natgillin/translations-raw huggingface dataset:
If the imported product and the reference product have the same origin, in other words if they have been manufactured by the same company or by associated undertaking or under licence, it is unnecessary to carry out an assessment of the specifications of the imported product.
Če bi uvoženo in referenčno sredstvo imeli skupen izvor, če bi ju torej proizvedla ista družba ali povezana podjetja ali podjetja, ki poslujejo na podlagi licence, ne bi bilo treba presojati specifikacij uvoženega sredstva.
On the other hand, if the imported product and the reference product have been manufactured by different undertakings, the removal of the condition of common origin means that there should be a systematic assessment of the active substances contained in the imported product.
Nasprotno, če bi uvoženo in referenčno sredstvo proizvedli različni podjetji, bi bila zaradi črtanja pogoja skupnega izvora uvedena sistematična presoja aktivnih snovi, ki jih vsebuje uvoženo sredstvo.
In fact, the identity of substances, as is argued by the French Government (see supra, point 31), is all the more certain when they have a common source of manufacture, since active substances comprise, in the wording of the directive, ‘any impurity inevitabl[y] resulting from the manufacturing process.’ 33
Kot zatrjuje francoska vlada (glej točko 31 spodaj), je identiteta snovi namreč toliko bolj gotova, če izhajata iz skupne proizvodnje, ker aktivne snovi v skladu z besedilom Direktive vsebujejo „vsako nečistočo, ki je neizogibna posledica proizvodnega procesa“ 33.
Accordingly, it must be determined that the French Republic, by requiring that the parallel import plant protection product and the reference product have a common origin, has not failed to fulfil its obligations under Article 28 EC.
Ugotoviti je torej treba, da Francoska republika s tem, da je zahtevala skupni izvor vzporedno uvoženega fitosanitarnega sredstva in referenčnega sredstva, ni v položaju neizpolnitve obveznosti iz člena 28 ES.
Consequently, the action must be dismissed.
Tožbo je treba zato zavrniti.
34 — Moreover, the directive obliges the Commission and the Member States, both in the procedure for authorisation of a plant protection product and in that for inclusion of a substance in Annex I to the directive, to treat industrial and commercial secrets as confidential, if a warranted request is made (Article 14, first paragraph of the directive).
34 – Poleg tega Direktiva Komisijo in države članice zavezuje, da tako v postopku za registracijo fitofarmacevtskega sredstva kot pri uvrstitvi snovi na seznam v Prilogi I industrijske in poslovne skrivnosti, če je zahteva utemeljena, obravnava kot zaupne (člen 14, prvi odstavek, te direktive).
Thirdly, the argument presented by the Netherlands Government on the subject of confidentiality of data must also be approved.
Tretjič, sprejeti je treba tudi utemeljitev nizozemske vlade v zvezi s pojmom zaupnosti podatkov.
The rule stated in Article 13 of the directive, to the effect that a Member State is not, when granting an authorisation, to make use
Zdi se namreč, da pravilo iz člena 13 Direktive – v skladu s katerim država članica pri izdajanju dovoljenja podatkov, ki jih je posredoval prvi vlagatelj za DDP, ne more uporabljati „v korist drugih
35 — Only in the area of experiments on vertebrate animals does the directive provide that the holders of earlier authorisations and the new applicant must come to an agreement, in order to avoid the repetition of experiments on vertebrate animals.
35 – Direktiva določa, da se morajo imetniki prej�njih registracij in novi vlagatelji dogovoriti le za preizkuse glede vretenčarjev, da se prepreči podvajanje preizkusov glede le-teh.
Failing such agreement, Member States are to impose terms, if the parties concerned are based on their territory, by determining both the procedure, and the reasonable balance of the interests of the parties concerned (Article 13(7), last three paragraphs).
