natgillin/translations-raw huggingface dataset:
(d) for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I, unless the five-year period expires before the period provided for in paragraphs 3(b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.
(d) v obdobju petih let od datuma odločitve po prejemu dodatnih podatkov, potrebnih za prvo uvrstitev v Prilogo I, ali zaradi spremembe pogojev ali zaradi ohranitve uvrstitve aktivne snovi v Prilogi I, ki je bila sprejeta zaradi spremembe pogojev za vključitev ali ohranitev aktivne snovi v Prilogi I, razen če petletno obdobje poteče pred potekom obdobja iz odstavkov 3(b) in (c), v tem primeru se obdobje petih let podalj�a tako, da poteče isti dan kot ti obdobji.
By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I.
Z odstopanjem od odstavka 1 lahko države članice za aktivno snov, ki je že v prometu dve leti po notifikaciji te direktive, z ustreznim upo�tevanjem določb Pogodbe, �e naprej uporabljajo predhodne nacionalne predpise glede zahtevanih podatkov, dokler se take snovi ne uvrsti v Prilogo I.
Regulation No 3600/92
Uredba �t. 3600/92
According to Article 1(1) thereof, Regulation No 3600/92 ‘lays down detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive [91/414] ….
Uredba �t. 3600/92 v skladu s členom 1(1) „določa podrobna pravila za izvajanje prve faze delovnega programa iz člena 8(2) Direktive 91/414/EGS […].
[That] first stage involves an assessment of the substances listed in Annex I to Regulation [3600/92] with a view to their possible inclusion in Annex I to Directive [91/414].’
[Ta] prva faza vključuje ocenjevanje snovi, na�tete v Prilogi I [k tej] uredbi, zaradi njihove možne vključitve v Prilogo I k Direktivi 91/414/EGS.“ V Prilogi I k Uredbi �t. 3600/92 je med drugim naveden „etofumesat“.
Article 4 of Regulation No 3600/92 provides:
Člen 4 Uredbe �t. 3600/92 določa:
Any producer wishing to secure the inclusion of an active substance referred to in Annex I hereto … in Annex I to Directive [91/414] shall so notify the Commission within six months of the date of entry into force of this Regulation.
Vsak proizvajalec, ki želi zagotoviti vključitev aktivne snovi iz Priloge I k tej uredbi ali katere koli soli, estra ali amina aktivne snovi v Prilogo I k Direktivi, o tem obvesti Komisijo v �estih mesecih od datuma začetka veljavnosti te uredbe.
Notification must be made to the Commission … in accordance with the notification as shown in Annex II hereto, completed and containing the undertaking referred to in part 5 of the specimen notification.
Prijava, izpolnjena v skladu z vzorcem iz Priloge II k tej uredbi, skupaj z izjavo iz točke 5 vzorca, se po�lje Komisiji […].
Any producer who has not notified in time any given active substance referred to in paragraph 1 will be permitted to participate in the programme referred to in Article 1 only collectively with other notifiers of that active substance or, in the case referred to in paragraph 4 hereof, in assisting the notifying Member State, with the agreement of the original notifiers.
Vsakemu proizvajalcu, ki določene aktivne snovi iz odstavka 1 ne prijavi pravočasno, se dovoli sodelovanje v programu iz člena 1 samo skupaj z drugimi prijavitelji za to aktivno snov, ali v primeru iz odstavka 4 tega člena kot pomoč državi članici prijaviteljici v soglasju s prvotnimi prijavitelji.
Article 6 of Regulation No 3600/92 provides:
Člen 6 te uredbe določa:
Within the timelimit referred to in the third indent of Article 5(4), the notifiers specified in the regulation referred to in that Article must, individually or collectively, send to the designated authority of the rapporteur Member State, for any given active substance:
V roku iz tretje alinee člena 5(4) morajo prijavitelji, določeni z uredbo iz istega člena, posamezno ali skupaj poslati imenovanemu organu države članice poročevalke za vsako aktivno snov:
(a) the summary dossier referred to in paragraph 2 hereof; and
(a) povzetek dokumentacije iz odstavka 2 tega člena; in
(b) the complete dossier referred to in paragraph 3 hereof.
