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351–400/400
državni nadzor
351 Prevajalska redakcija
izobraževanje
CELEX: 32000R2725
Vsaka država članica zagotovi, da državni nadzorni organ ali organi, imenovan/-i v skladu s členom 28(1) Direktive 95/46/ES, neodvisno spremlja/-jo in nadzoruje/-jo, v skladu s svojo notranjo zakonodajo, zakonitost obdelave osebnih podatkov po tej uredbi, ki jo opravlja država članica, skupaj s pošiljanjem podatkov v centralno enoto.
Each Member State shall provide that the national supervisory authority or authorities designated pursuant to Article 28(1) of Directive 95/46/EC shall monitor independently, in accordance with its respective national law, the lawfulness of the processing, in accordance with this Regulation, of personal data by the Member State in question, including their transmission to the Central Unit.
352 Prevajalska redakcija
izobraževanje
V situacijah, kadar se državno podjetje združi z drugim podjetjem, ki je tudi pod nadzorom iste države ali nad njim pridobi nadzor [21], se pojavi vprašanje, ali te transakcije res predstavljajo koncentracije v smislu člena 3 Uredbe o združitvi ali pa gre za dejavnosti notranjega prestrukturiranja "skupine podjetij v javnem sektorju" [22].
In those situations where a State-owned company merges with or acquires control of another company controlled by the same State (21), the question arises as to whether these transactions really constitute concentrations within the meaning of Article 3 of the Merger Regulation or rather internal restructuring operations of the 'public sector group of companies` (22).
353 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
Države članice lahko na svojem ozemlju dovolijo oskrbo z zdravili za uporabo v veterinarski medicini za živali za pridobivanje hrane, za katera se zahteva veterinarski recept pod ali v okviru nadzora osebe, registrirane za ta namen, ki predloži garancije v zvezi s kvalifikacijami, evidentiranjem in poročanjem v skladu z državno zakonodajo.
Member States may permit the supply on their territory of veterinary medicinal products for food-producing animals for which a veterinary prescription is required by or under the supervision of a person registered for this purpose who provides guarantees with respect to qualifications, record-keeping and reporting in accordance with national law.
354 Prevajalska redakcija
izobraževanje
z odobravanjem posojil ali sofinanciranjem skupaj z večstranskimi ustanovami, poslovnimi bankami ali drugimi zainteresiranimi viri, ali s sodelovanjem pri posojilih podjetjem zasebnega sektorja, s posojili kakršnim koli podjetjem v državni lasti, ki poslujejo konkurenčno in si prizadevajo za udeležbo v tržno usmerjenem gospodarstvu, ter posojil kakršnim koli podjetjem v državni lasti za olajšanje njihovega prehoda v zasebno lastništvo in nadzor, zlasti za olajševanje ali povečanje udeležbe zasebnega in/ali tujega kapitala v takih podjetjih;
by making, or cofinancing together with multilateral institutions, commercial banks or other interested sources, or participating in, loans to private sector enterprises, loans to any state-owned enterprise operating competitively and moving to participation in the market-oriented economy, and loans to any state-owned enterprise to facilitate its transition to private ownership and control; in particular to facilitate or enhance the participation of private and/or foreign capital in such enterprises;
355 Prevajalska redakcija
izobraževanje
CELEX: 32001D0427
Strategija Evropske unije na začetku novega tisočletja za preprečevanje in nadzor nad organiziranim kriminalom [3] v Priporočilu 6 poziva, naj Svetu pomagajo ustrezno usposobljeni strokovnjaki za preprečevanje kriminala kot so nacionalne kontaktne točke ali pa ustanovitev mreže strokovnjakov iz državnih organov za preprečevanje kriminala.
The European Union Strategy for the beginning of the new millennium on the prevention and control of organised crime(3) calls in Recommendation 6 for the Council to be assisted by suitably qualified experts on crime prevention, such as the national focal points, or by establishing a network of experts from national crime prevention organisations.
