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801–807/807
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801 Prevajalska redakcija
RS
EMEA
Izobraževalni paket za zdravstvene delavce Izobraževalni paket za zdravstvene delavce naj vsebuje naslednje elemente: • Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobren, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda, o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika, bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida, obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom, poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom (če je primerno za državo članico) na obrazcu v „ Izobraževalnem paketu za zdravstvene delavce “.
Educational healthcare professional’ s kit The educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “ Educational Healthcare Professional’ s Kit” o Safety advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends
802 Prevod
promet
se obratovanje, vzdrževanje, pregledi in preizkušanje jedrskega obrata izvajajo v skladu z odobrenimi postopki;
operation, maintenance, inspection and testing of a nuclear installation are conducted in accordance with approved procedures;
803 Prevod
promet
Obravnava Republike Moldavije, odobrena s tem sporazumom, v nobenem primeru ne sme biti ugodnejša od tiste, ki jo države članice priznavajo druga drugi.
Treatment granted to the Republic of Moldova hereunder shall in no case be more favourable than that granted by the Member States to each other.
804 Prevod
promet
CELEX: 31993D0115
ter glede na to, da bo kmalu ustanovljen Garancijski fond, s katerim bo zagotovljena primerna proračunska obravnava garancij za posojila Skupnosti, odobrena tretjim državam v skladu z zaključki Evropskega sveta na zasedanju 11. in 12. decembra 1992,
Whereas a Guarantee Fund will be established as soon as possible in order to provide appropriate budgetary treatment of the guarantees for Community loans granted to third countries, in accordance with the conclusions of the European Council on 11 and 12 December 1992,
805 Prevod
izobraževanje
CELEX: 32002R2342
Kadar izvajanje ukrepov, za katere je odobrena pomoč, zahteva oddajo javnih naročil, upravičenci do dotacij oddajo naročila za ekonomsko najugodnejše ponudbe, to pomeni, za ponudbe, ki imajo najboljše razmerje med ceno in kakovostjo, v skladu z načeli preglednosti in enake obravnave potencialnih izvajalcev, pri čemer morajo paziti, da ne prihaja do navzkrižja interesov.
Where implementation of the assisted actions requires the award of procurement contracts, beneficiaries of grants shall award the contract to the tender offering best value for money, that is to say, to the tender offering the best price-quality ratio, in compliance with the principles of transparency and equal treatment for potential contractors, care being taken to avoid any conflict of interests.
806 Prevod
izobraževanje
CELEX: 32002R2342
obračun potnih stroškov, ki ga podpiše uradnik, ki je bil na službenem potovanju, in upravni nadrejeni delavec, na katerega so bila prenesena ustrezna pooblastila, in iz katerega je zlasti razviden kraj službenega potovanja, datumi in ure odhoda in prihoda v kraj službenega potovanja, stroški prevoza, stroški dnevnic in drugi stroški, pravilno odobreni pri predložitvi dokazil;
the statement of mission expenses, signed by the official on mission and by the administrative superior to whom the appropriate powers have been delegated, and showing, in particular, the place of mission, the dates and times of departure and arrival at the place of mission, travel expenses, subsistence expenses, and other expenses duly authorised on production of supporting documents;
807 Prevod
promet
CELEX: 32003R0002
ponavljajoča se nepripravljenost ali nepotrebno odlašanje pri pridobivanju pooblastil za izvajanje misij upravnega in preiskovalnega sodelovanja v Hrvaški, da bi se preverila verodostojnost dokumentov ali točnost informacij v zvezi s preferencialno obravnavo, odobreno po Sporazumih, ali pri izvajanju ali pripravi ustreznih preiskav za prepoznavanje ali preprečevanje kršitev pravil o poreklu,
a repeated refusal or undue delay to obtain the authorisation to conduct administrative and investigative cooperation missions in Croatia, in order to verify the authenticity of documents or the accuracy of information relevant for granting the preferential treatment granted under the Agreements, or to carry out or arrange for appropriate inquiries to identify or prevent contravention of the rules of origin,
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801–807/807
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