natgillin/translations-raw huggingface dataset:
On 25 July 2001, the Commission adopted a proposal for a Council Regulation amending Annex I to Regulation No 2377/90 11classifying
Komisija je 25. julija 2001 sprejela predlog Uredbe Sveta o spremembi Priloge I k Uredbi �t. 2377/90, 11 s katero je bil progesteron uvr�čen v to prilogo.
‘The competent higher federal authority may refuse to grant an authorisation only if … 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 of the European Communities …’
„Pristojni vi�ji zvezni organ lahko zavrne dovoljenje le …, če bi dajanje v promet zdravila ali dajanje tega zdravila živalim nasprotovali zakonskim določbam ali uredbi, direktivi ali odločbi Sveta ali Komisije Evropskih skupnosti …“
II to Regulation No 2377/90, as a result of the adoption of Regulation No 1873/2003, progesterone can only be administered via the intravaginal route.
NMVO, prepoved iz člena 14 Uredbe �t.
Given that no MRLs were established for other applications of that veterinary medicinal product, the pro -hibition contained in Article 14 of Regulation No 2377/90 applies to cp-Pharma’s product and its marketing authorisation must be revoked in accordance with Paragraph 30(1) in conjunction with Paragraph 25(2)(7) of the AMG.
2377/90 velja za zdravilo cp-Pharme in je treba dovoljenje za promet za to zdravilo preklicati v skladu s povezanimi določbami členov 30(1) in v 25(2), točka 7, AMG.
That proposal was rejected by the Standing Committee which assists the Commission in accordance with Article 8 of Regulation No 2377/90.
Komisija je decembra 2002 Stalnemu odboru predložila nov predlog o uvrstitvi progesterona v Prilogo III k Uredbi �t. 2377/90.
In December 2002, the Commission submitted to the Standing Committee a second proposal classifying progesterone in Annex III to Regulation No 2377/90.
Ta predlog ni dobil pritrdilnega mnenja tega odbora.
That proposal did not obtain the favourable opinion of the Standing Committee.
Komisija je 24. oktobra 2003 sprejela Uredbo �t. 1873/2003, ki progesteron uvr�ča v Prilogo II k Uredbi �t.
According to the 11th recital in the preamble to Regulation No 1873/2003, the measures provided for in that regulation are in accordance with the opinion of the Standing Committee.
V skladu z enajsto uvodno izjavo Uredbe �t. 1873/2003 so ukrepi, predvideni v tej uredbi, v skladu z mnenjem Stalnega odbora.
In its action before the referring court, cp-Pharma submits that that court should annul the revocation of its marketing authorisation on the ground that the Commission unlawfully disregarded the recommendation of the Committee, which did not include a restriction to intravaginal application.
V tožbi pred predložitvenim sodi�čem cp-Pharma trdi, da mora to sodi�če preklic dovoljenja za promet razglasiti za ničnega, ker naj Komisija nezakonito ne bi upo�tevala mnenja Odbora, v katerem ni bila določena omejitev za intravaginalno uporabo.
IV — The main proceedings and the order for reference
IV – Spor o glavni stvari in vprašanje za predhodno odločanje
The referring court is uncertain whether the exclusion of progesterone administered by injection from the list in Annex II to Regulation No 2377/90 is compatible with Art -icles 1(1) and 3 of that regulation.
2377/90 poobla�ča Komisijo, da „doda omejitve glede načina uporabe na seznam snovi v Prilogi II, kadar člena 1(1) in 3 Uredbe [�t. 2377/90] ne določata omejitev za preprečevanje zlorabe“.
By decision dated 16 February 1999, cp-Pharma’s marketing authorisation for the veterinary medicinal product ‘progesterone ad us. vet’ was extended for a five-year duration pursuant to Paragraph 105 of the AMG.
Z odločbo z dne 16. februarja 1999 je bilo dovoljenje za promet cp-Pharme z zdravilom za uporabo v veterinarski medicini „progesteron za uporabo v veterini“ podalj�ano za pet let v skladu s členom 105 AMG.
According to the preliminary reference, the authorisation concerned ‘a solution for intramuscular injection with the active substance progesterone in animals of bovine species, to be applied in cases of “follicle cysts”, “nymphomania caused by follicle cysts”’.
