natgillin/translations-raw huggingface dataset:
By derogation and in a limited number of cases, Article 4(1) of Directive 96/22 states that Member States may authorise ‘the administering to farm animals, for therapeutic purposes, of …, testosterone and progesterone … 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 [of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1981 L 317, p.
Ne glede na to in v določenih primerih člen 4, točka 1, Direktive 96/22 določa, da smejo države članice dovoliti „dajanje živalim na kmetiji, za terapevtske namene, testosterona in progesterona […]. Zdravila za uporabo v veterinarski medicini, ki se uporabljajo za zdravljenje, morajo biti v skladu z zahtevami v prometu, predpisanimi v Direktivi [Sveta] 81/851/EGS [z dne 28. septembra 1981 o približevanju zakonodaj držav članic glede zdravil za uporabo v veterinarski medicini (UL L 317, str.
1)] and be administered only 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. …’.
1)], in jih lahko da samo veterinar, z injekcijo ali v obliki nožničnih spiral pri zdravljenju disfunkcije jajčnikov, ni pa dovoljeno dajanje zdravil v obliki podkožnih vstavkov živalim na kmetiji, ki so bile nedvoumno identificirane […]“.
Article 6 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p.
Člen 6 Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, str.
1) provides:
1) določa:
2008 — CASE C-448/06 active substances which it contains must be shown in Annex I, II or III of Regulation … No 2377/90.’
„Da bi zdravilo za uporabo v veterinarski medicini, namenjeno živalim za proizvodnjo živil, lahko pridobilo dovoljenja za promet, morajo biti zdravilne učinkovine, ki jih to zdravilo vsebuje, navedene v prilogah I, II ali III k Uredbi […] �t. 2377/90.“
Article 96 of Directive 2001/82 provides:
Člen 96 Direktive 2001/82 določa:
‘[Directives] 81/851/EEC, 81/852/EEC, 90/677/EEC and 92/74/EEC … are repealed …
„Direktive 81/851/EGS, 81/852/EGS, 90/677/EGS ter 92/74/EGS […] se razveljavijo […].
The reference made to the said Repealed Directives shall be construed as references to this Directive …’
Sklicevanja na navedene razveljavljene direktive se razumejo kakor sklicevanja na to direktivo […]“
The first sentence of Paragraph 30(1) of the German Law on medicinal products (Arzneimittelgesetz), in the version published on 11 December 1998 (BGBl. 1998 I, p.
Člen 30(1) nem�kega zakona o zdravilih (Arzneimittelgesetz), v različici, ki je bila objavljena 11. decembra 1998 (BGBl. 1998 I, str.
3586; ‘the AMG’), provides:
3586, v nadaljevanju: AMG), določa:
‘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 […] je treba preklicati, če naknadno nastane eden od razlogov za zavrnitev iz člena 25(2), točke 3, 5, 5a, 6 ali 7.“
Paragraph 25(2)(7) of the AMG provides:
Člen 25(2), točka 7, AMG določa:
‘The competent higher federal authority may refuse to grant an authorisation only if
„Pristojni vi�ji zvezni organ lahko dovoljenje zavrne le,
7. the marketing of the medical product or its administration to animals would contravene legal provisions or a regulation, directive or decision of the Council or Commission …’
7. če bi dajanje zdravila v promet ali dajanje tega zdravila živalim nasprotovalo zakonskim določbam ali uredbi, direktivi ali odločbi Sveta ali Komisije Evropskih skupnosti […]“
On 16 February 1999, cp-Pharma obtained an extension of the marketing authorisation for the veterinary medicinal product ‘progesterone ad us. vet’ for a period of five years.
Družbi cp-Pharma je bilo 16. februarja 1999 dovoljenje za to, da daje v promet zdravilo „progesteron za uporabo v veterini“, podalj�ano za pet let.
That authorisation concerned a solution for intramuscular injection, the active substance of which is progesterone, to be administered in cases of follicle cysts and ‘nymphomania caused by follicle cysts’.
To dovoljenje se je nana�alo na raztopino za intramuskularno aplikacijo (injekcijo) z aktivno snovjo progesteron, ki se uporabi v primerih „folikularnih cist“ in „nimfomanije, ki jo povzročijo folikularne ciste“.
By decision of 22 January 2004, the competent authority revoked the marketing authorisation on the ground that progesterone was listed in Annex II to Regulation No 2377/90 for administration only via the intravaginal route.
Z odločbo z dne 22. januarja 2004 je pristojni organ preklical dovoljenje za dajanje v promet na podlagi tega, da se v skladu s prilogo II k Uredbi �t. 2377/90 progesteron lahko uporablja le intravaginalno.
