natgillin/translations-raw huggingface dataset:
This definition applies whether the “tying” is by formal agreement or by any form of informal understanding between the recipient and the donor country, or whether a package includes components from the forms set out in Article 34 of the Arrangement that are not freely and fully available to finance procurement from the recipient country, substantially all other developing countries and from the Participants, or if it involves practices that the DAC or the Participants consider equivalent to such tying.
V tej prilogi so navedene podrobnosti o uporabi tehnik za zmanjšanje tveganja države iz člena 30(a) Sporazuma in izboljšav kreditnega tveganja kupca iz člena 31(a) Sporazuma, pri čemer te podrobnosti vključujejo merila, pogoje in posebne okoliščine, ki veljajo za njihovo uporabo, ter učinek na MPR.
Untied Aid
pri prodaji zrakoplovov, vključno s helikopterji ter nadomestnimi motorji in deli, je najpoznejši začetni datum kredita dejanski ali povprečni datum, ko kupec fizično prevzame blago. pri storitvah je najpoznejši začetni datum kredita datum, ko so računi predloženi stranki ali stranka sprejme storitev;
aid which includes loans or grants whose proceeds are fully and freely available to finance procurement from any country.
pri kvaziinvesticijskem blagu začetni datum kredita ni poznejši od dejanskega datuma ali povprečnega datuma, na katerega kupec prevzame blago, če pa je izvoznik odgovoren za usposobitev za zagon, je najpoznejši začetni datum kredita datum usposobitve za zagon, medtem ko je pri storitvah to datum, na katerega so računi predloženi stranki ali stranka prejme storitev. pri pogodbi za dobavo storitev, po kateri je dobavitelj odgovoren za usposobitev za zagon, je najpoznejši začetni datum kredita datum usposobitve za zagon.
Weighted Average Life of the Repayment Period
ločena vira energije, in sicer obnovljivi viri energije in fosilno gorivo.
the time that it takes to retire one-half of the principal of a credit.
Udeleženka ECA mora biti sposobna izpolnjevati svoje obveznosti izplačila zavarovalnine v svoji valuti, če lokalne valute potem, ko ECA prevzame obveznosti, ni več mogoče ‚transferirati‘ ali ‚konvertirati‘ (neposredni posojilodajalec bo temu vseeno izpostavljen).
Commission Implementing Regulation (EU) 2016/157
Izvedbena uredba Komisije (EU) 2016/157
supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta z določitvijo podrobnih pravil za zaščitne elemente na ovojnini zdravil za uporabo v humani medicini
Having regard to 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 [1], and in particular Article 54a(2) thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [1] in zlasti člena 54a(2) Direktive,
Directive 2001/83/EC, as amended, provides for measures to prevent the entry into the legal supply chain of falsified medicinal products by requiring the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.
Direktiva 2001/83/ES, kakor je bila spremenjena, določa ukrepe za preprečevanje vstopa ponarejenih zdravil v zakonito dobavno verigo, tako da zahteva namestitev zaščitnih elementov, tj. edinstvene oznake in pripomočka za zaščito pred poseganjem v zdravilo, na ovojnino nekaterih zdravil za uporabo v humani medicini zaradi njihove identifikacije in preverjanja avtentičnosti.
Diverging authentication mechanisms for medicinal products based on different national or regional traceability requirements may limit the circulation of medicinal products across the Union and increase costs for all players in the supply chain.
Različni mehanizmi za preverjanje avtentičnosti zdravil na podlagi različnih nacionalnih ali regionalnih zahtev glede sledljivosti lahko omejijo pretok zdravil v Uniji in povečajo stroške za vse udeležence v dobavni verigi.
It is therefore necessary to establish Union-wide rules for the implementation of the safety features for medicinal products for human use, with particular regard to the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features, and the establishment and management of the repository system containing information on the safety features.
Zato je treba določiti pravila na ravni Unije za uporabo zaščitnih elementov za zdravila za uporabo v humani medicini, zlasti glede značilnosti in tehničnih specifikacij edinstvene oznake, načinov preverjanja zaščitnih elementov ter vzpostavitve in upravljanja sistema arhivov, ki vsebujejo informacije o zaščitnih elementih.
