natgillin/translations-raw huggingface dataset:
In those circumstances, and without it being necessary to consider the principle of the protection of legitimate expectations, the principle of legal certainty not only permits but also requires that the termination of such a concession be coupled with a transitional period which enables the contracting parties to untie their contractual relations on acceptable terms both from the point of view of the requirements of the public service and from the economic point of view.
V teh okoli�činah in ne da bi bilo treba postavljati pod vpra�aj načelo legitimnih pričakovanj, načelo pravne varnosti ne le omogoča, ampak tudi določa, da mora biti za odpoved take koncesije določeno prehodno obdobje, ki sopogodbenikom omogoča ureditev njihovih pogodbenih razmerij ob sprejemljivih pogojih tako z vidika zahtev javnih služb kot z gospodarskega vidika.
It is for the referring court to determine whether, in particular, the extension of the length of the transitional period, brought about by legislation such as that at issue in the main proceedings, can be regarded as being necessary to comply with the principle of legal certainty.
Predložitveno sodi�če mora presoditi, ali je mogoče zlasti podalj�anje prehodnega obdobja na podlagi ureditve, kot je ta v postopku v glavni stvari, �teti za potrebno, da bi se spo�tovalo načelo pravne varnosti.
The reply to the first and second questions must therefore be that Articles 43 EC, 49 EC and 86(1) EC do not preclude legislation of a Member State, such as that at issue in the main proceedings, which provides for the extension, on conditions which it lays down, of the length of the transitional period at the end of which the early cessation of a concession for the distribution of natural gas such as that in question in those proceedings must occur, provided that such an extension can be regarded as being necessary to enable the contracting parties to untie their contractual relations on acceptable terms both from the point of view of the requirements of the public service and from the economic point of view.
Na prvo in drugo vpra�anje je torej treba odgovoriti tako, da členi 43 ES, 49 ES in 86(1) ES ne nasprotujejo temu, da ureditev države članice, kot je ta v postopku v glavni stvari, določa podalj�anje – pod pogoji, ki so določeni v tej ureditvi – prehodnega obdobja, v katerem mora priti do predčasnega poteka koncesije za distribucijo zemeljskega plina, kot je ta v postopku v glavni stvari, če je mogoče �teti, da je to podalj�anje potrebno, da bi se sopogodbenikom omogočila ureditev njihovih pogodbenih razmerij ob sprejemljivih pogojih tako z vidika zahtev javnih služb kot z gospodarskega vidika.
Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas and repealing Directive 98/30/EC does not preclude legislation of a Member State, such as that at issue in the main proceedings, from providing for the extension, on conditions which it lays down, of the length of the transitional period at the end of which the early cessation of a concession for the distribution of natural gas such as that in question in those proceedings must occur.
Direktiva Evropskega parlamenta in Sveta 2003/55/ES z dne 26. junija 2003 o skupnih pravilih notranjega trga z zemeljskim plinom in o razveljavitvi Direktive 98/30/ES ne nasprotuje temu, da ureditev države članice, kot je ta v postopku v glavni stvari, določa podaljšanje – pod pogoji, ki so določeni v tej ureditvi – prehodnega obdobja, v katerem mora priti do predčasnega poteka koncesije za distribucijo zemeljskega plina, kot je ta v postopku v glavni stvari.
In those circumstances, it must also be held that neither Article 10 EC nor the principle of proportionality precludes such legislation.
V teh okoliščinah je treba tudi šteti, da člen 10 ES in načelo sorazmernosti ne nasprotujeta taki ureditvi.
Articles 43 EC, 49 EC and 86(1) EC do not preclude legislation of a Member State, such as that at issue in the main proceedings, from providing for the extension, on conditions which it lays down, of the length of the transitional period at the end of which the early cessation of a concession for the distribution of natural gas such as that in question in those proceedings must occur, provided that such an extension can be regarded as being necessary to enable the contracting parties to untie their contractual relations on acceptable terms both from the point of view of the requirements of the public service and from the economic point of view.
Členi 43 ES, 49 ES in 86(1) ES ne nasprotujejo temu, da ureditev države članice, kot je ta v postopku v glavni stvari, določa podaljšanje – pod pogoji, ki so določeni v tej ureditvi – prehodnega obdobja, v katerem mora priti do predčasnega poteka koncesije za distribucijo zemeljskega plina, kot je ta v postopku v glavni stvari, če je mogoče šteti, da je to podaljšanje potrebno, da bi se sopogodbenikom omogočila ureditev njihovih pogodbenih razmerij ob sprejemljivih pogojih tako z vidika zahtev javnih služb kot z gospodarskega vidika.
