natgillin/translations-raw huggingface dataset:
In LDCOM's opinion, the State's position that a prudent majority investor would not have called into question France Télécom's functional integrity does not stand up to an analysis of the conduct of such an investor under the market conditions prevailing in June-July 2002.
Nadalje, kako tvrdi LDCOM, stajalište države prema kojem razuman većinski ulagač ne bi pozvao u pitanje funkcionalni integritet društva FT ne prolazi analizu postupanja takvih ulagača u tržišnim uvjetima koji su bili na snazi u lipnju i srpnju 2002.
Thus, investors who invest an extremely large proportion of their assets in a company threatened with collapse will be the first to demand a radical and immediate review of its strategy, involving, if necessary, a huge sell-off of strategic assets.
Prema tome, ulagači koji ulažu izrazito velik udio svoje imovine u društvo kojemu prijeti propast prvi će zahtijevati radikalno i neposredno preispitivanje strategije koja, ako je to potrebno, obuhvaća prodaju goleme količine strateške imovine.
The French authorities also stress that the legitimacy of such a measure could not be challenged because, as is mentioned above, it was based on a credible, detailed plan the content of which was mostly known at the time of the announcement of the loan proposal on 4 December 2002.
Francuska nadležna tijela istaknula su i da legitimnost takve mjere nije sporna jer se, kako je prethodno navedeno, temeljila na vjerodostojnom i podrobnom planu, čiji je sadržaj većinom bio poznat u trenutku objave obavijesti o nacrtu zajma od 4. prosinca 2002.
Moreover, the State had already received the undertaking, conditional on the presentation to the market of a credible plan, from the banking syndicate and it knew full well at the end of November that that condition would be met given the market's positive reaction to the appointment of the new management.
Nadalje, država je već bila raspolagala obvezom, koja je podlijegala predstavljanju vjerodostojnog plana tržištu, od sindikata banaka i krajem studenoga u potpunosti je bila svjesna da će uvjet biti ispunjen s obzirom na pozitivnu reakciju tržišta na imenovanje nove uprave.
The French authorities stress in this connection that it is not pertinent to assess the amount involved in the present case but that, in accordance with the Alitalia judgment, it is necessary to examine the conformity of the conditions of financing the operation for a company of comparable size.
Francuska nadležna tijela u tom pogledu naglašavaju da nije relevantno ocijeniti iznos o kojemu je riječ u ovom slučaju, ali da je, u skladu s presudom u predmetu Alitalia, potrebno ispitati usklađenost uvjeta financiranja rada za društvo usporedive veličine.
The Minister's July 2002 interview makes no mention of any decision being taken.‘… [W]hile remaining confident in the company's viability, the State was merely taking note of the market's doubts about France Télécom's situation and, in its capacity as majority shareholder, was trying to refine its analysis without being able, at that stage, to make an accurate diagnosis or take any decision’.
U intervjuu s ministrom iz srpnja 2002. ne spominje se nikakva odluka.
‘Moreover, there was no reason to suppose a priori that the phrase “appropriate steps” referred specifically to financial measures’.
„… [I]ako je i dalje imala povjerenje u održivost društva FT, država je tek utvrdila sumnje tržišta u pogledu situacije društva France Télécom te je, u svojstvu većinskog dioničara, nastojala unaprijediti svoju analizu, pri čemu u toj fazi nije mogla dati točnu dijagnozu ili donijeti odluku. Nadalje, ne postoji razlog zbog koje bi trebalo a priori pretpostaviti da se izraz ‚odgovarajuće mjere’ odnosio na financijske mjere”.
During the first half of 2002, France Télécom saw its credit rating downgraded following the publication of its 2001 annual accounts.
Tijekom prve polovine 2002. kreditni rejting društva FT znatno je snižen nakon objave njegove računovodstvene dokumentacije za 2001.
On 24 June 2002, Moody's downgraded the Company's rating to the lowest investment grade, just above that of junk bond, thereby making it very difficult for it to refinance its debt.
Agencija Moody's snizila je 24. lipnja 2002. rejting društva na najniži sigurni investicijski razred, koji prethodi razini „junk bond”, što je znatno otežalo refinanciranje njegova duga.
Consequently, in view of the particular circumstances of the case, there is no inextricable link between the measures that the French authorities took prior to December 2002 and the measures that they took in December 2002.
Prema tome, s obzirom na okolnosti ovog slučaja ne postoji neraskidiva veza između mjera koje su poduzela francuska nadležna tijela prije prosinca 2002. i mjera koje su poduzela u prosincu 2002.
