC) No 1591/2001 and of uncertainty about the situation with regard to Greek production, as a safety margin, a percentage increase of 12,5 % for Greece and 7,5 % for Spain and Portugal should be applied for the 2005/06 marketing year.
Ob upoštevanju najnovejšega stanja količin pod nadzorom, o katerem za tržno leto 2005/2006 poročajo države članice v skladu s točko (c)(i) člena 15(4) Uredbe (ES) št. 1591/2001, in ob upoštevanju negotovosti glede grške proizvodnje je treba kot varnostni dodatek uporabiti odstotek povečanja 12,5 % za Grčijo, 7,5 % za Španijo in Portugalsko.
For the 2005/06 marketing year, the revised production estimate for unginned cotton is hereby set at:
Za tržno leto 2005/2006 se predvidena proizvodnja neprečiščenega bombaža določi na:
1100000 tonnes for Greece,
1100000 ton za Grčijo,
335780 tonnes for Spain,
335780 ton za Španijo,
For the 2005/06 marketing year, the new provisional reduction in the guide price shall be:
Za tržno leto 2005/2006 se novo začasno znižanje normirane cene določi na:
EUR 39,650/100 kg for Greece,
39,650 EUR/100 kg za Grčijo,
EUR 23,918/100 kg for Spain,
23,918 EUR/100 kg za Španijo,
Commission Regulation (EC) No 2042/2005
Uredba Komisije (ES) št. 2042/2005
This Regulation shall enter into force on 16 December 2005.
Ta uredba začne veljati 16. decembra 2005.
Commission Regulation (EC) No 2043/2005
Uredba Komisije (ES) št. 2043/2005
In the week of 5 to 9 December 2005 applications were presented to the competent authorities in line with Article 5(1) of Regulation (EC) No 1159/2003 for import licences for a total quantity exceeding a country's delivery obligation quantity of ACP-India preferential sugar determined pursuant to Article 9 of that Regulation.
Zahtevki so bili predloženi zadevnim organom v tednu od 5. do 9. decembra 2005, v skladu s členom 5(1) Uredbe (ES) št. 1159/2003, za izdajo uvoznih dovoljenj za celotno količino, ki presega obvezno količino za dostavo za zadevno državo, določeno v skladu s členom 9 Uredbe (ES) št. 1159/2003 za preferenčni sladkor AKP-Indija.
In the case of import licence applications presented from 5 to 9 December 2005 in line with Article 5(1) of Regulation (EC) No 1159/2003 licences shall be issued for the quantities indicated in the Annex to this Regulation.
Na podlagi zahtevkov za uvozna dovoljenja, vloženih od 5. do 9. decembra 2005 v okviru člena 5(1) Uredbe (ES) št. 1159/2003, se dovoljenja izdajo v mejah količin, določenih v Prilogi k tej uredbi.
Week of 5.12.2005-9.12.2005: percentage of requested quantity to be granted
% za dostavo zahtevanih količin v tednu od 5.12.2005–9.12.2005
Commission Regulation (EC) No 2044/2005
Uredba Komisije (ES) št. 2044/2005
Commission Regulation (EC) No 1961/2001 [2] lays down the detailed rules of application for export refunds on fruit and vegetables.
Uredba Komisije (ES) št. 1961/2001 [2], določa podrobna pravila za uporabo izvoznih nadomestil za sadje in zelenjavo.
For this reason and because exports of fruit and vegetables are seasonal in nature, the quantities scheduled for each product should be fixed, based on the agricultural product nomenclature for export refunds established by Commission Regulation (EEC) No 3846/87 [3].
Iz tega razloga in zaradi sezonske narave izvoza sadja in zelenjave je treba določiti količine, predvidene za vsak proizvod, na podlagi nomenklature kmetijskih proizvodov za izvozna nadomestila, določene v Uredbi Komisije (EGS) št. 3846/87 [3].
Tomatoes, oranges, lemons and apples of classes Extra, I and II of the common quality standards can currently be exported in economically significant quantities.
Paradižniki, pomaranče, limone in jabolka razredov ekstra, I in II skupnih standardov kakovosti, se trenutno lahko izvozijo v gospodarsko pomembnih količinah.
This Regulation shall enter into force on 10 January 2006.