(Reference for a preliminary ruling from the Verwaltungsgericht Köln)
(Predlog za sprejetje predhodne odločbe, ki ga je vložilo Verwaltungsgericht Köln)
Opinion of Advocate General Mazák delivered on 16 January 2008 . . . . . .
Mazáka, predstavljeni 16. januarja 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Judgment of the Court (First Chamber), 17 July 2008 . . . . . . . . . . . .
Sodba Sodi�ča (prvi senat) z dne 17. julija 2008 . . . . . . . . . . . . . . .
Agriculture — Uniform legislation — Maximum residue limits of veterinary medicinal products in foodstuffs of animal origin — Determination procedure — Regulation No 2377/90
Kmetijstvo – Enotna zakonodaja – Najvišje mejne vrednosti ostankov zdravil v živilih živalskega izvora – Postopek določitve – Uredba št. 2377/90
(Council Regulation No 2377/90, Annex II; Commission Regulation No 1873/2003; Council Directive 96/22)
(Uredba Sveta št. 2377/90, priloga II; Uredba Komisije št. 1873/2003; Direktiva Sveta 96/22)
SUMMARY — CASE C-448/06 so that a total prohibition on marketing that substance following its inclusion in Annex IV to that regulation would be disproportionate.
POVZETEK – ZADEVA C-448/06 povzroči tveganja za javno zdravje, tako da bi bila popolna prepoved dajanja te snovi na trg zaradi vključitve te snovi v prilogo IV k tej uredbi nesorazmerna.
That conclusion is in no way called into question by the provisions of Directive 96/22 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of Betaagonists, as amended by Directive 2003/74, which allow Member States to authorise the administration of progesterone by intramuscular injection.
Tega sklepa nikakor ne izpodbijajo določbe Direktive 96/22 o prepovedi uporabe v živinoreji določenih snovi, ki imajo hormonalno ali tirostatično delovanje, in beta-agonistov, kot je bila spremenjena z Direktivo 2003/74, na podlagi katerih je dovoljeno dajanje progesterona z intramuskularno injekcijo.
The conditions under which Article 4 of that directive allows Member States to authorise the administration of progesterone to farm animals include that of compliance with the requirements relating to placing on the market laid down in Dir -ective 81/851, which was repealed subsequently by Directive 2001/82 on the Community code relating to veterinary medicinal products.
Med pogoji, od katerih je v skladu s členom 4 te direktive odvisna možnost držav članic, da dovolijo dajanje progesterona farmskim živalim, je namreč spo�tovanje zahtev glede dajanja v promet, določenih v Direktivi 81/851, ki je bila nato spremenjena z Direktivo 2001/82 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini.
That provision, read in conjunction with Article 6 of Directive 2001/82, permits Member States to authorise administration of progesterone to farm animals only if that substance is included in Annex I, II or III to Regulation No 2377/90 in accordance with the provisions thereof.
Ta določba v povezavi s členom 6 Direktive 2001/82 državam članicam omogoča, da dajanje progesterona farmskim živalim dopustijo le, če je ta snov vključena v priloge I, II ali III k Uredbi �t. 2377/90 v skladu z njenimi določbami.
Although it is true that Article 3 of Regulation No 2377/90 does not expressly provide for the possibility of including a substance in Annex II thereto for only some of its methods of administration, that fact cannot prevent the Commission from nevertheless making such an inclusion.
Čeprav je namreč res, da člen 3 Uredbe �t. 2377/90 ne določa izrecno možnosti, da bi se snov v prilogo II k tej uredbi vključila le za določene načine dajanja, ta okoli�čina ne more izključiti, da lahko Komisija vseeno vključi to snov.
That approach may appear particularly appropriate where, on the one hand, the substance in question cannot be included in Annex I or III to that regulation, but where, on the other, certain limitations on the methods of administration of that substance can make it possible to ensure that the presence of residues in animal tissue does not constitute a risk for human health,
Ta pristop se lahko zdi zlasti primeren, če po eni strani zadevne snovi ni mogoče vključiti v prilogo I ali III k tej uredbi, čeprav se lahko po drugi strani z določenimi omejitvami načina dajanja te snovi zagotovi, da prisotnost ostankov v živalskem tkivu ne
(see paras 31, 34, 42, 43, 45)
(Glej točke 31, 34, 42, 43 in 45.)
OPINION OF ADVOCATE GENERALMAZÁK delivered on 16 January 2008 1 terone ad us. vet’ in the form of a solution for intramuscular injection.