It is necessary therefore to examine whether, between 4 December 2002 (when the State announced its shareholder loan to France Télécom) and 20 December 2002 (when the State sent France Télécom a signed and initialled draft shareholder loan agreement), the conditions for State aid were met, and in particular, whether the State acted in the same way as a prudent private investor in a market economy.
Prema tome, valja ispitati jesu li, između 4. prosinca 2002., kada je najavljen dioničarski zajam države u korist društva FT, i 20. prosinca 2002., kada je država dostavila društvu FT parafiran i potpisan nacrt ugovora o dioničarskom zajmu, ispunjeni sastavni elementi državne potpore; konkretnije, je li država postupala na način na koji bi postupao razumni privatni operater u tržišnom gospodarstvu.
This performance was confirmed when the 2002 accounts were published.
Ta je učinkovitost bila potvrđena pri objavi računovodstvene dokumentacije iz 2002.
Furthermore, France Télécom was not in a cessation of payments situation.
FT više nije bilo nesolventno.
Moody's Investors Service, 13 September 2002.
Moody's investors services, September 13, 2002.
With regard to the comparison between the Minister's July declarations and a letter of intent, the French authorities stress that ‘(i) firstly, it is of the essence of the letter of intent that it is addressed to a beneficiary; (ii) secondly, and as an extension of the preceding observation, the effectiveness of the method is dependent on acceptance by the said beneficiary; and (iii), lastly, the scope of the commitment given (both as regards its object and as regards the force which its author wishes to give to it) depends exclusively on the terms employed’. ‘Thus … the general — to say the least — character of the Minister's remarks … rules out without doubt any commitment in favour of France Télécom or its creditors, and a fortiori any obligation as to the result to be achieved (and hence any idea of guarantee) as well as any obligation as to the means’.
U pogledu usporedbe izjava ministra iz srpnja i pisma namjere francuska nadležna tijela ističu da „i. kao prvo, potrebno je ispitati je li od ključne važnosti činjenica da je pismo namjere upućeno korisniku, ii. drugo, nastavno na prethodnu primjedbu, učinkovitost metode ovisi o prihvatu navedenog korisnika, iii. konačno, doseg obveze (u pogledu njezina predmeta i snage koju joj autor želi pridati) ovisi isključivo o upotrijebljenim izrazima.” „Prema tome… u najmanju ruku općenita narav ministrovih iskaza… bez sumnje isključuje obvezu u korist društva France Télécom ili njegovih vjerovnika i, a fortiori, obvezu u pogledu rezultata (a time i svako jamstvo), kao i obvezu u pogledu sredstava”.
‘The legal consultant's conclusions clearly fly in the face of the Commission's decision-making practice and of Community case law in the field of State aid, which make the existence of aid conditional on proof of a firm, precise and unconditional commitment on the part of the State concerned — something which the Minister's remarks of 12 July 2002 could in no way be construed as being’.
„Zaključci pravnog savjetnika očigledno su protivni praksi Komisije u području donošenja odluka i sudskoj praksi Zajednice u području državne potpore, što čini postojanje potpore uvjetovanim dokazom čvrste, precizne i bezuvjetne obveze predmetne države, dok se ministrovi iskazi od 12. srpnja 2002. ni u kojem slučaju ne mogu tako protumačiti”.
‘A state measure, in whatever form, must be sufficiently precise and concrete for the Commission to be able to determine the very existence of an advantage’.
„Državna mjera, neovisno o njezinu obliku, mora biti u dovoljnoj mjeri precizna i konkretna kako bi Komisija mogla utvrditi samo postojanje prednosti”.
Cable & Wireless expresses the view that the measures at issue constitute State aid. The market's confidence as a result of the announcement of the granting by the French authorities of the shareholder loan sufficed to confer an advantage on France Télécom.
Društvo Cable & Wireless navelo je da predmetne mjere predstavljaju državnu potporu.
The State thus retained this trust through successive declarations. In fact, the State's intervention had the effect of preventing any downgrading of France Télécom's credit rating to that of junk bond status, as is, moreover, clearly stated in S&P's press release of 12 July 2002, where the assurances provided by the State are hailed as being a key factor in France Télécom's not being reduced to junk bond status.
Francuska je vlada na taj način očuvala povjerenje putem uzastopnih izjava: Intervencija države dovela je do sprječavanja snižavanja kreditnog rejtinga društva na razinu „junk bond”, što je, osim toga, jasno navedeno u priopćenju za medije agencije S&P od 12. srpnja 2002., u kojemu je navedeno da su jamstva koja je pružila država bila ključna za činjenicu da FT nije sveden na razinu „junk bond”.
