natgillin/translations-raw huggingface dataset:
The Commission considers the French legislation does not comply with the obligations imposed on France by Article 28 EC, by requiring that the parallel import plant protection product and the reference product have a common origin.
Komisija meni, da s francosko ureditvijo, po kateri je zahtevano, da imata vzporedno uvoženo fitofarmacevtsko sredstvo in referenčno sredstvo skupni izvor, niso izpolnjene obveznosti iz člena 28 ES.
However, as is submitted by the French Government, the French legislation, or to be exact Decree 2001-317 of 4 April 2001, by making the issue of a marketing authorisation subject, inter alia, to a condition that there be such common origin, does no more than repeat, almost in the same words, the first condition stated by the Court in British Agrochemicals, cited above.
Vendar, kot zatrjuje francoska vlada, francoska ureditev, in sicer dekret �t.
As stated in point 10 above, Article 1 of the Decree requires a ‘common origin of the two products in the sense that they have been manufactured according to the same formulation by the same company or by an associated undertaking or under licence’, whereas paragraph 40 of that judgment states that the product for which marketing authorisation is sought must have a ‘common origin with that product [the reference product] in that it has been manufactured by the same company or by an associated undertaking or under licence according to the same formulation’.
2001-317, s tem da kot pogoj za izdajo DDP določa zlasti ta skupni izvor, le ponavlja, skoraj z enakimi besedami, prvi pogoj, ki ga je Sodi�če določilo v zgoraj navedeni sodbi British Agrochemicals Association, in sicer, kot je bilo navedeno v točki 10 teh sklepnih predlogov, člen 1 navedenega dekreta zahteva „skupni izvor obeh sredstev v smislu, da ju je po isti formuli proizvedla ista družba ali povezana podjetja ali podjetja, ki poslujejo na podlagi licence“; v točki 40 navedene sodbe pa je določeno, da mora imeti sredstvo, za katero se zahteva DDP, „skupni izvor s tem sredstvom [torej referenčnim sredstvom] v smislu, da ga je po isti formuli proizvedla ista družba ali povezano podjetje ali podjetje, ki posluje na podlagi licence“.
The Court then defined, in that judgment, the acceptable conditions of such a simplified authorisation procedure.
Sodi�če je nato v navedeni sodbi natančno opredelilo pogoje za dopustnost takega poenostavljenega postopka registracije.
In addition to the existence of a common origin in the sense that they have been manufactured by the same company or by an associated undertaking or under licence following the same formulation, the plant protection product for which parallel importation is sought and the reference product, without being in all respects identical, must, at the very least, have been manufactured following the same formulation while using the same active substance and have the same effects with due regard to differences which may exist in conditions relating to agriculture, plant protection and the environment, in particular climatic conditions, relevant to use of the product. 21
Poleg tega, da morata imeti fitofarmacevtsko sredstvo, katerega vzporedni uvoz se zahteva, in referenčno sredstvo skupni izvor v smislu, da ju je po isti formuli proizvedla ista družba ali povezano podjetje ali podjetje, ki posluje na podlagi licence, morata biti vsaj proizvedeni – pri čemer ni potrebno, da bi bili povsem enaki – po isti formuli z uporabo iste aktivne snovi in morata imeti iste učinke ob upo�tevanju razlik, ki lahko obstajajo glede pogojev kmetijstva, varstva rastlin in okolja, zlasti podnebnih razmer, ki so pomembni za uporabo sredstva 21.
19 — Case C-100/96, cited above, paragraph 31.20 — Case C-100/96, cited above, paragraph 32.21 — Ibidem, paragraph 40.
19 – Točka 31.20 – Ibidem, točka 32.21 – Ibidem, točka 40.
The Commission maintains that it is appropriate to apply to plant protection products the approach taken by the Court on medicinal products for human use.
Komisija trdi, da bi bilo treba na področju fitofarmacevtskih sredstev uporabiti re�itev, ki jo je Sodi�če sprejelo na področju zdravil za humano uporabo.