SKLEPNI PREDLOGI GENERALNEGA PRAVOBRANILCAJÁNA MAZÁKA, predstavljeni 16. januarja 2008 1 obliki raztopine za intramuskularno aplikacijo (injekcijo).
A — Regulation No 2377/90
A – Uredba št. 2377/90
The preliminary reference arose in an action brought by cp-Pharma Handels GmbH (hereinafter ‘cp-Pharma’) against the competent national authorities following the revocation of its marketing authorisation for the veterinary medicinal product ‘proges-
Vpra�anje za predhodno odločanje je bilo postavljeno v okviru tožbe, ki jo je vložilo cp-Pharma Handels GmbH (v nadaljevanju: cp-Pharma) zoper pristojne nacionalne organe zaradi odvzema dovoljenja za promet z zdravilom za uporabo v veterinarski medicini „progesteron za uporabo v veterini“ v
Article 1(1)(a) of Regulation No 2377/90 provides that ‘“residues of veterinary medicinal products”: means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the vet -erinary medicinal product in question has been administered’.
Člen 1(1)(a) Uredbe �t. 2377/90 določa, da „ostanki zdravil za uporabo v veterinarski medicini“ pomenijo vse farmakolo�ko aktivne snovi, bodisi zdravilne učinkovine, pomožne snovi bodisi produkte razgradnje in njihove metabolite, ki ostanejo v živilih, pridobljenih iz živali, ki so prejemale zadevna zdravila za uporabo v veterinarski medicini.
Article 1(1)(b) of Regulation No 2377/90 provides that the ‘“maximum residue limit”: means the
Člen 1(1)(b)
— Annex IV is reserved for substances for which no MRL can be established because residues of such substances constitute a threat to consumer health in any amount (Article 5).
V Prilogi IV so navedene snovi, za katere se NMVO ne sme določiti, ker ostanki te snovi v vseh količinah pomenijo tveganje za zdravje potro�nika (člen 5).
Articles 2 to 5 of Regulation No 2377/90 provide for four annexes to be drawn up in which pharmacologically active substances, intended for use in veterinary medicines to be administered to foodproducing animals, may be included:
Členi 2, 3, 4 in 5 Uredbe �t. 2377/90 določajo, da se v �tiri priloge, v katerih so navedeni seznami farmakolo�ko aktivnih snovi, ki se jih namerava uporabiti v veterinarski medicini za dajanje snovi živalim za proizvodnjo živil, lahko vključi:
— Annex I is reserved for substances for which an MRL may be established following an assessment of the risks which the substance presents to human health (Article 2);
V Prilogi I so navedene snovi, za katere se lahko določi NMVO po presoji tveganja, ki ga snov prina�a za zdravje ljudi (člen 2);
— Annex II is reserved for substances in respect of which it does not appear necessary, for the protection of public health, to fix an MRL (Article 3); 5
V Prilogi II so navedene snovi, za katere za varovanje javnega zdravja ni treba določiti NMVO (člen 3); 5
— Annex III is reserved for substances for which it is not possible to establish an MRL definitively but for which, without compromising consumer health, a
V Prilogi III so navedene snovi, za katere ni mogoče dokončno določiti NMVO, ampak se lahko, ne da bi bilo ogroženo zdravje potro�nikov, določi NMVO za
5 — Article 3 of Regulation No 2377/90 provides that ‘[w]here, following an evaluation of a pharmacologically active substance used in veterinary medicinal products, it appears that it is not necessary for the protection of public health to establish a maximum residue limit, that substance shall be included in a list in Annex II …’.
5 – Člen 3 Uredbe �t. 2377/90 (EGS) določa, da „[k]adar se po presoji farmakolo�ko aktivne snovi, ki se uporablja v zdravilih za uporabo v veterinarski medicini, pokaže, da za za�čito javnega zdravja ni treba določiti najvi�je mejne vrednosti ostankov, se tak�na snov vključi v seznam v Prilogi II“.
The substances in question included progesterone.
Mnenju je dano poročilo, v katerem je opisana ocena varnosti snovi odbora, ki da razloge za svoj sklep.“
Article 7(6) of Regulation No 2377/90 provides that ‘[t]he Commission shall prepare draft measures taking account of Community legislation and shall start the procedure provided for in Article 8. …’
Člen 7(6) Uredbe �t. 2377/90 določa, da „Komisija pripravi osnutek ukrepov, ki upo�tevajo zakonodajo Skupnosti in začne s postopkom, predvidenim v členu 8“.
Article 15 of Regulation No 2377/90 provides, inter alia, that that regulation ‘shall in no way prejudice the application of Community legislation prohibiting the use in livestock farming of certain substances having a hormonal action’.