According to that authority, since no MRL has been established for other applications, the prohibition set out in Article 14 of that regulation applied to that medicinal product and therefore the authorisation had to be revoked.
Ta organ meni, da ker za ostale uporabe tega zdravila za uporabo v veterinarski medicini niso bile določene NMVO, je za to zdravilo veljala prepoved iz člena 14 te uredbe in je treba dovoljenje za promet za to zdravilo torej preklicati.
Following the rejection of its objection to that decision to revoke the authorisation, cp-Pharma brought an action before the referring court seeking annulment of that decision on the ground that the Commission had disregarded the recommendation of the CVMP, which asked it to include progesterone in Annex II to Regulation No 2377/90 without limiting its use to intravaginal administration.
Potem ko ji je bila zavrnjena pritožba zoper to odločbo o preklicu, je družba cp-Pharma pri predložitvenemu sodi�ču vložila tožbo, s katero je predlagala razglasitev ničnosti te odločbe, ker Komisija ni upo�tevala mnenja CMV, ki jo je pozval k vključitvi progesterona v prilogo II k Uredbi �t. 2377/90, ne da bi bila določena omejitev te snovi le za intravaginalno uporabo.
Moreover, such a possibility appears, mutatis mutandis, to have been excluded by the Court in Case C-32/00 P Commission v Boehringer [2002] ECR I-1917, paragraph 55, in which it held that, where the substance in question is entered in Annex III to that regulation, the only limitation on the validity of an MRL envisaged by that regulation concerns the indication of the limited duration of its validity.
Sicer se zdi, da je Sodi�če to možnost mutatis mutandis izključilo v točki 55 sodbe z dne 26. februarja 2002 v zadevi Komisija proti Boehringer (C-32/00 P, Recueil, str. I-1917), ker je presodilo, da če gre za snov, ki je vključena v prilogo III k tej uredbi, se edina omejitev glede veljavnosti NMVO, ki jo ta določa, nana�a na določitev omejenega trajanja te veljavnosti.
The referring court observes, in addition, that the CVMP had proposed that progesterone be entered in Annex II to Regulation No 2377/90 without any restrictions, as the risks to health through progesterone residues were estimated to be minimal.
Predložitveno sodi�če ugotavlja tudi, da je CMV predlagal, da se progesteron vključi v prilogo II k Uredbi �t. 2377/90, saj je menilo, da so zdravstvena tveganja zaradi ostankov zelo majhna.
Finally, that court notes that the provisions of Directive 96/22, establishing measures to avoid any misuse in the administration of progesterone as a veterinary medicinal product, provide expressly that that substance may be administered by injection.
Nazadnje, to sodi�če ugotavlja, da določbe Direktive 96/22, ki določajo ukrepe za preprečevanje zlorab pri dajanju progesterona kot zdravila za uporabo v veterinarski medicini, izrecno določajo, da se to snov lahko da z injekcijo.
Having regard to the foregoing, the Verwaltungsgericht Köln decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling:
Glede na te ugotovitve je Verwaltungsgericht Köln prekinilo odločanje in Sodi�ču v predhodno odločanje predložilo to vpra�anje:
Cp-Pharma and the Polish Government take the view, contrary to that of the Greek Government and the Commission, that Regulation No 1873/2003 is invalid in that Regulation No 2377/90 does not expressly authorise the Commission to establish an MRL solely for certain methods of administration of progesterone and Direct- ive 96/22 permits Member States to authorise marketing of that substance in injectable form.
1873/2003 neveljavna, ker naj Komisiji v skladu z Uredbo �t. 2377/90 ne bi bilo izrecno dovoljeno, da določi NMVO le za določene načine dajanja progesterona, in ker naj bi bilo državam članicam v skladu z Direktivo 96/22 dopu�čeno, da dovolijo prodajo te snovi v obliki, ki se jo da z injekcijo.
Cp-Pharma adds that, in any event, the Commission could not adopt a measure concerning the MRL for progesterone which contradicts the opinion of the CVMP, while the Polish Government submits that Regulation No 1873/2003 is insufficiently reasoned with regard to the grounds on which the Commission decided not to follow that opinion.
Družba cp-Pharma dodaja, da Komisija v nobenem primeru ni mogla sprejeti ukrepa glede NMVO za progesteron, ki je v nasprotju z mnenjem CMV, medtem ko poljska vlada zatrjuje, da Uredba �t. 1873/2003 ni dovolj obrazložena, saj niso navedeni razlogi, zaradi katerih se je Komisija odločila, da ne upo�teva tega mnenja.
