natgillin/translations-raw huggingface dataset:
This is the case of products which, inter alia, are to be distributed outside the Union, intended for destruction, requested as samples by competent authorities, or are returned products which cannot be returned to saleable stock.
To velja za zdravila, ki se med drugim distribuirajo zunaj Unije, so namenjena za uničenje, jih pristojni organi zahtevajo kot vzorce ali pa gre za vrnjena zdravila, ki jih ni mogoče vrniti v prodajno zalogo.
Although Directive 2011/62/EU introduced provisions to regulate the sale of medicinal products at a distance to the public and mandated the Commission to establish the modalities of verification of the safety features by persons authorised or entitled to supply medicinal products to the public, the supply of medicinal products to the public is still mostly regulated at national level.
Čeprav je Direktiva 2011/62/EU uvedla določbe, ki urejajo prodajo zdravil javnosti na daljavo, in pooblastila Komisijo, da določi načine preverjanja zaščitnih elementov, ki jih izvajajo osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti, se dobava zdravil javnosti večinoma še vedno ureja na nacionalni ravni.
The end of the supply chain may be organised differently in the different Member States and involve specific healthcare professionals.
Konec dobavne verige je lahko v različnih državah članicah različno organiziran in vključuje določene zdravstvene delavce.
It should be possible for the Member States to exempt specific institutions or persons authorised or entitled to supply medicinal products to the public from the obligation of verification of the safety features, in order to accommodate the particular characteristics of the supply chain in their territory and ensure that the impact of the verification measures on those parties is proportionate.
Zato bi morale imeti države članice možnost, da izvzamejo določene ustanove ali osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti od obveznosti preverjanja zaščitnih elementov, da bi tako upoštevale posebne značilnosti dobavne verige na svojem ozemlju in zagotovile, da je vpliv ukrepov preverjanja na te strani sorazmeren.
The verification of the authenticity of a unique identifier is not only paramount to the authentication of a medicinal product but also informs the person performing the operation of whether that product is expired, recalled, withdrawn or indicated as stolen.
Preverjanje avtentičnosti edinstvene oznake ni le bistvenega pomena za preverjanje avtentičnosti zdravila, ampak zagotavlja osebi, ki izvaja postopek, tudi informacije o tem, ali je zdravilu potekel rok uporabnosti in ali je zdravilo odpoklicano, umaknjeno ali označeno kot ukradeno.
Persons authorised or entitled to supply medicinal products to the public should verify the authenticity and decommission a unique identifier at the time the medicinal product is supplied to the public so to access the most up-to-date information concerning the product and avoid that products which are expired, recalled, withdrawn or indicated as stolen are supplied to the public.
Osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti bi morale preveriti avtentičnost edinstvene oznake in jo deaktivirati ob izdaji zdravila javnosti, tako da bi imele dostop do najnovejših informacij o zdravilu in preprečiti, da bi se zdravila s pretečenim rokom uporabnosti, odpoklicana ali umaknjena zdravila ali zdravila, označena kot ukradena, izdajala javnosti.
In order to avoid an excessive impact on the daily operations of healthcare institutions, it should be possible for the Member States to allow persons authorised or entitled to supply medicinal products to the public operating within healthcare institutions to perform the verification of the authenticity and the decommissioning of a unique identifier earlier than the time the medicinal products is supplied to the public, or exempt them from such an obligation, subject to certain conditions.
Da bi preprečili prevelik vpliv na vsakodnevne dejavnosti zdravstvenih ustanov, bi bilo treba državam članicam omogočiti, da osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti, ki svojo dejavnost izvajajo v zdravstvenih ustanovah, dovolijo preverjanje avtentičnosti edinstvene oznake in njeno deaktiviranje še pred izdajo zdravil javnosti ali jih v določenih pogojih izvzamejo od take obveznosti.
In certain Member States, the persons authorised or entitled to supply medicinal products to the public are allowed to open a pack of a medicinal product in order to supply part of that pack to the public.
V nekaterih državah članicah lahko osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti odprejo pakiranje zdravila in izdajo le del tega pakiranja javnosti.
It is therefore necessary to regulate the verification of the safety features and the decommissioning of the unique identifier in this specific situation.
Zato je treba urediti preverjanje zaščitnih elementov in deaktiviranje edinstvene oznake v tem posebnem primeru.
The effectiveness of an end-to-end verification system in preventing falsified medicinal products from reaching the public depends upon the systematic verification of the authenticity of the safety features and the subsequent decommissioning of the unique identifier of every supplied pack, so that that unique identifier cannot be re-used by traffickers.
