natgillin/translations-raw huggingface dataset:
The specific rules on the aid that Germany may grant in the framework of the German Alcohol Monopoly (‘the Monopoly’) as provided for in Article 182(4) of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [3] will expire on 31 December 2010.
Posebna pravila o pomoči, ki jo Nemčija lahko dodeli v okviru nemškega alkoholnega monopola (v nadaljnjem besedilu: monopol), kot so določena v členu 182(4) Uredbe Sveta (ES) št. 1234/2007 z dne 22. oktobra 2007 o vzpostavitvi skupne ureditve kmetijskih trgov in o posebnih določbah za nekatere kmetijske proizvode (Uredba o enotni SUT) [3], bodo prenehala veljati 31. decembra 2010.
According to the report submitted by the Commission pursuant to Article 184(3) of Regulation (EC) No 1234/2007, the importance of the Monopoly has decreased in recent years.
Glede na poročilo, ki ga je predložila Komisija na podlagi člena 184(3) Uredbe (ES) št. 1234/2007, monopol v zadnjih letih izgublja svojo pomembnost.
Between 2001 and 2008, about 70 agricultural bonded distilleries (landwirtschaftliche Verschlussbrennereien) left the Monopoly.
Med letoma 2001 in 2008 je okoli 70 kmetijsko vezanih žganjarn (landwirtschaftliche Verschlussbrennereien) izstopilo iz monopola.
However, more time is needed to facilitate this adaptation process and to enable distillers to survive on the free market.
Vendar je potrebno več časa, da se olajša postopek prilagoditve in žganjarnam omogoči preživetje na prostem trgu.
An extension of several more years is deemed necessary to complete the process of abolishing the Monopoly, as well as the aid, and to allow for its definitive phasing-out.
Za dokončanje postopka ukinitve monopola ter pomoč v ta namen je potrebnih nekaj dodatnih let.
In some parts of Germany, alcohol distilleries are traditionally linked to small and medium-sized farms and play an important role for the farms to continue their activities by providing an additional income to farmers and securing employment in rural areas.
V nekaterih delih Nemčije so žganjarne tradicionalno povezane z malimi in srednje velikimi kmetijami, katerim z zagotavljanjem dodatnega prihodka kmetom in delovnih mest na podeželskih območjih omogočajo nadaljnje opravljanje njihovih dejavnosti.
This deadline also coincides with the beginning of the new programming period for rural development 2014-2020, meaning, for Germany, the possibility of transferring parts of the funds used for the Monopoly into its rural development programme.
Ta rok tudi sovpada z začetkom novega programskega obdobja za razvoj podeželja 2014–2020, kar pomeni, da bo lahko Nemčija del sredstev, uporabljenih za monopol, prenesla v svoj program za razvoj podeželja.
The small-scale flat-rate distilleries (Abfindungsbrennereien), distillery users (Stoffbesitzer) and fruit cooperative distilleries (Obstgemeinschaftsbrennereien) contribute in particular to the preservation of traditional landscapes and biodiversity by helping to preserve orchards, which supply distillers with raw material.
Žganjarne, za katere je proizvodnja v davčne namene ocenjena po standardni stopnji (Abfindungsbrennereien), uporabniki žganjarn (Stoffbesitzer) in združenja proizvajalcev sadnega žganja (Obstgemeinschaftsbrennereien) prispevajo zlasti k ohranjanju tradicionalnih krajin in biotske raznovrstnosti, saj pripomorejo k ohranitvi sadovnjakov, ki žganjarnam zagotavljajo surovine.
In order to ensure that this aid is indeed in the course of being phased out, Germany should present, on a yearly basis, annual phasing-out plans, as from 2013.
Zaradi zagotovitve, da se ta pomoč dejansko postopno opušča, bi morala Nemčija od leta 2013 vsako leto predložiti letni načrt postopnega opuščanja.
The production of ethyl alcohol in the framework of the Monopoly is limited and corresponds at present to less than 10 % of the total production of ethyl alcohol of agricultural origin in Germany.
Proizvodnja etilnega alkohola v okviru monopola je omejena in trenutno predstavlja manj kot 10 % celotne proizvodnje etilnega alkohola kmetijskega porekla v Nemčiji.
Since, in particular, all bonded distilleries will have entered the free market by 31 December 2013, that percentage will decrease considerably after that date.
Zlasti ob upoštevanju, da bodo do 31. decembra 2013 vse vezane žganjarne vstopile na prosti trg, se bo navedeni odstotek po tem datumu precej zmanjšal.