In order to answer the question referred by the national court, it is appropriate to note that, as the Court has already held in paragraph 80 of the judgment in Case C-198/03 P Commission v CEVA and Pfizer [2005] ECR I-6357, the Commission must be given a discretion which is sufficient to allow it to determine, on a fully informed basis, the measures that are necessary and appropriate for the protection of public health.
Za odgovor na vpra�anje, ki ga je zastavilo predložitveno sodi�če, je treba poudariti, da kot je Sodi�če že razsodilo v točki 80 sodbe z dne 12. julija 2005 v zadevi Komisija proti CEVA in Pfizerju (C-198/03 P, ZOdl., str. I-6357), mora biti Komisiji priznano dovolj �iroko pooblastilo za odločanje po prostem preudarku, ki ji omogoča ob popolnem poznavanju vzrokov določiti potrebne in varovanju javnega zdravja prilagojene ukrepe.
That is evidently all the more justified with regard to a file such as that concerning progesterone which, as the Court has already recognised, is particularly complex since it raises questions which are delicate and controversial from a scientific viewpoint (Commission v CEVA and Pfizer, paragraph 81).
To se zdi toliko bolj upravičeno pri snovi, kot je progesteron, za katero je Sodi�če že potrdilo, da je posebej zahtevna, saj z znanstvenega vidika poraja občutljiva in sporna vpra�anja (zgoraj navedena sodba Komisija proti CEVA in Pfizerju, točka 81).
That complexity is due to the fact that progesterone, in addition to therapeutic treatment, is liable to be used unlawfully as a growth stimulate and, currently, there are no reliable methods of analysis permitting distinction between endogenous progesterone, produced naturally by the animals, and exogenous progesterone, resulting from the administration of medicinal products, and therefore monitoring of the abusive use of that substance.
Ta zahtevnost je posledica dejstva, da se lahko progesteron, poleg terapevtskega zdravljenja, nezakonito uporablja kot pospe�evalec rasti in da v tem trenutku ni dovolj zanesljivih analitičnih metod, ki bi omogočale razlikovanje med endogenim progesteronom, ki ga naravno proizvajajo živali, in eksogenim progesteronom, ki nastane z dajanjem zdravil, in torej tudi nadzor zlorab pri uporabi te snovi.
Furthermore, the Commission, when it adopted Regulation No 1873/2003, was faced with a situation of ongoing scientific uncertainty with regard to the possible harmful effects of progesterone, characterised by divergent scientific opinions adopted by the CVMP, on the one hand, and by the SCVPH and other international scientific bodies, on the other (see, to that effect, Commission v CEVA and Pfizer, paragraph 82).
Poleg tega je bila Komisija ob sprejetju Uredbe �t. 1873/2003 soočena z dlje trajajočo znanstveno negotovostjo glede mogočih �kodljivih učinkov progesterona, ki so jo označevala nasprotja med znanstveno sprejetimi mnenji CMV na eni strani ter CSMVSP in drugimi mednarodnimi znanstvenimi organizacijami na drugi (glej v tem smislu zgoraj navedeno sodbo Komisija proti CEVA in Pfizerju, točka 82).
In such circumstances, it is necessary to ascertain whether the Commission has exceeded the limits of its discretion by providing for the inclusion of progesterone in Annex II to Regulation No 2377/90 only in respect of its intravaginal use.
V takih okoli�činah je treba preveriti, ali je Komisija s tem, da je vključila progesteron v prilogo II k Uredbi �t. 2377/90 le za intravaginalno uporabo, prekoračila meje odločanja po prostem preudarku.
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, as the Advocate General observed in point 52 of his Opinion, prevent the Commission from nevertheless making such an inclusion.
Čeprav je 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, kot je navedel generalni pravobranilec v točki 52 sklepnih predlogov, da lahko Komisija vseeno vključi to snov.
That approach may appear particularly appropriate where, as in the dispute in the main proceedings, the substance in question cannot be included in Annex I or III to that regulation, but where 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, so that a total prohibition on marketing that substance following its inclusion in Annex IV to that regulation would be disproportionate.
Ta pristop se lahko zdi prav posebno primeren, če po eni strani, kot v postopku v glavni stvari, zadevne snovi ni mogoče vključiti v prilogo I ali II k tej uredbi, čeprav se lahko po drugi strani z določenimi omejitvami načina dajanja te snovi zagotovi, da prisotnost ostankov v živalskem tkivu ne povzroči tveganja za javno zdravje, tako da bi bila popolna prepoved dajanja te snovi na trg zaradi vključitve te snovi v prilogo IV te uredbe nesorazmerna.