The Commission refers to Kohlpharma, cited above, where it was held that the condition of common origin is not determinative but merely useful evidence of the essential
Zato se Komisija sklicuje na zgoraj navedeno sodbo Kohlpharma, v skladu s katero pogoj skupnega izvora ni odločujoč, ampak le koristen pri dokazovanju, da sta sredstvo, za katero se zahteva
What is more, such products are designed to be used on plant products which are intended for sale and for human and animal consumption.
Poleg tega so taka sredstva namenjena uporabi za rastlinske pridelke, ti pa so namenjeni za prodajo in prehrano ljudi ali živali.
There is no doubt that plant protection products are dangerous.
Fitofarmacevtska sredstva so zagotovo nevarna 24. Da bi se o tem prepričali, je na
For the reasons set out above, it does not appear to me that the approach taken in that judgment should be extended to the area of plant protection products, 22and, consequently, it does not appear appropriate to review the usefulness of the condition of common origin clearly postulated in British Agrochemicals within the context of parallel imports of plant protection products.
Iz razlogov, navedenih v nadaljevanju, menim, da re�itve iz navedene sodbe ne smemo raz�iriti na področje fitofarmacevtskih sredstev 22, zato se mi ne zdi primerno ponovno obravnavati koristnosti pogoja skupnega izvora, ki je jasno določen v zgoraj navedeni sodbi British Agrochemicals Association v okviru vzporednih uvozov fitofarmacevtskih sredstev.
of that, one need only read the Sixth environment action programme which aims inter alia to reduce the risks associated with the use of pesticides, strengthen the monitoring
primer dovolj, da preberemo �esti okoljski akcijski program, katerega namen je zlasti zmanj�ati tveganja, ki so povezana z uporabo pesticidov, okrepiti nadzor nad njihovo uporabo in distribucijo ter spodbujati zamenjavo najnevarnej�ih aktivnih snovi z varnej-
First, the dangers of plant protection products and medicinal products are not the same.
Prvič, nevarnost fitofarmacevtskih sredstev je drugačna od nevarnosti zdravil.
While a medicinal product is prescribed by a doctor, or at least is sold by a pharmacist, and ingested solely by a single patient, a plant protection product, such as the insecticide at issue in this action, which is used, according to the French Government, on, inter alia, vegetables, fruit trees, and vines,
Medtem ko zdravilo predpi�e zdravnik ali ga vsaj proda farmacevt in ga uporablja en sam pacient, se lahko fitofarmacevtsko sredstvo, kot je insekticid, v zvezi s katerim je bila vložena tožba zaradi neizpolnitve obveznosti, ki se v skladu z navodili francoske vlade uporablja zlasti za zelenjavo, sadno drevje
23 — The objective of environmental protection is, according to academic writing, likely to grow in importance.
23 – Po mnenju teorije se mora cilj varstva okolja �e naprej razvijati.
‘In the agricultural-food industry, action in favour of environmental protection has been slow to emerge.
„V agroživilskem sektorju je dolgo trajalo preden so bili sprejeti ukrepi v korist varstva okolja zahtevali.
Given the absence of self-sufficiency when the CAP was established, the objective of performance and intensifying production by means of chemical and mechanical fertilisation was fundamental.
Ker samooskrba �ri nastanku SKP ni obstajala, je bil primarni cilj učinkovitost in intenzifikacija proizvodnje s kemikalijami in mehanizacijo gnojenja.
Environmental questions were accordingly not raised.
Okoljska vpra�anja se torej niso bila postavljala.
Those production-oriented methods very quickly revealed their harmful effects through the widespread pollution of the aquatic environment, the transformation of the countryside and even the impoverishment of the genetic heritage of fauna and flora (S. Leclerc, Politique agricole commune et environment, Apogée, Rennes 1993) … .