(b) popolno dokumentacijo iz odstavka 3 tega člena.
The summary dossier shall include the following:
Povzetek dokumentacije mora vsebovati:
(c) for each point of Annex II to Directive [91/414], the available summaries and results of trials, the name of the person or institute that has carried out the trials; the same information for each point of Annex III to the Directive relevant to the assessment of the criteria referred to in Article 5 of the Directive and for one or more preparations which are representative for the conditions of use referred to in [point] (b);
(c) za vsako točko iz Priloge II k Direktivi [91/414] razpoložljive povzetke in rezultate poskusov, ime osebe ali ustanove, ki je izvajala poskuse; enake podatke tudi za vsako točko Priloge III k [tej] direktivi, ki so pomembni za ocenjevanje meril iz člena 5 navedene direktive in za enega ali več pripravkov, ki so reprezentativni za pogoje uporabe iz pododstavka (b);
The complete dossier shall contain the protocols and the complete study reports concerning all the information referred to in paragraph 2(c).
Popolna dokumentacija vsebuje protokole in popolna poročila o �tudijah glede vseh podatkov iz odstavka 2(c).
‘(5) It has appeared from the various examinations made that plant protection products containing ethofumesate may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive [91/414], in particular with regard to the uses which were examined and detailed in the Commission
„(5) Različna izvedena preučevanja so pokazala, da lahko pričakujemo, da fitofarmacevtska sredstva z etofumesatom na splo�no izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive [91/414], zlasti v zvezi z uporabami, ki so bile preučene in podrobno opisane v poročilu Komisije o pregledu. Zato je primerno vključiti
FEINCHEMIE SCHWEBDA AND BAYER CROPSCIENCE review report. It is therefore appropriate to include ethofumesate in Annex I to Directive [91/414], in order to ensure that in all Member States authorisations of plant protection products containing ethofumesate can be granted in accordance with the provisions of Directive [91/414].
FEINCHEMIE SCHWEBDA IN BAYER CROPSCIENCE etofumesat v Prilogo I Direktive [91/414], da se v vseh državah članicah zagotovi, da se fitofarmacevtska sredstva, ki vsebujejo etofumesat, lahko registrirajo v skladu z določbami Direktive 91/414/EGS.
(8) After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive [91/414] as regards plant protection products containing ethofumesate, and in particular, to review existing authorisations in accordance with the provisions of Directive [91/414] to ensure that the conditions regarding ethofumesate set out in Annex I to Directive [91/414] are satisfied.
(8) Po vključitvi je treba državam članicam omogočiti določeno obdobje za izvajanje določb Direktive [91/414] v zvezi s fitofarmacevtskimi sredstvi, ki vsebujejo etofumesat in zlasti za ponovni pregled obstoječih registracij v skladu z določbami Direktive [91/414], da zagotovijo, da so izpolnjeni pogoji v zvezi z etofumesatom iz Priloge I k Direktivi [91/414].
A longer period should be provided within which a complete dossier for each such plant protection product, satisfying the requirements of Annexes II and III to Directive [91/414] should be submitted and that product re-evaluated in accordance with the uniform principles laid down in Directive [91/414]’.
Predpisati je treba tudi dalj�e obdobje, v katerem se predloži celotna dokumentacija za vsako tak�no fitofarmacevtsko sredstvo, ki izpolnjuje zahteve iz Prilog II in III k Direktivi [91/414] in v katerem se pripravek ponovno oceni v skladu z enotnimi načeli iz Direktive [91/414].“
Member States shall review the authorisation for each plant protection product containing ethofumesate to ensure that the conditions relating to ethofumesate set out in Annex I to Directive [91/414] are complied with.
