natgillin/translations-raw huggingface dataset:
The main issue in the present case turns on the proper interpretation of Article 4 of Directive 2002/37 and Article 13 of Directive 91/414, and how the provisions of those two directives interact.
Temeljno vpra�anje v obravnavanem primeru je pravilna razlaga člena 4 Direktive 2002/37 in člena 13 Direktive 91/414 ter kako določbi teh direktiv medsebojno učinkujeta.
Agrichem agrees that the principal aim of Directive 91/414 is related to regulating the plant protection products available on the market, but disputes that that should produce an effect by which the holder of an existing authorisation should have that authorisation withdrawn.
Agrichem se strinja, da je temeljni cilj Direktive 91/414 povezan z ureditvijo fitofarmacevtskih sredstev, ki so na voljo na trgu, vendar ugovarja, da naj bi povzročil, da bi bilo treba imetniku registracije slednjo preklicati.
In my view it is clear from the recitals in the preamble to Directive 91/414 18that the primary purpose of that directive is to ensure
Po mojem mnenju iz uvodnih izjav v preambuli Direktive 91/414 18jasno izhaja, da je prednostni namen navedene direktive
The starting point must be to look at the purpose of the legislation at issue.
Tožeči stranki in Nizozemska navajajo, da je namen predpisov varstvo intelektualne
18 — Set out in point 5 above.
18 – Pojasnjene v točki 5 zgoraj.
FEINCHEMIE SCHWEBDA AND BAYER CROPSCIENCE
FEINCHEMIE SCHWEBDA IN BAYER CROPSCIENCE stracije, in časovno obdobje, v katerem mora imetnik te podatke imeti.
Article 4 of Directive 2002/37 that the placement of plant protection products on the market is regulated, rather than to ensure the protection of intellectual property rights.
zagotoviti pravno ureditev dajanja fitofarmacevtskih sredstev v promet, in ne zagotoviti varstvo pravic intelektualne lastnine.
That principal purpose should be borne in mind when addressing the specific provisions of Directives 91/414 and 2002/37.
Pri sklicevanju na posebne določbe direktiv 91/414 in 2002/37 je treba upo�tevati ta prednostni namen.
Article 4 of Directive 2002/37 concerns the information required of the holder of an existing authorisation and the time when the holder must have that information.
V predložitvenem sklepu je predloži -tveno sodi�če menilo, da iz besedila člena 4(1) Direktive 2002/37 ne izhaja, da mora država članica preklicati registracijo zadevnega fitofarmacevtskega sredstva.
The CTB stated that authorisations for plant protection products containing ethofumesate as an active substance must in any event satisfy the conditions laid down by Directive 2002/37.
CTB je ugotovil, da morajo registracije za fitofarmacevtska sredstva, ki vsebujejo etofumesat kot aktivno snov, v vsakem primeru izpolnjevati pogoje, določene z Direktivo 2002/37. Niti Direktiva 2002/37 niti Direktiva 91/414 ne določata pogoja, da je med preverjanjem skladnosti treba izkazati, da je obstoječa registracija podprta z dokumentacijo iz Priloge II.
The CTB concluded that it did not have the competence to request such a dossier.
CTB je ugotovil, da ni bil pristojen zahtevati navedene dokumentacije.
In the order for reference, the referring court took the view that it did not appear from the wording of Article 4(1) of Directive 2002/37 that a Member State is required to terminate the authorisation of the plant protection product in question.
Člen 4 Direktive 2002/37
The referring court appears to be in agreement with the contested decision.
Zdi se, da se predložitveno sodi�če z izpodbijano odločbo strinja.
That court stated that the scheme of a review of authorisations (to be completed by 1 September 2003) laid down by Article 4(1) of Directive 2002/37 is intended to ensure that the conditions relating to ethofumesate set out in Annex I are complied with.
Navedeno sodi�če je ugotovilo, da je namen sheme pregleda registracij (ki morajo biti dopolnjene do 1. septembra 2003), določene s členom 4(1) Direktive 2002/37, zagotoviti, da so izpolnjeni pogoji v zvezi z etofumesatom iz Priloge I.