Če dogovora ni, ga predpi�ejo države članice, če imajo zadevne osebe sedež na njihovem ozemlju, in določijo postopek in sprejemljivo ravnotežje interesov zadevnih strank (člen 13(7), zadnji trije pododstavki, Direktive).
33 — Article 2(3) of the directive.
33 – Člen 2(3) Direktive.
VII — Costs ordered to pay the costs if they have been applied for in the successful party’s pleadings.
VII – Stroški so bili ti prigla�eni.
Since the French Republic applied for costs and the Commission has been unsuc- cessful, the latter should be ordered to pay the costs.
Ker je Francoska republika predlagala, naj se plačilo stro�kov naloži Komisiji, in ker ta s svojimi predlogi ni uspela, se ji naloži plačilo stro�kov.
Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be
V skladu s členom 69(2) Poslovnika se neuspeli stranki naloži plačilo stro�kov, če
Having regard to all of the foregoing reflections, it is suggested that the Court should:
Na podlagi vsega navedenega predlagam, naj Sodi�če:
2. order the Commission to pay the costs.
2. naloži plačilo stro�kov Komisiji Evropskih skupnosti.
2008 — CASE C-201/06
2008 – ZADEVA C-201/06
JUDGMENT OF THE COURT (Third Chamber)
SODBA SODIŠČA (tretji senat) z dne 21. februarja 2008 *
ACTION under Article 226 EC for failure to fulfil obligations, brought on 4 May 2006,
V zadevi C-201/06, zaradi tožbe zaradi neizpolnitve obveznosti na podlagi člena 226 ES, vložene 4. maja 2006,
Commission of the European Communities, represented by B. Stromsky, acting as Agent, with an address for service in Luxembourg, applicant, v
Komisija Evropskih skupnosti, ki jo zastopa B. Stromsky, zastopnik, z naslovom za vročanje v Luxembourgu, tožeča stranka, proti
French Republic, represented by G. de Bergues and R. Loosli-Surrans, acting as Agents, defendant,
Francoski republiki, ki jo zastopata G. de Bergues in R. Loosli-Surrans, zastopnika, tožena stranka,
Advocate General: V. Trstenjak, Registrar: R. Grass, having regard to the written procedure, after hearing the Opinion of the Advocate General at the sitting on 11 September 2007,
Trstenjak, sodni tajnik: R. Grass, na podlagi pisnega postopka, po predstavitvi sklepnih predlogov generalne pravobranilke na obravnavi 11. septembra 2007
2008 — CASE C-201/06 gives the following
2008 – ZADEVA C-201/06 izreka naslednjo
By its application, the Commission of the European Communities seeks a declaration from the Court that, by requiring, for the purpose of the grant of an import authorisation for a plant protection product imported in parallel, that the imported product and the product already authorised in France have a common origin, the French Republic has failed to fulfil its obligations under Article 28 EC.
Komisija Evropskih skupnosti Sodi�ču predlaga, naj ugotovi, da Francoska republika s tem, da je za izdajo dovoljenja za uvoz vzporedno uvoženega fitofarmacevtskega sredstva zahtevala skupno poreklo uvoženega sredstva in sredstva, ki je bilo v Franciji že registrirano, ni izpolnila obveznosti iz člena 28 ES.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p.
Direktiva Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet (UL L 230, str.
1) establishes uniform rules on the conditions and procedures for authorisation to place plant protection products on the market (‘the marketing authorisation’) and for their review and withdrawal.
1) uvaja enotna pravila o pogojih in postopkih za pridobitev dovoljenja za dajanje fitofarmacevtskih sredstev v promet (v nadaljevanju: DDP) ter nadzor in odvzem take registracije.
Its objective is not only to harmonise the rules relating to the conditions and procedures for approval of those products, but also to ensure a high level of protection of human and animal health and also of the environment from the threats and risks posed by unrestricted use of those products.
