natgillin/translations-raw huggingface dataset:
The French Republic denies the alleged failure to fulfil obligations and states that it adopted Decree No 2001-317 in order to comply with the judgment in British Agrochemicals Association, in which the Court accepted, among the criteria for the issue of a simplified marketing authorisation in respect of parallel imports, that of the common origin of the products in question.
Francoska republika izpodbija zatrjevano neizpolnitev obveznosti in navaja, da je sprejela dekret �t. 2001-317, da bi se uskladila z zgoraj navedeno sodbo British Agrochemicals Association, v kateri naj bi Sodi�če med merili za poenostavljen postopek izdaje DDP za vzporedne uvoze priznalo merilo skupnega porekla zadevnega sredstva.
That criterion seeks to ensure that the active substances contained in those products are identical.
To merilo naj bi zagotavljalo, da so aktivne snovi, ki so vsebovane v navedenih sredstvih, enake.
Variations in the composition of a product may give rise to changes in its physical or chemical properties.
Odstopanja v sestavini sredstva bi torej lahko povzročila spremembo njegovih fizikalnih ali kemičnih lastnosti.
The French Republic states in that regard that, under Directive 91/414, the same active substance may be authorised according to specifications which differ from one Member State to the other.
Francoska republika v zvezi s tem poudarja, da bi lahko bila v okviru Direktive 91/414 ista aktivna snov registrirana z različnimi specifikacijami glede na državo članico.
During the transitional period in the course of which existing active substances are subject to an assessment programme with a view to their inclusion in Annex I to that directive, each Member State continues to authorise plant protection products in accordance with the relevant national provisions and Article 8(2) of the directive.
V obdobju presoje aktivnih snovi z namenom, da bi bile vključene v Prilogo I k tej direktivi, naj bi namreč vsaka država članica �e naprej registrirala fitofarmacevtska sredstva v skladu s svojimi nacionalnimi določbami in členom 8(2) te direktive.
If the reference product and the imported product have the same manufacturing origin, the French Republic is of the opinion that it is not necessary to assess the imported product.
Francoska republika meni, da če bi referenčno in uvoženo sredstvo imeli skupno poreklo proizvodnje, presoja uvoženega sredstva ne bi bila potrebna.
In the absence of a common origin of those products, such an assessment is necessary and must also apply to the active substance or substances which have not yet been entered in Annex I to Directive 91/414.
Kadar sredstvi ne bi imeli skupnega porekla, bi bilo treba tako presojo izvesti in prav tako presojo aktivne oziroma aktivnih snovi, ki �e niso vpisane v Prilogo I k Direktivi 91/414.
The abolition of the condition relating to common origin would effectively make the simplified procedure in respect of parallel imports more cumbersome by systematically imposing an assessment of the active substances contained in the imported product.
Opustitev pogoja v zvezi s skupnim poreklom bi otežilo poenostavljeni postopek vzporednega uvoza, saj bi bila sistematično uvedena presoja aktivnih snovi, ki jih vsebuje uvoženo sredstvo.
Such a measure would constitute a much greater barrier to trade than that alleged, in the present case, by the Commission.
Tak ukrep naj bi pomenil veliko večjo oviro prometa, kot jo v obravnavani zadevi navaja Komisija.
Far from being simplified, such a procedure would be close to that set out in Article 10 of Directive 91/414 in respect of the mutual recognition of marketing authorisations.
Tak postopek, ki nikakor ne bi bil poenostavljen, bi bil podoben postopku iz člena 10 Direktive 91/414 za vzajemno priznavanje registracij.
As regards the facts of the complaint mentioned in the reasoned opinion of 5 July 2005, the French Republic states that the parallel import authorisation in respect of Deltamex was withdrawn because the importer had not proved that its product was manufactured according to the same formulation as the French reference product Decis and not on account of the absence of a common origin in respect of those products.
Francoska republika v zvezi z dejstvi, zaradi katerih je bila vložena ta tožba, navedena v obrazloženem mnenju z dne 5. julija 2005, navaja, da je bilo dovoljenje za vzporedni uvoz Deltamexa preklicano, ker uvoznik ni dokazal, da je bilo njegovo sredstvo proizvedeno po isti formuli kot francosko referenčno sredstvo Decis, in ne ker sredstvi nimata skupnega porekla.
The importer first applied in Austria for an authorisation to import a plant protection product authorised in Germany under the name of Inter Delta M, by relying on the marketing authorisation for a reference product also called Decis.