In contrast, the scheme of re-evaluations of existing authorisations (to be completed by 28 February 2007) laid down by Article 4(2) of that directive is intended to determine whether each plant protection product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414.
Nasprotno je namen sheme ponovnega ocenjevanja obstoječih registracij (ki morajo biti dopolnjene do 28. februarja 2007), določene s členom 4(2) navedene direktive, ugotoviti, ali vsa fitofarmacevtska sredstva izpolnjujejo pogoje iz člena 4(1)(b), (c), (d) in (e) Direktive 91/414.
The basis for that evaluation is an Annex III dossier.
Podlaga za to oceno je dokumentacija iz Priloge III.
State concerned must withdraw authorisations unless a full dossier is provided by 1 September 2003.
Posledično je učinek člena 4(1) v tem, da mora zadevna država članica preklicati registracije, če do 1. septembra 2003 ni predložena popolna dokumentacija.
The referring court also stated that it was not apparent from the wording of Article 4(1) of Directive 2002/37 that Member States are required to terminate the authorisation if the authorisation holder is unable to provide, before 1 September 2003, an Annex II dossier, as Article 4(1) does not require an Annex II dossier to be submitted by the authorisation holder for the review.
Predložitveno sodi�če je tudi navedlo, da iz besedila člena 4(1) Direktive 2002/37 ni razvidno, da morajo države članice preklicati registracijo, če imetnik registracije pred 1. septembrom 2003 ne more predložiti dokumentacije iz Priloge II, ker člen 4(1) ne zahteva, da imetnik registracije predloži dokumentacijo iz Priloge II za pregled.
Furthermore, that court assumes that the review can be carried out on the basis of data already known to the authority which previously granted the authorisation.
Ob tem navedeno sodi�če meni, da se lahko pregled opravi na podlagi podatkov, ki so že znani organu, ki je predhodno izdal registracijo.
The Commission’s first contention appears to be correct from the plain wording of Article 4 of Directive 2002/37.
Komisijina prva trditev se zdi pravilna glede na besedilo člena 4 Direktive 2002/37.
However, it does not follow that a party that holds an existing authorisation should not be permitted to retain it.
Vendar iz tega člena ne izhaja, da imetnik obstoječe registracije ne bi smel ohraniti.
Agrichem is also in agreement with the contested decision.
Tudi Agrichem se strinja z izpodbijano odločbo. Trdi, da je etofumesat snov, ki je že bila odobrena (na podlagi dokumentacije iz Priloge II).
That implies that there is no reason based on health concerns to withdraw an existing authorisation.
To pomeni, da ni nobenega razloga, povezanega z zdravjem, za preklic obstoječe registracije.
It also argues that the staggered time-periods for review of existing authorisations under Article 4(1) of Directive 2002/37, and for the more substantial re-evaluation under Article 4(2) thereof, imply that a dossier is required for the latter but not the former.
Poleg tega navaja, da postopna časovna obdobja za pregled obstoječih registracij na podlagi člena 4(1) Direktive 2002/37 in za ponovno bolj vsebinsko ocenjevanje na podlagi njenega člena 4(2) nakazujejo, da se dokumentacija zahteva za obstoječe registracije in ne za prvi pregled.
Requiring a dossier for a review under Article 4(1) would lead to there being little difference between the two types of evaluation.
Zahteva po dokumentaciji na podlagi člena 4(1) bi privedla do manj�e razlike med tema vrstama ocene.
In contrast, the Commission submits that Directive 2002/37 was enacted on the basis that Member States cannot authorise a body to place an ethofumesate product on the market unless that body possesses an appropriate dossier.
Nasprotno Komisija trdi, da je bila Direktiva 2002/37 izdana na podlagi domneve, da lahko države članice dovolijo subjektu,
Alternative meanings for Article 4 have been suggested by the Netherlands and by the Commission.
Nizozemska in Komisija sta predlagali alternativne razlage člena 4.
The Netherlands suggests that although it is not apparent from the text of Article 4(1) that a dossier is needed, the requirement for a dossier is not in conflict with the wording of that article.