Države članice pregledajo registracijo za vsako fitofarmacevtsko sredstvo, ki vsebuje etofumesat, da zagotovijo izpolnjevanje pogojev v zvezi z etofumesatom iz Priloge I k Direktivi [91/414].
Where necessary, they shall amend or withdraw the authorisation in accordance with Directive [91/414] before 1 September 2003.
Kjer je potrebno, registracijo spremenijo ali prekličejo v skladu z Direktivo [91/414] pred 1. septembrom 2003.
Member States shall, for each authorised plant protection product containing ethofumesate as either the only active substance or as one of several active substances
Države članice za vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje etofumesat kot edino aktivno snov ali kot eno od več aktivnih snovi, ki so vse bile vključene
2008 — CASE C-361/06 all of which were listed in Annex I to Directive [91/414] by 1 March 2003, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive [91/414], on the basis of a dossier satisfying the requirements of Annex III thereto.
2008 – ZADEVA C-361/06 v Prilogo [I] k Direktivi [91/414], do 1. marca 2003 ponovno ocenijo to sredstvo v skladu z enotnimi načeli iz Priloge VI k Direktivi [91/414] na osnovi dokumentacije, ki je skladna z zahtevami iz Priloge III k navedeni direktivi.
On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive [91/414].
Na osnovi te ocene določijo, ali pripravek izpolnjuje zahteve iz člena 4(1)(b), (c), (d) in (e) Direktive [91/414].
Where necessary and by 28 February 2007 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.’
Kjer je potrebno in najpozneje do 28. februarja 2007, spremenijo ali prekličejo registracijo za vsako tak�no fitofarmacevtsko sredstvo.“
1962, No 288, ‘the Bmw’), the CTB is to withdraw the authorisation or registration referred to in Article 4 of that law if that is necessary for the implementation of a Community measure.
288, v nadaljevanju: Bmw) College prekliče registracijo ali dovoljenje iz člena 4 tega člena, če je to potrebno za izvr�itev ukrepa Skupnosti.
Ethofumesate is an active substance which was already on the market two years after notification of Directive 91/414.
Etofumesat je aktivna snov, ki je že bila v prometu dve leti po notifikaciji Direktive 91/414.
Consequently, it comes under the transitional measures provided for in Articles 8(2) and 13(6) of that directive.
Zato zanj veljajo prehodne določbe iz členov 8(2) in 13(6) navedene direktive.
It was by operation of those transitional measures that Agrichem was granted authorisations to place on the market a certain number of plant protection products containing ethofumesate as an active substance.
Na podlagi teh prehodnih določb je Agrichem pridobil registracije za dajanje nekaterih fitofarmacevtskih sredstev, ki vsebujejo „etofumesat“ kot aktivno snov, v promet.
As notifiers for the purposes of Article 4 of Regulation No 3600/92, Feinchemie and Bayer followed the procedure provided for in that regulation, with the result that ethofumesate was included in Annex I to Directive 91/414.
Prijavitelja v smislu člena 4 Uredbe �t. 3600/92, družbi Feinchemie in Bayer, sta ravnala v skladu s postopkom iz te Uredbe in posledično je bil etofumesat uvr�čen v Prilogo I k Direktivi 91/414.
In accordance with Article 6(2) of Directive 91/414, those undertakings submitted an Annex II dossier to the Commission.
V skladu s členom 6(2) te direktive sta podjetji Komisiji predložili dokumentacijo iz Priloge II.
Agrichem did not act with the applicants, either as notifier of the active substance ethofumesate or as co-notifier.
Agrichem ni nastopil kot prijavitelj ali soprijavitelj aktivne snovi „etofumesat“.
Following the inclusion of ethofumesate in Annex I to Directive 91/414, the CTB, by seven decisions taken on 23 January 2004 pursuant to the Bmw, withdrew the authorisations held by Agrichem to place on the market plant protection products containing ethofumesate as an active substance, on the grounds that no deadline had been set for the use of those products and that Agrichem did not hold, or have access to, a complete Annex II dossier.