Uvoznik naj bi namreč zahtevek za pridobitev dovoljenja za uvoz fitofarmacevtskega sredstva, ki je v Nemčiji registrirano pod imenom Inter Delta M, najprej vložil v Avstriji, pri čemer se je opiral na registracijo referenčnega sredstva, prav tako imenovanega Decis.
That product was then authorised under the name of Mac Deltamethrin 2.5 EC.
To sredstvo naj bi bilo torej registrirano pod imenom Mac Deltamethrin 2,5 EC.
A number of differences of presentation, between the imported product and the reference product, gave rise to doubts as regards whether the formulation of those two products was identical.
Zaradi več razlik pri predstavitvi uvoženega sredstva in referenčnega sredstva naj bi nastal dvom o enakosti formule teh sredstev, uvoznik pa ni podal dokazov, ki bi ta dvom odpravili.
The Kingdom of the Netherlands, which was granted leave by order of the President of the Court of 9 October 2006 to intervene in support of the form of order sought by the French Republic, takes the view that the condition as to the common origin of the products is necessary and justified as the absence of that condition would contribute towards lowering the level of protection provided for by Directive 91/414, would fail to have regard for the data protection rights of the holders of the marketing authorisation in respect of the reference product and would jeopardise the procedure for the mutual recognition of marketing authorisations established by Article 10 of that directive.
Kraljevina Nizozemska, katere intervencija v podporo ugotovitev Francoske republike je bila dovoljena s sklepom predsednika Sodi�ča z dne 9. oktobra 2006, meni, da je pogoj v zvezi s skupnim poreklom sredstev nujen in utemeljen, ker bi njegov neobstoj prispeval k znižanju stopnje varstva, določenega v Direktivi 91/414, kr�itvi pravic varstva podatkov imetnikov DDP za referenčno sredstvo in ogrožanju postopka vzajemnega priznavanja DDP, določenega s členom 10 te direktive.
By requiring that the imported product be identical to the reference product, the French legislation meets the objectives of Directive 91/414 while ensuring that the authorisation procedure for parallel importation is transparent.
Francoska zakonodaja naj bi z zahtevo, da je uvoženo sredstvo enako referenčnemu sredstvu, le izpolnjevala cilje Direktive 91/414 in hkrati zagotavljala preglednost postopka registracije za vzporedni uvoz.
The criterion regarding the common origin of the products is necessary and proportionate.
Merilo v zvezi s skupnim poreklom sredstev naj bi bilo nujno in sorazmerno.
Alongside the arguments put forward by the French Republic, with which it concurs, the Kingdom of the Netherlands refers to the risks associated with trafficking in plant protection products stemming from the importation of imitations.
Kraljevina Nizozemska poleg trditev Francoske republike, s katerimi se strinja, navaja tveganja, povezana s prometom s fitofarmacevtskimi sredstvi zaradi uvoza ponaredkov.
This action raises the question whether Article 28 EC precludes Article 1 of Decree No 2001-317 in so far as the latter restricts the simplified authorisation procedure for the parallel importation of plant protection products only to cases where the imported product and the reference product have a common origin, 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.
V obravnavani tožbi je postavljeno vpra�anje, ali člen 28 ES nasprotuje členu 1 dekreta �t. 2001-317, če ta omeji pravico do poenostavljenega postopka pridobitve dovoljenja za vzporedni uvoz le na primere, ko imata uvoženo in referenčno sredstvo skupno poreklo v smislu, da ju je po isti formuli proizvedla ista družba ali povezana podjetja ali podjetja, ki poslujejo na podlagi licence.
According to the basic relevant rule, all plant protection products placed on the market of a Member State must be authorised by the competent authorities of that Member State.
V skladu s temeljnim načelom na tem področju morajo vsako fitofarmacevtsko sredstvo, dano na trg v državi članici, odobriti pristojni organi v tej državi članici.
Article 3(1) of Directive 91/414 thus provides that no plant protection product can be placed on the market and used in a Member State unless a prior marketing authorisation has been issued by that Member State in accordance with the directive.
Člen 3(1) Direktive 91/414 določa, da v državi članici ni mogoče niti dati v promet niti uporabljati nobenega fitofarmacevtskega sredstva, ne da bi pred tem država članica izdala DDP v skladu z Direktivo.