V predložitvenem sklepu je navedeno, da se je zadevno dovoljenje nana�alo na „raztopino za intramuskularno aplikacijo (injekcijo) z aktivno snovjo progesteron pri govedih, ki se uporabi v primerih ‚folikularnih cist‘, ‘nimfomanije, ki jo povzročijo folikularne ciste‘“.
By decision dated 22 January 2004, the competent national authorities revoked cp-Pharma’s authorisation on the grounds that following the amendment of Annex
Z odločbo z dne 22. januarja 2004 so pristojni nacionalni organi preklicali dovoljenje cp-Pharme na podlagi tega, da se v skladu s spremembo Priloge II k Uredbi �t.
12 — [2002] ECR I-1917, paragraph 55.
2377/90 kot posledice sprejetja Uredbe �t.
CP-PHARMA in conjunction with Article 4(1) of [Direct- ive 96/22]), in so far as application of an injection solution as a pharmaceutical form is excluded by virtue of the note marked (*) against the listing of progesterone in Annex II to [Regulation No 2377/90]?’
CP-PHARMA v delu, v katerem je v opombi, označeni z (*), o vključitvi progesterona v Prilogo II k Uredbi (EGS) �t. 2377/90 izključena uporaba farmacevtske oblike, kakr�na je injekcijska raztopina?“
In that regard, the referring court notes that the Court observed that the only limitation on the validity of an MRL envisaged by Regulation No 2377/90 concerns the indication of the limited duration of its validity where the substance in question is entered in Annex III to that regulation.
Glede tega predložitveno sodi�če opozarja, da je Sodi�če upo�tevalo, da se edina omejitev glede veljavnosti NMVO, ki jo določa Uredba �t. 2377/90, nana�a na določbo glede omejenega trajanja njegove veljavnosti, če je zadevna snov vključena v Prilogo III te uredbe.
The Greek and Polish Governments and the Commission submitted written observations.
Gr�ka in poljska vlada ter Komisija so predložile pisna stali�ča.
A hearing was requested by cp-Pharma. cp-Pharma, the Greek Government and the Commission presented oral submissions at the hearing on 18 October 2007.
Cp-Pharma je zahtevala obravnavo. Cp-Pharma, gr�ka vlada in Komisija so predložile ustna stali�ča na obravnavi 18. oktobra 2007.
Moreover, Article 4(1) of Direct- ive 96/22, as amended by Directive 2003/74, sets out rules as to what measures Member States are to take in order to prevent misuse when progesterone is administered as a veterinary medicinal product.
Nadalje člen 4(1) Direktive 96/22, kot je bila spremenjena z Direktivo 2003/74, določa pravila, kak�ne ukrepe morajo sprejeti države članice, da preprečijo zlorabo pri dajanju progesterona kot zdravila za uporabo v veterinarski medicini.
That provision also expressly provides for progesterone to be administered by injection by a veterinarian.
Ta določba izrecno določa tudi, da mora progesteron dati veterinar z injekcijo.
The referring court considers that that provision may be exhaustive in nature in relation to the prevention of misuse of progesterone and thus precludes the adoption of ‘deviating’, stricter rules by a Commission regulation.
Predložitveno sodi�če ugotavlja, da je ta določba po naravi glede preprečevanja zlorabe progesterona lahko izčrpna in torej izključuje, da bi se z uredbo Komisije sprejela „drugačna“, strožja pravila.
It is clear from the recitals in the preamble to Regulation No 1873/2003 that the placing of progesterone in Annex II to Regulation No 2377/90, subject to restrictions concerning its use, were dictated by the necessity to protect public health given the existence of contradictory scientific opinions regarding the possible risks to human health associated with the misuse of that product.
2377/90, ki določa, da je kljub dejstvu, da ta uredba nikakor ne posega v uporabo zakonodaje Skupnosti, ki prepoveduje uporabo nekaterih snovi s hormonskim delovanjem v živinoreji, ne izključuje možnosti, da sprejme dodatne omejitve glede uporabe hormonov, ki jih že obravnavajo drugi predpisi Skupnosti – prepoved uporabe progesterona z injekcijo ni v nasprotju s členom 4 Direktive 96/22.