356 Prevajalska redakcija
izobraževanje
v členu 8(2) se stavek "kot je opredelila Komisija v Prilogi I k okviru Skupnosti za državno pomoč za raziskovanje in razvoj" glasi "kot je opredelila Komisija v Prilogi I k okviru Skupnosti za državno pomoč za raziskovanje in razvoj [5] in Nadzorni organ EFTE v Poglavju 14 svojih postopkovnih in vsebinskih pravil na področju državne pomoči [6];"
in Article 8 (2) the phrase "as defined by the Commission in Annex I to the Community framework for State aids for research and development" shall read "as defined by the Commission in Annex I to the Community framework for State aids for research and development (5) and by the EFTA Surveillance Authority in Section 14 of its Procedural and Substantive Rules in the Field of State Aid (6);
357 Prevajalska redakcija
izobraževanje
Poleg tega, da Pogodba nalaga Komisiji nadzor državne pomoči v Skupnosti, skupaj z drugimi oblikami javnih intervencij, morajo nacionalni organi in organi Skupnosti pri odločanju o podelitvi ali odobritvi javnih sredstev za ukrepe, namenjene spodbujanju tveganega kapitala, čimbolj omejiti naslednje tri ločene, čeprav med seboj povezane kategorije tveganja:
Aside from the fact that the Treaty imposes on the Commission the requirement to control State aid within the Community, and in common with other forms of public intervention, national and Community authorities, when deciding whether to commit or to authorise public funds for measures designed to promote risk capital, should reduce as far as possible the following three distinct though connected categories of risk:
358 Prevajalska redakcija
izobraževanje
CELEX: 31993L0022
Poleg tega lahko ne glede na določbe iz odstavkov 1 in 4 države članice glede na določbe, predpisane z zakonom, odobrijo razkritje nekaterih informacij drugim oddelkom v državni upravi, ki so odgovorni za zakonodajo o nadzoru kreditnih institucij, finančnih institucij, investicijskih družb in zavarovalnic, ter inšpektorjem, ki dobijo navodila teh oddelkov.
In addition, notwithstanding the provisions referred to in paragraphs 1 and 4, Member States may, by virtue of provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment firms and insurance undertakings and to inspectors instructed by those departments.
359 Prevajalska redakcija
izobraževanje
CELEX: 31993R0339
ker morajo imeti carinski organi v primeru, če pri pregledu za sprostitev v prosti promet ugotovijo, da imajo proizvodi značilnosti, na podlagi katerih lahko sklepajo, da gre za resno in neposredno nevarnost za zdravje in varnost, preprečiti sprostitev tega blaga in obvestiti državne organe, pristojne za nadzor trga, tako da lahko ti sprejmejo ustrezne ukrepe;
Whereas, in particular, if the customs authorities find, when carrying out checks in connection with releases for free circulation, that goods display certain characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health and safety, these authorities must be in a position to suspend the release of those goods and to inform the national authorities responsible for monitoring the market so that the latter may take suitable action;
360 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet se o podrobnostih nadzorovanega distribucijskega sistema dogovori s pristojnimi državnimi organi in mora tak program izvajati nacionalno in tako zagotovi, da imajo vsi strokovnjaki zdravstvenega varstva, ki nameravajo predpisati in/ ali izdati zdravilo Tracleer, že pred predpisovanjem zagotovljeno opremo za predpisovanje, ki vsebuje:
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Tracleer are provided with a Prescriber Kit containing the following:
361 Prevajalska redakcija
izobraževanje
CELEX: 31993R2454
Brez poseganja v odstavek 3 je povračilo ali odpust uvoznih dajatev v primerih iz odstavka 1(c) in (f) do (n), razen v primeru uničenja blaga na ukaz državnega organa ali brezplačne dobave dobrodelnim organizacijam, ki svoje dejavnosti izvajajo v Skupnosti, odvisen od njegovega nameravanega ponovnega izvoza s carinskega območja Skupnosti, ki poteka pod nadzorom carinskih organov.
Without prejudice to paragraph 3, repayment or remission of import duties in the cases referred to in paragraph 1 (c) and (f) to (n) shall, except where the goods are destroyed by order of a public authority or delivered free of charge to charities carrying out their activities in the Community, be conditional upon their re-export from the customs territory of the Community under the supervision of the customs authorities.
362 Prevajalska redakcija
izobraževanje
CELEX: 32002L0083
Poleg tega lahko države članice, ne glede na odstavka 1 in 4, v skladu z zakonskimi določbami dovolijo razkrivanje nekaterih podatkov drugim službam njihove državne uprave, ki so pristojni za zakonodajo v zvezi z nadzorom kreditnih institucij, finančnih institucij, institucij za opravljanje investicijskih storitev in zavarovalnic, ter inšpektorjem, ki delujejo v imenu teh služb.
In addition, notwithstanding paragraphs 1 and 4, Member States may, under provisions laid down by law, authorise the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment services and assurance undertakings and to inspectors acting on behalf of those departments.
