natgillin/translations-raw huggingface dataset:
— similar effects of the two products with due regard to differences which may exist in conditions relating to agriculture, plant health or the environment in particular climatic conditions, relevant to 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.“ za referenčno sredstvo je treba pridobiti dovoljenje za dajanje v promet, ki ga izda minister za kmetijstvo […]
— common origin of the two products in the sense that they have been
Enakost sredstva, ki se uvozi na nacionalno ozemlje, in referenčnega sredstva se presoja glede na ta tri merila:
Under Article 4 of that Decree, ‘the marketing authorisation of the product introduced into French territory may be refused or withdrawn … on grounds of protection of human and animal health and also protection of the environment … when there is no identity, within the meaning of Article 1, with the reference product …’.
Na podlagi člena 4 tega dekreta „se dovoljenje za dajanje v promet za sredstvo, uvoženo na nacionalno ozemlje, lahko zavrne ali razveljavi […] iz razlogov varovanja zdravja ljudi in živali ter varstva okolja; […] ker sredstvo ni enako referenčnemu sredstvu v smislu člena 1 […]“.
That decree is supplemented by the order of 17 July 2001 establishing a simplified marketing authorisation procedure for parallel imports of plant protection products. 5
Ta dekret je dopolnjen z odlokom z dne 17. julija 2001 o uvedbi poenostavljenega postopka za izdajo DDP v okviru vzporednega uvoza fitofarmacevtskih sredstev 5.
On 17 April 2000, the French authorities granted Endres-Merath a marketing authorisation for Deltamex for a period of 10 years.
Francoski organi so 17. aprila 2000 podjetju Endres-Merath odobrili DDP za Deltamex za obdobje desetih let.
However, by a decision of 31 July 2001, they withdrew that authorisation.
Vendar so francoski organi z odločbo z dne 31. julija 2001 to dovoljenje razveljavili.
III — Background to proceedings
III – Dejansko stanje
That withdrawal was raised in the course of a bilateral meeting of the French authorities and the Commission on 24 June 2004 in Paris, when the Commission inquired about the reasons for the withdrawal.
Ta razveljavitev je bila obravnavana na dvostranskem sestanku francoskih organov in Komisije 24. junija 2004 v Parizu, ker je Komisija želela izvedeti razloge za navedeno razveljavitev.
The representatives of the Ministry of Agriculture indicated that the data relating to Deltamex lacked clarity and that impurities and labelling problems were causing difficulties.
Predstavniki ministrstva za kmetijstvo so navedli, da podatki v zvezi z Deltamexom niso bili jasni in so nakazovali na težave glede nečistoč in označevanja.
On 29 February 2000, Endres-Merath, an undertaking based at Tettnang (Germany), applied to the French authorities for authorisation to place on the French market, under the name of Deltamex, the plant protection product Deltamethrin, originating in Austria, where it was marketed under the name of Mac-Deltamethrin.
Podjetje Endres-Merath s sedežem v Tettnangu (Nemčija) je 29. februarja 2000 pred francoskimi organi vložilo vlogo za izdajo dovoljenja za dajanje fitofarmacevtskega sredstva deltamethrin s poreklom iz Avstrije, kjer je bil tržen pod imenom Mac-Deltamethrin, v promet v Franciji pod imenom Deltamex.
The corresponding prod- uct already authorised in France is called Decis.
Ustrezno/Podobno sredstvo, ki je že registrirano v Franciji, je Decis.
According to the information provided by the French Government, Deltamex, just like Decis, is an insecticide which acts on contact and on ingestion, with a rapid and irreversible effect on insect nervous systems.
V skladu s pojasnili francoske vlade je Deltamex tako kot Decis insekticid, ki deluje zaradi stika in užitja, pri čemer nastane hitra in trajna reakcija na živčni sistem mrčesa.
It is used on, inter alia, cereals, rapeseeed, maize, vegetable crops, potatoes, peas, vines and tree cultivations.