Nizozemska predlaga, da čeprav iz besedila člena 4(1) ni razvidno, da je potrebna dokumentacija, zahteva po dokumentaciji ni v nasprotju s besedilom tega člena.
The Commission has offered two possible interpretations of Articles 4(1) and 4(2).
Komisija je ponudila dve mogoči razlagi člena 4(1) in (2).
First, the Commission suggests that the first deadline (in Article 4(1)) requires the presentation of an Annex II dossier, whereas the second deadline (in Article 4(2)) requires the re-evaluation of an Annex III dossier (on the rationale that as multiple products will be
Prvič, Komisija predlaga, da prvi rok (v členu 4(1)) terja predložitev dokumentacije iz Priloge II, medtem ko drugi rok (v členu 4(2)) zahteva ponovno ocenjevanje dokumentacije iz Priloge III (na podlagi načela, da več ko bo
on the market, with multiple substances in them, checking each one will take longer).
večdelnih sredstev iz več snovi na trgu, dalj�e bo preverjanje vsakega od njih).
Alternatively, the Commission argues that Article 4(1) is superfluous and merely clarifies the general requirement to submit a dossier at the end of the first period.
Podredno Komisija meni, da člen 4(1) ni potreben in pojasnjuje le splo�no zahtevo za predložitev dokumentacije do izteka prvega obdobja.
In my view, the interpretations offered by the Netherlands and the Commission would involve interpreting Article 4 in a manner contrary to its plain wording, and in the case of the Commission’s first argument, contrary to the plain wording of recital 8 of Directive 2002/37.
Po mojem mnenju bi razlagi, ki jih predlagata Nizozemska in Komisija, vključevali razlago člena 4, ki bi bila v nasprotju z besedilom in v primeru Komisijine prve trditve v nasprotju z besedilom uvodne izjave 8 Direktive 2002/37.
It is accepted by all parties that Article 6 of Directive 91/414 provides a framework which envisages the enactment of a series of directives, inter alia, Directive 2002/37.
Vse stranke se strinjajo, da člen 6 Direktive 91/414 tvori okvir za izdajo �tevilnih direktiv, med njimi Direktive 2002/37.
However, the question of the relationship between the two directives is a matter of some dispute.
Vendar je vpra�anje razmerja med direktivama precej sporno.
Taking the most straightforward interpretation of that provision, the review procedure for existing authorisations set out under Article 4(1) demands only basic information (as found in Annex I), and not a full Annex II or III dossier.
Če sprejmemo najbolj preprosto razlago te določbe, postopek pregleda za obstoječe registracije, določen v členu 4(1), zahteva le osnovne podatke (kot so navedeni v Prilogi I), in ne celotne dokumentacijo iz Priloge II ali iz Priloge III.
It merely involves checking that ‘the conditions relating to ethofumesate … are complied with’.
Vključuje le preverjanje „izpolnjevanja pogojev v zvezi z etofumesatom“.
It does not require a full re-evaluation of the plant protection product as such (that task is laid down by Article 4(2)).
Ne zahteva popolnega ponovnega ocenjevanja fitofarmacevtskega sredstva kot takega (ta naloga je urejena s členom 4(2)).
Therefore, Article 4(1) does not logically require withdrawal of an existing authorisation on the grounds that a company holding that authorisation does not have access to an Annex II (or III) dossier.
Zato člen 4(1) logično ne nalaga preklica obstoječe registracije iz razlogov, ker podjetje, ki je imetnik te registracije, nima dostopa do dokumentacije iz Priloge II (ali iz Priloge III).
On that basis, the question referred to this Court may be answered in the affirmative.
Na tej podlagi se lahko pritrdilno odgovori na vpra�anje, predloženo temu sodi�ču.
The starting point of those parties who propose that the question referred be answered in the negative is that Directive 2002/37 should be interpreted in the light of Directive 91/414, rather than constituting lex specialis.