363 Prevajalska redakcija
izobraževanje
v členu 5(1) se izraz "smernice Skupnosti o državnih pomočeh za reševanje in prestrukturiranje podjetij v težavah" glasi "smernice Skupnosti o državnih pomočeh za reševanje in prestrukturiranje podjetij v težavah [5] in postopkovna in vsebinska pravila Nadzornega organa EFTA na področju državne pomoči, Poglavje 16 o pomoči za reševanje in prestrukturiranje podjetij v težavah [6]";
in Article 5(1), the terms 'the Community guidelines on State aid for rescuing and restructuring firms in difficulty' shall read 'the Community guidelines on State aid for rescuing and restructuring firms in difficulty(5) and the EFTA Surveillance Authority's procedural and substantive rules in the field of State aid, Chapter 16 on aid for rescuing and restructuring firms in difficulty(6)';
364 Prevajalska redakcija
izobraževanje
CELEX: 31993R0339
Če državni organi, pristojni za nadzor trga, po posredovanju v skladu s členom 4 ocenijo, da proizvodne predstavlja resne in neposredne nevarnosti za zdravje in varnost in/ali ne velja za neskladnega s predpisi Skupnosti ali z ustrezno nacionalno zakonodajo o varnosti proizvodov, se ta proizvod sprosti v prosti promet, če so bile za sprostitev v prosti promet izpolnjene vse ostale zahteve in postopki.
Where, after intervening in accordance with Article 4, the national authorities responsible for monitoring the market consider that the product in question does not present a serious and immediate risk to health and safety and/or cannot be regarded as being in breach of Community or national laws on product safety, the product in question shall be released for free circulation provided that all the other requirements and formalities pertaining to such release have been met.
365 Prevajalska redakcija
izobraževanje
CELEX: 31993R0339
Če državni organi, pristojni za nadzor trga, ugotovijo, da proizvod predstavlja resno in neposredno nevarnost, sprejmejo ukrepe, s katerimi preprečijo dajanje proizvoda na trg, kot je predvideno z ustrezno nacionalno zakonodajo ali predpisi Skupnosti, in zahtevajo od carinskih organov, da na računu, ki je priložen proizvodu, in na vsaki drugi spremni dokumentaciji navedejo eno izmed naslednjih opozoril:
Where the national authorities responsible for monitoring the market find that the product in question presents a serious and immediate risk, they shall, in accordance with the Community or national rules applicable, take measures to prohibit the product from being placed on the market and ask the customs authorities to include one of the following endorsements on the commercial invoice accompanying the product and on any other relevant accompanying document: - 'Producto peligroso
366 Prevajalska redakcija
izobraževanje
CELEX: 31997L0070
Ribiška plovila, ki ribarijo v notranjih vodah ali teritorialnem morju države članice ali iztovarjajo svoj ulov v njenih pristaniščih in niso ribiška plovila, ki plujejo pod zastavo navedene države članice, nadzoruje država članica v skladu s členom 4 Torremolinoškega protokola in brez diskriminacije na podlagi zastave ali državne pripadnosti upravljavca, da bi preverila, ali so v skladu s to direktivo.
Fishing vessels operating in the internal waters or territorial sea of a Member State or landing their catch in its ports and not being fishing vessels flying the flag of that Member State shall be subject to control by the Member State, in accordance with Article 4 of the Torremolinos Protocol and without discrimination with regard to flag or nationality of the operator, in order to verify that they comply with this Directive.
367 Prevajalska redakcija
izobraževanje
CELEX: 31995L0026
Poleg tega lahko ne glede na določbe iz odstavkov 2 in 5 države članice glede na določbe, predpisane z zakonom, odobrijo razkritje nekaterih podatkov drugim oddelkom v državni upravi, odgovornim za zakonodajo o nadzoru KNPVP in podjetij, ki prispevajo k poslovni dejavnosti, kreditnih institucij, finančnih institucij, investicijskih podjemov in zavarovalnic, ter inšpektorjem, ki so dobili navodila teh oddelkov.
In addition, notwithstanding the provisions referred to in paragraphs 2 and 5, Member States may, by virtue of provisions laid down by law, authorize the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of Ucits and of undertakings contributing towards their business activity, credit institutions, financial institutions, investment undertakings and insurance undertakings and to inspectors instructed by those departments.
368 Prevajalska redakcija
izobraževanje
CELEX: 32002D0941
Z Odločbo Komisije 97/102/ES z dne 16. januarja 1997 o posebnih pogojih za uvoz ribiških in ribogojnih proizvodov s poreklom iz Rusije [3], se "Odbor za ribištvo Ruske Federacije, ki ga podpira Državni odbor za sanitarno-epidemiološki nadzor (Goskomsanpidnadzor)" opredeli kot pristojni organ v Rusiji za preverjanje in potrjevanje skladnosti ribiških proizvodov in proizvodov iz ribogojstva z zahtevami Direktive 91/493/EGS.