In addition to the commitment given in September 2002 by the banking syndicate to underwrite that part of an increase in the capital of FT which was intended for private investors, consideration must be given to other key factors, namely the sale by FT of some EUR 2,5 billion in non-strategic assets between July and December 2002, the appointment of a new management team for the company in October 2002, and the resolution in November 2002 of the dispute between FT and the German operator Mobilcom. Taken as a whole, those factors brought about a marked improvement in FT's operational prospects and performance during the second half of 2002.
Osim obveze sindikata banaka iz rujna 2002. da će, u pogledu dijela namijenjenog privatnim ulagačima, jamčiti uspješno povećanje kapitala društva FT, valja uzeti u obzir ostale elemente od ključne važnosti, odnosno prodaju imovine društva FT koja nije ključna između srpnja i prosinca 2002. u visini od otprilike 2,5 milijardi eura, zatim imenovanje novog tima direktora poduzetnika u listopadu 2002. te rješavanje spora između društva FT njemačkog operatera Mobilcom u studenome 2002.. Svi su ti elementi doveli do znatnog poboljšanja poslovnih izgleda i učinkovitosti društva FT tijekom druge polovice 2002.
Commission Decision (EU) 2018/1617
Odluka Komisije (EU) 2018/1617
concerning a measure adopted by France pursuant to Council Directive 93/42/EEC with regard to the Terrafor and Defiligne medical devices
o mjeri koju je poduzela Francuska u skladu s Direktivom Vijeća 93/42/EEZ u pogledu medicinskih proizvoda Defilignea i Terrafora
(notified under document C(2018) 6943)
(priopćeno pod brojem dokumenta C(2018) 6943)
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, and in particular Article 8(2) thereof,
uzimajući u obzir Direktivu Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima, a posebno njezin članak 8. stavak 2.,
On 16 August 2016, the French authorities adopted a decision based on the national provisions transposing Directive 93/42/EEC (hereinafter ‘Directive 93/42/EEC’ or ‘the Directive’) with regard to two medical devices with the same composition, the same route of administration and the same purposes, marketed under the names ‘Terrafor’ or ‘Defiligne’ (hereinafter ‘the device’), and manufactured by the Claytone-Terrafor Laboratory (hereinafter ‘the manufacturer’).
Francuska tijela donijela su 16. kolovoza 2016. odluku na temelju nacionalnih odredbi kojima se prenosi Direktiva 93/42/EEZ (u daljnjem tekstu „Direktiva 93/42/EEZ” ili „Direktiva”) koja se odnosi na dva medicinska proizvoda istog sastava, puta primjene i namjene, koji su stavljeni na tržište pod nazivima „Terrafor” ili „Defiligne” (dalje u tekstu „proizvod”) i koje proizvodi laboratorij Claytone-Terrafor (dalje u tekstu „proizvođač”).
The device in question takes the form of capsules administered orally, which, according to the instructions for use, ‘prevent digestive problems, reduce digestive discomfort, restore digestive comfort and reduce abdominal circumference’.
Predmetni je proizvod u obliku kapsula za oralnu primjenu namijenjenih, prema uputama za uporabu, „sprečavanju i smanjenju probavnih smetnji, olakšavanju probave i smanjenju opsega struka”.
The substance used in manufacturing the device is Octalite, a mineral complex of natural origin (clay).
Tvar koja se upotrebljava u proizvodnji tog proizvoda jest oktalit, mineralni kompleks prirodnog podrijetla (glina).
According to the decision taken by the French authorities, in view of the essential requirements of the Directive and given the presence of lead in the device, it may pose a risk to the health of users.
Prema odluci francuskih tijela, uzimajući u obzir bitne zahtjeve iz Direktive i prisutnost olova u tom proizvodu, on može predstavljati rizik za zdravlje potrošača.
As a consequence, the decision provides that ‘the manufacture, placing on the market, distribution, export and use of the Terrafor and Defiligne medical devices […] shall be suspended until the products have been brought into line with the legislative and regulatory provisions which apply to them’. Moreover, ‘the Claytone-Terrafor laboratory is required to withdraw the Terrafor and Defiligne medical devices from all the distributors concerned’.
Stoga se odlukom predviđa da se „proizvodnja, stavljanje u promet, distribucija, izvoz i uporaba medicinskih proizvoda Terrafora i Defilignea […] obustavljaju do njihova usklađivanja s relevantnim zakonima i propisima”; osim toga, „laboratorij Claytone-Terrafor mora povući medicinske proizvode Defiligne i Terrafor od svih predmetnih distributera”.