Namenjena ni le poenotenju pravil o pogojih in postopkih za registracijo fitofarmacevtskih sredstev, temveč naj bi za zdravje ljudi in živali ter okolja zagotovila visoko stopnjo varstva zoper grožnje in nevarnosti, ki izhajajo iz nezadostno nadzorovane uporabe fitofarmacevtskih sredstev.
The directive also aims to eliminate barriers to the free movement of those products.
Poleg tega je Direktiva namenjena odpravi omejitev prostega pretoka le-teh.
Directive 91/414 concerns, inter alia, the authorisation, placing on the market, use and control within the Community of plant protection products in commercial form.
Direktiva 91/414 se nana�a med drugim na dovoljenje, dajanje v promet, uporabo in nadzor fitofarmacevtskih sredstev v tržni obliki znotraj Evropske skupnosti.
Article 2(10) defines ‘placing on the market’ as any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community.
V skladu s členom 2, točka 10, Direktive pomeni „dajanje v promet“ vsako razpolaganje, bodisi odplačno ali neodplačno, razen skladi�čenja, povezanega z izvozom z ozemlja Evropske skupnosti.
Importation of a plant protection product into the territory of the Community is deemed to constitute placing on the market for the purposes of the directive.
Uvoz fitofarmacevtskih sredstev na ozemlje Skupnosti se za namene te direktive �teje za dajanje v promet.
Article 3(1) of Directive 91/414 provides:
V členu 3(1) Direktive 91/414 je določeno:
‘Member States shall prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorised the product in accordance with this Directive … .’
„Države članice predpi�ejo, da se fitofarmacevtskih sredstev ne sme dati v promet in jih uporabljati na njihovem ozemlju, če sredstvo ni bilo registrirano v skladu s to direktivo […].“
Article 4 of the directive sets out, inter alia, the conditions which a plant protection product must satisfy before it can be authorised.
V členu 4 te direktive so med drugim navedeni pogoji, ki morajo biti izpolnjeni za registracijo fitofarmacevtskega sredstva.
Under that article, authorisations must stipulate the requirements relating to the placing on the market and use of the products and are to be granted for a fixed period of up to 10 years only, which is to be determined by the Member States.
V skladu z istim členom morajo registracije določati zahteve v zvezi dajanjem v promet in uporabo sredstva. Izdajo se lahko največ za obdobje desetih let, ki ga določijo države članice.
Authorisations can be reviewed at any time and must, in certain circumstances, be cancelled.
Registracija se lahko pregleda kadar koli, pod določenimi pogoji pa tudi prekliče.
Where a Member State withdraws a marketing authorisation, it must immediately inform the holder.
Če država članica prekliče registracijo, o tem nemudoma obvesti imetnika registracije.
The first subparagraph of Article 9(1) of Directive 91/414 provides, in particular, that ‘[a]pplication for authorisation of a plant protection product shall be made by or on behalf of the person responsible for first placing it on the market in a Member State to the competent authorities of each Member State where the plant protection product is intended to be placed on the market’.
Člen 9(1), prvi pododstavek, navedene direktive določa zlasti, da se „[z]ahtevek za registracijo fitofarmacevtskega sredstva predloži pristojnemu organu vsake države članice, kjer se namerava fitofarmacevtsko sredstvo dati v promet, odgovorna oseba za prvo dajanje v promet v državi članici, ali pa se predloži v imenu te odgovorne osebe“.
Under Article 10(1) of Directive 91/414, a Member State in which an application is made for the authorisation of a plant protection product already authorised in another Member State must, subject to certain conditions and allowing for certain exceptions, refrain from requiring the repetition of tests and analyses already carried out.
V skladu s členom 10(1) Direktive 91/414 se mora država članica, v kateri je vlagatelj vložil zahtevek za registracijo fitofarmacevtskega sredstva, že registriranega v drugi državi članici, izogibati zahtevam za ponovitev testov in analiz v zvezi z registracijo sredstva.