In Commission Decision 97/102/EC of 16 January 1997 laying down special conditions governing imports of fishery and aquaculture products originating in Russia(3), the "Committee of Fisheries of the Federation of Russia, assisted by the State Committee for Sanitary and Epidemiological Surveillance (Goskomsanepidnadzor)" is identified as the competent authority in Russia for verifying and certifying compliance of fishery and aquaculture products with the requirements of Directive 91/493/EEC.
369 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
Na zahtevo pristojnih organov mora imetnik dovoljenja za promet z zdravilom predložiti svoje tehnično poročilo, da omogoči izvajanje analizne metode določanja zaostankov zdravila za uporabo v veterinarski medicini v državnem referenčnem laboratoriju, pooblaščenem v skladu z Direktivo 96/23/ES z dne 29. aprila 1996 o nadzornih ukrepih določenih snovi in njihovih zaostankov v živih živalih in živalskih izdelkih [12].
At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(12).
370 Prevajalska redakcija
izobraževanje
CELEX: 31997L0070
Ribiška plovila, ki niti ne ribarijo v notranjih vodah ali teritorialnem morju države članice niti ne iztovarjajo svojega ulova v pristaniščih države članice in plujejo pod zastavo druge države članice, nadzoruje država članica, če so v njenih pristaniščih, v skladu s členom 4 Torremolinoškega protokola in brez diskriminacije na podlagi zastave ali državne pripadnosti upravljavca, da bi preverila, ali so v skladu s to direktivo.
Fishing vessels, which are not operating in the internal waters or territorial sea of a Member State nor landing their catch in the ports of a Member State and flying the flag of another Member State, shall be subject to control by the Member State, when in its ports, in accordance with Article 4 of the Torremolinos Protocol and without discrimination with regard to flag or nationality of the operator, in order to verify that they comply with this Directive.
371 Prevajalska redakcija
izobraževanje
CELEX: 32001D0380
Komisija je na podlagi Uredbe (ES) št. 1266/1999 in Uredbe (ES) št. 2222/2000 analizirala upravljalske zmogljivosti državnega in področnega programa/projekta, postopke finančnega nadzora ter strukture, ki se nanašajo na javne finance in ugotovila, da se Republika Bolgarija pri izvajanju omenjenih ukrepov ravna po določbah iz členov 4 do 6 in iz Priloge k Uredbi (ES) št. 2222/2000, z minimalnimi pogoji iz Priloge k Uredbi (ES) št. 1266/1999.
Pursuant to Regulation (EC) No 1266/1999 and Regulation (EC) No 2222/2000, the Commission has analysed the national and sectorial programme/project management capacity, financial control procedures and structures regarding public finance and has established that, for the implementation of the aforementioned measures, the Republic of Bulgaria complies with the provisions of Articles 4 to 6 and of the Annex to Regulation (EC) No 2222/2000, with the minimum conditions set out in the Annex to Regulation (EC) No 1266/1999.
372 Prevajalska redakcija
izobraževanje
PONOVNO POTRJUJEJO Deklaracijo o okolju in razvoju iz Ria, v kateri je pod njenim načelom 2 navedeno, da imajo države v skladu z Ustanovno listino Združenih narodov in načeli mednarodnega prava suvereno pravico do izkoriščanja svojih virov v skladu s svojimi okoljevarstvenimi in razvojnimi usmeritvami ter odgovornost, da zagotovijo, da dejavnosti pod njihovo jurisdikcijo ali nadzorom ne povzročajo škode okolju drugih držav ali območjem zunaj meja državne jurisdikcije,
REAFFIRMING the Rio Declaration on Environment and Development which states, in its Principle 2, that States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental and developmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction,
373 Prevajalska redakcija
izobraževanje
CELEX: 32003D0846
Na podlagi analize posamičnega primera sposobnosti za upravljanje državnega in sektorskega programa/projekta, postopkov finančnega nadzora in strukture javnih financ, predvidene v členu 12(2) Uredbe (ES) št. 1266/1999, je Komisija sprejela Sklep 2002/638/ES z dne 31. julija 2002 o prenosu upravljanja pomoči na izvajalske agencije za predpristopne ukrepe v kmetijstvu in razvoju podeželja v Romuniji v predpristopnem obdobju [4] glede nekaterih ukrepov, predvidenih v programu Sapard.