As is apparent from those observations, in the case of administration by intravaginal spiral, the concentration of progesterone in the body of the animal increases significantly, then falls rapidly without leaving significant residues when the spiral is removed, whereas administration by injection leaves long-lasting residues potentially dangerous to human health.
Kot izhaja iz teh stali�č, se pri dajanju v obliki nožničnih spiral koncentracija progesterona v telesu živali občutno poveča, nato pa se po odstranitvi spirale hitro zmanj�a, ne da bi povzročila večje ostanke, medtem ko dajanje z injekcijo povzroči dalj�o prisotnost, ki bi lahko bila nevarna za zdravje ljudi.
In those circumstances, having regard both to the extent of the Commission’s discretion and to all the factual circumstances in light of which Regulation No 1873/2003 was adopted, it does not appear that the approach followed by the Commission, taking account both of considerations of protection of human health and of requirements based on the principle of proportionality, disregarded the limits of the Commission’s discretion.
V teh okoli�činah se glede na obseg odločanja po prostem preudarku, ki ga ima Komisija, in glede na vse dejanske okoli�čine, glede katerih je bila sprejeta Uredba �t. 1873/2003, ne zdi, da bi Komisija s pristopom, ki je ustrezal tako pomislekom glede za�čite javnega zdravja kot zahtevam glede načela sorazmernosti, kr�ila omejitve pooblastila te institucije za odločanje po prostem preudarku.
Contrary to cp-Pharma’s submissions, the fact that the CVMP had recommended the inclusion of progesterone in Annex II to Regulation No 2377/90 without any restriction as to its method of administration is not such as to call that conclusion into question.
V nasprotju s tem, kar trdi družba cp-Pharma, okoli�čina, da je CMV priporočil vključitev progesterona v prilogo II k Uredbi �t. 2377/90 brez kakr�ne koli omejitve glede načina dajanja, ne more omajati tega sklepa.
In that regard, it is sufficient to note, firstly, that there is no provision of Regulation No 2377/90 which lays down that the opinions of the CVMP are binding and, secondly, that it follows expressly from the third recital in the preamble to that regulation that, in the course of establishing MRLs, the Commission must take account of any scientific assessment of the safety of the substances concerned which may have been undertaken by international organisations, in particular the Codex Alimentarius, or by other scientific committees established within the Community.
Glede tega je dovolj poudariti, da nobena določba Uredbe �t. 2377/90 ne določa, da so mnenja CMV zavezujoča, ter da iz tretje uvodne izjave te uredbe izrecno izhaja, da mora Komisija v okviru določanja NMVO upo�tevati vsako znanstveno presojo varnosti zadevnih snovi, ki jo izvedejo mednarodne organizacije, kot je Codex Alimentarius, ali drugi znanstveni odbori s sedežem v Skupnosti.
In other words, in the course of exercising its discretion, the Commission was in no way required to take account only of the opinion of the CVMP, which favoured
Z drugimi besedami, pri odločanju po prostem preudarku Komisija nikakor ni bila zavezana upo�tevati le mnenja CMV, ki je podprlo vključitev progesterona v prilogo
2008 — CASE C-448/06 inclusion of progesterone in Annex II to that regulation, but could legitimately base its decision on other information and scientific assessments, including the opinions of the SCVPH, which had pointed out the risks to human health resulting from the presence of residues of that substance in foodstuffs of animal origin.
II k tej uredbi, ampak se je lahko legitimno oprla na druge informacije in znanstvene presoje, vključno z mnenji CSMVSP, kjer so bila poudarjena tveganja za zdravje ljudi, ki nastanejo s prisotnostjo ostankov te snovi v živilih živalskega izvora.
Nor did the Commission, contrary to the submissions of the Polish Government, infringe the obligation to give reasons by not specifically mentioning the scientific data which led it not to follow the opinion of the CVMP and by not indicating the extent to which the data contradicted that opinion.
Komisiji, v nasprotju s tem, kar trdi poljska vlada, tudi ni mogoče očitati, da je s tem, da ni izrecno na�tela znanstvenih podatkov, zaradi katerih ni upo�tevala mnenja CMV, in s tem, da ni navedla, koliko ti podatki nasprotujejo temu mnenju, kr�ila obveznost obrazložitve.
It must be pointed out that the sixth recital in the preamble to Regulation No 1873/2003 refers expressly to the opinions of the SCVPH, differing from those of the CVMP, which had confirmed on several occasions both the risks arising from use of progesterone and the fact that it is impossible to establish MRLs for that substance.