In order to ensure continuity in the granting of the aid, this Regulation should apply from 1 January 2011.
Da se zagotovi neprekinjeno dodeljevanje pomoči, bi bilo treba to uredbo uporabljati od 1. januarja 2011.
In Article 182 of Regulation (EC) No 1234/2007, paragraph 4 is replaced by the following:
V členu 182 Uredbe (ES) št. 1234/2007 se odstavek 4 nadomesti z naslednjim:
The derogation contained in the second paragraph of Article 180 of this Regulation shall apply to aid payments granted by Germany in the existing national framework of the German Alcohol Monopoly (“the Monopoly”) for products marketed after further transformation by the Monopoly as ethyl alcohol of agricultural origin listed in Annex I to the Treaty on the Functioning of the European Union (TFEU).
Odstopanje iz drugega odstavka člena 180 te uredbe se uporablja za plačila pomoči, ki jih dodeli Nemčija v obstoječem nacionalnem okviru nemškega alkoholnega monopola (v nadaljnjem besedilu: monopol) za proizvode, ki jih po nadaljnjem preoblikovanju trži monopol, na primer etilni alkohol kmetijskega porekla iz Priloge I k Pogodbi o delovanju Evropske unije (PDEU).
That derogation shall operate only until 31 December 2017, shall be without prejudice to the application of Article 108(1) and the first sentence of Article 108(3) TFEU and shall be conditional upon compliance with the following provisions:
Navedeno odstopanje velja do 31. decembra 2017 in ne vpliva na uporabo člena 108(1) in prvega stavka člena 108(3) PDEU ter se uporablja če so izpolnjeni naslednji pogoji:
the total production of ethyl alcohol under the Monopoly benefiting from the aid shall gradually decrease from the maximum of 600000 hl in 2011 to 420000 hl in 2012 and to 240000 hl in 2013 and may amount to a maximum of 60000 hl per year from 1 January 2014 until 31 December 2017, on which date the Monopoly shall cease to exist;
celotna proizvodnja etilnega alkohola v okviru monopola, za katero se prejme pomoč, se postopoma zmanjšuje z največ 600000 hl leta 2011 na 420000 hl leta 2012 in na 240000 hl leta 2013 ter lahko znaša največ 60000 hl na leto od 1. januarja 2014 do 31. decembra 2017, na dan, ko monopol preneha obstajati;
Upon leaving the Monopoly, each agricultural bonded distillery shall be allowed to receive a compensatory aid of EUR 257,50 per hl of nominal distilling rights within the meaning of the applicable German legislation.
Ob izstopu iz monopola bo vsaka kmetijsko vezana žganjarna lahko prejela kompenzacijsko pomoč v višini 257,50 EUR na hl nominalnih pravic za žganjekuho, kakor določa veljavna nemška zakonodaja.
the small-scale flat-rate distilleries, distillery users and fruit cooperative distilleries may benefit from the aid granted by the Monopoly until 31 December 2017, on condition that the production benefiting from the aid does not exceed 60000 hl per year;
žganjarne, za katere je proizvodnja v davčne namene ocenjena po standardni stopnji, uporabniki žganjarn in združenja proizvajalcev sadnega žganja lahko prejemajo pomoč, dodeljeno v okviru monopola, do 31. decembra 2017, pod pogojem, da proizvodnja, za katero se prejme pomoč, ne presega 60000 hl letno;
the total amount of aid paid from 1 January 2011 to 31 December 2013 shall not exceed EUR 269,9 million and the total amount of aid paid from 1 January 2014 to 31 December 2017 shall not exceed EUR 268 million; and
skupni znesek pomoči, plačan od 1. januarja 2011 do 31. decembra 2013, ne presega 269,9 milijona EUR, skupni znesek pomoči, plačan od 1. januarja 2014 do 31. decembra 2017, pa ne presega EUR 268 milijonov EUR, ter
before 30 June each year, Germany shall submit a report to the Commission on the functioning of the Monopoly and the aid granted in the framework thereof in the previous year.
Nemčija vsako leto pred 30. junijem Komisiji predloži poročilo o delovanju monopola in pomoči, dodeljeni v okviru monopola, v predhodnem letu.
The Commission shall forward that report to the European Parliament and the Council.
Komisija to poročilo posreduje Evropskemu parlamentu in Svetu.
Moreover, the annual reports to be submitted in the years 2013 to 2016 shall include an annual phasing-out plan for the following year concerning the small-scale flat-rate distilleries, distillery users and fruit cooperative distilleries.’.