Ta uredba začne veljati 10. januarja 2006.
to the Commission Regulation of 14 December 2005 fixing the export refunds on fruit and vegetables (tomatoes, oranges, lemons and apples)
k Uredbi Komisije z dne 14. decembra 2005 o določitvi izvoznih nadomestil za sadje in zelenjavo (paradižniki, pomaranče, limone in jabolka)
Refund application period 10.1.2006 to 9.3.2006
Rok za predložitev zahtevka za nadomestilo: 10.1.2006–9.3.2006
Licence application period 17.1.2006 to 16.3.2006
Rok za predložitev zahtevka za izdajo dovoljenja: 17.1.2006–16.3.2006
Commission Regulation (EC) No 2045/2005
Uredba Komisije (ES) št. 2045/2005
to the Commission Regulation of 14 December 2005 setting the export refunds for nuts (system A1)
k Uredbi Komisije z dne 14. decembra 2005 o določitvi izvoznih nadomestil za lupinasto sadje (A1)
Period for lodging licence applications: from 10 January 2006 to 23 June 2006.
Rok za vložitev prijav za dovoljenja: od 10. januarja do 23. junija 2006.
Commission Regulation (EC) No 2047/2005
Uredba Komisije (ES) št. 2047/2005
to Commission Regulation of 15 December 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables
k Uredbi Komisije z dne 15. decembra 2005 o določitvi pavšalnih uvoznih vrednosti za določanje vhodne cene nekaterega sadja in zelenjave
Commission Regulation (EC) No 2048/2005
Uredba Komisije (ES) št. 2048/2005
On the basis of information on export licence applications available to the Commission on 14 December 2005, the quantity still available for the period until 15 January 2006, for destination zone (1) Africa, referred to in Article 9(5) of Regulation (EC) No 883/2001, could be exceeded unless the issue of export licences with advance fixing of the refund is restricted.
Na podlagi informacij o zahtevkih za izvozna dovoljenja, s katerimi je Komisija razpolagala na dan 14. decembra 2005, bi lahko bila količina, razpoložljiva v obdobju do 15. januarja 2006, za namembno območje (1) Afrika iz člena 9(5) Uredbe (ES) št. 883/2001, izčrpana, če se izdaja izvoznih dovoljenj z vnaprejšnjo določitvijo nadomestila ne omeji.
Therefore, a single percentage for the acceptance of applications submitted from 7 to 13 December 2005 should be applied and the submission of applications and the issue of licences suspended for this zone until 16 January 2006,
Zato je potrebno uporabljati enoten odstotek za sprejem zahtevkov, vloženih v obdobju od 7. do 13. decembra 2005, in ustaviti predložitev zahtevkov ter izdajo dovoljenj za to območje do 16. januarja 2006 –
Export licences with advance fixing of the refund for wine-sector products for which applications are submitted from 7 to 13 December 2005 under Regulation (EC) No 883/2001 shall be issued in concurrence with 36,59 % of the quantities requested for zone (1) Africa.
Izvozna dovoljenja z vnaprejšnjo določitvijo nadomestila za proizvode vinskega sektorja, za katera so bili zahtevki vloženi v obdobju od 7. do 13. decembra 2005 v skladu z Uredbo (ES) št. 883/2001, se izdajo sočasno s 36,59 % količin, zahtevanih za območje (1) Afrika.
The issue of export licences for wine-sector products referred to in paragraph 1 for which applications are submitted from 14 December 2005 and the submission of export licence applications from 16 December 2005 for destination zone (1) Africa shall be suspended until 16 January 2006.
Izdaja izvoznih dovoljenj za proizvode vinskega sektorja iz odstavka 1, za katera se zahtevki vložijo od 14. decembra 2005, ter vlaganje zahtevkov za izvozna dovoljenja od 16. decembra 2005 za namembno območje (1) Afrika, se ustavita do 16. januarja 2006.
Commission Regulation (EC) No 2049/2005
Uredba Komisije (ES) št. 2049/2005
laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
o določitvi pravil v zvezi s plačevanjem pristojbin Evropski agenciji za zdravila s strani mikro, malih in srednje velikih podjetij in o nudenju upravne pomoči mikro, malim in srednje velikim podjetjem s strani Evropske agencije za zdravila v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta
Having regard to European Parliament and Council Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [1], and in particular Article 70(2) thereof,
ob upoštevanju Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [1], in zlasti člena 70(2) Uredbe,
Regulation (EC) No 726/2004, which replaces Council Regulation (EEC) No 2309/93 of 22 July 1993 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 [2], provides that the revenue of the European Medicines Agency (hereinafter referred to as the Agency) must consist of a contribution from the Community and fees paid by companies.