On the basis of a case-by-case analysis of the national and sectorial programme/project management capacity, financial control procedures and structures regarding public finance, as provided for in Article 12(2) of Regulation (EC) No 1266/1999, the Commission adopted Decision 2002/638/EC of 31 July 2002 conferring management of aid on implementing agencies for pre-accession measures in agriculture and rural development in Romania in the pre-accession period(4) with regard to certain measures provided for in Sapard.
374 Prevajalska redakcija
izobraževanje
CELEX: 31996L0023
Kadar osebje klavnice ali nadzornik klavnice ali, v primeru zasebnega podjetja, lastnik ali lastniki klavnice ali lastnik živali ali oseba, ki je odgovorna za živali, nočejo sodelovati s pristojnim organom ali kakorkoli ovirajo njegovo delo v času pregledov in vzorčenja, ki jih terja izvajanje državnih načrtov za nadzor nad ostanki škodljivih snovi in v času preiskav ter pregledov, ki jih predvideva ta direktiva, jim morajo pristojni državni organi izreči ustrezne sodne in/ali administrativne kazni.
Any failure to cooperate with the competent authority and any obstruction by slaughterhouse personnel or the slaughterhouse supervisor or, in the case of a private enterprise, by the slaughterhouse owner or owners, or by the owner of the animals or person having charge of them, during inspection and sampling as required for the implementation of national plans for monitoring residues and during the investigations and checks provided for in this Regulation, shall result in appropriate criminal and/or administrative penalties being imposed by the competent national authorities.
375 Prevajalska redakcija
izobraževanje
GLEDE NA ustrezne določbe Deklaracije Konference Združenih narodov o človekovem okolju in še posebej glede na njeno 21. načelo, po katerem imajo države v skladu z Ustanovno listino Združenih narodov in načeli mednarodnega prava suvereno pravico izkoriščati lastne naravne vire v skladu s svojo okoljsko politiko, ter odgovornost, da zagotovijo, da dejavnosti, ki so pod njihovo jurisdikcijo ali nadzorom, ne povzročajo škode okolju drugih držav ali na območjih zunaj meja njihove državne jurisdikcije,
CONSIDERING the pertinent provisions of the Declaration of the United Nations Conference on the Human Environment, and in particular principle 21, according to which States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction,
376 Prevajalska redakcija
izobraževanje
Medtem ko Komisija doslej ni izvrševala svojih pooblastil na področju nadzora državnih pomoči ter na področju izvoznih kreditov in zavarovanj izvoznih kreditov, so delo Skupine Sveta za izvozne kredite [4] in primeri pred Sodiščem Evropskih skupnosti [5] pokazali, da vsaj na enem področju, to je na področju kratkoročnih zavarovanj izvoznih kreditov, dejanska ali morebitna izkrivljanja konkurence v Skupnosti lahko upravičujejo ukrepe Skupnosti na podlagi pravil o državni pomoči, ne da bi čakali na napredek na drugih področjih.
While the Commission has so far refrained from exercising its State aid control powers in the areas of export credits and export-credit insurance, work by the Council's Export Credits Group (4) and cases before the Court of Justice of the European Communities (5) have shown that in one area at least, that of short-term export-credit insurance, the actual or potential distortions of competition in the Community may justify action by the Commission under the State aid rules without waiting for progress on other fronts.
377 Prevajalska redakcija
izobraževanje
CELEX: 32001R0438
Sistemi upravljanja in nadzora vključujejo postopke za preverjanje zagotavljanja sofinanciranih izdelkov in storitev ter resničnost navedenih izdatkov, pa tudi zagotavljanje upoštevanja pogojev, določenih v ustrezni odločbi Komisije po členu 28 Uredbe (ES) št. 1260/1999 ter z veljavnimi nacionalnimi predpisi in predpisi Skupnosti, ki se nanašajo zlasti na upravičenost izdatkov za pomoč iz Strukturnih skladov v okviru zadevne pomoči, javna naročila, državne pomoči (vključno s pravili o združevanju pomoči), varstvo okolja in enakost med moškimi in ženskami.
Management and control systems shall include procedures to verify the delivery of the products and services co-financed and the reality of expenditure claimed and to ensure compliance with the terms of the relevant Commission decision under Article 28 of Regulation (EC) No 1260/1999 and with applicable national and Community rules on, in particular, the eligibility of expenditure for support from the Structural Funds under the assistance concerned, public procurement, State aid (including the rules on the cumulations of aid), protection of the environment and equality of opportunity.