Poleg tega morajo letna poročila, predložena v letih 2013 do 2016, vključevati letni načrt postopnega opuščanja za prihodnje leto za žganjarne, za katere je proizvodnja v davčne namene ocenjena po standardni stopnji, uporabnike žganjarn in združenja proizvajalcev sadnega žganja.“
Opinion of 15 September 2010 (not yet published in the Official Journal) .
Mnenje z dne 15. septembra 2010 (še ni objavljeno v Uradnem listu)
Position of the European Parliament of 23 November 2010 (not yet published in the Official Journal) and decision of the Council of 10 December 2010.
Stališče Evropskega parlamenta z dne 23. novembra 2010 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 10. decembra 2010.
The volumes sold by the Monopoly have fallen since 2003 and the budget decreased from EUR 110 million in 2003 to EUR 80 million in 2008.
Količine, prodane v okviru monopola, se od leta 2003 zmanjšujejo, proračun pa se je s 110 milijonov EUR leta 2003 zmanjšal na 80 milijonov EUR leta 2008.
Some distilleries have thus already made efforts to prepare for their entry into the free market by creating cooperatives, investing in less energy-consuming equipment to reduce production costs and increasingly marketing their alcohol directly.
Tako so se nekatere žganjarne že začele pripravljati za vstop na prosti trg z ustanavljanjem zadrug, vlaganjem v energetsko varčnejšo opremo za zmanjšanje proizvodnih stroškov in z intenzivnejšim neposrednim trženjem svojega alkohola.
Agricultural bonded distilleries processing mainly cereals and potatoes should therefore continue to be able to receive aid through the Monopoly until 31 December 2013.
Kmetijsko vezane žganjarne, ki predelujejo predvsem žita in krompir, bi zato morale pomoč prek monopola prejemati še naprej do 31. decembra 2013.
By that date, all bonded distilleries should have entered the free market.
Do tega datuma bi morale vse vezane žganjarne vstopiti na prosti trg.
Taking this into account, as well as the fact that the production of those distilleries is local and very limited, they should continue to be able to benefit from the aid granted under the Monopoly for a final period until 31 December 2017.
Ob upoštevanju tega in dejstva, da je proizvodnja navedenih žganjarn lokalna in zelo omejena, bi morale te še naprej prejemati pomoč, dodeljeno v okviru monopola, za končno obdobje do 31. decembra 2017.
By this date, the Monopoly is to be abolished.
Do tega datuma je treba monopol ukiniti.
the production by agricultural bonded distilleries benefiting from the aid shall gradually decrease from 540000 hl in 2011 to 360000 hl in 2012 and to 180000 hl in 2013.
proizvodnja kmetijsko vezanih žganjarn, ki prejemajo pomoč, se postopoma zmanjšuje s 540000 hl leta 2011 na 360000 hl leta 2012 in na 180000 hl leta 2013.
By 31 December 2013, all agricultural bonded distilleries shall leave the Monopoly.
Do 31. decembra 2013 bodo vse kmetijsko vezane žganjarne izstopile iz monopola.
This compensatory aid may be granted no later than 31 December 2013.
Kompenzacijska pomoč se lahko dodeli najpozneje 31. decembra 2013.
It may, however, be paid in several instalments, of which the last shall be no later than 31 December 2017;
Vendar pa se lahko izplača v več obrokih, od katerih se zadnji izplača najpozneje 31. decembra 2017;
Regulation (EU) No 1235/2010 of the European Parliament and of the Council
Uredba (EU) št. 1235/2010 Evropskega parlamenta in Sveta
amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
o spremembah Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila in Uredbe (ES) št. 1394/2007 o zdravilih za napredno zdravljenje, glede farmakovigilance zdravil za uporabo v humani medicini
Regulation (EC) No 726/2004 [5] creates a Union-wide marketing authorisation procedure for certain categories of medicinal products (the ‘centralised procedure’), lays down rules for the pharmacovigilance of those products and establishes the European Medicines Agency (the ‘Agency’).
V Uredbi (ES) št. 726/2004 [5] je določen postopek pridobitve dovoljenja za promet za vso Unijo za nekatere kategorije zdravil (v nadaljnjem besedilu: centraliziran postopek), opredeljena so pravila za farmakovigilanco teh zdravil in z navedeno uredbo je bila ustanovljena Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija).
Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products for human use placed on the Union market, as the full safety profile of medicinal products for human use can be known only after they have been placed on the market.