Under the first paragraph of Article 17 of Directive 91/414:
Člen 17, prvi odstavek, Direktive 91/414 določa, da:
‘Member States shall make the necessary arrangements for plant protection products which have been placed on the market and for their use to be officially checked to see whether they comply with the requirements of this Directive and in particular with the requirements of the authorisation and information appearing on the label.’
„Države članice sprejmejo potrebne ukrepe, da se fitofarmacevtska sredstva, dana v promet, in njihova uporaba uradno nadzoruje zaradi ugotavljanja skladnosti z zahtevami te direktive in zlasti z zahtevami iz registracije ter s podatki na etiketi.“
However Directive 91/414 does not contain any provision governing the conditions for the grant of marketing authorisations where there are parallel imports.
Vendar navedena direktiva ne vsebuje nobene določbe o pogojih za izdajo dovoljenja za dajanje v promet v primerih vzporednega uvoza.
Under Article L.253-1 of the Code rural (Rural Code):
Člen L.253-1 code rural (zakonik o kmetijstvu) določa:
The use of the products referred to in the first paragraph under conditions other than those provided for in the authorisation is prohibited.
Uporaba sredstev, navedenih v prvem pododstavku, pod pogoji, ki niso določeni v registraciji, je prepovedana.
The conditions for the issue of plant protection product marketing authorisations in France are set out in Decree No 94-359 of 5 May 1994 on the control of plant protection products (JORF, 7 May 1994, p.
Pogoji za izdajo DDP fitofarmacevtskih sredstev v Franciji so določeni v dekretu �t. 94-359 z dne 5. maja 1994 o nadzoru fitofarmacevtskih sredstev (JORF z dne 7. maja 1994, str.
6683), which was adopted in order to transpose Directive 91/414 into national law.
6683), ki je bil sprejet za prenos Direktive 91/414 v nacionalni pravni red.
Article 1 of Decree No 2001-317 of 4 April 2001 establishing a simplified procedure for marketing authorisations for plant protection products from the European Economic Area (JORF, 14 April 2001, p.
Člen 1 dekreta �t. 2001-317 z dne 4. aprila 2001, s katerim je določen poenostavljen postopek za izdajo dovoljenja za dajanje v promet za fitofarmacevtska sredstva s poreklom iz Evropskega gospodarskega prostora (JORF z dne 14. aprila 2001, str. 5811), ki je bil uzakonjen v členih od R. 253-52 do R.
The reference product must have a marketing authorisation issued by the minister responsible for agriculture …
„[Uvoz fitofarmacevtskega sredstva s poreklom iz države Evropskega gospodarskega prostora, v kateri je bilo [DDP] za sredstvo v skladu z Direktivo 91/414 […] že izdano […], ki je enako sredstvu, v nadaljevanju imenovanemu ‚referenčno sredstvo‘, na nacionalno ozemlje je dovoljen pod temi pogoji: za referenčno sredstvo je treba pridobiti DDP, ki ga izda minister za kmetijstvo […]
The identity of the product introduced into the national territory with the reference product shall be assessed in the light of the following three criteria:
2008 – ZADEVA C-201/06 enakost sredstva, ki se uvozi na nacionalno ozemlje, in referenčnega sredstva se presoja glede na ta tri merila:
— 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;
— 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;
— manufacture using the same active substance or substances;
— proizvodnja sredstva z uporabo iste ali istih aktivnih snovi;
— similar effects of the two products with due regard to differences which may exist in conditions relating to agriculture, plant health and the environment in particular climatic conditions, connected with the use of the products.’
— podobni učinki obeh sredstev ob upo�tevanju razlik, ki lahko obstajajo glede pogojev kmetijstva, varstva rastlin in okolja, zlasti podnebnih razmer, ki so pomembni za uporabo sredstva.“
Under Article 1 of the ministerial order of 17 July 2001 on the application of Decree No 2001-317 (JORF, 27 July 2001, p.