Ti produktivistični ukrepi so zelo hitro pokazali svoje �kodljive učinke v obliki onesnaževanja vodnih okolij, spremembe pokrajin ali celo poslab�anja favne in flore (S. Leclerc, ‚Politique agricole commune et environnement‘, dopolnjena izd., Rennes 1993) […].
In 1985, taking into account environmental data in production and marketing of agricultural food products will be presented as a “component” of the Common Agricultural Policy. … The Court of Justice had to recognise that environmental protection is a “mandatory public interest requirement” which may justify certain national restrictions on trade (the “Danish bottles” case, Case 302/86 Commission v Denmark, [1988] ECR 4607) … .
Leta 1985 je bilo upo�tevanje okoljskih podatkov v fazi proizvodnega procesa in trženja agroživilskih proizvodov ‚sestavni del‘ skupne kmetijske politike (Zelena knjiga o perspektivah SKP: COM(85)333 konč., 13. julij 1985: Bilten ES, �t. 7/8 1985, str.
The environmental objective of the agricultural-food legislation is likely to become more important.
12). […] Sodi�če je moralo priznati, da je varstvo okolja ‚nujni razlog v splo�nem interesu‘, zaradi katerega so lahko dovoljene določene nacionalne omejitve trgovine (sodba Sodi�ča Evropskih skupnosti z dne 20. septembra 1988 v zadevi Komisija proti Danski, imenovana ‚danske steklenice‘, 302/86, Recueil, str. 4607) […].
22 — To that effect, see Ouart, P. E., EU-Parallelimporte von Pflanzenschutzmitteln, Wettbewerb in Recht und Praxis, 2005, Heft 3, pp. 323-330, arguing that the Kohlpharma cannot be transposed to plant protection products, given that the legislation in the latter field is significantly different from that affecting the field of medicinal products.
24 – V deveti uvodni izjavi Direktive je navedeno, da „[…] morajo predpisi, ki urejajo registracijo, zagotoviti visoka merila varstva, ki morajo zlasti preprečiti registracijo fitofarmacevtskih sredstev, glede katerih niso bile opravljene ustrezne �tudije o tem, kak�no tveganje pomenijo za zdravje, podtalnico in okolje; pri čemer je varovanje podtalnice, okolja ter zdravja ljudi in živali pomembnej�e kot izbolj�evanje proizvodnje rastlin“.
24 — The Directive thus states in the 9th recital of its preamble ‘the provisions governing authorisation must ensure a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, ground water and the environment [have not been properly investigated]; the protection of human and animal health and of the environment should take priority over the objective of improving plant production;’
22 – V tem smislu glej Ouart, P. E., „EU-Parallelimporte von Pflanzenschutzmitteln“, Wettbewerb in Recht und Praxis, 2005, zvezek 3, str. od 323 do 330, v skladu s katerim sodne prakse iz sodbe Kohlpharma ni mogoče prenesti na fitofarmacevtska sredstva, ker obstajajo velike razlike med zakonodajo na tem področju in zakonodajo na področju zdravil.
OPINION OF MS TRSTENJAK — CASE C-201/06 of the use and distribution of pesticides and promote replacement of the more dangerous active substances by safer substances such as non-chemical substitutes, 25 or peruse the academic literature on the subject.
�imi, kot so snovi, ki niso kemične 25, ali da preberemo literaturo s tako vsebino 26.
26 Moreo- ver, there is no other method of preventing the spread of active substances into the environment which is as efficient but less restrictive.
Ne obstaja noben manj strog ukrep, s katerim bi bilo mogoče preprečiti raz�irjanje aktivnih snovi v okolje.
The requirement of a common origin for the imported product and the reference product cannot be considered to infringe the principle of proportionality.
Torej naj ne bi bilo mogoče �teti, da je zahteva skupnega izvora uvoženega in referenčnega sredstva v nasprotju z načelom sorazmernosti.
In his Opinion delivered on 2 October 1997 in British Agrochemicals, Advocate General Léger, reasoning by analogy with the statement made by the Court in Case C-440/93 Scotia Pharmaceuticals, 27was of the view that ‘the procedure which must be followed in the case of parallel imports of plant protection products cannot result in the introduction onto the market of products capable of presenting a hazard for human health’.