Pravila o farmakovigilanci so potrebna za varovanje javnega zdravja, da se odkrijejo, ocenijo in preprečijo neželeni učinki zdravil za uporabo v humani medicini, ki se dajejo na trg Unije, saj se lahko celotni varnostni profil zdravil za uporabo v humani medicini ugotovi šele potem, ko so bila zdravila dana v promet.
Member States should consider measures to monitor and evaluate the risk of environmental effects of such medicinal products for human use, including those which may have an impact on public health.
Države članice bi morale sprejeti ukrepe za spremljanje in ocenjevanje tveganja vpliva teh zdravil za uporabo v humani medicini na okolje, tudi tistih, ki lahko vplivajo na javno zdravje.
The Commission should, based, inter alia, on data received from the Agency, the European Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to Union legislation on medicinal products for human use or other relevant Union legislation are required.
Komisija bi morala tudi na podlagi podatkov, prejetih od Agencije, Evropske agencije za okolje in držav članic, pripraviti poročilo o razsežnosti problema, obenem pa oceniti, ali so potrebne spremembe zakonodaje Unije o zdravilih za uporabo v humani medicini ali druge zadevne zakonodaje Unije.
In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use.
Glede na pridobljene izkušnje in na podlagi ocene sistema farmakovigilance Unije, ki jo je izdelala Komisija, je postalo jasno, da je potrebno sprejeti ukrepe za izboljšanje delovanja zakonodaje Unije o farmakovigilanci zdravil za uporabo v humani medicini.
The main tasks of the Agency in the area of pharmacovigilance laid down in Regulation (EC) No 726/2004 should be maintained and further developed, in particular as regards the management of the Union pharmacovigilance database and data-processing network (the ‘Eudravigilance database’), the coordination of safety announcements by the Member States and the provision to the public of information regarding safety issues.
Glavne naloge Agencije v zvezi s farmakovigilanco, določene v Uredbi (ES) št. 726/2004, bi bilo treba ohraniti in dodatno razviti, zlasti kar zadeva vodenje podatkovne baze Unije o farmakovigilanci in omrežja za obdelavo podatkov (v nadaljnjem besedilu: podatkovna baza Eudravigilance), usklajevanje varnostnih sporočil držav članic ter obveščanje javnosti o vprašanjih varnosti.
In order to allow all competent authorities to receive, access simultaneously and share pharmacovigilance information for medicinal products for human use authorised in the Union, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information.
Da se vsem pristojnim organom zagotovi, da lahko istočasno prejemajo informacije o farmakovigilanci zdravil za uporabo v humani medicini, odobrenih v Uniji, dostopajo do njih in jih skupaj uporabljajo, bi bilo treba voditi podatkovno bazo Eudravigilance in jo okrepiti kot enotno točko prejema takih informacij.
Member States should therefore not impose any additional reporting requirements on marketing authorisation holders.
Države članice zato imetnikom dovoljenj za promet ne bi smele nalagati dodatnih zahtev za poročanje.
The database should be fully and permanently accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public.
Podatkovna baza bi morala biti v celoti in stalno dostopna državam članicam, Agenciji in Komisiji, v ustreznem obsegu pa tudi imetnikom dovoljenj za promet in javnosti.
In order to increase transparency as regards pharmacovigilance issues, a European medicines web-portal should be created and maintained by the Agency.
Za večjo preglednost v zvezi z vprašanji farmakovigilance bi morala Agencija postaviti in voditi evropski spletni portal o zdravilih.
In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Union level, it is appropriate to create a new scientific committee within the Agency: the Pharmacovigilance Risk Assessment Committee.
Da bi se zagotovila razpoložljivost potrebnega strokovnega znanja in izkušenj ter sredstev za ocene na področju farmakovigilance na ravni Unije, je treba ustanoviti nov znanstveni odbor v okviru Agencije: Odbor za ocenjevanje tveganja na področju farmakovigilance.
That committee should be composed of members appointed by Member States who are competent in the safety of medicines including the detection, assessment, minimisation and communication of risk, and in the design of post-authorisation safety studies and pharmacovigilance audits, and of members appointed by the Commission, who are independent scientific experts, or representatives of healthcare professionals and patients.
Navedeni odbor bi morali sestavljati člani, ki jih imenujejo države članice in so usposobljeni za področje varnosti zdravil, vključno z odkrivanjem, ocenjevanjem, zmanjševanjem in sporočanjem tveganj, ter za pripravo varnostnih študij po pridobitvi dovoljenja za promet in presojo farmakovigilance, ter članov, ki jih imenuje Komisija in so neodvisni znanstveni strokovnjaki ali predstavniki zdravstvenih delavcev in bolnikov.