V skladu s členom 1 ministrskega odloka z dne 17. julija 2001 o uporabi odloka �t. 2001-317 (JORF z dne 27. julija 2001, str.
12091), any applicant for a marketing authorisation for a plant protection product from a State of the European Economic Area must lodge in support of his application a dossier which is to include a form detailing the information listed in the Annex to that order, a proposed label in French for the product the marketing of which as a parallel import is applied for, and an original label of the imported product(s).
12091) mora vsak vlagatelj zahtevka za pridobitev DDP fitofarmacevtskega sredstva s poreklom iz države članice Evropskega gospodarskega prostora k zahtevku predložiti informacije, ki vsebujejo obrazec s podatki, katerih seznam je v prilogi k temu odloku, osnutek embalaže sredstva, katerega registracija se zahteva zaradi vzporednega uvoza, v francoskem jeziku ter originalna embalaža uvoženega sredstva ali sredstev.
The Annex to that ministerial order provides that any applicant for a marketing authorisation for such a plant protection product must, in support of his application, provide information relating to the identity of the importer, the identification of the imported product and the reference product, the intended uses of the product to which the application relates, and the identification in French of the import and the trade name to be used in France for the product in question.
V prilogi k ministrskemu odloku je določeno, da mora vsak vlagatelj zahtevka za pridobitev DDP takega fitofarmacevtskega sredstva ob zahtevku predložiti podatke o istovetnosti uvoznika, o istovetnosti uvoženega sredstva in referenčnega sredstva, o namenih uporabe sredstva, katerega registracija se zahteva, ter o francoski oznaki uvoza in predlaganem trgovskem imenu za zadevno sredstvo v Franciji.
The prelitigation procedure
Predhodni postopek
The Commission received a complaint concerning the withdrawal of a number of plant protection product authorisations issued under the simplified procedure applicable to parallel imports, in particular that of an insecticide called Deltamex, whose active substance is deltamethrine.
Komisija je prejela pritožbo v zvezi s preklicem več dovoljenj za fitofarmacevtska sredstva, izdanih v okviru poenostavljenega postopka, ki se uporablja za vzporedne uvoze, med drugim za insekticid, imenovan Deltamex, katerega aktivna snov je deltametrin.
By letter of 18 October 2004, the Commission sent a letter of formal notice to the French Republic, requesting that it submit its observations on the compliance with Community law of the conditions for parallel importation of plant protection products.
Komisija je z dopisom z dne 18. oktobra 2004 Francoski republiki poslala pisni opomin, naj predloži svoja stali�ča v zvezi z združljivostjo pogojev za vzporedni uvoz fitofarmacevtskih sredstev s pravom Skupnosti.
That formal notice covered three aspects of the French legislation, namely:
Ta opomin se je nana�al na tri vidike francoske zakonodaje, in sicer na:
— the requirement for an authorisation in respect of all the operators who parallel import the same product;
— zahtevo, da vsi subjekti, ki vzporedno uvažajo isto sredstvo, pridobijo dovoljenje;
— the requirement that the imported product and the reference product be absolutely identical, assessed in the light of their composition (active substances and excipients), presentation (packaging and labelling) and common origin (manufacturers who are in the same group of undertakings or have a licence agreement), and
— zahtevo po popolni enakosti uvoženega sredstva in referenčnega sredstva glede na njuno sestavo (aktivne snovi in vezna sredstva), njuno predstavitev (embalaža in označevanje) in njuno skupno poreklo (proizvajalca sta iz iste skupine podjetij ali sta sklenila licenčni dogovor) ter
— the excessive burden of the obligation on the parallel importer to provide proof of that absolute identity.
— čezmeren pomen obveznosti vzporednega uvoznika, da to popolno enakost dokaže.
In a reasoned opinion of 5 July 2005, the Commission stated that the French Republic had failed to fulfil its obligations under Article 28 EC by requiring that a plant protection product introduced as a parallel import and the reference product must have a ‘common origin’.