Stranke, ki predlagajo odklonilni odgovor na vpra�anje za predhodno odločanje, izhajajo iz domneve, da bi bilo treba Direktivo 2002/37 razlagati v luči Direktive 91/414 in da ne pomeni lex specialis.
That is because Directive 2002/37 is a Commission Directive, envisaged in Article 6 of Directive 91/414, which amends that directive only to the extent of including a further substance in Annex I. The applicants contend that Directive 2002/37 should therefore be interpreted in the light of Directive 91/414.
Razlog za to je, da je Direktiva 2002/37 direktiva Komisije, predvidena v členu 6 Direktive 91/414, ki to direktivo spreminja le v tem, da v Prilogo I vključuje novo snov. Tožeči stranki zatrjujeta, da bi bilo treba zato Direktivo 2002/37 razlagati v luči Direktive 91/414.
Agrichem accepts that argument but argues that when the plain meaning of the words in Directive 2002/37 is considered, Directive 91/414 does not have to modify the meaning of Directive 2002/37, as the two are complementary.
Agrichem priznava to navedbo, vendar trdi, da glede na nedvoumno besedilo Direktive 2003/37 Direktiva 91/414 ne more spremeniti pomena Direktive 2002/37, ker se ti direktivi dopolnjujeta.
Agrichem submits that Directive 91/414 would modify the meaning of Directive 2002/37 only in the event of a conflict, which is not the case.
Agrichem potrjuje, da bi Direktiva 91/414 spremenila pomen Direktive 2002/37 le v primeru navzkrižja določb, v tem primeru pa temu ni tako.
The Commission submits that the transitional regime in Article 8, under which a Member State may apply its own national provisions, will come to an end when the substance which is the subject of those provisions is entered in Annex I. The Commission contends that once an active substance is listed in Annex I, then all parties must have an Annex II or III dossier in accordance with Community legislation.
Agrichem podredno zatrjuje, da čeprav je bila izdaje Direktive 2002/37 predvidena z Direktivo 91/414, Direktiva 2002/37 pomeni lex specialis, ker prehodne določbe ureja podrobneje kot člen 8 Direktive 91/414.
However, the argument is circular, because it takes one straight back to the question of whether Article 4(1) of Directive 2002/37 does or does not require a body holding an existing authorisation for a plant protection product to be in possession of Annex II dossier.
Vendar gre za krožno trditev, ker se vrača na vpra�anje, ali člen 4(1) Direktive 2002/37 zahteva ali ne, da subjekt, ki je imetnik obsto­ječe registracije fitofarmacevtskega sredstva, poseduje dokumentacijo iz Priloge II.
Article 8 expressly creates a structure for dealing with the transitional period, during which it may be decided to include in Annex I an active substance contained in a plant protection product subject to an existing authorisation.
Člen 8 izrecno ustvarja strukturo za ureditev prehodnega obdobja, v katerem je mogoče odločiti o uvrstitvi v Prilogo I aktivne snovi, ki jo vsebuje fitofarmacevtsko sredstvo, ki je predmet obstoječe registracije.
The applicants, the Netherlands and the Commission submit that, in contrast to later amending directives, Directive 2002/37 is something of an anomaly, in that it provides for a longer period before the delivery of an Annex II dossier than that envisaged by Article 8 of Directive 91/414.
Tožeči stranki, Nizozemska in Komisija potrjujejo, da je Direktiva 2002/37, v nasprotju s poznej�imi direktivami o spremembah, poseben primer, ker predvideva dalj�e obdobje pred predložitvijo dokumentacije iz Priloge II v primerjavi z obdobjem iz člena 8 Direktive 91/414.
These parties have referred to Directive 2005/53 as an example of a more typical amending directive.
Te stranke so Direktivo 2005/53 navedle kot primer bolj tipične direktive o spremembah.
FEINCHEMIE SCHWEBDA AND BAYER CROPSCIENCE would be precisely the effect of the Commission’s reading.
FEINCHEMIE SCHWEBDA IN BAYER CROPSCIENCE precej izrecno določa, da Direktiva 2005/53 ne vpliva na obveznosti, ki so nastale na podlagi prej�njih direktiv o spremembah.