In accordance with Article 4 of Directive 2011/62/EU of the European Parliament and of the Council [2] and Article 54a(2) and (3) of Directive 2001/83/EC, the Commission has assessed the benefits, costs and cost-effectiveness of different policy options for the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features and the establishment and management of the repository system.
V skladu s členom 4 Direktive 2011/62/EU Evropskega parlamenta in Sveta [2] ter členom 54a(2) in (3) Direktive 2001/83/ES je Komisija ocenila koristi, stroške in stroškovno učinkovitost različnih možnosti politike za značilnosti in tehnične specifikacije edinstvene oznake, načine preverjanja zaščitnih elementov ter vzpostavitev in upravljanje sistema arhivov.
The policy options identified as the most cost-effective have been introduced as core elements of this Regulation.
Možnosti politike, ki so opredeljene kot stroškovno najučinkovitejše, so bile vključene kot temeljni elementi te uredbe.
This Regulation sets out a system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification.
Ta uredba določa sistem, v katerem se identifikacija in preverjanje avtentičnosti zdravil zagotavljata s sistemom zagotavljanja sledljivosti vseh zdravil od proizvajalca do končnega uporabnika, ki morajo imeti nameščene zaščitne elemente, ter dodatno tudi s preverjanjem zdravil z večjim tveganjem ponaredbe, ki ga izvajajo trgovci na debelo.
In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public, although certain derogations may apply.
V praksi bi bilo treba avtentičnost in celovitost zaščitnih elementov, ki se namestijo na ovojnino zdravila na začetku dobavne verige, preveriti ob izdaji zdravila, čeprav lahko veljajo nekatera odstopanja.
However, medicinal products at higher risk of falsification should be additionally verified by wholesalers throughout the supply chain, to minimise the risk of falsified medicinal products circulating undetected for lengthy periods of time.
Vendar pa bi morali trgovci na debelo zdravila z večjim tveganjem ponaredbe dodatno preverjati v celotni dobavni verigi, da se zmanjša tveganje, da ponarejena zdravila dlje časa krožijo neodkrita v dobavni verigi.
The verification of the authenticity of a unique identifier should be performed by comparing that unique identifier with the legitimate unique identifiers stored in a repositories system.
Avtentičnost edinstvene oznake bi bilo treba preveriti tako, da se navedena edinstvena oznaka primerja z zakonitimi edinstvenimi oznakami, shranjenimi v sistemu arhivov.
When the pack is supplied to the public, or is distributed outside the Union, or in other specific situations, the unique identifier on that pack should be decommissioned in the repositories system so any other pack bearing the same unique identifier could not be successfully verified.
Kadar se pakiranje da na voljo javnosti ali se distribuira zunaj Unije ali v drugih posebnih okoliščinah, bi bilo treba edinstveno oznako na pakiranju v sistemu arhivov deaktivirati, tako da ne bi bilo mogoče potrditi avtentičnosti nobenega drugega pakiranja z isto edinstveno oznako.
It should be possible to identify and verify the authenticity of an individual pack of a medicinal product for the entire time the medicinal product stays on the market and the additional time necessary for returning and disposing of the pack after it has expired.
Vsako posamezno pakiranje bi moralo biti mogoče identificirati in preveriti njegovo avtentičnost v celotnem obdobju njegove razpoložljivosti na trgu in v dodatnem obdobju, potrebnem za njegovo vrnitev in odstranitev po izteku roka uporabnosti.
For this reason, the character sequence resulting from the combination of the product code and the serial number sequence should be unique to a given pack of a medicinal product until at least one year after the expiry date of that pack or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
Zato bi moralo biti zaporedje znakov, ki izhaja iz kombinacije šifre proizvoda in serijske številke, za posamezno pakiranje zdravila edinstveno, in sicer vsaj še eno leto po datumu izteka roka uporabnosti navedenega pakiranja zdravila ali pet let po dajanju zdravila v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje.
The inclusion of the product code, the national reimbursement and identification number, the batch number and expiry date in the unique identifier contributes to patient safety by facilitating recall, withdrawal and return procedures and pharmacovigilance in this sector.