College je po uvrstitvi te snovi v Prilogo I k Direktivi 91/414 s sedmimi odločbami z dne 23. januarja 2004, ki jih je sprejelo na podlagi Bmw, preklicalo registracije, ki jih je imel Agrichem za dajanje fitofarmacevtskih sredstev, ki vsebujejo „etofumesat“ kot aktivno snov, v promet, z obrazložitvijo, da ni bil določen rok uporabe teh izdelkov, da Agrichem ni imel popolne dokumentacije iz Priloge II in da ni imel dostopa do take dokumentacije.
On 28 January 2004, Agrichem brought a complaint before the CTB against those decisions, submitting that it did not have to provide an Annex II dossier or show that it had access to such a dossier, given that, in particular, Article 4(1) of Directive 2002/37 merely required it to comply with the conditions set out in Annex I to Directive 91/414, as amended by Directive 2002/37.
Agrichem je 28. januarja 2004 pri College vložil ugovor zoper navedene odločbe, v katerem je zatrjeval, da mu ni treba predložiti dokumentacije iz Priloge II oziroma dokazati, da ima dostop do take dokumentacije, in sicer zlasti zato, ker člen 4(1) Direktive 2002/37 zahteva zgolj, da se upo�tevajo zahteve iz Priloge I k Direktivi 91/414, kot je bila spremenjena z Direktivo 2002/37.
By decision of 30 January 2004, the CTB amended one of its decisions of 23 January 2004, to the effect that the withdrawal of one of the authorisations at issue was to take effect on 30 January 2004.
College je z odločbo z dne 30. januarja 2004 spremenilo eno izmed svojih odločb z dne 23. januarja 2004, tako da je določilo, da začne preklic ene od zadevnih registracij veljati 30. januarja 2004.
By decision of 20 February 2004, the latter granted interim relief and suspended the decisions of the CTB of 23 January 2004 for six weeks.
Slednje je z odločbo z dne 20. februarja 2004 ugodilo navedenemu predlogu in za �est tednov začasno zadržalo odločbe, ki jih je izdalo College z dne 23. januarja 2004.
After Agrichem — as well as Feinchemie and Bayer, in their capacity as interested third parties — had been heard by the CTB’s Adviescommissie voor de bezwaarschriften (Consultative committee for complaints), the CTB, by decision of 19 November 2004, revoked the withdrawal of the seven authorisations at issue, on the ground that neither Directive 2002/37 nor Directive 91/414 gives it the power to require — for the purposes of the review, in accordance with Article 4(1) of Directive 2002/37, of existing authorisations — an Annex II dossier to back up such authorisations.
Potem ko je družbe Agrichem ter Feinchemie in Bayer, slednji kot tretji zainteresirani osebi, zasli�al Adviescommissie voor de bezwaarschriften (posvetovalni odbor za ugovore) pri College, je slednje z odločbo z dne 19. novembra 2004 razveljavilo preklic sedmih zadevnih registracij, z obrazložitvijo, da mu ne Direktiva 2002/37 ne Direktiva 91/414 ne dajeta pristojnosti, da v okviru pregleda veljavnih registracij na podlagi člena 4(1) Direktive 2002/37 za njihovo utemeljitev zahteva dokumentacijo iz Priloge II.
They submit that it is apparent from Article 13(1) and (3) of Directive 91/414 that the holder of an authorisation for a plant protection product who is not at the same time a notifier of the active substance included in Annex I to that directive which is contained in the product must hold, or have access to, an Annex II dossier and that, for a period of five years following the inclusion of ethofumesate in Annex I to that directive, the data submitted by the notifiers concerned in the Annex II dossier cannot, without the consent of those notifiers, be used by third parties or for the benefit of third parties.