Generalni pravobranilec Léger je v sklepnih predlogih z dne 2. oktobra 1997 k zgoraj navedeni sodbi British Agrochemicals z utemeljevanjem po analogiji s trditvijo Sodi�ča, sprejeto v sodbi z dne 5. oktobra 1995 v zadevi Scotia Pharmaceuticals 27, ocenil, da „posledica postopka, ki ga je treba izvesti v okviru vzporednega uvoza fitofarmacevtskih sredstev, ne sme biti dajanje sredstev, ki bi lahko bila nevarna za zdravje ljudi, na trg“ 28.
28 At point 75 of his Opinion he also stated that ‘although it is necessary that the components of the imported product and of the reference product should be created by the same company, that criterion is not sufficient.’ A fortiori, that first condition, necessary but not sufficient, cannot be removed.
Generalni pravobranilec Léger je v točki 75 sklepnih predlogov tudi navedel, da „čeprav je potrebno, da sestavine uvoženega sredstva in referenčnega sredstva proizvede ista družba, to merilo ne zadostuje.“ Ta prvi pogoj, ki je potreben, a ne zadostuje, se nikakor ne sme izbrisati.
The Court has moreover already underlined ‘the paramount importance to be accorded to the protection of health’ 29and
Sodi�če je poleg tega že poudarilo, „da je treba priznati odločilen pomen varovanju zdravja“ 29, in menilo, da bi morali nujni
The Communication of the Commission on that sixth programme (COM(2001), 31 final; page 47) states that ‘one group of chemicals that requires particular attention is pesticides (i.e. plant protection products and biocides).
V sporočilu Komisije o tem �estem programu (COM(2001), 31 konč., str. 47) je navedeno: „[s]kupina kemičnih snovi zahteva posebno pozornost: pesticidi (in sicer fitofarmacevtska sredstva in biocidi).
They can affect human health via their contamination of groundwaters, soils, food and even the air.
Z onesnaženjem podtalnice, zemlje, prehrambnih izdelkov in celo zraka lahko prizadenejo zdravje ljudi.
Gaps in the current data on the issue make it difficult to be precise about the scale and trends of the problem but there is sufficient evidence to suggest it is serious and growing.
Ker trenutno glede tega ni zadostnih podatkov, je težko natančneje določiti razsežnost in gibanja v zvezi z njim, vendar je na podlagi dokazov mogoče sklepati, da je problem resen in postaja �e bolj pereč.
The contamination of groundwaters is of particular concern.
Skrb povzroča zlasti onesnaževanje podtalnice.
On average, 65% of European drinking water is supplied from groundwaters and, even after remedial action has been taken to prevent further contamination, they often take a long time to recover to acceptable quality levels.
V povprečju se 65 % evropske pitne vode zagotavlja iz nje in celo po sprejetju korektivnih ukrepov za preprečevanje nadaljnjega onesnaževanja je mnogokrat potrebnega veliko časa, da podtalnica ponovno doseže sprejemljivo raven kakovosti.
Also of concern is the contamination of our foodstuffs and evidence of continuing accumulation of certain pesticides in plants and animals with associated impacts on their health and ability to reproduce’.
Razlog za zaskrbljenost so tudi onesnaževanje živil ter dokazi o nadaljnjem kopičenju določenih pesticidov v rastlinah in živalih s poznej�im učinkom na njihovo zdravje in sposobnost reprodukcije“.
What was at issue in that case was examination of the Community legislation relating to marketing authorisation for medicinal products for human use and the determination of the extent of the discretion allowed to the relevant competent national authorities.
V tej zadevi je bila analizirana zakonodaja Skupnosti na področju DDP za zdravila za humano uporabo in določen obseg pooblastila za odločanje po prostem preudarku, ki ga imajo nacionalni organi, pristojni na tem področju.