Uredba (ES) št. 726/2004, ki nadomešča Uredbo Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil [2], določa, da morajo biti prihodki Evropske agencije za zdravila (v nadaljnjem besedilu Agencija) sestavljeni iz prispevka Skupnosti in pristojbin podjetij.
In the context of the system established by Regulation (EEC) No 2309/93, Council Regulation (EC) No 297/95 [3] provides for fees payable to the Agency.
V okviru sistema, vzpostavljenega z Uredbo (EGS) št. 2309/93, Uredba Sveta (ES) št. 297/95 [3], določa pristojbine, ki se plačujejo Agenciji.
Pursuant to Regulation (EC) No 726/2004, the situation of micro, small and medium-sized enterprises (SMEs) has to be considered separately.
V skladu z Uredbo (ES) št. 726/2004 je treba položaj mikro, malih in srednje velikih podjetij (MSP) obravnavati ločeno.
In order to reduce the cost for SMEs of marketing medicinal products authorised via the centralised procedure, that Regulation therefore foresees the adoption of specific provisions allowing a reduction of fees, deferring the payment of fees, and providing administrative assistance.
Da bi za MSP zmanjšali stroške trženja zdravil, za katere je bilo dovoljenje za promet pridobljeno s centraliziranim postopkom, navedena Uredba predvideva sprejem posebnih določb o znižanju pristojbin, odlogu plačila pristojbin in nudenju upravne pomoči.
Such provisions should apply equally to the human and veterinary sectors and should aim at promoting innovation and the development of new medicinal products by SMEs.
Takšne določbe bi se morale uporabljati tako za sektor zdravil za humano uporabo kot za sektor zdravil za veterinarsko uporabo ter imeti za cilj spodbujanje inovacije in razvoj novih zdravil s strani MSP.
The definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/EC [4] should apply, for reasons of coherence and transparency.
Zaradi skladnosti in preglednosti je treba uporabljati opredelitev mikro, malih in srednje velikih podjetjih v skladu s Priporočilom Komisije 2003/361/ES [4].
Experience gained since the adoption of Regulation (EEC) No 2309/93 shows that the main financial and administrative entry hurdles for SMEs are the various steps involved in pre-marketing authorisation procedures, such as the seeking of scientific advice, the submission of the marketing authorisation application, and the undergoing of inspections.
Izkušnje, pridobljene po sprejetju Uredbe (EGS) št. 2309/93, kažejo, da imajo MSP glavne finančne in administrativne težave na začetku z raznimi dejanji, potrebnimi pred pridobitvijo dovoljenja za promet, kot so iskanje znanstvenega svetovanja, predložitev vloge za pridobitev dovoljenja za promet in nadzori, ki so jim podvržena.
Provisions laid down in this Regulation should therefore be focused on these aspects.
Določbe iz te uredbe bi se zato morale osredotočiti na te vidike.
The fees for the marketing authorisation application and the related inspections conducted for the purpose of assessing the application could constitute a significant financial constraint for SMEs.
Pristojbine v zvezi z vlogami za pridobitev dovoljenja za promet in s tem povezanim nadzorom v zvezi z ocenjevanjem vloge, bi lahko za MSP pomenili veliko finančno obremenitev.
Consequently, in order to avoid a weakening of the financial situation of undertakings during the assessment of the marketing authorisation application, it is appropriate to defer the payment of these fees until the end of the procedure.
Da bi se izognili poslabšanju finančnega stanja podjetij med postopkom ocenjevanja vloge za pridobitev dovoljenja za promet, je primerno odložiti plačilo teh pristojbin do konca postopka.
SMEs operating in the pharmaceutical sector are often innovative companies, such as those active in the fields of gene or somatic cell therapy, which can notably benefit from the pooling of scientific expertise at a Community level.
MSP v farmacevtskem sektorju, kot na primer tista, ki delujejo na področju genske ali somatične celične terapije, so pogosto inovativne družbe, ki lahko z združevanjem strokovnega znanja na ravni Skupnosti veliko pridobijo.
Furthermore, the scientific evaluation of a marketing authorisation application is more likely to be favourable in the case of medicinal products which have obtained scientific advice.
Poleg tega so možnosti za dosego dobrega rezultata znanstvenega ocenjevanja vloge za pridobitev dovoljenja za promet v primeru zdravil, za katere je bilo uporabljeno znanstveno svetovanje, povečane.