In accordance with the ninth and 10th recitals in the preamble to Regulation No 1873/2003, the limitations on the use of progesterone is based on the possibility, foreseen by Regulation No 178/2002, for Community institutions to take into account the results of risk assessment for the purpose of avoiding risks from the misuse of that substance.
Nadalje, kot lahko opazimo iz sprememb Direktive 96/22 po sprejetju Direktive 2003/74, je bila uporaba progesterona z injekcijo začasen ukrep, ki se je uporabljal do presoje progesterona v okviru Uredbe �t. 2377/90 in do določitve NMVO.
for distinguishing naturally produced progesterone and the residues arising as a result of the hormone being administered by man.
Nadalje je v zadevi C-157/96 14 Sodi�če odločilo, da kadar se pojavijo negotovosti glede obstoja ali obsega tveganj za zdravje ljudi, lahko institucije sprejmejo za�čitne ukrepe, ne da bi morali čakati, da sta resničnost in resnost teh nevarnosti v celoti dokazani. Iz uvodnih izjav Uredbe �t. 1873/2003 je očitno, da je vključitev progesterona v Prilogo II k Uredbi �t.
That government considers however that a broad interpretation of Article 3 of Regulation No 2377/90 would permit the placing of progesterone, subject to the limitation on its use via the intravaginal route, in Annex II to that regulation given the lack of any existing method
2377/90 progesteron, za katerega velja omejitev intravaginalne uporabe, lahko vključi v Prilogo II k tej uredbi, saj ni nobene metode za ločevanje med naravno proizvedenim progesteronom in ostanki, ki nastanejo kot rezultat tega, da je hormon živali dal človek. Glede na �iroko diskrecijsko pravico, ki jo ima Komisija na
The Commission considers that it had the power pursuant to Article 3 of Regulation No 2377/90, in order to prevent misuse of the substance progesterone, to limit the manner in which that substance may be administered when it placed that substance in Annex II to that regulation.
Komisija meni, da je bila v skladu s členom 3 Uredbe �t. 2377/90, da bi preprečila zlorabo snovi progesteron, pristojna za omejitev načina dajanja te snovi, s tem ko je to snov vključila v Prilogo II k tej uredbi.
The Commission stresses the complex legislative history which led to the adoption of Regulation No 1873/2003.
Komisija poudarja kompleksno zgodovino zakonodaje, ki je vodila k sprejetju Uredbe �t. 1873/2003.
15The Commission submits that the inclusion of a product in Annex II to Regulation
15 Komisija trdi, da vključitev zdravila v Prilogo II k Uredbi �t. 2377/90 na splo�no predpostavlja, da nadzor nad NMVO
15 — See Commission v CEVA and Pfizer, cited in footnote 13, paragraphs 12 to 32, and point 21 above.
15 – Glej v opombi 13 navedeno sodbo Komisija proti CEVA in Pfizer, točke od 12 do 32 in točko 21 zgoraj.
In certain cases, however, such as in the case of progesterone, that decision may not be adopted without restrictions in order to ensure that the use of medicinal products in food producing animals is safe.
Vendar pa v nekaterih primerih, kot je primer progesterona, te odločitve ni mogoče sprejeti brez omejitev, da se tako zagotovi varno uporabo zdravil za živali, ki so namenjene za proizvodnjo hrane.
or otherwise for progesterone, the Commission had to take into account the fact that it is an active substance capable of protecting animal health.
drugače, mora Komisija upo�tevati dejstvo, da gre za aktivno snov, ki lahko varuje javno zdravje.
In addition, the Commission had to take account of the limitations on the use of progesterone imposed by Dir -ective 96/22 in order to prevent misuse of that product as a growth promoter.
Poleg tega mora Komisija upo�tevati omejitve uporabe progesterona, ki jih določa Direktiva 96/22, da bi tako preprečila neprimerno uporabo tega zdravila kot pospe�evalca rasti.
By limiting the authorisation of progesterone to adminis -tration via the vaginal route, this guaranteed that progesterone would not be misused and was the only manner to ensure that vet -erinary medicinal products containing proges -terone could be authorised by a Community decision on MRLs without infringing Directive 96/22.