I also recall that Directive 2005/53 does not concern ethofumesate; and that it had not entered into force at the material time.
Prav to naj bi bila posledica Komisijine razlage. Opozarjam tudi, da Direktiva 2005/53 ne zadeva etofumesata in da v upo�tevnem času �e ni začela veljati.
These parties cite Article 3 of that directive, which states that for the active substances added by that directive, Member States must verify that the authorisation holder has access to an Annex II dossier.
Navedene stranke citirajo člen 3 navedene direktive, ki določa, da morajo države članice za aktivne snovi, dodane s to direktivo, preveriti, ali ima imetnik registracije dostop do dokumentacije iz Priloge II.
They point out that the 10th recital to Directive 2005/53 clearly states that Article 13 of Directive 91/414 is intended to apply to holders of existing authorisations, and that all authorisation holders should have access to an Annex II dossier.
Opozarjajo, da je iz desete uvodne izjave Direktive 2005/53 jasno razvidno, da je namen člena 13 Direktive 91/414, da se uporablja za imetnike obstoječih registracij in da imajo vsi imetniki registracij dostop do dokumentacije iz Priloge II.
I therefore agree with Agrichem that the interpretation found in the preamble to Directive 2005/53 should not be retrospectively applied to Directive 2002/37.
Zato se strinjam z Agrichemom, da se razlage, ki se sklepa iz preambule Direktive 2005/53, ne bi smelo retroaktivno uporabljati za Direktivo 2002/37.
The Commission therefore argues that Directive 2002/37 should have the same requirements read into it, on the basis that Directive 2005/53 simply rendered explicit an intention that was implicit in the earlier directives regarding the interaction between Directive 91/414 and the amending directives.
Komisija zato trdi, da bi morala Direktiva 2002/37 vsebovati enake zahteve, ker je Direktiva 2005/53 izrecno zapisala namen, ki je bil impliciten v prej�njih direktivah, glede medsebojnega vpliva med Direktivo 91/414 in direktivami o spremembah.
Article 13 of Directive 91/414
Člen 13 Direktive 91/414
Agrichem submits that the interpretation proposed by the Commission would apply a prospective interpretation (found in the recitals) to a previous directive.
Agrichem trdi, da bi se pri razlagi, ki jo predlaga Komisija, uporabila predvidena razlaga (iz uvodnih izjav) za prej�njo direktivo.
Agrichem submits that as well as being contrary to the principle of legal certainty, such an interpretation is explicitly ruled out by the recitals themselves.
Agrichem meni, da ta razlaga ni le v nasprotju z načelom pravne varnosti, temveč je izrecno izključena z uvodnimi izjavami.
The relationship between Article 4(1) of Directive 2002/37 and the provisions of Directive 91/414 is defined by the second sentence of Article 4(1), which states that amendment or withdrawal of authorisations should be done in accordance with the provisions of Directive 91/414.
Razmerje med členom 4(1) Direktive 2002/37 in določbami Direktive 91/414 je opredeljeno z drugim stavkom člena 4(1), ki določa, da je treba registracije spremeniti ali preklicati v skladu z določbami Direk -tive 91/414.
I do not accept the Commission’s argument.
Komisijina trditev se mi zdi nesprejemljiva.
The only provision of Directive 91/414 which might lead to withdrawal of an author-
Edina določba Direktive 91/414, ki bi lahko vodila do preklica registracije, je
OPINION OF MS SHARPSTON — CASE C-361/06 of Article 13 does not extend to holders of existing authorisations.
2002/37 ne temelji na zahtevku. Zato se področje uporabe člena 13 ne raz�irja na imetnike obstoječih registracij.
isation is Article 13.
člen 13.
That article concerns the use of the information constituting an Annex II dossier which was submitted in order to add an active substance to the list of permitted substances found in Annex I to Directive 91/414.
Ta člen zadeva uporabo podatkov iz dokumentacije iz Priloge II, ki je bila predložena z namenom, da se aktivna snov doda na seznam dovoljenih snovi iz Priloge I k Direktivi 91/414.