Vključitev šifre proizvoda, nacionalne številke zdravila na pozitivni listi zdravil in identifikacijske številke, številke serije ter datuma izteka roka uporabnosti zdravila v edinstveno oznako prispeva k varnosti pacientov, saj olajša odpoklic, umik in vračanje zdravil ter farmakovigilanco v tem sektorju.
In order to have a negligible probability that a serial number can be guessed by falsifiers, the serial number should be generated according to specific randomisation rules.
Serijska številka bi morala biti sestavljena v skladu s posebnimi pravili naključne izbire, tako da je verjetnost, da ponarejevalci uganejo serijsko številko, zanemarljiva.
Compliance with certain international standards, while not mandatory, can be used as proof that certain requirements of this Regulation are fulfilled.
Skladnost z nekaterimi mednarodnimi, sicer nezavezujočimi, standardi se lahko uporabi kot dokazilo, da so nekatere zahteve iz te uredbe izpolnjene.
Where it is not possible to prove compliance with international standards, it should be the responsibility of the persons to whom the obligations are addressed to prove, by verifiable means, that they comply with those requirements.
Kadar ni mogoče dokazati skladnosti z mednarodnimi standardi, bi morale osebe, na katere se obveznosti nanašajo, na preverljiv način dokazati skladnost z navedenimi zahtevami.
The unique identifier should be encoded using a standardised data structure and syntax so that it can be correctly recognised and decoded throughout the Union by commonly-used scanning equipment.
Edinstvena oznaka bi se morala zakodirati s standardizirano strukturo in sintakso podatkov, da se lahko pravilno prepozna in dekodira po vsej Uniji z običajno opremo za skeniranje.
The global uniqueness of the product code not only contributes to the unambiguity of the unique identifier but also facilitates the decommissioning of a unique identifier when this operation takes place in a Member State different from the Member State where the medicinal product was initially intended to be placed on the market.
Globalna edinstvenost šifre proizvoda ne prispeva le k nedvoumnosti edinstvene oznake, ampak omogoča tudi deaktiviranje edinstvene oznake, kadar se to izvaja v drugi državi članici od tiste, v kateri je bilo zdravilo prvotno namenjeno dajanju v promet.
A product code which conforms to certain international standards should be presumed to be globally unique.
Za šifro proizvoda, ki ustreza nekaterim mednarodnim standardom, bi bilo treba domnevati, da je globalno edinstvena.
To facilitate the verification of the authenticity and decommissioning of a unique identifier by wholesalers and persons authorised or entitled to supply medicinal products to the public, it is necessary to ensure that the structure and printing quality of the two-dimensional barcode encoding the unique identifier allow for high-speed reading and minimisation of reading errors.
Da bi trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil lažje preverjali avtentičnost in deaktiviranje edinstvene oznake, je treba zagotoviti, da struktura in kakovost tiskanja dvodimenzionalnih črtnih kod z zapisom edinstvene oznake omogočata hitro branje in čim manj napak pri branju.
The data elements of the unique identifier should be printed on the packaging in human-readable format so to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.
Podatkovni elementi edinstvene oznake morajo biti natisnjeni na ovojnini v človeku berljivi obliki zapisa, da se omogoči preverjanje avtentičnosti edinstvene oznake in njeno deaktiviranje v primeru, če je dvodimenzionalna črtna koda neberljiva.
A two-dimensional barcode can store more information than the data elements of the unique identifier.
V dvodimenzionalni črtni kodi je lahko zapisanih več informacij kot pa samo podatkovni elementi edinstvene oznake.
It should be possible to use that residual storage capacity to carry further information and avoid the placing of additional barcodes.
Treba bi bilo omogočiti, da se izkoristi preostala shranjevalna zmogljivost za zapis dodatnih informacij, in se tako izogniti uporabi dodatnih črtnih kod.
The presence of multiple two-dimensional barcodes on the packaging can engender confusion with regard to which barcode should be read for the purpose of verifying the authenticity of and identifying a medicinal product.
Zaradi prisotnosti več dvodimenzionalnih črtnih kod na ovojnini lahko pride do zmede v zvezi s tem, katero črtno kodo je treba prebrati za preverjanje avtentičnosti in identifikacijo zdravila.