Z omejitvijo dovoljenja za dajanje progesterona vaginalno se je preprečila zloraba progesterona, kar je bil edini način, da se zdravila za uporabo v veterinarski medicini z vsebnostjo progesterona lahko dovoli z odločbo Komisije o NMVO, ne da bi bila kr�ena Direktiva 96/22.
If an injectable solution of progesterone were marketed it would be difficult to ascertain whether it was administered in order to promote growth.
Če bi bila raztopina za vnos progesterona z injekcijo dana v promet, bi bilo težko ugotoviti, ali je bila dana za pospe�itev rasti.
The administration of progesterone by means other than vaginal administration can lead to residues and an increase in the total quantity of progesterone in animal tissues.
Z dajanjem progesterona drugače kot vaginalno lahko nastanejo ostanki, kar vodi k povečanju celotne količine progesterona v tkivih živali.
The Commission emphasises that Article 4(1) of Directive 96/22 empowers the Member States to authorise the administration of progesterone to foodproducing animals for therapeutic purposes under certain conditions.
Komisija poudarja, da člen 4(1) Direktive 96/22 državam članicam omogoča, da pod določenimi pogoji dovolijo dajanje progesterona živalim za proizvodnjo hrane v terapevtske namene.
That provision does not however provide that the use of progesterone in veterinary medicinal products is always lawful if the conditions laid down therein are met.
Ta določba pa ne določa, da je uporaba progesterona v veterinarski medicini vedno zakonita, če so izpolnjeni določeni pogoji.
Indeed, Article 4(1) of Directive 96/22 expressly requires the product to comply with the requirements for placing on the market which in turn requires that the rules relating to MRLs are complied with.
Člen 4(1) Direktive 96/22 izrecno zahteva, da so zdravila v skladu z zahtevami za dajanje v promet, kar samo pomeni, da morajo biti pravila glede NMVO usklajena
The Commission considers that in accordance with Article 7(6) of Regulation No 2377/90 it must prepare draft measures taking account of other Community measures.
Komisija meni, da mora v skladu s členom 7(6) Uredbe �t. 2377/90 pripraviti osnutke ukrepov, tako da upo�teva ostale ukrepe Skupnosti.
In deciding whether to adopt an MRL
Pri odločanju, ali naj sprejme NMVO ali naj za progesteron določi
The effects of Regulation No 1873/2003 were therefore sudden, radical and excessive.
Direktiva 96/22 tudi jasno omogoča, da progesteron vbrizga veterinar z injekcijo.
pharmaceutical product or the classification of products in the corresponding annexes depending on their form.
Vendar pa se s sprejetjem Uredbe �t.
Moreover, Dir -ective 96/22 clearly permits the administration of progesterone by injection, by a veterinarian.
1873/2003 progesterona ne more več dajati v taki obliki.
However, with the adoption of Regulation No 1873/2003, progesterone cannot be administered in this form.
Poljska vlada zavrača trditve Komisije, da prepoved uporabe progesterona z injekcijo pomeni posebno zagotovilo za preprečitev zlorabe.
Poland rejects the Commission claims that the prohibition of the use of progesterone in injectable form acts as an extra guarantee in order to prevent its misuse.
Poljska vlada meni, da je prepoved povsem odveč, saj so ustrezne omejitve določene v Direktivi 96/22 in Uredbi �t. 2377/90.
The limits contained in Directive 96/22 concerning the administration of progesterone by injection were established by the Council, in accordance with the procedure laid down by Article 37 EC.
Omejitve iz Direktive 96/22 glede dajanja progesterona z injekcijo je določil Svet v skladu s postopkom, določenim v členu 37 ES. Uredba �t.
Regulation No 1873/2003, by de facto prohibiting the administration of injectable progesterone, impinges on the Council’s power and violates Article 37 EC.
1873/2003 z de facto prepovedjo dajanja progesterona z injekcijo posega v pristojnost Sveta in kr�i člen 37 ES.
The Polish Government also considers that Regulation No 1873/2003 is inadequately reasoned.