Uporablja se zlasti za žita, oljno repico, koruzo, zelenjavo, krompir, grah, vinsko trto in sadno drevje.
5 — Official Journal of the French Republic, 27 July 2001, p. 12091.
5 – JORF, 27. julij 2001, str. 12091.
when the French Republic has already, following marketing authorisation of a reference plant protection product, all information relevant to monitoring the efficiency and safety of the product;
To obrazloženo mnenje se ne nana�a na druge očitke, ki so bili navedeni v pisnem opominu.
— by requiring ‘perfect identity’ of the parallel import plant protection product and the reference product, inter alia with regard to the quantitative and qualitative composition of its excipients, and also the form of the product and its packaging, and by requiring that the parallel import plant protection product and the reference product have a common origin;
– zahtevala „popolno enakost“ vzporedno uvoženega fitofarmacevtskega sredstva in referenčnega sredstva, zlasti glede količinske in kakovostne sestave pomožnih snovi ter oblike sredstva in njegove embalaže, in s tem, da je zahtevala skupni izvor teh sredstev;
The French authorities replied, by a letter dated 15 September 2005, that the requirement imposed by Decree 2001-317 that the two products have a common origin, understood as meaning that they have been manufactured according to the same formulation by the same company or by an associated undertaking or under licence, is no more than the repetition of the wording of the judgment in Case C-100/96 British Agrochemicals Association. 6
Francoski organi so z dopisom z dne 15. septembra 2005 odgovorili, da zahteva, določena z dekretom �t. 2001-317, glede skupnega izvora dveh sredstev, ki jo je treba razumeti tako, da ju je po isti formuli proizvedla ista družba ali povezana podjetja ali podjetja, ki poslujejo na podlagi licence, povzema besedilo sodbe Sodi�ča z dne 11. marca 1999 v zadevi British Agrochemicals Association 6.
The Commission was not satisfied with that reply and brought the present action on 4 May 2006, on the basis of Article 226 EC.
Ker Komisija s tem odgovorom ni bila zadovoljna, je 4. maja 2006 na podlagi člena 226 ES vložila to tožbo.
The Commission claims that the Court should:
Francoski organi na ta pisni opomin niso odgovorili.
— declare that, by requiring that the parallel import plant protection product and
– ugotovi, da Francoska republika s tem, da zahteva skupni izvor vzporedno
By letter of 13 July 2005, the Commission sent to the French Republic a reasoned opinion in which it stated that, by requiring that the parallel import plant protection product and the reference product have a ‘common origin’ the French Republic has failed to fulfil its obligations under Article 28
Komisija je z dopisom z dne 13. julija 2005 na Francosko republiko naslovila obrazloženo mnenje, v katerem je navedla,
That condition exceeds, moreover, what may be considered necessary for the protection of public health, animal health and the environment.
Ta pogoj naj bi poleg tega presegal, kar je nujno za dosego cilja varovanja javnega zdravja in živali ter varstva okolja.
The French Republic contends that the Court should:
Francoska republika Sodi�ču predlaga, naj:
The Court stated in Case C-112/02 Kohlpharma 7that, as regards two medic-
Sodi�če je tako v sodbi z dne 1. aprila 2004 v zadevi Kohlpharma 7navedlo, da v
inal products which are not significantly different, the absence of a common origin for the reference medicinal product and the imported medicinal product may not in itself constitute a ground for refusing a marketing authorisation to the second medicinal product.
zvezi z dvema zdraviloma, med katerima ni pomembnih razlik, sam neobstoj skupnega izvora med referenčnim zdravilom in uvoženim zdravilom ne more biti razlog za zavrnitev DDP za drugo zdravilo.
That approach, taken in relation to medicinal products, can be applied to plant protection products.
To re�itev, sprejeto v zvezi z zdravili, naj bi bilo mogoče prenesti na fitofarmacevtska sredstva.