378 Prevajalska redakcija
RS
EMEA
Države članice se morajo o podrobnostih sistema za nadzorovano distribucijo dogovoriti z imetnikom dovoljenja za promet z zdravili in izvajati ta program na državni ravni, da tako zagotovi naslednje: • pred lansiranjem zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati zdravilo Revlimid, in vsi farmacevti, ki bodo izdajali zdravilo Revlimid, prejeti Neposredno obvestilo zdravstvenim delavcem, kot je opisano spodaj; • pred predpisovanjem (kjer je ustrezno, in v skladu s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) zdravilo Revlimid, prejeli paket s podatki za zdravnike, ki vsebuje naslednje: o izobraževalni paket za zdravstvene delavce, o izobraževalne brošure za bolnike, o kartice bolnika, o povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare system and must implement such programme nationally to ensure that: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’ s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
379 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet z zdravili se mora o podrobnostih sistema za nadzorovano distribucijo dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na državni ravni, da tako zagotovi naslednje: • pred lansiranjem zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati zdravilo Revlimid, in vsi farmacevti, ki bodo izdajali zdravilo Revlimid, prejeti Neposredno obvestilo zdravstvenim delavcem, kot je opisano spodaj; • pred predpisovanjem (kjer je ustrezno, in v skladu s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) zdravilo Revlimid, prejeli paket s podatki za zdravnike, ki vsebuje naslednje: o izobraževalni paket za zdravstvene delavce, o izobraževalne brošure za bolnike, o kartice bolnika, o povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
380 Prevod
izobraževanje
Protokol 26 o pooblastilih in nalogah Nadzornega organa EFTA na področju državnih pomoči
Protocol 26 on the powers and functions of the EFTA Surveillance Authority in the field of Sate aid
381 Prevod
izobraževanje
Komisija ES in Nadzorni organ EFTA redno pripravljata poročila o državnih pomočeh v njunih državah.
the EC Commission and the EFTA Surveillance Authority shall periodically prepare surveys on State aid in their respective States.
382 Prevod
promet
za postopke in dejavnosti, ne glede na mesto njihovih učinkov, ki potekajo pod njeno jurisdikcijo ali nadzorom na območju njene državne jurisdikcije ali zunaj meja državne jurisdikcije.
in the case of processes and activities, regardless of where their effects occur, carried out under its jurisdiction or control, within the area of its national jurisdiction or beyond the limits of national jurisdiction.
383 Prevod
promet
Les établissements publics de l'État placés sous la surveillance d'un membre du gouvernement (javne državne ustanove pod nadzorom člana vlade),
Les établissements publics de l'État placés sous la surveillance d'un membre du gouvernement (public establishments of the State placed under the supervision of a member of the Government),
384 Prevod
promet
"Družba v državni lasti" pomeni družbo v lasti ali pod nadzorom Čila s pomočjo udeležbe v lastništvu, in vključuje vse družbe, ustanovljene po začetku veljavnosti tega sporazuma, katerih edini namen je prodaja sli odstranitev udeležbe v kapitalu ali sredstvih obstoječega subjekta v državni ali vladni lasti.
A 'State owned company" shall mean any company owned or controlled by Chile by means of an interest share in the ownership thereof, and it shall include any company created after the entry into force of this Agreement for the sole purpose of selling or disposing of its interest share in the capital or assets of an existing State-owned or Government Entity.
