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ukrep za nadzor prometa
51 Prevajalska redakcija
izobraževanje
CELEX: 32004R0549
za nadzorovanje zračnega prostora v njeni pristojnosti, skladno z regionalnimi sporazumi o zračnem prometu Mednarodne organizacije civilnega letalstva (ICAO), zlasti za sposobnost odkrivanja, prepoznavanja in presojanja vseh zrakoplovov, ki uporabljajo ta zračni prostor, z namenom zavarovati varnost letenja in sprejeti ukrepe za izpolnjevanje potreb varovalne in obrambne politike.
for the surveillance of airspace that is under its responsibility in accordance with ICAO Regional Air Navigation agreements, including the capability to detect, identify and evaluate all aircraft using such airspace, with a view to seeking to safeguard safety of flights and to take action to ensure security and defence needs,
52 Prevajalska redakcija
RS
EMEA
Države članice se bodo z imetnikom dovoljenja za promet z zdravilom pred uvedbo zdravila na trg dogovorile o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
53 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).
54 Prevajalska redakcija
RS
EMEA
6. Imetnik dovoljenja za promet z zdravilom se mora prav tako v vsaki državi članici pred uvedbo zdravila na trg dogovoriti o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
16 o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
55 Prevajalska redakcija
izobraževanje
CELEX: 32003L0085
Epidemija slinavke in parkljevke v nekaterih državah članicah leta 2001 je pokazala, da zaradi intenzivnih premikov in prometa z živalmi, dovzetnimi za slinavko in parkljevko, lahko izbruh hitro doseže epizootske razsežnosti, kar lahko povzroči motnje v takem obsegu, da se strmo zmanjša donosnost reje živali dovzetnih vrst ter drugih panog kmetijstva in so potrebna precejšnja finančna sredstva za odškodnine kmetom in uporaba ukrepov nadzora.
The foot-and-mouth disease epidemic in certain Member States in 2001 demonstrated that due to intensive movement of and trade in animals susceptible to foot-and-mouth disease, an outbreak can quickly take on epizootic proportions, causing disturbances on a scale liable to reduce sharply the profitability of farming of animals of susceptible species and other parts of the rural economy and also requiring substantial financial resources to compensate farmers and the application of control measures.
56 Prevajalska redakcija
izobraževanje
CELEX: 32001L0046
Če je resna nevarnost v skladu z odstavkom 1 potrjena, države članice zagotovijo, da končno odlagališče pošiljke z neželenimi snovmi, vključno z morebitno dekontaminacijo, nadaljnjim ukrepanjem za predelavo proizvodov v neškodljive proizvode, predelavo ali uničenjem, ne more škodljivo vplivati na zdravje ljudi ali živali ali na okolje, če pa obstaja možnost ali tveganje, da so se neželene snovi razširile tudi na druge pošiljke ali krmno ali prehransko verigo, takoj identificirajo te druge pošiljke proizvodov, ki jih štejejo za nevarne, in nad njimi uvedejo nadzor, poleg tega pa, če je to primerno, identificirajo žive živali, hranjene z nevarnimi proizvodi, in izvajajo ukrepe, predvidene v Direktivi 96/23/ES ali v drugih ustreznih določbah Skupnosti v zvezi z zdravjem živali ali varno hrano proizvodov živalskega izvora, pri čemer zagotovijo usklajenost raznih nadzornih služb, da se izognejo dajanju nevarnih proizvodov v promet in zagotovijo izvajanje postopkov za umik proizvodov, ki so že v prometu.
Where the existence of a serious risk is confirmed in accordance with paragraph 1, Member States shall ensure that the final destination of the consignment containing undesirable substances, including possible decontamination, further action to render the products harmless, reprocessing or destruction, cannot have harmful effects on human or animal health or on the environment and where it is possible that the undesirable substances or the risk of such substances being present has extended to other consignments or to the feed or food chain they shall immediately identify and put under control other consignments of the products deemed hazardous and also, where appropriate, identify live animals fed with hazardous products and implement the measures provided for in Directive 96/23/EC or in other relevant Community provisions relating to animal health or to the food safety of products of animal origin ensuring coordination between the relevant control services, in order to avoid the hazardous products being put into circulation and to ensure the enforcement of recall procedures for the products already in circulation.
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ukrep za nadzor prometa