Kako je sistem zagotavljanja sledljivosti zdravila od proizvajalca do končnega uporabnika učinkovit pri preprečevanju, da bi ponarejena zdravila dosegla potrošnike, je odvisno od sistematičnega preverjanja avtentičnosti zaščitnih elementov in posledičnega deaktiviranja edinstvene oznake vsakega izdanega pakiranja, tako da ponarejevalci ne morejo ponovno uporabiti edinstvene oznake.
It is therefore important to ensure that such operations, should they not be performed at the time the medicinal product is supplied to the public due to a technical problem, are performed as soon as possible thereafter.
Zato je pomembno zagotoviti, da se takšni postopki, če se ne izvedejo ob izdaji zdravila javnosti zaradi tehnične težave, izvedejo naknadno v najkrajšem možnem času.
An end-to-end verification system requires the setting up of a repositories system which stores, inter alia, the information on the legitimate unique identifiers of a medicinal product and can be queried for the purposes of verifying the authenticity of and decommissioning a unique identifier.
Sistem zagotavljanja sledljivosti zdravila od proizvajalca do končnega uporabnika zahteva vzpostavitev sistema arhivov, v katerih so med drugim shranjene informacije o zakonitih edinstvenih oznakah zdravila in po katerih se lahko išče za namene preverjanja avtentičnosti edinstvene oznake in njenega deaktiviranja.
This repositories system should be established and managed by the marketing authorisation holders, since they are responsible for placing the product on the market, and by the manufacturers of medicinal products bearing the safety features, since they bear the costs of the repositories system in accordance with Article 54a(2)(e) of Directive 2001/83/EC.
Ta sistem arhivov bi morali vzpostaviti in upravljati imetniki dovoljenja za promet z zdravilom, saj so odgovorni za dajanje zdravila v promet, in proizvajalci zdravil, ki morajo imeti nameščene zaščitne elemente, saj krijejo stroške sistema arhivov v skladu s členom 54a(2)(e) Direktive 2001/83/ES.
However, wholesalers and persons authorised or entitled to supply medicinal products to the public should be entitled to participate to the establishment and management of the repositories system, should they wish to, as their daily work will depend upon the correct functioning of the repositories system.
Vendar pa bi morali biti trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti upravičeni do sodelovanja pri vzpostavitvi in upravljanju sistema arhivov, če to želijo, saj bo njihovo vsakodnevno delo odvisno od pravilnega delovanja sistema arhivov.
In addition, national competent authorities should be consulted in the setting up of the repositories system as their early involvement will benefit their subsequent supervision activities.
Poleg tega bi se bilo treba pri vzpostavljanju sistema arhivov posvetovati tudi z nacionalnimi pristojnimi organi, saj bi njihova vključenost v začetnih fazah koristila pri nadaljnjih nadzornih dejavnostih.
Limiting the use of the repository system should not be used for the purpose of gaining market advantage.
Uporaba sistema arhivov se ne bi smela omejiti zaradi pridobivanja tržne prednosti.
For this reason, membership of specific organisations should not be a prerequisite for using the repository system.
Zato članstvo v posebnih organizacijah ne bi smelo biti predpogoj za uporabo sistema arhivov.
The structure of the repositories system should be such as to ensure that medicinal product verification is possible throughout the Union.
Struktura sistema arhivov bi morala zagotavljati, da je preverjanje zdravila mogoče po vsej Uniji.
This may require the transfer of data and information on a unique identifier between repositories within the repositories system.
Pri tem bi lahko bil potreben prenos podatkov in informacij o edinstveni oznaki med različnimi arhivi v sistemu arhivov.
In order to minimise the number of necessary connections between repositories and ensure their interoperability, each national and supranational repository part of the repositories system should connect to and exchange data through a central repository acting as information and data router.
Da bi se kar najbolj zmanjšalo število potrebnih povezav med arhivi in zagotovila njihova interoperabilnost, bi moral biti vsak nacionalni in nadnacionalni arhiv, ki je del sistema arhivov, povezan in si izmenjevati podatke z osrednjim arhivom, ki deluje kot usmerjevalnik informacij in podatkov.
The repositories system should comprise the necessary interfaces providing access, either directly or by means of software, to wholesalers, persons authorised or entitled to supply medicinal products to the public and national competent authorities so that they can comply with their obligations under this Regulation.
Sistem arhivov bi moral vključevati potrebne vmesnike, ki omogočajo dostop bodisi neposredno bodisi prek programske opreme trgovcem na debelo, osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti ter pristojnim nacionalnim organom, da bodo ti lahko izpolnjevali svoje obveznosti iz te uredbe.
Given the sensitive nature of the information on the legitimate unique identifiers and the potential negative impact on public health should such information fall in the hands of traffickers, the responsibility for ensuring the upload of such information in the repositories system should be placed on the marketing authorisation holder or the person responsible for placing the product bearing the unique identifier on the market.