Therefore, access to the Agency’s scientific advice for SMEs seeking marketing authorisation should be facilitated through fee reductions.
Zato je treba za MSP, ki so v postopku za pridobitev dovoljenja za promet, z znižanjem pristojbin olajšati dostop do znanstvenega svetovanja Agencije.
As an additional incentive, a conditional fee exemption should be given to applicants who have requested such advice and who have actually taken it into account for the development of their medicinal product.
Kot dodatno spodbudo je treba za vlagatelje vlog, ki so zaprosili za tako svetovanje in so ga pri razvoju svojih zdravil tudi dejansko upoštevali, uvesti pogojno oprostitev plačevanja pristojbin.
Another incentive should also be provided, in the form of a fee reduction, for the establishment of maximum residue limits (MRL) for veterinary medicinal products in order to further support the establishment of such limits.
Predvideti bi bilo treba tudi drugo spodbudo, in sicer v obliki nižjih pristojbin za določanje najvišjih mejnih vrednosti ostankov (MVO) zdravil za veterinarsko uporabo, da bi spodbudili določanje takih mejnih vrednosti.
Translations can constitute a significant administrative burden for SMEs.
Prevodi lahko za MSP pomenijo znatno administrativno obremenitev.
The Agency should therefore make appropriate arrangements to provide for the translations of certain documents required for the granting of marketing authorisation, in particular the draft summary of the product characteristics and the draft text of the labelling and package leaflet.
Zato bi morala Agencija storiti, kar je potrebno za zagotovitev prevodov določenih dokumentov, potrebnih za izdajo dovoljenja za promet, zlasti osnutka povzetka značilnosti proizvoda in osnutka besedila na oznakah ter navodilih za uporabo.
A lack of experience with the centralised procedure and the Agency as an administrative organisation should not impair the development and marketing of new medicinal products.
Pomanjkanje izkušenj s centraliziranim postopkom in Agencijo kot upravno organizacijo ne bi smelo škodovati razvoju in trženju novih zdravil.
Consequently, it is appropriate to create an SME office, with the sole remit of offering administrative assistance to SMEs.
Zato je primerno ustanoviti Urad za MSP, čigar edina naloga bo nuditi upravno pomoč MSP.
The SME office should provide a single interface between the applicant SME and the Agency, so as to facilitate communication and to answer practical or procedural enquiries.
Da bi poenostavil komunikacijo in odgovoril na praktična in postopkovna vprašanja, bi moral biti Urad za MSP edini vmesni člen med vlagateljem vloge (MSP) in Agencijo.
In order to provide practical guidance to applicant SMEs, the Agency should publish a user guide on the administrative and procedural aspects linked to the centralised procedure which are of particular relevance for SMEs.
Da bi vlagateljem vlog (MSP) zagotovila praktična navodila, bi morala Agencija objaviti priročnik o tistih administrativnih in postopkovnih vidikih centraliziranega postopka, ki so za MSP posebej pomembni.
The Agency should report annually on the operation of the provisions laid down in this Regulation, so that feedback on their practical application is available.
Da bi se pridobile povratne informacije iz prakse izvajanja, bi morala Agencija vsako leto poročati o izvajanju določb iz te uredbe.
In order to ensure that SMEs benefit, to the largest extent possible, from the derogation provided for in this Regulation it should enter into force immediately.
Da bi imela MSP čim večjo korist od izjem, ki jih predvideva ta uredba, bi le-ta morala začeti veljati takoj.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use and of the Standing Committee for Veterinary Medicinal Products,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za humano uporabo in Stalnega odbora za veterinarska zdravila –
This Regulation establishes the circumstances in which, by derogation from the relevant provisions of Regulation (EC) No 297/95, micro, small and medium-sized enterprises (SMEs) may pay reduced fees, defer payment of fees, or receive administrative assistance when submitting applications under Regulation (EC) No 726/2004 to the European Medicines Agency, hereinafter ‘the Agency’.
Ta uredba določa pogoje, v katerih lahko z odstopanjem od ustreznih določb iz Uredbe (ES) št. 297/95, mikro, mala in srednje velika podjetja (MSP) plačajo nižje pristojbine, odložijo plačilo pristojbin ali prejmejo upravno pomoč ob predložitvi vlog v skladu z Uredbo (ES) št. 726/2004 Evropski agenciji za zdravila, v nadaljnjem besedilu „Agenciji“.