That requirement applies even when the product concerned already has a marketing authorisation in another Member State (see to that effect, Joined Cases C-260/06 and C-261/06 Escalier and Bonnarel [2007] ECR I-9717, paragraph 24).
Ta zahteva velja tudi, če je bilo za zadevno sredstvo DDP že izdano v drugi državi članici (glej v tem smislu sodbo z dne 8. novembra 2007 v združenih zadevah Escalier in Bonnarel, C-260/06 in C-261/06, ZOdl., str. I-9717, točka 24).
However, Directive 91/414 tempers that principle by providing, in Article 10(1), that, when there is presented in one Member State a marketing authorisation application for a plant protection product already authorised in another Member State, the former State must, subject to certain conditions and allowing for certain exceptions, refrain from requiring the repetition of tests and analyses already carried out in that other State, which thereby permits a saving of time and money involved in gathering the required information (see Escalier and Bonnarel, paragraph 25).
Direktiva 91/414, s tem da v členu 10(1) določa, da če je v državi članici vložen zahtevek za izdajo DDP fitofarmacevtskega sredstva, ki je v drugi državi članici že registrirano, se mora druga država članica pod določenimi pogoji izogibati zahtevam za ponovitev testov in analiz, ki so bili že izvedeni v zvezi z registracijo sredstva v tej državi članici, s čimer se prihranijo čas in stro�ki, ki bi se porabili za izvedbo predpisanih zahtev (glej zgoraj navedeno sodbo Escalier in Bonnarel, točka 25).
By contrast, Directive 91/414 contains no specific provision as regards parallel imports by which an operator buys a product in one Member State for the purpose of reselling it in another in order to benefit from a difference in price between those two geographical markets.
Direktiva 91/414 nasprotno v zvezi z vzporednimi uvozi, v okviru katerih subjekt kupi sredstvo v eni državi članici, da bi ga prodal v drugi državi članici, zato da bi se okoristil z razliko v ceni med tema geografskima trgoma, ne vsebuje nobene posebne določbe.
The directive does not set out the conditions for the authorisation of a plant protection product covered by a marketing authorisation granted in accordance with its provisions and imported in parallel to a plant protection product already covered by a marketing authorisation in the Member State of importation.
Ta direktiva ne določa pogojev za registracijo fitofarmacevtskega sredstva, za katero je bilo izdano DDP v skladu z njenimi določbami in ki se glede na fitofarmacevtsko sredstvo, za katero je bilo v državi članici uvoznici DDP že izdano, uvaža vzporedno.
Such a situation falls, however, within the scope of the provisions on the free movement of goods with the result that the legality of national measures restricting parallel imports must be examined in the light of Article 28 EC et seq. (see, to that effect, Escalier and Bonnarel, paragraph 28, and Commission v Germany, paragraph 27).
Tak položaj se nana�a na določbe v zvezi s prostim pretokom blaga s tem, da je treba zakonitost nacionalnih ukrepov, ki ovirajo vzporedne uvoze, preučiti ob upo�tevanju člena 28 ES in naslednjih (glej v tem smislu zgoraj navedeni sodbi Komisija proti Nemčiji, točka 27, in Escalier in Bonnarel, točka 28).
It is not therefore necessary, in order to protect human and animal health and the environment, to make parallel importers subject to the marketing authorisation procedure provided for by that directive, given that the competent authorities in the Member State of importation already have all the information necessary for the exercise of that scrutiny.
Vzporednih uvoznikov zaradi varstva zdravja ljudi in živali ali okolja torej ni treba podvreči postopku pridobitve DDP, določenemu v tej direktivi, ker imajo pristojni organi države članice uvoznice že vse informacije, ki so potrebne za izvajanje njihovega nadzora.
To make the imported product subject to the marketing authorisation procedure would go beyond what is necessary to achieve the objectives of Directive 91/414 as to the protection of public and animal health and of the
S podreditvijo uvoženega sredstva postopku pridobitve DDP bi bilo preseženo, kar je nujno za dosego ciljev navedene direktive v zvezi z varstvom zdravja ljudi in živali ter okolja, in bi lahko bilo neutemeljeno kr�eno načelo prostega
COMMISSION v FRANCE environment and could, without justification, run counter to the principle of the free movement of goods laid down in Article 28 EC (see, to that effect, British Agrochemicals Association, paragraph 32).
KOMISIJA PROTI FRANCIJI pretoka blaga, določeno v členu 28 ES (glej v tem smislu zgoraj navedeno sodbo British Agrochemicals Association, točka 32).