Člen 15 Uredbe �t. 2377/90 inter alia določa, da ta uredba „na noben način ne posega v uporabo zakonodaje Skupnosti, ki prepoveduje uporabo nekaterih snovi s hormonskim delovanjem v živinoreji“.
Article 8(1) of Regulation No 2377/90 provides that ‘[t]he Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products’ (hereinafter ‘the Standing Committee’).
Člen 8(1) Uredbe �t. 2377/90 določa: „[K]omisiji pomaga Stalni odbor za zdravila za uporabo v veterinarski medicini“ (v nadaljevanju: Stalni odbor).
In its original version, Article 14 of Regulation No 2377/90 provided as follows:
Člen 14 Uredbe �t. 2377/90 v izvirni različici določa:
Article 3(a) of Directive 96/22, as amended by Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 amending Council Directive 96/22/EC, 8requires Member States, inter alia, to provisionally prohibit the administration to farm animals of substances having a gestagenic action, of which progesterone is one.
Člen 3(a) Direktive 96/22, kot je bila spremenjena z Direktivo 2003/74/ES Evropskega parlamenta in Sveta z dne 22. septembra 2003 o spremembi Direktive Sveta 96/22/ES, 8zahteva, da države članice inter alia začasno prepovejo dajanje snovi domačim živalim z gestagenim delovanjem, med katere se uvr�ča progesteron.
‘With effect from 1 January 1997, the administration to foodproducing animals of vet -erinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II or III shall be prohibited within the Community …’
„Od 1. januarja 1997 se za živali za proizvodnjo živil v Skupnosti prepove uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo farmakolo�ko aktivne snovi, ki niso navedene v Prilogi I, II ali III …“
7 — Regulation … laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ 1997 L 67, p. 1).
7 – Uredba (…) o določitvi postopka Skupnosti za določitev najvi�jih dovoljenih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora (UL L 67, str. 1).
8 — Directive … concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (OJ 2003 L 262, p. 17).
8 – Direktiva Evropskega parlamenta in Sveta 2003/74/ES z dne 22. septembra 2003 o spremembi Direktive Sveta 96/22/ES o prepovedi uporabe v živinoreji določenih snovi, ki imajo hormonalno ali tirostatično delovanje, in beta-agonistov (UL L 262, str. 17).
Article 4(1) of Directive 96/22, as amended, provides, inter alia, that notwithstanding the terms of Article 3, Member States may authorise the administering to farm animals, for therapeutic purposes, of progesterone.
Člen 4(1) Direktive �t. 96/22 inter alia določa, da smejo države članice kljub členu 3 dovoliti dajanje progesterona živalim na kmetiji za terapevtske namene.
That provision also provides that veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Council Directive 81/851/EEC.
Po tej določbi morajo biti zdravila za uporabo v veterinarski medicini, ki se uporabljajo za zdravljenje, v skladu z zahtevami v prometu, predpisanimi v Direktivi 81/851/EGS.
9Moreover, veterinary medicinal products may only be administered by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified.
9 Zdravila lahko da samo veterinar, z injekcijo ali v obliki nožničnih spiral pri zdravljenju disfunkcije jajčnikov, ni pa dovoljeno dajanje zdravil v obliki podkožnih vsadkov živalim na kmetiji, ki so bile nedvoumno identificirane.
Treatment of identified animals must be registered by the vet -erinarian responsible.
Zdravljenje identificiranih živali mora evidentirati odgovorni veterinar.
Article 7(1) of Regulation No 178/2002 provides that:
Člen 7(1) Uredbe �t. 178/2002 določa:
C — Regulation No 1873/2003
1873/2003 je spremenil Prilogo II k Uredbi �t. 2377/90 s tem, da je v to prilogo vključil farmakolo�ko aktivno snov progesteron glede samic goveda, ovc, koz in kopitarjev.
‘In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment.’
„V nekaterih primerih, kadar je po oceni razpoložljivih informacij ugotovljena možnost neželenih učinkov na zdravje, obstaja pa znanstvena negotovost, se lahko sprejmejo začasni ukrepi za obvladovanje tveganja za zagotovitev visoke ravni varovanja zdravja, ki jo je Skupnost izbrala, dokler niso na voljo nadaljnje znanstvene informacije za bolj izčrpno oceno tveganja.“
The inclusion of the active substance progesterone in Annex II to Regulation No 2377/90 was qualified by a note or
Vključitev aktivne snovi progesteron v Prilogo II k Uredbi �t. 2377/90 je bila opredeljena z opombo, označeno z zvezdico (*), in
9 — Directive of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p. 1).