Menili sta, da iz člena 13(1) in (3) Direktive 91/414 izhaja, da mora imetnik registracije fitofarmacevtskega sredstva, ki ni hkrati tudi prijavitelj aktivne snovi, ki jo vsebuje ta izdelek in je uvr�čena v Prilogo I k tej direktivi, imeti dokumentacijo iz Priloge II oziroma dostop do nje, ter da podatkov, ki jih zadevni prijavitelji predložijo kot dokumentacijo iz Priloge II, v obdobju petih let od uvrstitve etofumesata v Prilogo I k tej direktivi ne smejo uporabiti tretje osebe oziroma se jih ne sme uporabiti za potrebe tretjih oseb brez dovoljenja navedenih prijaviteljev.
According to those undertakings, in so far as, on 1 September 2003, Agrichem did not hold, or have access to, an Annex II dossier, the existing authorisations for plant protection products containing the active substance ethofumesate marketed by Agrichem had to be withdrawn.
Ti podjetji sta menili, da bi bilo treba, če Agrichem 1. septembra 2003 ni imel dokumentacije iz Priloge II in tudi ne dostopa do take dokumentacije, obstoječe registracije za fitofarmacevtska sredstva z aktivno snovjo etofumesatom, ki jih je tržilo navedeno podjetje, preklicati.
In that respect, the national court observes, first, that paragraphs 1 and 2 of Article 4 of Directive 2002/37 provide for different levels of review of authorisations to place plant protection products on the market.
V zvezi s tem predložitveno sodi�če najprej opozarja na različni stopnji nadzora registracij za dajanje fitofarmacevtskih sredstev v promet, opredeljeni v členu 4(1) in (2) Direktive 2002/37. Drugič, opozarja, da je rok za pregled iz odstavka 1 tega člena znatno kraj�i od roka za ponovno ocenjevanje iz odstavka 2 navedenega člena.
Third, the national court states that the very wording of those provisions shows that it is only in the context of the re-evaluation of existing authorisations to place plant protection products on the market that the competent authorities must be provided with an Annex II dossier and an Annex III dossier.
Tretjič, poudarja, da iz samega besedila teh določb izhaja, da je treba dokumentacijo iz Priloge II in dokumentacijo iz Priloge III pristojnim organom predložiti le ob ponovnem ocenjevanju veljavnih registracij za dajanje fitofarmacevtskih sredstev v promet.
Finally, as regards the arguments submitted by Feinchemie and Bayer in relation to the confidentiality of information produced in the course of the procedure for inclusion of an active substance in Annex I to Directive 91/414, the national court states that it has not been shown that the CTB based the contested decision on information contained in the Annex II dossier submitted by those undertakings and queries whether the holders of an existing authorisation, issued pursuant to Article 8(2) of Directive 91/414 and reviewed under Article 4(1) of Directive 2002/37, are to be regarded as applicants for authorisation within the meaning of Article 13(3) of Directive 91/414.
Nazadnje predložitveno sodi�če v zvezi s trditvami družb Feinchemie in Bayer glede zaupnosti podatkov, ki so bili posredovani v postopku uvrstitve aktivne snovi v Prilogo I k Direktivi 91/414, opozarja, da ni bilo ugotovljeno, da je College izpodbijano odločbo oprlo na podatke iz dokumentacije iz Priloge II, ki sta jo predložili družbi, in dvomi, da je treba imetnike registracij, izdanih na podlagi člena 8(2) Direktive 91/414 in pregledanih na podlagi člena 4(1) Direktive 2002/37, obravnavati kot vlagatelje za registracijo v smislu člena 13(3) Direktive 91/414.
Consequently, the national court considers it likely that the CTB was not required, in the context of a review of an authorisation under Article 4(1) of Directive 2002/37, to check that the holder of the authorisations at issue in the main proceedings was indeed in possession of an Annex II dossier, or had access to such a dossier, or, if the holder did not fulfil those conditions, to withdraw the authorisations.