By letter of 4 October 2016, the French authorities notified the Commission of their decision of 16 August 2016 in the context of Directive 93/42/EEC.
Dopisom od 4. listopada 2016. francuska su tijela obavijestila Komisiju o svojoj odluci od 16. kolovoza 2016. u skladu s Direktivom 93/42/EEZ.
As part of the consultations referred to in Article 8(2) of Directive 93/42/EEC, the Commission sent the manufacturer an email on 26 October 2016 asking it to state its position on the decision taken by the French authorities.
U okviru savjetovanja iz članka 8. stavka 2. Direktive 93/42/EEZ službe Komisije pozvale su proizvođača porukom e-pošte od 26. listopada 2016. da navede svoje stajalište o odluci francuskih tijela.
By letter of 30 November 2016, the manufacturer sent the Commission a memorandum setting out its reasons for contesting the decision taken by the French authorities.
Dopisom od 30. studenoga 2016. proizvođač je službama Komisije dostavio memorandum u kojem navodi razloge zbog kojih osporava odluku francuskih tijela.
On 19 December 2016, at the manufacturer's request, a meeting was held between the manufacturer and the Commission.
Dana 19. prosinca 2016. na zahtjev proizvođača održan je sastanak između proizvođača i službi Komisije.
In the course of 2017, numerous e-mails were exchanged between the manufacturer and the Commission.
Tijekom 2017. proizvođač i službe Komisije razmijenili su brojne poruke e-pošte.
In particular, the Commission asked the manufacturer several times to contact the French authorities in order to identify the information which would be necessary to allow the decision of those authorities to be lifted.
Konkretno, službe Komisije pozvale su proizvođača u više navrata da se obrati francuskim tijelima kako bi se utvrdili elementi nužni za ukidanje njihove odluke.
By email of 20 March 2017, the manufacturer sent the Commission a report from the NAMSA laboratory which, according to the manufacturer, showed that the device was safe. The Commission asked the manufacturer several times to send that document to the French authorities.
Porukom e-pošte od 20. ožujka 2017. proizvođač je Komisiji dostavio izvješće laboratorija NAMSA kojim se, prema proizvođaču, dokazuje sigurnost proizvoda.
In July 2017, the manufacturer submitted a complaint to the European Ombudsman concerning the Commission's delay in adopting a decision.
U srpnju 2017. proizvođač je Europskom ombudsmanu podnio pritužbu u vezi s kašnjenjem Komisije u donošenju odluke.
On 5 April 2018, the Ombudsman decided to close the case, concluding that there had been no maladministration on the Commission's part in its handling of the case.
Ombudsman je 5. travnja 2018. odlučio zatvoriti predmet zaključivši da nije bilo nepravilnosti u postupanju Komisije u obradi ovog predmeta.
By email of 20 November 2017, the Belgian authorities notified the Commission of their decision of 28 October 2016 to prohibit the placing on the market, putting into service, distribution and importation of the Terrafor medical device, and to order the withdrawal of the device from the market.
Porukom e-pošte od 20. studenoga 2017. belgijska tijela obavijestila su Komisiju o svojoj odluci od 28. listopada 2016. o zabrani stavljanja u promet, stavljanja u uporabu, distribucije i uvoza medicinskog proizvoda Terrafora te o povlačenju tog proizvoda iz prometa.
On 7 February 2018, at the manufacturer's request, a meeting was held between the manufacturer, the French authorities, the Belgian authorities, the NAMSA laboratory and the Commission.
Dana 7. veljače 2018. na zahtjev proizvođača održan je sastanak između proizvođača, francuskih i belgijskih tijela, laboratorija NAMSA te službi Komisije.
In March 2018, the Commission submitted additional written questions to the manufacturer, to its notified body (TÜV Rheinland LGA Products GmbH) and to the Belgian and French authorities. They replied to these questions during March and April 2018.
U ožujku 2018. službe Komisije poslale su dodatna pisana pitanja proizvođaču, njegovu prijavljenom tijelu (TÜV Rheinland LGA Products GMBH) te belgijskim i francuskim tijelima, koji su odgovorili na ta pitanja tijekom ožujka i travnja 2018.
EXAMINATION OF THE JUSTIFICATION FOR THE MEASURE
ISPITIVANJE OPRAVDANOSTI MJERE
Directive 93/42/EEC establishes a system under which medical devices must meet the essential requirements set out in Annex I to the Directive which apply to them (Article 3, first paragraph).