Ugotoviti je namreč treba, da so v �esti uvodni izjavi Uredbe �t. 1873/2003 izrecno navedena mnenja SCVPH, ki se razlikujejo od mnenj CMV, v katerih so bila večkrat potrjena tveganja, ki izhajajo iz uporabe progesterona, in nezmožnost določitve NMVO za to snov.
Furthermore, the eighth and tenth recitals in the preamble to that regulation state the reasons for which, according to the Commission, only intravaginal administration of progesterone can prevent the misuse of that substance.
Poleg tega so v osmi in deseti uvodni izjavi te uredbe na�teti razlogi, zaradi katerih se lahko po mnenju Komisije zloraba te snovi prepreči le z intravaginalnim dajanjem.
With regard to the argument raised by the Polish Government that Regulation No 1873/2003 infringes the principle of proportionality because it is based on a purely hypothetical risk to human health which is not supported by the scientific data set out in its reasoning, it suffices to note that, as has been recalled in paragraph 39 of
Glede trditve poljske vlade, da je z Uredbo �t. 1873/2003 kr�eno načelo sorazmernosti, ker temelji na popolnoma hipotetičnem tveganju za javno zdravje, ki ni podprto z znanstvenimi podatki, povzetimi v obrazložitvi, je dovolj poudariti, da, kot je bilo
CP-PHARMA the present judgment, the existence of such a risk, confirmed by a number of scientific opinions, is clearly apparent from the reasoning of that regulation.
CP-PHARMA opozorjeno v točki 39 te sodbe, obstoj tega tveganja, ki je potrjeno z več znanstvenimi mnenji, jasno izhaja iz obrazložitve te uredbe.
Secondly, Article 6 of Directive 2001/82 expressly provides that, in order for a veterinary medicinal product to receive marketing authorisation for administration to foodproducing animals, the active substances which that medicinal product contains must appear in Annex I, II or III to Regulation No 2377/90.
Drugič, člen 6 Direktive 2001/82 izrecno določa, da morajo biti zato, da se dovoli, da se daje zdravilo za uporabo v veterinarski medicini v promet za dajanje živalim za proizvodnjo živil, aktivne snovi, ki jih to zdravilo vsebuje, navedene v prilogah I, II, ali II k Uredbi �t. 2377/90.
Accordingly, it is clear that Article 4 of Directive 96/22, 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.
Zato je treba ugotoviti, da člen 4 Direktive 96/22 v povezavi s členom 6 Direktive 2001/82 omogoča državam članicam, da dopustijo dajanje progesterona farmskim živalim le, če je ta snov vključena v priloge I, II ali III k Uredbi �t. 2377/90 v skladu z njenimi določbami.
On the grounds set out in paragraphs 31 to 33 of the present judgment, the Commission could legitimately restrict the inclusion of progesterone in Annex II to that regulation to a specific method of administration, that is to say intravaginally. In
Torej je lahko Komisija zaradi razlogov, navedenih v točkah od 31 do 33 te sodbe, vključitev progesterona v prilogo II k tej uredbi legitimno omejila na poseben način dajanja te snovi, in sicer intravaginalno. V takih okoli�činah ne moremo
2008 — CASE C-448/06 those circumstances, there is no incompatibility between the provisions of Regulation No 2377/90 and those of Article 4 of Directive 96/22.
2008 – ZADEVA C-448/06 govoriti o nezdružljivosti med določbami Uredbe �t. 2377/90 in določbami člena 4 Direktive 96/22.
Having regard to all of the foregoing, the answer for the referring court must be that examination of the question referred has disclosed no factor of such a kind as to affect the validity of Regulation No 1873/2003.
Glede na zgornje ugotovitve je treba predložitvenemu sodi�ču odgovoriti, da pri preučitvi postavljenega vpra�anja ni bil ugotovljen noben dejavnik, ki bi vplival na veljavnost Uredbe �t. 1873/2003.
Examination of the question referred has disclosed no factor of such a kind as to affect the validity of Commission Regulation (EC) No 1873/2003 of 24 October 2003 amending Annex II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.
Pri preučitvi postavljenega vprašanja ni bil ugotovljen noben dejavnik, ki bi vplival na veljavnost Uredbe Komisije (ES) št. 1873/2003 z dne 24. oktobra 2003 o spremembi Priloge II k Uredbi Sveta (EGS) št. 2377/90 o določitvi postopka Skupnosti za določitev najvišjih dovoljenih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora.
Case C-488/06 P
Zadeva C-488/06 P
L & D SAv Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM)
L & D SAproti Uradu za usklajevanje na notranjem trgu (znamke in modeli) (UUNT)