In that regard, the Court has already held that if a plant protection product must be regarded as having already been authorised in the Member State of importation, the competent authorities of that State must allow the product concerned to benefit from the marketing authorisation granted to the plant protection product already on the market, unless that is precluded by considerations relating to the effective protection of human and animal health and of the environment (British Agrochemicals Association, paragraph 36).
Sodi�če je v zvezi s tem že odločilo, da če je treba za fitofarmacevtsko sredstvo �teti, da je bilo v državi članici uvoznici že registrirano, morajo pristojni organi te države članice priznati DDP za zadevno sredstvo, izdano za fitofarmacevtsko sredstvo, ki je že na trgu, če temu ne nasprotujejo pomisleki o učinkovitem varovanju zdravja ljudi in živali ter okolja (zgoraj navedena sodba British Agrochemicals Association, točka 36).
However, a plant protection product introduced into the territory of a Member State as a parallel import cannot, automatically or absolutely and unconditionally, have the benefit of a marketing authorisation issued to a plant protection product already on the market of that State.
Vendar DDP, izdano za na trgu obstoječe fitofarmacevtsko sredstvo, ne more niti samodejno niti absolutno oziroma brezpogojno veljati za fitofarmacevtsko sredstvo, ki je bilo v državo članico uvoženo z vzporednim uvozom.
If the plant protection product cannot be regarded as having already been authorised in the Member State of importation, that State must issue a marketing authorisation according to the conditions laid down by Directive 91/414 or prohibit its being placed on the market and used (see, to that effect, British Agrochemicals Association, paragraph 37, and Escalier and Bonnarel, paragraphs 30 and 31).
Če uvoženega sredstva ni mogoče �teti za sredstvo, ki je bilo v državi članici uvoznici že registrirano, mora ta država DDP izdati v skladu s pogoji, določenimi v Direktivi 91/414, oziroma mora prepovedati dajanje tega sredstva na trg in njegovo uporabo (glej v tem smislu zgoraj navedeni sodbi British Agrochemicals Association, točka 37, in Escalier in Bonnarel, točki 30 in 31).
In order to verify whether a product authorised in another Member State in accordance with Directive 91/414 is to be regarded as having already been authorised in the Member State of importation, it is for the competent authorities of that Member State (i) to ascertain whether the importation of the plant protection product covered by the marketing authorisation in the other Member State constitutes a parallel import of a product already covered by a marketing authorisation in the Member State of importation, and (ii) to examine, when requested by the parties concerned, whether the product concerned may have the benefit of the marketing authorisation issued in favour of a plant protection product already on the market of the Member State of importation.
Pristojni organi države članice uvoznice morajo – da bi preverili, ali je treba za sredstvo, ki je bilo v drugi državi članici registrirano v skladu z Direktivo 91/414, �teti, da je bilo v državi članici uvoznici že registrirano – preveriti, ali sta izpolnjena pogoja, in sicer, prvič, ali uvoz fitofarmacevtskega sredstva, za katero je bilo v drugi državi članici DDP že izdano, pomeni vzporedni uvoz glede na sredstvo, za katero je bilo v državi članici uvoznici DDP že izdano, in, drugič – na predlog zadevnih strank – ali za zadevno sredstvo lahko izdajo DDP, ki je bilo izdano za fitofarmacevtsko sredstvo, ki je že prisotno na trgu te države članice.
To that end, the notion of common origin allows parallel imports to be distinguished from other situations in which the importer of a product authorised in another Member State seeks to benefit from a marketing authorisation already granted in the Member State of importation.
Pojem skupnega porekla zato omogoča razlikovanje vzporednih uvozov in drugih primerov, v katerih uvoznik sredstva, ki je v drugi državi članici že registrirano, vlaga zahtevek za pridobitev DDP, ki je bilo v državi članici uvoznici že izdano.
Furthermore, a common origin constitutes an important indication that the products at issue are identical, which would show that the marketing authorisation for the reference product may be used for the imported product (see, to that effect, Kohlpharma, paragraphs 16 and 17).
Skupno poreklo je poleg tega pomemben pokazatelj enakosti zadevnih sredstev, saj dokazuje, da je mogoče DDP referenčnega sredstva uporabiti v korist uvoženega sredstva (glej v tem smislu zgoraj navedeno sodbo Kohlpharma, točki 16 in 17).