385 Prevod
okolje
DRUGO: SOP-001-22-67/98
če sprejme državno funkcijo, poslovodsko ali nadzorstveno funkcijo v gospodarski družbi ali javnem zavodu, plačano službo ali začne opravljati pridobitno dejavnost, ali postane notar ali odvetnik;
3) if he accepts public office, a managerial or supervisory post in a commercial company or public institution, or a paid job, or if he decides to carry out a lucrative activity or to become a notary or attorney;
386 Prevod
izobraževanje
Da bi zagotovili enotno izvajanje, uporabo in razlago predpisov o državni pomoči na celotnem ozemlju pogodbenic ter njihov harmoničen razvoj, se Komisija ES in Nadzorni organ EFTA ravnata po naslednjih pravilih:
In order to ensure a uniform implementation, application and interpretation of the rules on State aid throughout the territory of the Contracting Parties as well as to guarantee their harmonious development, the EC Commission and the EFTA Surveillance Authority shall observe the following rules:
387 Prevod
izobraževanje
redno ali na prošnjo enega od obeh nadzornih organov se organizira izmenjava informacij in mnenj o vprašanjih splošne politike, kot so izvajanje, uporaba in razlaga predpisov o državni pomoči, določenih v Sporazumu;
exchange of information and views on general policy issues such as the implementation, application and interpretation of the rules on State aid set out in the Agreement shall be held periodically or at the request of either surveillance authority;
388 Prevod
izobraževanje
ne glede na določbe tega protokola Komisija ES in Nadzorni organ EFTA na prošnjo drugega nadzornega organa zagotovita informacije za vsak primer posamično ter izmenjata mnenja o posameznih programih in primerih državne pomoči;
notwithstanding the provisions of this Protocol, the EC Commission and the EFTA Surveillance Authority shall, at the request of the other surveillance authority, provide on a case-by-case basis information and exchange views on individual State aid programmes and cases;
389 Prevod
promet
spremljanju, nadzoru, skladnosti in izvrševanju, vključno z usposabljanjem in krepitvijo zmogljivosti na lokalni ravni, razvojem in financiranjem državnih in regionalnih programov opazovalcev in dostopom do tehnologije in opreme.
monitoring, control, surveillance, compliance and enforcement, including training and capacity-building at the local level, development and funding of national and regional observer programmes and access to technology and equipment.
390 Prevod
promet
CELEX: 31992R0601
ker sistem predhodnega nadzora, opredeljenega s to uredbo, ne vpliva na določbe Uredbe Sveta (EGS) št. 1765/82 z dne 30. junija 1982 o skupnih pravilih za uvoz iz držav z državno trgovino fn, niti na določbe Uredbe Sveta št. 3420/83 z dne 14. novembra 1983 o uvoznih režimih za izdelke s poreklom v državah z državno trgovino, ki niso liberalizirani na ravni Skupnosti fn;
Whereas the system of prior surveillance provided for by this Regulation does not affect the provisions of Council Regulation (EEC) No 1765/82 of 30 June 1982 on common rules for imports from State-trading countries nor of Council Regulation (EEC) No 3420/83 of 14 November 1983 on import arrangements for products originating in State-trading countries, not liberalized at Community level;
391 Prevod
okolje
DRUGO: SOP-001-22-67/98
Z opravljanjem dejanj izvršbe in zavarovanja ni združljivo opravljanje državnih funkcij ali poslovodskih in nadzornih funkcij v gospodarskih družbah ali javnih zavodih, plačane službe, pridobitnih dejavnosti in dejavnosti notarjev in odvetnikov.
The performance of acts of execution and the interim protection of claims shall be incompatible with public office or managerial and supervisory functions in commercial companies and public institutions, and with paid jobs, lucrative activities, notarial office and attorneyship.
392 Prevod
promet
izvede preverjanje z analizo, nadzorom, preizkušanjem in pregledom in tako zagotovi, da sta fizično stanje in obratovanje jedrskega objekta še naprej v skladu z njegovim projektom, veljavnimi državnimi zahtevami in obratovalnimi omejitvami in pogoji.
verification by analysis, surveillance, testing and inspection is carried out to ensure that the physical state and the operation of a nuclear installation continue to be in accordance with its design, applicable national safety requirements, and operational limits and conditions.
393 Prevod
izobraževanje
Informacije, ki izhajajo iz držav Efte, Nadzornega organa EFTA, Stalnega odbora držav Efte in Sodišča EFTA npr. v zvezi s konkurenco, državnimi pomočmi, javnimi naročili in tehničnimi standardi, bodo objavljene v devetih uradnih jezikih ES v posebnem delu EGP Uradnega lista ES.
Information emanating from the EFTA States, the EFTA Surveillance Authority, the Standing Committee of the EFTA States and the EFTA Court regarding, for example, competition, State aid, public procurement and technical standards will be published in the nine official languages of the EC in a special EEA section of the Official Journal of the EC.