The rules on Scientific Committees of the Agency laid down in Regulation (EC) No 726/2004 should apply to the Pharmacovigilance Risk Assessment Committee.
Za Odbor za ocenjevanje tveganja na področju farmakovigilance bi se morala uporabljati pravila o znanstvenih odborih Agencije, določena v Uredbi (ES) št. 726/2004.
In order to ensure harmonised responses across the Union to safety concerns regarding medicinal products for human use, the Committee for Medicinal Products for Human Use and the coordination group established by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [6] should rely on the recommendations of the Pharmacovigilance Risk Assessment Committee with regard to any question relating to the pharmacovigilance of medicinal products for human use.
Da bi se v vsej Uniji zagotovil usklajen odziv na pomisleke glede varnosti zdravil za uporabo v humani medicini, bi Odbor za zdravila za humano uporabo in skupina za usklajevanje, ustanovljena z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [6] morala upoštevati priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance pri vseh vprašanjih, povezanih s farmakovigilanco zdravil za uporabo v humani medicini.
However, for the sake of consistency and continuity of the safety assessments, the final responsibility for issuing an opinion on the risk-benefit assessment of medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004 should remain with the Committee for Medicinal Products for Human Use and with the authorities competent for the granting of marketing authorisations.
Vendar pa bi zaradi doslednosti in stalnosti varnostnih ocen za podajanje mnenj o oceni tveganja in koristi zdravil za uporabo v humani medicini, odobrenih v skladu z Uredbo (ES) št. 726/2004, še vedno moral biti pristojen Odbor za zdravila za humano uporabo, kakor tudi organi, pristojni za izdajanje dovoljenj za promet.
It is appropriate that the Pharmacovigilance Risk Assessment Committee should give a recommendation as part of any Union-wide post-authorisation assessment based on pharmacovigilance data relating to medicinal products for human use and it should be responsible for making recommendations on risk management systems and monitoring their effectiveness.
Primerno je, da bi Odbor za ocenjevanje tveganja na področju farmakovigilance kot del ocenjevanja po izdaji dovoljenja za vso Unijo vsakič podal priporočilo na podlagi podatkov o farmakovigilanci v zvezi z zdravili za uporabo v humani medicini ter da bi bil odgovoren za dajanje priporočil v zvezi s sistemom obvladovanja tveganj in spremljanje njegove učinkovitosti.
Such Union-wide assessments should follow the procedures laid down in Directive 2001/83/EC also for medicinal products for human use that were authorised through the centralised procedure.
Tovrstna ocenjevanja za vso Unijo bi morala biti v skladu s postopki iz Direktive 2001/83/ES, tudi za zdravila za uporabo v humani medicini, ki so pridobila dovoljenje po centraliziranem postopku.
In accordance with Directive 2001/83/EC the Agency provides the secretariat to the coordination group.
V skladu z Direktivo 2001/83/ES Agencija zagotavlja storitve sekretariata skupini za usklajevanje.
In view of the enlarged mandate of the coordination group in the area of pharmacovigilance, the technical and administrative support by the secretariat of the Agency to the coordination group should be reinforced.
Zaradi razširjenih pristojnosti in pooblastil skupine za usklajevanje na področju farmakovigilance bi bilo treba okrepiti tehnično in upravno podporo, ki jo skupini za usklajevanje zagotavlja sekretariat Agencije.
Provision should be made for the Agency to ensure appropriate coordination between the coordination group and the Agency’s Scientific Committees.
Določiti bi bilo treba, da Agencija zagotavlja ustrezno usklajevanje med skupino za usklajevanje in znanstvenimi odbori Agencije.
In order to protect public health, the pharmacovigilance activities of the Agency should be adequately funded.
Da bi se varovalo javno zdravje, bi morala imeti Agencija zadostna sredstva za financiranje svojih dejavnosti v zvezi s farmakovigilanco.
It should be ensured that adequate funding is possible for pharmacovigilance activities by empowering the Agency to charge fees to marketing authorisation holders.
Določiti bi bilo treba, da se omogočijo zadostna sredstva za financiranje dejavnosti farmakovigilance tako, da se Agencijo pooblasti za zaračunavanje pristojbin imetnikom dovoljenj za promet.
However, the management of those collected funds should be under the permanent control of the Management Board in order to guarantee the independence of the Agency.
Vendar bi moralo biti upravljanje teh zbranih sredstev pod stalnim nadzorom uprave, da bi se zagotovila neodvisnost Agencije.