In paragraph 40 of British Agrochemicals Association, the Court ruled that where the competent authority of a Member State finds that a plant protection product imported from a State party to the Agreement on the European Economic Area in which it is already covered by a marketing authorisation granted in accordance with the Directive, if not identical in all respects to a product already authorised within the Member State of importation, at least,
Sodi�če je v točki 40 zgoraj navedene sodbe British Agrochemicals Association odločilo, da kadar pristojni organ države članice ugotovi, da fitofarmacevtsko sredstvo, uvoženo v državo podpisnico Sporazuma o Evropskem gospodarskem prostoru, v kateri je bilo DDP že izdano v skladu z Direktivo 91/414, ki če že ni povsem enako sredstvu, za katero je registracija na ozemlju države članice uvoznice že izdana, mora vsaj:
— shares a common origin with that product in that it has been manufactured by the same company or by an associated undertaking or under licence according to the same formulation,
— imeti 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,
— was manufactured using the same active ingredient, and
— biti proizvedeno z uporabo iste ali istih aktivne snovi in
— also has the same effect with due regard to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product,
— poleg tega imeti podobne učinke ob upo�tevanju razlik, ki lahko obstajajo glede pogojev kmetijstva, varstva rastlin in okolja, zlasti podnebnih razmer, ki so pomembni za uporabo sredstva,
COMMISSION v FRANCE that product must be able to benefit from the marketing authorisation already granted in the Member State of importation, unless that is precluded by considerations concerning the protection of human and animal health and of the environment.
KOMISIJA PROTI FRANCIJI mora za to sredstvo, razen če temu ne nasprotujejo ugotovitve v zvezi z varstvom zdravja živali in ljudi ter okolja, veljati DDP, ki je že izdano v državi članici uvoznici.
Contrary to what the Commission submits, Kohlpharma does not call that assessment into question.
V nasprotju s tem, kar zatrjuje Komisija, se v zgoraj navedeni sodbi Kohlpharma te presoje ne postavlja pod vpra�aj.
In that case, the Court took as a basis the premise that, for the purposes of assessing their safety and efficacy, the imported medicinal product and the reference medicinal product did not differ significantly although they had been manufactured by two separate undertakings.
V tej zadevi Sodi�če temelji na trditvi, v skladu s katero se uvoženo zdravilo in referenčno zdravilo zaradi ocene njune varnosti in učinkovitosti nista bistveno razlikovali, čeprav sta ju proizvedli dve različni podjetji.
After pointing out that the principle of proportionality requires that the legislation in question be applied within the limit of what is necessary in order to achieve its primary objective of protecting public health, the Court stated that the circumstances of that case were characterised by the fact that the active ingredient had been sold to two different manufacturers of medicinal products established in two Member States, with the result that the applicant for the parallel import authorisation could, for the purpose of assessing its safety and efficacy, demonstrate by means of available or accessible information that the medicinal product to be imported did not differ significantly from the medicinal product which had already been authorised (Kohlpharma, paragraphs 11, 14 and 19).
Sodi�če je po tem, ko je opozorilo, da je v skladu z načelom sorazmernosti zadevno ureditev treba uporabiti, kolikor je nujno za dosego njenega temeljnega cilja varstva javnega zdravja, poudarilo, da je bilo za okoli�čine v obravnavani zadevi značilno, da je bila aktivna snov prodana dvema proizvajalcema zdravil s sedežem v dveh državah članicah, tako da je vlagatelj za registracijo vzporednega uvoza lahko po potrebi z informacijami, ki jih je imel na voljo in tistimi, do katerih je imel dostop, zaradi ocene njegove varnosti in učinkovitosti dokazal, da se zdravilo, ki naj bi se uvozilo, ne razlikuje bistveno od zdravila, ki je bilo že registrirano (zgoraj navedena sodba Kohlpharma, točke 11, 14 in 19).
In such circumstances, the assessment of safety and efficacy carried out for the medicinal product which had already been authorised could be used in the application for a marketing authorisation for the second medicinal product without any risk to public health (Kohlpharma, paragraph 21, third indent).
V teh okoli�činah se lahko ocena varnosti in učinkovitosti zdravila, ki je že registrirano, brez kakr�negakoli tveganja za javno zdravje, uporablja za zdravilo, ki je predmet zahtevka za DDP (zgoraj navedena sodba Kohlpharma, točka 21, tretja alinea).