Poljska vlada tudi meni, da Uredba �t. 1873/2003 ni ustrezno obrazložena.
It should be noted that the Committee recommended that progesterone be inscribed in Annex II to Regulation No 2377/90 without any limitations.
Povedati je treba, da je Odbor priporočil, da se progesteron vključi v Prilogo II k Uredbi �t. 2377/90 brez omejitev.
In addition to Regulation No 1873/2003 being adopted contrary to the opinion of the Committee, the Polish Government claims that the recitals in the preamble to that regulation give the impression that it was adopted in conformity with the Committee’s opinion.
Ker je bila Uredba �t. 1873/2003 sprejeta v nasprotju z mnenjem Odbora, poljska vlada trdi, da uvodne izjave te uredbe dajejo vtis, da je bila sprejeta v skladu z mnenjem Odbora.
Moreover, the only reason for limiting the use of progesterone given by the Commission in the recitals in the preamble to Regulation No 1873/2003 was to provide an additional safeguard in order to avoid misuse.
Nadalje je bil edini razlog za omejitev uporabe progesterona, ki ga je Komisija podala v uvodnih izjavah Uredbe �t. 1873/2003, zagotovitev dodatne varnosti za preprečitev zlorabe.
The Commission however does not explain why
Vendar pa Komisija ne pojasnjuje, zakaj
In the present case the referring court expresses doubts, in the light of the ruling of the Court in the Boehringer case, as to whether the Commission has the power pursuant to Articles 1(1) and 3 of Regulation No 2377/90 when placing progesterone in Annex II to that regulation to impose conditions on the mode of application of that substance.
V tej zadevi predložitveno sodi�če izraža dvome glede odločitve Sodi�ča v sodbi Boehringer, ali je Komisija v skladu s členo - ma 1(1) in 3 Uredbe �t. 2377/90 pri vključitvi progesterona v Prilogo II k tej Uredbi pristojna za določitev pogojev glede načina uporabe te snovi.
As a supporting argument, the referring Court also considers that the rules contained in Article 4(1) of Direct- ive 96/22, as amended by Directive 2003/74, on the prevention of misuse of progesterone
Predložitveno sodi�če kot dodatni argument dodaja, da so pravila iz člena 4(1) Direktive 96/22, kot je bila spremenjena z Direktivo 2003/74, glede varstva proti zlorabi progesterona izčrpna določba,
CP-PHARMA is an exhaustive provision, which precludes the adoption of deviating stricter rules by Commission regulation.
CP-PHARMA ki izključuje sprejetje drugačnih, strožjih pravil z uredbo Komisije.
indications mentioned by them, which is independent of the prohibition laid down by Directive 96/22.
določene v Direktivi 96/22. 18 Sodi�če je tudi ugotovilo, da referenc zadevnih opozoril ni mogoče razumeti kot predmet ali učinek uvr�čanja omejitev glede veljavnosti NMVO, določenih za to snov, v besedilo Uredbe �t. 2377/90. 19
In addition to the above findings, at paragraph 55 of its judgment the Court stated that the only limitation on the validity of an MRL envisaged by Regulation No 2377/90 concerns the indication of the limited dur -ation of its validity where the substance in question is entered in Annex III to that regulation.
Kot nadaljevanje zgornjih ugotovitev je v točki 55 sodbe Sodi�če ugotovilo, da se edina omejitev glede veljavnosti NMVO, ki jo določa Uredba �t. 2377/90, nana�a na določanje omejenega trajanja njihove veljavnosti, če je zadevna snov vključena v Prilogo III k tej uredbi.
In the Boehringer case, the Court examined whether the Commission when fixing the provisional MRL for a veterinary medicinal product, thereby listing it in Annex III to Regulation No 2377/90, can make reference to specific provisions of Directive 96/22 relating to that product.
V sodbi Boehringer je Sodi�če presojalo, ali se lahko Komisija pri določanju začasnih NMVO za zdravila za uporabo v veterinarski medicini, torej s tem, da zdravilo uvrsti v Prilogo II k Uredbi �t. 2377/90, sklicuje na nekatere določbe Direktive 96/22 glede tega zdravila.