9 – Direktiva Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic glede zdravil za uporabo v veterinarski medicini (UL L 317, str. 1).
10 — Regulation of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1).
10 – Uredba (ES) �t. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splo�nih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane (UL L 31, str. 1).
II — Relevant national law
II – Upoštevno nacionalno pravo
III — Legislative history leading to the adoption of Regulation No 1873/2003
III – Zgodovina zakonodaje pred sprejetjem Uredbe št. 1873/2003
The first sentence of Paragraph 30(1) of the Law on Medicinal Products in the version published on 11 December 1998 (BGBl. 1998 I, p. 3586) (Arzneimittelgesetz) (‘AMG’) provides:
Prvi stavek člena 30(1) zakona o zdravilih v različici, objavljeni 11. decembra 1998 (BGBl. 1998 I, str.
‘An authorisation shall be withdrawn if it subsequently becomes known that one of the grounds for refusal under Paragraph 25(2)(2), (3), (5), (5a), (6) or (7) existed at the time of issue; an authorisation must be revoked where one of the grounds for refusal under Paragraph 25(2)(3), (5), (5a), (6) or (7) subsequently arises.’
„Dovoljenje se ne izda, če so v času izdaje obstajali razlogi za zavrnitev iz člena 25(2), točke 2, 3, 5, 5a, 6 ali 7; dovoljenje je treba preklicati, če nastanejo razlogi za zavrnitev iz člena 25(2), točke 3, 5, 5a, 6 ali 7.“
Paragraph 25(2)(7) of the AMG states:
Člen 25(2), točka 7, AMG določa:
In 1993 an application for the establishment of an MRL for progesterone in cattle and horses was submitted to the Commission.
Leta 1993 je bila pri Komisiji vložena vloga za določitev NMVO za progesteron za govedo in konje.
In October 1996, the Committee recommended that progesterone be included in Annex II to Regulation No 2377/90.
Oktobra 1996 je Odbor priporočil vključitev progesterona v Prilogo II k Uredbi �t. 2377/90.
In April 1997, the Commission sent new scientific information to the Agency and requested a re-assessment of the risks relating, inter alia, to progesterone.
Aprila 1997 je Komisija Agenciji poslala nov znanstveni podatek in zahtevala ponovno presojo tveganj, povezanih inter alia s progesteronom.
In April 1998, the Commission requested the Agency that the Committee should have the possibility to take account of scientific information which was to become available in the course of 1998 from a number of sources and the results of a number of specific studies commissioned by the Commission.
Aprila 1998 je Komisija EMEI poslala dopis s pro�njo, da bi Odbor lahko upo�teval znanstvene podatke, ki naj bi bili na voljo leta 1998 in naj bi prihajali iz več virov, ter izsledke več posebnih �tudij, ki jih je naročila Komisija.
In April 1999, the Commission asked the Agency to update the evaluation the former had requested in 1997 of progesterone.
Aprila 1999 je Komisija od Agencije zahtevala, naj posodobi presojo, ki jo je leta 1997 zahtevala za progesteron.
On 30 April 1999, the Scientific Committee on Veterinary Measures Relating to Public Health (‘the SCVPH’) issued a report which concluded, inter alia, that no acceptable daily intake could be established for the hormone progesterone.
Znanstveni odbor za veterinarske ukrepe v zvezi z javnim zdravstvom (Scientific Committee on Veterinary Measures Relating to Public Health, v nadaljevanju: SCVPH) je 30. aprila 1999 izdal poročilo, v katerem je bilo zapisano, inter alia, da se za progesteron ne more določiti sprejemljivega dnevnega vnosa.
In December 1999, the Committee confirmed its earlier opinion recommending that progesterone be included in Annex II to Regulation No 2377/90.
Decembra 1999 je Odbor potrdil svoje prej�nje mnenje, v katerem je priporočil vključitev progesterona v Prilogo II k Uredbi �t. 2377/90.
On 3 May 2000, the SCVPH adopted a re-evaluation of its opinion of April 1999.
SCVPH je 3. maja 2000 sprejel ponovno presojo njegovega mnenja, ki ga je izdal aprila 1999.
In its re-evaluation the SCVPH concluded that recent scientific information did not provide convincing data or arguments making a revision of its previous conclusions necessary.
V svoji ponovni presoji je SCVPH sklenil, da nedavni znanstveni podatek ni predložil prepričljivih podatkov ali argumentov, zaradi katerih bi bila potrebna revizija prej�njih sklepov.