394 Prevod
promet
CELEX: 32002D0818
Ugotovljeno je bilo, da je Koreja z odpisom dolgov, spreminjanjem dolgov v lastniške deleže in subvencioniranjem obresti s strani bank v državni lasti ali pod državnim nadzorom odobrila subvencije v smislu člena 1 Sporazuma o subvencijah in povračilnih ukrepih naslednjim ladjedelnicam:
It was established that Korea has granted through debt forgiveness, debt-for-equity-swaps and interest relief by government-owned and government-controlled banks, subsidies within the meaning of Article 1 of the SCM Agreement to the following shipyards:
395 Prevod
promet
spodbujajo sodelovanje med državami v postopkih za presojo vplivov na okolje v zvezi z dejavnostmi pod njihovo jurisdikcijo ali nadzorom, ki bi lahko imele znatne škodljive učinke na morsko okolje drugih držav ali območij izven meja državne jurisdikcije, na podlagi obveščanja, izmenjave podatkov in posvetovanj;
promote cooperation between and among States in environmental impact assessment procedures related to activities under their jurisdiction or control which are likely to have a significant adverse effect on the marine environment of other States or areas beyond the limits of national jurisdiction, on the basis of notification, exchange of information and consultation;
396 Prevod
promet
CELEX: 31999D0852
izvajanje zakona o romunskih državnih mejah, vključno z združitvijo mejne straže in mejne policije; pospešitev demilitarizacije Ministrstvu za notranje zadeve podrejenih organov; okrepitev mejnega nadzora za preprečitev nezakonite imigracije in za omogočanje polnega sodelovanja pri schengenskem informacijskem sistemu,
implement law on the Romanian state frontiers including the merger of the Border Guard and the Border Police; speed up the demilitarisation of the bodies subordinated to the Ministry of the Interior; strengthen border controls to prevent illegal immigration and to enable full participation in the Schengen Information System,
397 Prevod
promet
ga v glavnem financira država ali regionalni ali lokalni organi oblasti, ali drugi subjekt, organiziran na podlagi javnega prava, ali ga nadzira eden od navedenih organov, ali imajo upravni, vodilni ali nadzorni odbor; katerega več kot polovica članov so imenovali državni, regionalni ali lokalni organi oblasti ali drugi subjekti, organizirani na podlagi javnega prava.
financed, for the most part, by the State, or regional or local authorities, or other bodies governed by public law, or subject to management supervision by those bodies, or having an administrative, managerial or supervisory board; more than half of whose members are appointed by the State, regional or local authorities or by other bodies governed by public law.
398 Prevod
promet
CELEX: 31999D0852
dokončanje zakonodajnega okvira za notranji in zunanji finančni nadzor; krepitev osrednje organizacije znotraj Ministrstva za finance za prilagajanje notranjih revizijskih/nadzornih enot pri proračunskih uporabnikih ter uvedba "funkcionalne neodvisnosti" za državne notranje nadzornike/revizorje tako na državni kot decentraliziranih ravneh in ex- ante finančne kontrole,
complete the legislative framework for internal and external financial control; strengthen the central organisation within the Ministry of Finance for harmonising internal audit/control units in spending centres, and introduce "functional independence" for national internal controllers/auditors at both central and decentralised levels and ex-ante financial control,
399 Prevod
izobraževanje
če je za programe in primere državne pomoči sprožen postopek iz prvega in drugega pododstavka člena 93(2) Pogodbe o ustanovitvi Evropske gospodarske skupnosti ali drug ustrezen postopek iz sporazuma med državami Efte o ustanovitvi Nadzornega organa EFTA, Komisija ES oziroma Nadzorni organ EFTA obvesti drugi nadzorni organ ter prizadete stranke, naj predložijo svoje pripombe;
if the procedure referred to in the first and second subparagraphs of Article 93(2) of the Treaty establishing the European Economic Community or the corresponding procedure set out in an agreement between the EFTA States establishing the EFTA Surveillance Authority is opened for State aid programmes and cases, the EC Commission or the EFTA Surveillance Authority shall give notice to the other surveillance authority as well as to the parties concerned to submit their comments;
400 Prevod
promet
ki so v vsaj 50-odstotni lasti državljanov držav članic ES ali Nekdanje jugoslovanske republike Makedonije, ali pa podjetja s sedežem v eni od teh držav, v katerih so direktor ali direktorji, predsednik uprave ali nadzornega sveta in večina članov takih odborov državljani držav članic Skupnosti ali Nekdanje jugoslovanske republike Makedonije in v katerih poleg tega, kadar gre za osebne ali kapitalske družbe, vsaj polovica kapitala pripada tem državam ali državnim organom ali državljanom omenjenih držav;
which are owned to an extent of at least 50% by nationals of EC Member States or of the former Yugoslav Republic of Macedonia, or by a company with its head office in one of these States, of which the manager or managers, Chairman of the Board of Directors or the Supervisory Board, and the majority of the members of such boards are nationals of EC Member States or of the former Yugoslav Republic of Macedonia and of which, in addition, in the case of partnerships or limited companies, at least half the capital belongs to those States or to public bodies or nationals of the said States;
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