This Regulation shall apply to SMEs within the meaning of Recommendation 2003/361/EC in the version of 6 May 2003 which are established in the Community.
Ta uredba se uporablja za MSP v smislu Priporočila 2003/361/ES v različici z dne 6. maja 2003, ki imajo sedež v Skupnosti.
Unless otherwise specified, this Regulation shall apply both to applications concerning medicinal products for human use and to applications concerning veterinary medicinal products, within the meaning of Directives 2001/83/EC [5] and 2001/82/EC [6] of the European Parliament and of the Council respectively.
Če ni drugače določeno, se ta uredba uporablja za vloge v zvezi z zdravili za humano uporabo in vloge v zvezi z veterinarskimi zdravili v skladu z direktivama 2001/83/ES [5] in 2001/82/ES [6] Evropskega parlamenta in Sveta, v tem zaporedju.
For the purposes of this Regulation, applicant means an undertaking seeking to benefit from the application of the provisions laid down in Chapters II and III.
Vlagatelj v tej uredbi pomeni podjetje, ki želi biti upravičeno do uporabe določb, določenih v poglavjih II in III.
Submission of information
Predložitev podatkov
An SME wishing to benefit from the provisions of this Regulation shall submit to the Agency the information necessary to demonstrate compliance with the criteria mentioned in Article 2(1).
MSP, ki želi biti upravičeno do uporabe določb iz te uredbe, predloži Agenciji potrebne informacije, s katerimi dokaže skladnost z merili iz člena 2(1).
FEE DEFERRALS AND REDUCTIONS
ODLOG PLAČILA IN ZNIŽANJE PRISTOJBIN
Fee deferrals
Odlog plačila pristojbin
The payment of the following fees shall be deferred until the notification of the final decision on the marketing authorisation is issued, or the application is withdrawn:
Do izdaje uradnega obvestila o dokončni odločbi o dovoljenju za promet ali do umika vloge, se plačilo odloži pri naslednjih pristojbinah:
the fee for an application for a marketing authorisation of a medicinal product, as referred to in points (a) and (b) of Article 3(1) and points (a) and (b) of Article 5(1) of Regulation (EC) No 297/95;
pristojbini za vlogo za pridobitev dovoljenja za promet z zdravilom, določeni v točkah (a) in (b) člena 3(1) in točkah (a) in (b) člena 5(1) Uredbe (ES) št. 297/95;
the fee for inspections undertaken for the purpose of assessing a marketing authorisation application for a medicinal product, as referred to in Article 3(4) and Article 5(4) of Regulation (EC) No 297/95.
pristojbini za nadzore za ocenitev vloge za pridobitev dovoljenja za promet z zdravilom, določeni v členu 3(4) in členu 5(4) Uredbe (ES) št. 297/95.
The fees referred to in paragraph 1 shall be payable within 45 days of the date of the notification of the final decision on the marketing authorisation, or within 45 days of the date of the notification of withdrawal of the application.
Pristojbine iz odstavka 1 se plačajo v roku 45 dni od datuma uradnega obvestila o dokončni odločbi o dovoljenju za promet ali v roku 45 dni od datuma uradnega obvestila o umiku vloge.
Conditional fee exemption
Pogojna oprostitev od pristojbin
Without prejudice to Article 5, where an application for marketing authorisation is submitted for a medicinal product on which scientific advice has already been given by the Agency, the fee payable to the Agency for the examination of that application shall be due only if a marketing authorisation is granted.
V primeru predložitve vloge za pridobitev dovoljenja za promet za zdravilo, za katerega je Agencija že nudila znanstveno svetovanje, se, brez poseganja v člen 5, pristojbina, ki se plača Agenciji za oceno navedene vloge, plača samo, če se dovoljenje za promet izda.
Fee reductions
Znižanje pristojbin
The following reductions shall apply:
Uporabljajo se naslednja znižanja:
in the case of inspections a 90 % reduction to the inspection fee, as referred to in Article 3(4) and Article 5(4) of Regulation (EC) No 297/95;
v primeru nadzora se pristojbina za nadzor iz člena 3(4) in člena 5(4) Uredbe (ES) št. 297/95 zniža za 90 %;
in the case of scientific advice a 90 % reduction to the scientific advice fee, as referred to in Article 8(1) of Regulation (EC) No 297/95;
v primeru znanstvenega svetovanja se pristojbina za znanstveno svetovanje iz člena 8(1) Uredbe (ES) št. 297/95 zniža za 90 %;