This may lead to mistakes in the verification of the authenticity of medicinal products and to falsified medicinal products being inadvertently supplied to the public.
To lahko privede do napak pri preverjanju avtentičnosti zdravil in do nenamernega izdajanja ponarejenih zdravil.
For this reason, the presence of multiple two-dimensional barcodes on the packaging of a medicinal product for the purposes of identification and verification of the authenticity should be avoided.
Za namene identifikacije in preverjanja avtentičnosti zdravila bi se bilo zato treba izogibati nameščanju več dvodimenzionalnih črtnih kod na ovojnino zdravila.
The verification of both safety features is necessary to ensure the authenticity of a medicinal product in an end-to end verification system.
Preverjanje obeh zaščitnih elementov je nujno potrebno za zagotovitev avtentičnosti zdravila v sistemu zagotavljanja sledljivosti zdravila od proizvajalca do končnega uporabnika.
The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer.
S preverjanjem avtentičnosti edinstvene oznake naj bi se zagotovilo, da je zdravilo proizvedel zakoniti proizvajalec.
The verification of the integrity of the anti-tampering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.
Preverjanje celovitosti pripomočka za zaščito pred poseganjem v zdravilo kaže, ali je bila ovojnina odprta ali spremenjena, odkar je zapustila proizvajalca, s čimer se zagotovi, da je vsebina pakiranja avtentična.
The verification of the authenticity of the unique identifier is a critical step to ensure the authenticity of the medicinal product bearing it and should only be based on the comparison with trusted information on the legitimate unique identifiers uploaded in a secure repositories system by verified users.
Preverjanje avtentičnosti edinstvene oznake je ključni korak za zagotovitev avtentičnosti zdravila, na katerem je nameščena, in bi moralo temeljiti le na primerjavi z zanesljivimi informacijami o zakonitih edinstvenih oznakah, ki jih preverjeni uporabniki vnesejo v varen sistem arhivov.
It should be possible to revert the status of a unique identifier that has been decommissioned in order to avoid the unnecessary waste of medicinal products.
Status edinstvene oznake, ki je bila deaktivirana, bi moralo biti mogoče povrniti v aktivni status, da bi se izognili nepotrebnemu odlaganju zdravil.
It is however necessary to subject the reverting of the status to strict conditions to minimise the threat to the security of the repositories system that such operation could generate if abused by counterfeiters.
Vendar bi za povrnitev statusa morali veljati strogi pogoji, da se čim bolj zmanjša ogrožanje varnosti sistema arhivov, ki bi lahko bila posledica take dejavnosti, če bi jo zlorabili ponarejevalci.
Those conditions should apply regardless of whether the decommissioning operation took place at the moment of supply to the public or at an earlier point in time.
Navedeni pogoji bi se morali uporabljati ne glede na to, ali je do deaktiviranja prišlo ob izdaji zdravila javnosti ali pred tem.
Competent authorities should be able to access information on the safety features of a medicinal product while this product is in the supply chain or after it has been supplied to the public, recalled or withdrawn from the market.
Pristojni organi bi morali imeti dostop do informacij o zaščitnih elementih zdravila, in sicer ko je zdravilo v dobavni verigi ali po izdaji zdravila javnosti, njegovem odpoklicu ali umiku iz prometa.
To this end, manufacturers should retain records of operations with or on the unique identifier of a given medicinal product after the identifier has been decommissioned from the repositories system for a minimum of one year after the expiry date of that medicinal product or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
V ta namen bi morali proizvajalci hraniti evidenco o dejavnostih v zvezi z edinstveno oznako določenega zdravila po njenem deaktiviranju v sistemu arhivov, in sicer najmanj eno leto po datumu izteka roka uporabnosti navedenega zdravila ali pet let po tem, ko je bilo pakiranje zdravila dano v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje.
Past incidents of falsification show that certain medicinal products, such as those returned by persons authorised or entitled to supply medicinal products to the public or wholesalers, or medicinal products distributed by persons who are neither the manufacturer nor a wholesaler holding the marketing authorisation nor a designated wholesaler, are at higher risk of being falsified.