The Commission refers to the statement in Case C-114/04 Commission v Germany, 8in paragraph 24, that ‘the marketing of medicinal products and plant protection products raise comparable issues’ and, in paragraph 27, that ‘the question of law at issue in these proceedings and in the caselaw relating to parallel imports of medicinal products is the same’.
Komisija se sklicuje na sodbo z dne 14. julija 2005 v zadevi Komisija proti Nemčiji 8, v kateri je Sodi�če v točki 24 navedlo, da „so v promet z zdravili in fitofarmacevtskimi sredstvi […] vpleteni primerljivi interesi“, in v točki 27, da je „zadevno pravno vpra�anje […] enako v obravnavani zadevi in v sodni praksi v zvezi z vzporednimi uvozi zdravil“.
IV — Observations submitted to the Court
IV – Stališča, predložena Sodišču
Lastly, the Commission argues that the grant of a marketing authorisation to a
Nazadnje Komisija meni, da dejstvo – da oseba, ki ne izpolnjuje pogoja skupnega
The Commission claims that to subject the issuing and continuation of authorisation
Komisija trdi, da je pogojevanje izdaje in veljavnosti dovoljenja za vzporedni uvoz
COMMISSION v FRANCE but are matters to which the regulation of pharmaceutical products has no regard.
KOMISIJA PROTI FRANCIJI kar naj ne bi bila naloga ureditve fitofarmacevtskih sredstev.
person who does not satisfy the condition of common origin does not, contrary to what is maintained by the Netherlands Government (see infra, point 32), infringe the data protection rights of the holder of the reference product marketing authorisation laid down in Article 13 of the directive, since that provision relates exclusively to initial marketing authorisations and does not apply to parallel imports.
izvora, pridobi DDP, v nasprotju s tem, kar zatrjuje nizozemska vlada (glej točko 32 spodaj) – ne kr�i pravice imetnika DDP za referenčno sredstvo do varstva podatkov, določeno v členu 13 Direktive, ker naj bi se ta določba nana�ala le na prvotna DDP in naj ne bi veljala za vzporedne uvoze.
The French legislation, by requiring that the imported product be identical to the reference product, does no more than meet the objectives of the directive while also ensuring that marketing authorisation procedure is transparent.
Francoska ureditev naj bi z zahtevo, da je uvoženo sredstvo enako referenčnemu sredstvu, le izpolnjevala cilje Direktive in hkrati zagotavljala preglednost postopka DDP. Dekret �t.
Decree 2001-317 was, moreover, adopted to achieve conformity with British Agrochemicals Association, cited above.
2001-317 naj bi bil sicer sprejet za uskladitev z zgoraj navedeno sodbo British Agrochemicals Association.
That condition of common origin ensures that the active substances have the same origin, which provides the best safeguard that the substances are identical, particularly in their specification (degree of impurities, etc.).
Ta pogoj skupnega izvora naj bi zagotavljal, da imajo aktivne učinkovine enak izvor, kar naj bi bilo največje zagotovilo v zvezi z enakostjo teh snovi in zlasti njihovih specifikacij (na primer vsebnost nečistoč).
Quantitative or qualitative differences in composition of the active substance or substances might distort the action or even the effects of the product, inter alia by increasing its toxicity.
Kakovostne ali količinske razlike v sestavi aktivne ali aktivnih snovi bi lahko namreč izkrivile delovanje ali same učinke sredstva, zlasti s povečanjem njegove toksičnosti.
The French Government denies the alleged failure to fulfil its obligations.
Francoska republika prereka zatrjevano neizpolnitev obveznosti.
The principles identified in Kohlpharma, cited above, pronounced in the context of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, 9 cannot be applied to the area of plant protection products.
Načela iz zgoraj navedene sodbe Kohlpharma, sprejete na področju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini 9, naj ne bi bilo mogoče prenesti na področje fitofarmacevtskih sredstev.