Komisija je v obrazloženem mnenju z dne 5. julija 2005 trdila, da Francoska republika, s tem da je zahtevala „skupno poreklo“ vzporedno uvoženega fitofarmacevtskega sredstva in referenčnega sredstva, ni izpolnila obveznosti iz člena 28 ES.
The other complaints made in the letter of formal notice were not referred to in that reasoned opinion.
Drugi očitki iz pisnega opomina v tem obrazloženem mnenju niso bili omenjeni.
As the Commission was not satisfied with the French Republic’s reply to the reasoned opinion, it brought the present action.
Ker Komisija z odgovorom Francoske republike na obrazloženo mnenje ni bila zadovoljna, je vložila to tožbo.
The Commission submits that Article 1 of Decree No 2001-317 constitutes a restriction on the free movement of goods contrary to Article 28 EC, because it makes the grant of a parallel import authorisation subject to compliance with a condition insisting on the common origin of the imported product and the reference product.
Komisija trdi, da člen 1 dekreta �t. 2001-317 pomeni omejitev prostega pretoka blaga v nasprotju s členom 28 ES, ker pridobitev dovoljenja za vzporedni uvoz podreja upo�tevanju pogoja v zvezi s skupnim poreklom uvoženega sredstva in referenčnega sredstva.
That condition goes beyond what may be considered as necessary for the protection of public health, animal health and the environment.
Ta pogoj naj bi presegal tisto, kar bi bilo mogoče �teti za potrebno za varstvo javnega zdravja, živali in okolja.
The Commission submits that, in respect of products which are not significantly different, the absence of their common origin cannot suffice to justify a refusal of parallel importation, as the determinative criterion in respect of parallel importation is that of the essential identity of the products.
Komisija zatrjuje, da pri sredstvih, med katerimi ni pomembnih razlik, neobstoj njihovega skupnega porekla ne bi mogel zadostovati za utemeljitev zavrnitve vzporednega uvoza, pri čemer je bistvena enakost sredstev odločilno merilo za vzporedni uvoz. To re�itev, ki jo je Sodi�če sprejelo v sodbi z dne 1. aprila 2004 v zadevi Kohlpharma (C-112/02, Recueil, str.
That approach, adopted by the Court in respect of pharmaceutical products in Case C-112/02 Kohlpharma [2004] ECR I-3369, paragraph 18, can be applied to plant protection products (judgment
I-3369, točka 18), naj bi bilo mogoče prenesti na fitofarmacevtska sredstva (sodba z dne 14. julija 2005 v zadevi Komisija proti Nemčiji, C-114/04, neobjavljena v ZOdl., točki 24 in 27). Na fitofarmacevtskem področju
COMMISSION v FRANCE of 14 July 2005 in Case C-114/04 Commission v Germany, not published in the ECR, paragraphs 24 and 27).
KOMISIJA PROTI FRANCIJI naj ne bi bilo mogoče iz nobenega razloga v zvezi z varstvom javnega zdravja zahtevati skupnega porekla, kadar se ta pogoj ne zahteva za zdravila za uporabo v humani medicini. Sodi�če naj bi v sodbi z dne 11. marca 1999 v zadevi British Agrochemicals Association (C-100/96, Recueil, str.
It is true that in Case C-100/96 British Agrochemicals Association [1999] ECR I-1499 the Court accorded some importance to the common origin of the products at issue.
I-1499) priznalo določen pomen skupnemu poreklu zadevnih sredstev.
However, that judgment does not permit the inference that the condition relating to common origin is of less importance for pharmaceutical products than for plant protection products.
Vendar naj na podlagi te sodbe ne bi bilo mogoče �teti, da ima pogoj v zvezi s skupnim poreklom manj�i pomen glede farmacevtskih sredstev kot glede fitofarmacevtskih sredstev.