Pretekli primeri ponarejanja zdravil kažejo, da je pri nekaterih zdravilih tveganje za ponaredbo večje, denimo pri tistih, ki jih osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ali trgovci na debelo vrnejo, ali pri tistih, ki jih distribuirajo osebe, ki niso niti proizvajalci niti trgovci na debelo z dovoljenjem za promet z zdravilom niti pooblaščeni trgovci na debelo.
The authenticity of those medicinal products should therefore be subject to additional verifications by wholesalers throughout the supply chain to minimise the risk that falsified products entering the legal supply chain freely circulate in the Union territory until they are verified at the time of supply to the public.
Avtentičnost navedenih zdravil bi zato morali trgovci na debelo dodatno preverjati v celotni dobavni verigi, da se čim bolj zmanjša tveganje, da so ponarejena zdravila, ki vstopajo v zakonito dobavno verigo, na ozemlju Unije v prostem pretoku do preverjanja njihove avtentičnosti ob izdaji javnosti.
The verification by wholesalers of the authenticity of medicinal products at higher risk of being falsified would be equally effective whether performed by scanning individual unique identifiers or an aggregated code allowing the simultaneous verification of multiple unique identifiers.
Preverjanje avtentičnosti zdravil z večjim tveganjem ponaredbe, ki bi ga izvajali trgovci na debelo, bi bilo enako učinkovito, če bi se skenirale posamezne edinstvene oznake ali zbirna koda, ki omogoča hkratno preverjanje več edinstvenih oznak.
In addition, the verification could be performed at any time between the reception of the medicinal product by the wholesaler and its further distribution, to equal results.
Poleg tega se preverjanje lahko opravi kadar koli od trenutka, ko trgovec na debelo prejme zdravilo, do njegove nadaljnje distribucije, pri čemer so rezultati enaki.
For those reasons, it should be left to the choice of the wholesaler whether to scan individual unique identifiers or aggregated codes, where available, or the timing of the verification, provided that the wholesaler ensures the verification of all unique identifiers of those products at higher risk of falsification in his physical possession, as required by this Regulation.
Zaradi tega bi bilo treba odločitev glede skeniranja posameznih edinstvenih oznak ali zbirnih kod, če so na voljo, oziroma časovnega razporeda preverjanja prepustiti trgovcu na debelo, pod pogojem, da trgovec na debelo zagotovi preverjanje vseh edinstvenih oznak zdravil z večjim tveganjem ponaredbe, ki jih ima v fizični posesti, kakor zahteva ta uredba.
In the complex Union supply chain, it may happen that a medicinal product changes ownership but remains in the physical possession of the same wholesaler, or that a medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, but no sale takes place.
V kompleksni dobavni verigi Unije se lahko zgodi, da se spremeni lastnik zdravila, vendar zdravilo ostane v fizični posesti istega trgovca na debelo, ali pa da se zdravilo distribuira na ozemlju države članice med dvema skladiščema, ki pripadata istemu trgovcu na debelo ali isti pravni osebi, vendar se medtem ne prodaja.
In those cases, the wholesalers should be exempted from performing a verification of the unique identifier as the risk of falsification is negligible.
V takih primerih bi morali biti trgovci na debelo izvzeti od preverjanja edinstvene oznake, saj je tveganje ponaredbe zanemarljivo.
As a general principle, in an end-to-end verification system, the decommissioning of the unique identifier in the repository system should be performed at the end of the supply chain when the medicinal product is supplied to the public.
Kot splošno pravilo bi bilo treba v sistemu zagotavljanja sledljivosti zdravila od proizvajalca do končnega uporabnika na koncu dobavne verige, ko se zdravilo izda javnosti, edinstveno oznako deaktivirati v sistemu arhivov.
Certain packs of medicinal products, however, may not eventually be supplied to the public and it is therefore necessary to ensure the decommissioning of their unique identifiers at a different point of the supply chain.
Nekatera pakiranja zdravila pa se morda navsezadnje ne izdajo javnosti, zato je treba zagotoviti, da se njihova edinstvena oznaka deaktivira na različnih točkah dobavne verige.