While the Court was able to find guidance in the caselaw which it had developed in relation to medicinal products in order to set out principles governing plant protection products such as the need for a marketing authorisation for parallel imports, it does not at all follow that what may not be necessary for medicinal products, such as a common origin for the imported product and the reference product, is also not necessary for plant protection products.
Čeprav bi Sodi�če lahko iz sodne prakse, ki jo je sprejelo na področju zdravil, dobilo navdih za določitev načel na področju fitofarmacevtskih sredstev, kot je nujnost DDP v okviru vzporednega uvoza, to nikakor ne pomeni, da tisto, kar ni nujno za zdravila, tako kot skupni izvor uvoženega sredstva in referenčnega sredstva, ni nujno za fitofarmacevtska sredstva.
28 — Point 70 of that Opinion.
28 – Točka 70 navedenih sklepnih predlogov.
COMMISSION v FRANCE held that the imperative requirements of protection of public health must prevail over other considerations, in particular over the principle of free movement of goods within the European Community.
KOMISIJA PROTI FRANCIJI razlogi varovanja javnega zdravja imeti prednost pred drugimi preudarki, zlasti pred načelom prostega pretoka blaga v Evropski skupnosti 30. Sodi�če je navedlo tudi to, da „v večini primerov �kode za okolje in zdravje zaradi njene narave ni mogoče odpraviti retroaktivno“ 31.
30The Court has also stated that ‘more often than not, damage to the environment or to health cannot, by reason of its nature, be eliminated retroactively.’ 31 that judgment that ‘the effects of withdrawal of the relevant marketing authorisation are in the circumstances of this case the same for parallel importers as those which have been identified in the caselaw relating to parallel imports of medicinal products (Ferring, cited above, paragraph 25).
„posledice razveljavitve DDP za referenčno sredstvo v obravnavani zadevi enake za vzporedne uvoznike in uvoznike, navedene v sodni praksi v zvezi z vzporednimi uvozi zdravil (zgoraj navedena sodba Ferring, točka 25).
In both cases, the parallel importers lose the capacity to market the products in question’.
V obeh primerih je bil vzporednim uvoznikom onemogočen promet z zadevnim sredstvom“ 32.
32Para-graph 24 of the same judgment, which states that the issues raised by such marketing are comparable, intended to point out that the marketing of plant protection products merits no less attention that that given to medicinal products.
V točki 24 iste sodbe, v kateri je poudarjena primerljivost interesov zaradi tega prometa, je Sodi�če želelo pripomniti, da promet s fitofarmacevtskimi sredstvi zasluži pozornost, ki ni manj�a od pozornosti, ki se zahteva pri zdravilih.
The Court did not at all intend in that judgment to rule out that in some circumstances the marketing of plant protection products may require even greater attention than that of medicinal products.
Sodi�če v tej sodbi nikakor ni želelo potrditi, da se pri prometu s fitofarmacevtskimi sredstvi morebiti ne more zahtevati večja pozornosti, kot je nujna na področju zdravil.
That was simply not the issue in that case.
To sploh ni bilo vpra�anje v tej zadevi.
The judgment in Commission v Germany, delivered without hearing an opinion and not published in the European Court Reports, was in no way intended to alter the condition of common origin as defined and laid down in British Agrochemicals.
Namen zgoraj navedene sodbe Komisija proti Nemčiji, v kateri je bilo odločeno brez sklepnih predlogov in ki ni bila objavljena v Zbirki odločb, nikakor ni bil ponovno obravnavanje pogoja skupnega izvora, ki je bil opredeljen in predpisan z zgoraj navedeno sodbo British Agrochemicals Association.
The Commission claims that the approach adopted in Kohlpharma, cited above, in relation to medicinal products, can be transposed to the area of plant protection products, in accordance with Commission v Germany, cited above, which states that the marketing of those two types of products ‘raises comparable issues’ (paragraph 24) and that ‘the question of law at issue is the same’ (paragraph 27) in both cases.