Direktivom 93/42/EEZ uspostavlja se sustav prema kojem medicinski proizvodi moraju biti u skladu s bitnim zahtjevima propisanima u Prilogu I. te direktive koji se na njih odnose (članak 3. prvi stavak).
In order to prove compliance with these essential requirements, the manufacturer must follow one of the conformity assessment procedures provided for in the Directive, which allows the CE marking to be affixed to the devices (Article 11 and Article 17(1)).
Kako bi dokazao poštovanje tih bitnih zahtjeva, proizvođač mora primijeniti jedan od postupaka ocjenjivanja sukladnosti iz te direktive, što omogućuje stavljanje CE oznake sukladnosti na proizvode (članak 11. i članak 17. stavak 1.).
Devices bearing the CE marking indicating that they have undergone a conformity assessment may move freely within the Union (Article 4(1)).
Proizvodi koji nose CE oznaku sukladnosti, kojom se označava da je ocijenjena njihova sukladnost, mogu se slobodno kretati unutar Unije (članak 4. stavak 1.).
However, in accordance with Article 8 (safeguard clause) of Directive 93/42/EEC, ‘where a Member State ascertains that the devices […], when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision […]’ (Article 8(1)).
Međutim, u skladu s člankom 8. (Zaštitna klauzula) Direktive 93/42/EEZ, „ako neka država članica utvrdi da proizvodi […] ispravno instalirani, održavani i upotrebljavani u skladu s njihovom namjenom, mogu ugroziti zdravlje i/ili sigurnost pacijenata, korisnika ili, gdje je to primjenjivo, drugih osoba, ona je dužna poduzeti sve odgovarajuće privremene mjere da povuče takve proizvode iz prometa ili zabrani ili ograniči njihovo stavljanje u promet ili stavljanje u uporabu. Ta država članica odmah obavješćuje Komisiju o svim takvim mjerama, [i] navodi razloge za svoju odluku […]” (članak 8. stavak 1.).
The Commission must then determine whether the measures are justified or not (Article 8(2)).
Komisija tada mora utvrditi jesu li mjere opravdane ili nisu (članak 8. stavak 2.).
It is therefore for the Member States to determine whether a product is liable to compromise the health and safety of persons and, if so, to take the requisite measures.
Stoga države članice moraju procijeniti može li proizvod ugroziti zdravlje ili sigurnost ljudi i, ako je tako, poduzeti potrebne mjere.
Such an exercise may entail complex technical and scientific assessments on the part of the national authorities.
Taj postupak podrazumijeva da nacionalna tijela možda moraju provesti složene tehničke ili znanstvene ocjene.
It is for the Commission to verify whether or not these measures are justified, and in particular to make sure that the legal and factual reasons for their adoption are valid.
Komisija mora nadzirati opravdanost tih mjera i posebno osigurati osnovanost pravnih i činjeničnih razloga za njihovo donošenje.
The Commission enjoys wide discretion in this context.
U tom smislu Komisija uživa znatna diskrecijska prava.
In the present case, in the decision and note notified on 4 October 2016, the French authorities take the view that the devices in question ‘may pose a risk to health’ and ‘do not comply with the essential requirements’.
U predmetnom slučaju francuska tijela u odluci i obavijesti dostavljenima 4. listopada 2016. smatraju da predmetni proizvodi „mogu predstavljati rizik za zdravlje” i „ne poštuju bitne zahtjeve”.
However, where there is a risk to the health and/or safety of persons, resulting in particular from failure to comply with the essential requirements referred to in Annex I to Directive 93/42/EEC, a safeguard clause procedure may be initiated under Article 8(1) of that Directive.
Postojanje rizika za zdravlje i/ili sigurnost osoba, osobito zbog nepoštovanja bitnih zahtjeva iz Priloga I. Direktivi 93/42/EEZ, podrazumijeva pokretanje postupka zaštitne klauzule na temelju članka 8. stavka 1. te direktive.
It follows that, in the present case, the safeguard clause procedure applies, with the result that it is for the Commission to determine whether the measure taken by the French authorities is justified or not.
Iz toga slijedi da se u ovom slučaju primjenjuje postupak zaštitne klauzule te Komisija mora utvrditi je li mjera koju su poduzela francuska tijela opravdana ili ne.
The decision taken by the French authorities makes provision for suspension of the ‘manufacture, placing on the market, distribution, exportation and use’ of the device and its withdrawal from the distributors concerned.
U odluci francuskih tijela predviđa se obustava „proizvodnje, stavljanja u promet, distribucije, izvoza i uporabe” proizvoda te povlačenje proizvoda od predmetnih distributera.