While the sole objective of Directive 2001/83 is the protection of human health, the directive aims not only to ensure that protection by avoiding the involuntary ingestion of chemical substances to be found on plants, but also to guarantee the protection of animal health and the environment from the consequences of the use of chemical substances designed for treating plants.
Medtem ko se Direktiva 2001/83 nana�a le na varovanje zdravja ljudi, namen Direktive ni le zagotoviti tega varovanja, s tem da se prepreči neprostovoljno zaužitje kemičnih snovi, ki so na rastlinah, ampak tudi zagotoviti varovanje zdravja živali in varstvo okolja pred posledicami uporabe kemičnih snovi pri pridelavi rastlin.
Further, the current disparities among Member States as regards habits of consumption, professional practices and agricultural and environmental conditions, particularly climatic, are all specific factors to be taken into account,
Poleg tega naj bi bile neenakosti med državami članicami glede načinov potro�nje, poklicnih navad in pogojev kmetijstva ter okolja, zlasti podnebnih razmer, tako posebni dejavniki, ki jih je treba upo�tevati,
The French Government points out that, under the directive, the same active substance may currently be authorised with specifications which differ from State to State.
Francoska vlada poudarja, da je lahko v okviru Direktive ista aktivna snov dejansko registrirana z različnimi specifikacijami glede na države.
Consequently, if the requirement was not made that the reference product and the imported product be manufactured by the same company or by associated undertakings
Če ne bi bilo zahtevano, da referenčno sredstvo in uvoženo sredstvo proizvaja ista družba ali povezana podjetja ali podjetja, ki poslujejo na podlagi licence,
OPINION OF MS TRSTENJAK — CASE C-201/06 trade is a measure having equivalent effect.
Skupnosti 10.
prohibitions or restrictions may be justified on grounds of ‘the protection of health and life of humans, animals or plants’.
Vendar je v členu 30 ES dopu�čena možnost prepovedi ali omejitev, ki jih utemeljujejo razlogi ”varovanja zdravja in življenja ljudi, živali ali rastlin“.
The Court has also stated that protection of the environment is a mandatory requirement which may limit the scope of Article 28 EC.
Sodi�če je tako navedlo, da varstvo okolja pomeni nujno zahtevo, ki lahko omeji uporabo člena 28 ES 11.
11 However, the principle of proportionality, which underpins the last sentence of Article 30 EC, requires that the power of Member States to prohibit imports of products from other Member States be restricted to what is necessary for the attainment of legitimately pursued health protection objectives. 12
Vendar načelo sorazmernosti, ki je temelj zadnjega stavka člena 30 ES, zahteva, da se možnost držav članic, da prepovejo uvoz blaga iz drugih držav članic, omeji na tisto, kar je nujno za dosego legitimno zasledovanih ciljev varovanja zdravja 12.
The Netherlands Government agrees with the arguments advanced by the French Government and considers that the requirement of common origin is in accord with the principle of proportionality.
Nizozemska vlada se strinja s trditvami francoske vlade in meni, da je zahteva skupnega izvora v skladu z načelom sorazmernosti.
The Netherlands Government also submits that data protection will be not effective if common origin cannot be used as a criterion and argues that, if that requirement is not retained, the risks of trafficking in plant protection products, already significant, will be even greater.
Nizozemska vlada prav tako zatrjuje, da varstvo podatkov ne bi bilo učinkovito, če skupni izvor ne bi mogel biti merilo, in poudarja, da bi bilo že tako veliko tveganje nedovoljenega prometa s fitofarmacevtskimi sredstvi �e večje, če ne bi bilo te zahteve.
While the directive provides that plant protection product marketing authorisations are issued by the Member States, the active substances must be authorised by the Commission and recorded on a list,
Čeprav direktiva določa, da DDP za fitofarmacevtska sredstva izdajo države članice, mora aktivne snovi odobriti Komisija in te morajo biti uvr�čene na seznam v Prilogi I
10 — Case 8/74 Dassonville [1974] ECR 837, and Case 120/78 Rewe-Zentral (‘Cassis de Dijon’), [1979] ECR 649.