Komisija navaja, da bi bilo mogoče re�itev iz zgoraj navedene sodbe Kohlpharma na področju zdravil prenesti na področje fitofarmacevtskih sredstev na podlagi zgoraj navedene sodbe Komisija proti Nemčiji, pri čemer je v zadnji navedeno, da so v prometu s tema vrstama sredstev „vpleteni primerljivi interesi“ (točka 24) in da je v teh dveh primerih „zadevno pravno vpra�anje enako“ (točka 27).
Yet, in doing so, the Commission quite fails to state what the ‘question of law at issue’ was.
Vendar pa s tem Komisija ravno opusti opredelitev katero je „zadevno pravno vpra�anje“.
In that case, the Commission asked the Court to find that, by not having allowed to parallel importers a reasonable period in which to dispose of their stocks when a marketing authorisation for a relevant plant protection product was withdrawn, the Federal Republic of Germany had failed to fulfil its obligations under Article 28 EC.
V zadevi, v kateri je bila izrečena sodba Kohlpharma, je Komisija Sodi�ču predlagala, naj ugotovi, da Zvezna republika Nemčija, s tem da vzporednim uvoznikom ni odobrila razumnega roka za odprodajo njihovih zalog ob preklicu DDP za referenčno fitofarmacevtsko sredstvo, ni izpolnila obveznosti iz člena 28 ES.
The Court merely stated in
Sodi�če je tako v tej sodbi navedlo le, da so
Secondly, the French Government correctly states that removal of the condition of common origin, far from making the issuing of a marketing authorisation easier, would only serves to make the parallel imports procedure more cumbersome and be a hindrance to trade that is much more significant that that to which the Commission objects.
Drugič, francoska vlada utemeljeno navaja, da črtanje pogoja skupnega izvora nikakor ne bi olaj�alo izdaje DDP, ampak le otežilo postopek vzporednega uvoza in bi pomenilo veliko večjo oviro prometa, kot jo očita Komisija.
Indeed, the same active substance may have been authorised
Ista aktivna snov bi lahko bila dejansko registrirana z različnimi specifikacijami glede na državo članico, ker bi v obdobju presoje aktivnih snovi z namenom, da bi jih
30 — The Court held that, even if there was no absolute certainty that BSE was transmissible to humans, there was a serious risk, and refused to grant the application of the United Kingdom.
30 – Ker je Sodi�če ugotovilo, da je obstajalo resno tveganje, čeprav ni povsem gotovo, ali se goveja spongiformna encefalopatija prena�a na ljudi, predlogu Združenega kraljestva za izdajo začasne odredbe ni ugodilo.
32 — Commission v Germany, cited above, paragraph 26.
32 – Zgoraj navedena sodba Komisija proti Nemčiji (točka 26).
35In fact, if that easily checked requirement was removed, the applicant for marketing authorisation for a parallel import product would have to prove that the product for which importation was sought is identical to the already authorised reference product.
Če bi bila ta zahteva, ki jo je mogoče preprosto preveriti, izbrisana, bi moral vlagatelj za DDP za vzporedno uvoženo sredstvo dokazati enakost sredstva, uvoz katerega zahteva, in sredstva, za katero je bila registracija že odobrena.
Since the file containing all the information relating to the reference product is confidential, evidence of that would, as a matter of logic, be difficult to obtain, unless the holder of the first marketing authorisation agrees to share such information.
Torej, ta dokaz bi bilo logično težko predložiti, ker bi bil spis z vsemi podatki v zvezi z referenčnim sredstvom zaupen, razen če bi bil vlagatelj za prvo DDP pripravljen te podatke deliti.
with specifications which differ from State to State, given that during the period in which the active substances are subject to the programme of assessment for the purposes of obtaining Commission approval, each Member State continues to authorise plant protection products in conformity with its national rules.
Komisija priznala, vsaka država članica �e naprej registrirala fitofarmacevtska sredstva v skladu s svojimi nacionalnimi določbami.