The Court thus examined the legal effect of the inclusion of references to the permitted therapeutic indications for a substance, which mirror those contained in Directive 96/22, when listing that substance in Annex III to Regulation No 2377/90.
Sodi�če je presodilo tudi zakonski učinek vključitve referenc glede dovoljenih terapevtskih indikacij za snov, ki so odsev tistih, ki jih vsebuje Direktiva 96/22 za vključitev te snovi v Prilogo III k Uredbi �t. 2377/90.
16The administration of the substance in question to farm animals was prohibited in accordance with Article 3 of Directive 96/22.
16 Dajanje zadevne snovi živalim na kmetiji je bilo prepovedano v skladu s členom 3 Direktive 96/22.
However, in accordance with Article 4 of that directive, Member States may authorise the administration of the substance in question for specific therapeutic purposes which were defined in the directive.
Vendar pa v skladu s členom 4 te direktive države članice lahko dovolijo dajanje te snovi za terapevstske namene, ki so bili določeni v tej direktivi.
17In the Boehringer case, the Court found that the references were merely declaratory in nature and intended solely as a reminder that, by virtue of Directive 96/22, the use of the substance in question was prohibited, save for specific therapeutic purposes.
17V sodbi Boehringer je Sodi�če ugotovilo, da so bile reference le deklaratorne po naravi in so bile zgolj opozorilo, da je bila, ob pomoči Direktive 96/22, uporaba te snovi prepovedana, razen za posebne terapevtske namene.
The Court therefore considered that the references could not be understood as having the object or effect of laying down a prohibition on the marketing and use of the substance, subject to the therapeutic
Sodi�če je torej menilo, da referenc ni mogoče razumeti kot predmet ali učinek določanja prepovedi dajanja v promet ali uporabe snovi, podrejen terapevtskim indikacijam, ki jo določajo, ki je neodvisna od prepovedi,
8), the Commission amended Annex III to Regulation No 2377/90 by fixing provisional MRLs for a particular substance and by specifying under its heading ‘Other provisions’, inter alia, the therapeutic indications authorised for that substance.
8), dodala Prilogo III k Uredbi �t. 2377/90 z določanjem začasnih MVO za neko snov in s specificiranjem inter alia terapevtskih indikacij, ki so za to snov dovoljene, v naslovu Ostale določbe.
17 — See Article 1(2)(b) of Directive 96/22.
17 – Glej člen 1(2)(b) Direktive 96/22.
It should be noted in that regard that Articles 1(1) and 3 of Regulation No 2377/90 are silent as to whether limitations on the mode of administration may be imposed on substances listed in Annex II thereof and thus, as argued by the Greek Government, do not specifically exclude such limitations.
Glede tega je treba povedati, da člena 1(1) in 3 Uredbe �t. 2377/90 ne govorita o tem, ali se omejitve glede dajanja lahko določijo za snovi, določene v Prilogi II k tej uredbi, in torej izrecno ne izključujeta teh omejitev, kot je ugovarjala gr�ka vlada.
It is therefore necessary, in my view, to examine the scheme and purpose of Regulation No 2377/90 to determine whether such limitations may be imposed.
Tako je po mojem mnenju treba pri določanju, ali se te omejitve sme naložiti, preučiti sistematiko in namen Uredbe �t. 2377/90.
do not merely mirror or recall the terms of Directive 96/22, in particular Articles 3 and 4(1) thereof.
ponavljajo določb Direktive 96/22, zlasti členov 3 in 4(1).
Article 3 of Directive 96/22 provisionally prohibits, inter alia, the administering of progesterone to farm animals.
Člen 3 Direktive 96/22 začasno prepoveduje, inter alia, dajanje progesterona živalim na kmetiji.
Notwithstanding the provisions of Article 3 of Directive 96/22, in accordance with Article 4(1) of that directive, as amended, Member States may authorise, under certain conditions, the administering to farm animals of progesterone by injection or vaginal spirals.
Kljub določbam člena 3 Direktive 96/22 v skladu s členom 4(1) te direktive, kot je bila spremenjena, lahko države članice pod določenimi pogoji dovolijo, da se progesteron živalim na kmetiji vbrizga z injekcijo ali da v obliki nožničnih spiral.