837) in z dne 20. februarja 1979 v zadevi Rewe-Zentral, imenovana „Cassis de Dijon“ (120/78, Recueil, str. 649).
11 — Case 302/86 Commission v Denmark [1988] ECR 4607, paragraph 9.
4607, točka 9).
Thus, the obligation imposed by national legislation on manufacturers and importers, as part of a system under which the marketing of beer and soft drinks is authorised only in re-usable containers, to establish a deposit-and-return system for empty containers must be regarded as necessary to achieve the objectives pursued in relation to the protection of the environment so that the resulting restrictions on the free movement of goods cannot be regarded as disproportionate (paragraph 13).
Tako je treba obveznost proizvajalcev in uvoznikov – ki jo določa nacionalna zakonodaja v okviru ureditve za vzpostavitev sistema vračil kavcij in vračanja prazne embalaže, ki komercializacijo piva in osvežilnih pijač dovoljuje samo v embalaži, ki jo je mogoče ponovno uporabiti – obravnavati kot nujno za dosego ciljev, ki se jih zasleduje na področju varstva okolja, tako da omejitve, ki iz tega izhajajo za prosti pretok blaga, niso nesorazmerne (točka 13).
12 — Case 174/82 Sandoz [1983] ECR 2445, paragraph 18.
12 – Sodba z dne 14. julija 1983 v zadevi Sandoz (174/82, Recueil, str. 2445, točka 18).
Under Article 28 EC, quantitative restrictions on imports and all measures having equivalent effect are prohibited between Member States.
Na podlagi člena 28 ES so med državami članicami prepovedane količinske omejitve pri uvozu in vsi ukrepi z enakim učinkom.
Any measure which is capable of hindering, directly or indirectly, actually or potentially, intra-Community
Ukrep z enakim učinkom pomeni vsak ukrep, ki bi lahko neposredno ali posredno, dejansko ali potencialno oviral trgovino v
17 a maximum period of 12 years, the distribution of plant protection products containing constituents not specified in Annex I to the directive, provided that they have already been on the market two years after the date of notification of the directive.
Vendar lahko države članice v največ dvanajstih letih dovolijo distribucijo fitofarmacevtskih sredstev, ki vsebujejo sestavine, ki niso uvr�čene v Prilogo I k Direktivi, če so že v prometu dve leti po datumu notifikacije Direktive 14.
14 That period, which expired on 26 July 2003, has however been extended several times.
Ta rok, ki se je iztekel 26. julija 2003, pa je bil večkrat podalj�an.
The Commission has commenced a programme for the gradual examination, during this provisional phase, of the active substances in question 15and, after the appropriate assessment, for decision on their inclusion in Annex I to the directive. 16
V tem prehodnem obdobju je Komisija sprejela program za postopen pregled zadevnih aktivnih snovi 15in, po ustrezni presoji, za odločitev o njihovi uvrstitvi v Prilogo I k tej direktivi 16.
As has been stated in point 6 of this Opinion, the directive contains no provision governing the conditions for the grant of marketing authorisation for plant protection products 18 which are parallel imports.
Kot je navedeno v točki 6 teh sklepnih predlogov, v Direktivi ni nobene določbe, ki bi posebej urejala pogoje za pridobitev DDP za fitofarmacevtska sredstva 18pri vzporednih uvozih.
As the Court has stated, it is apparent from the reasons underlying Directive 91/414 that it has the objective, firstly, of removing
Kot je navedlo Sodi�če, iz obrazložitve Direktive 91/414 izhaja, da je njen namen
13 — The use of plant protection products was regulated for the first time in 1979 by Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (OJ 1979 L 33, p. 36).