Predložitveno sodi�če zato meni, da je verjetno, da College v okviru pregleda registracij na podlagi člena 4(1) Direktive 2002/37 ni bilo treba niti preveriti, ali ima imetnik registracij v postopku v glavni stvari dokumentacijo iz Priloge II oziroma dostop do take dokumentacije, niti preklicati navedenih registracij, če navedeni imetnik pogojev ni izpolnjeval.
However, the national court maintains that the interpretation to be given to Article 4(1) of Directive 2002/37 is not so obvious as to leave no room for reasonable doubt.
Vendar pa meni, da razlaga, ki jo je treba izpeljati iz člena 4(1) Direktive 2002/37, ni tako jasna, da nikakor ne dopu�ča upravičenega dvoma.
‘Must Article 4(1) of Directive 2002/37/EC be interpreted as meaning that that provision does not require Member States to terminate the authorisation of a plant
„Ali je treba člen 4(1) Direktive 2002/37/ES razlagati tako, da od držav članic ne zahteva preklica registracije fitofarmacevtskega sredstva, ki vsebuje etofumesat, pred
2008 — CASE C-361/06 protection product containing ethofumesate before 1 September 2003 on the ground that the authorisation holder does not have, or have access to, a dossier satisfying the conditions set out in Annex II to Directive 91/414/EEC?’
1. septembrom 2003, če imetnik registracije nima ali nima dostopa do dokumentacije, ki izpolnjuje pogoje, določene v Prilogi II k Direktivi 91/414/EGS?“
The request that the oral procedure be reopened
Predlog za ponovno odprtje ustnega postopka
By letter of 7 December 2007, Feinchemie and Bayer asked the Court to order the reopening of the oral procedure pursuant to Article 61 of the Rules of Procedure, on the ground that the Advocate General’s Opinion was based on facts and arguments which were not and could not have been debated between the parties.
Družbi Feinchemie in Bayer sta z dopisom z dne 7. decembra 2007 Sodi�ču predlagali, naj na podlagi člena 61 Poslovnika odredi ponovno odprtje ustnega postopka, z obrazložitvijo, da sklepni predlogi generalne pravobranilke temeljijo na dejstvih in trditvah, o katerih se stranki nista izrekli oziroma nista mogli izreči.
First, according to points 85 to 88 of the Opinion, the competition rules are essential to the analysis of the question referred for a preliminary ruling.
Prvič naj bi bile v skladu s točkami od 85 do 88 navedenih sklepnih predlogov za preučitev vpra�anja za predhodno odločanje odločilne določbe o svobodni konkurenci.
However, the parties have never exchanged views on this point.
Vendar pa naj stranki ne bi nikdar izmenjali stali�č o tem vpra�anju.
In addition, Feinchemie submits that, by proposing that the provisions concerning data protection laid down in Directive 91/414 should not be applied to holders of existing authorisations, the Advocate General’s Opinion actually runs counter to the competition rules.
Poleg tega družba Feinchemie meni, da sklepni predlogi generalne pravobranilke, v katerih ta predlaga, naj se za imetnike obstoječih registracij ne uporabijo določbe Direktive 91/414 o varovanju podatkov, nasprotujejo prav pravilom prava konkurence.
Second, in point 95 of her Opinion, the Advocate General takes no account of the difference between data protection and the confidentiality of information in a dossier, which constitutes a new position which has also not been debated between the parties.
Drugič naj generalna pravobranilka v točki 95 sklepnih predlogov ne bi upo�tevala razlike med varstvom podatkov in zaupnostjo podatkov v dokumentaciji, kar naj bi bilo novo stali�če, o katerem se poleg tega stranki nista izrekli.
Third, and lastly, Feinchemie and Bayer submit that point 97 of the Opinion shows that the view put forward by the Advocate General is based on a manifestly incorrect interpretation of Directive 91/414.
Tretjič in nazadnje, družbi Feinchemie in Bayer zatrjujeta, da iz točke 97 navedenih sklepnih predlogov izhaja, da stali�če generalne pravobranilke temelji na očitno napačni razlagi Direktive 91/414.