I therefore turn to examine that provision.
Zato bom preučila to določbo.
Article 13 was interpreted as applying to those bodies making applications for authorisation, rather than holders of existing authorisations.
Agrichem tudi opozarja, da je bila v sodbi Stichting Zuid­Hollandse Milieufede­ratie 19sprejeta razlaga člena 13 tako, da se uporablja za tiste subjekte, ki vložijo zahtevek za registracijo, in ne za imetnike obstoječih registracij.
As existing authorisations for plant protection products containing ethofumesate have to be confirmed by re-examination under Article 4(1) of Directive 2002/37, the validity of such authorisations should remain unaffected by, and should not fall into, the sphere of operation of Article 13.
Ker je obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo etofumesat, treba potrditi s ponovnim preskusom na podlagi člena 4(1) Direktive 2002/37, področje delovanja člena 13 ne bi smelo vplivati na veljavnost take registracije, za katero se ta člen ne uporablja.
The essential question to be answered is whether companies in Agrichem’s position fall within the scope of Article 13.
Bistveno vpra�anje, na katero je treba odgovoriti, je, ali se za podjetja, ki so v enakem položaju kot Agrichem, uporablja člen 13.
Agrichem argues that as a holder of existing authorisations, rather than a company which wishes to bring new plant protection products on to the market, it does not fall within the scope of Article 13.
Agrichem trdi, da kot imetnik obstoječih registracij, in ne kot podjetje, ki želi dati na trg nova fitofarmacevtska sredstva, ne sodi na področje uporabe člena 13.
The provisions of that article are therefore irrelevant to it.
Zanj torej določbe tega člena niso upo�tevne.
The applicants suggest that the definition of the term ‘applicant’ should apply to all bodies other than the notifying applicants.
Tožeči stranki predlagata, da bi se definicija pojma „vlagatelj“ uporabljala za vse subjekte, razen prijavitelje kot vlagatelje.
They argue that as the directives aim to protect the investments of companies which have researched and developed certain active substances, Articles 4 and 13 together operate to create a framework for authorisations in which the requirements which have to be met are set out in Article 13 if authorisation is to be sought or retained.
Ker je namen direktiv za�čititi naložbe podjetij, ki so raziskovala in razvila nekatere aktivne snovi, po njunem mnenju člena 4 in 13 skupaj vplivata na vzpostavitev okvira za registracije, v katerem so zahteve, ki morajo biti izpolnjene, določene v členu 13, če je treba za registracijo zaprositi ali jo ohraniti.
Agrichem points out that the wording of Article 13 refers to ‘applicant’.
Agrichem poudarja, da se besedilo člena 13 nana�a na „vlagatelja“.
A review under Article 4(1) of Directive 2002/37 is not based on an application.
Ponovni pregled na podlagi člena 4(1) Direktive
However, that contention relies upon implying an extra concept (namely, retained) into Article 13.
Poleg tega se zdi, da člen 13(7) razlikuje med vlagatelji in imetniki obstoječih registracij.
The Commission has also argued that the scope of Article 13 extends to holders of existing authorisations and that such holders should be treated differently from new applicants only during the transitional period, which is brought to an end by Article 13(6) when the product concerned is added to Annex I. Once a substance is entered into Annex I, Article 13(1) must be applied.
Komisija je v nadaljevanju zatrjevala, da se področje uporabe člena 13 razteza na imetnike obstoječih registracij in da bi bilo treba te imetnike obravnavati drugače kot nove vlagatelje le v prehodnem obdobju, ki se po členu 13(6) konča, ko se zadevno sredstvo uvrsti v Prilogo I. Člen 13(1) je treba uporabiti, ko je snov uvr�čena v Prilogo I.
The referring court suggests that the applicants’ interpretation of the scope of Article 13(1) may give the notifying party an unjustified competitive advantage.
Predložitveno sodi�če predlaga, da bi razlaga področja uporabe člena 13(1), ki jo podajata tožeči stranki, lahko dala prijavitelju neutemeljeno konkurenčno prednost.