13 – Uporaba fitofarmacevtskih sredstev je bila prvič urejena leta 1979 z Direktivo Sveta 79/117/EGS z dne 21. decembra 1978 o prepovedi prometa in uporabe fitofarmacevtskih sredstev, ki vsebujejo nekatere aktivne snovi (UL 1979, L 33, str. 36).
That directive determined at that time the list of products presenting, or likely to present, a risk to human or animal health and the use of which was prohibited on Community territory.
Ta direktiva je takrat določala seznam sredstev, ki pomenijo ali ki bi lahko pomenila tveganje za zdravje ljudi in živali in katerih uporaba je na ozemlju Skupnosti prepovedana.
Since then, the original list of those prohibited products has been amended several times to take account of technical and scientific progress.
Od tedaj je bil prvotni seznam teh prepovedanih sredstev večkrat spremenjen zaradi upo�tevanja tehničnega in znanstvenega napredka.
With the coming of the Single Market, Directive 79/117/EEC was replaced by Directive 91/414.
S približevanjem k enotnemu trgu je Direktivo 79/117 nadomestila Direktiva.
The latter directive sets up an overall framework of harmonisation which allows the free movement of goods to be safeguarded while at the same time ensuring the safety of plant protection substances with regard to the need to protect the environment and public health.
Zadnjenavedena direktiva določa splo�ni okvir za usklajevanje, ki omogoča zagotovitev prostega pretoka živil, s tem da se zagotovi ne�kodljivost fitofarmacevtskih sredstev ob upo�tevanju potrebe po varstvu okolja in varovanju javnega zdravja.
The directive provides for approval of active substances at European level in order to eliminate the diversity of the national procedures for the approval of plant protection products which were in force until then.
Določa homologacijo aktivnih snovi na evropski ravni, da bi preprečila različne nacionalne postopke homologacije fitofarmacevtskih sredstev, ki so veljali do zdaj.
Those active substances are to be recorded on a list, to be found in Annex I of the directive.
Te aktivne snovi bodo torej uvr�čene na seznam v Prilogi I k Direktivi.
A programme was launched to allow assessment of all the substances currently traded in the Member States and when appropriate to include them in the list of authorised substances (see Talbot-Rochdi, G. Politique agricole commune — Régime juridique des produits agroalimentaires’ Jurisclasseur Europe, fascicule 1326, paragraph 143 et seq.).
Uveden je bil program, ki omogoča presojo vseh snovi, ki se trenutno tržijo v državah članicah, in po potrebi vključitev na seznam dovoljenih snovi (glej Talbot-Rochdi, G., „Politique agricole commune – Régime juridique des produits agroalimentaires“, JurisClasseur Europe, zvezek 1326, točka 143 in naslednje).
14 — Article 8(2), first paragraph, of the directive.15 — Second paragraph of Article 8(2).16 — Fourth paragraph of Article 8(2).
14 – Člen 8(2), prvi pododstavek, navedene direktive.15 – Drugi pododstavek istega člena.16 – Četrti pododstavek navedenega člena.
The Court, in British Agrochemicals, 19cited above, has stated that, where two marketing authorisations are granted in accordance with the directive, the objectives which it pursues as to protection of human and animal health and of the environment do not call for the same treatment.
Sodi�če je v zgoraj navedeni sodbi British Agrochemicals Association 19 navedlo, da če obstajata dve DDP, izdani v skladu z Direktivo, ciljev varovanja zdravja ljudi in živali ter varstva okolja, ki ju zasleduje Direktiva, ni treba upo�tevati enako.
In such a situation, application of the directive’s provisions concerning the procedure for the grant of marketing authorisation would go beyond what is necessary to achieve those objectives and could, without justification, run counter to the principle of the free movement of goods laid down in Article 28 of the Treaty. 20
V takem primeru naj bi namreč uporaba določb te direktive v zvezi s postopkom izdaje DDP presegala, kar je nujno za dosego njenih ciljev, in bi lahko neutemeljeno kr�ila načelo prostega pretoka blaga, navedenega v členu 28 ES 20.