Zaradi občutljive narave informacij o zakonitih edinstvenih oznakah in morebitnega negativnega vpliva na javno zdravje v primeru, da bi te informacije prišle v roke preprodajalcem, bi moral biti za nalaganje takih informacij v sistem arhivov odgovoren imetnik dovoljenja za promet z zdravilom ali oseba, ki je odgovorna za dajanje zdravila z nameščeno edinstveno oznako v promet.
The information should be retained for a period of time sufficiently long to allow the appropriate investigation of incidents of falsification.
Informacije bi bilo treba hraniti tako dolgo, da se lahko ustrezno preiščejo primeri ponarejanja.
In order to harmonise the data format and data exchange across the repositories system and guarantee the interoperability of the repositories as well as the readability and the accuracy of the transferred data, each national and supranational repository should exchange information and data using the data format and data exchange specifications defined by the central repository.
Da bi se harmonizirala oblika zapisa podatkov in izmenjava podatkov prek sistema arhivov ter zagotovila interoperabilnost arhivov ter berljivost in točnost posredovanih podatkov, bi morala izmenjava informacij in podatkov v nacionalnih in nadnacionalnih arhivih potekati v obliki zapisa podatkov in na podlagi specifikacij za izmenjavo podatkov, ki so določene v osrednjem arhivu.
To ensure medicinal product verification without hindering the movement of medicinal products within the single market, it should be possible for wholesalers and persons authorised or entitled to supply medicinal products to the public to verify the authenticity of and decommission a unique identifier in any Member State, regardless of where in the Union the medicinal product bearing that unique identifier was originally intended to be placed on the market.
Da bi se zagotovilo preverjanje zdravil brez oviranja pretoka zdravil na enotnem trgu, bi bilo treba trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogočiti, da preverijo avtentičnost edinstvene oznake in jo deaktivirajo v kateri koli državi članici, ne glede na to, kje v Uniji naj bi se zdravilo, na katerem je nameščena navedena edinstvena oznaka, prvotno dalo v promet.
To this end, the status of a unique identifier should be synchronised between repositories and, where necessary, verification queries should be redirected by the central repository to the repositories serving the Member States where the product was intended to be placed on the market.
Zato bi bilo treba status edinstvene oznake med posameznimi arhivi uskladiti, po potrebi pa bi bilo treba poizvedbe za namene preverjanja iz osrednjega arhiva preusmeriti na arhive držav članic, v katerih je bilo zdravilo namenjeno dajanju v promet.
In order to ensure that the functioning of the repositories system supports an end-to-end verification of the authenticity of medicinal products, it is necessary to set out the characteristics and operations of the repositories system.
Za zagotovitev, da sistem arhivov deluje tako, da podpira preverjanje avtentičnosti zdravil od proizvajalca do končnega uporabnika, je treba določiti značilnosti in delovanje sistema arhivov.
The investigation of suspected or confirmed incidents of falsification would benefit from knowing as much information as possible on the product subject to the investigation.
Pri preiskavi domnevnih ali potrjenih primerov ponarejanja bi bilo koristno imeti na voljo čim več informacij o zdravilu, ki se preiskuje.
For this reason, records of all operations concerning a unique identifier, including the users performing those operations and the nature of the operations should be stored in the repositories system, be accessible for the purpose of investigating events flagged as potential incidents of falsification in the repositories system, and be made immediately available to competent authorities upon request.
Zato bi morala biti evidenca vseh dejavnosti v zvezi z edinstveno oznako, vključno z uporabniki, ki izvajajo navedene dejavnosti, in naravo dejavnosti, shranjena v sistemu arhivov, biti dostopna za namene preiskovanja dogodkov, ki so označeni kot možni primeri ponarejanja v sistemu arhivov, ter bi morala biti na zahtevo nemudoma na voljo pristojnim organom.
In accordance with Article 54a(3) of Directive 2001/83/EC, it is necessary to ensure the protection of personal data as provided for in Union law, the legitimate interests to protect information of a commercially confidential nature and the ownership and confidentiality of the data generated by the use of the safety features.
V skladu s členom 54a(3) Direktive 2001/83/ES je nujno upoštevati varstvo osebnih podatkov, kot je določeno v pravu Unije, legitimne interese glede varovanja poslovno zaupnih informacij ter lastništvo in zaupnost podatkov, ki nastanejo z uporabo zaščitnih elementov.
For this reason, manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public should only have ownership of and access to the data they generate when they interact with the repositories system.
Zato bi morali imeti proizvajalci, imetniki dovoljenj za promet z zdravilom, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti lastništvo in dostop samo do podatkov, ki jih sami ustvarijo pri uporabi sistema arhivov.
Although the present delegated Regulation does not require any personal data to be stored in the repositories system, the protection of personal data should be ensured in case users of the repositories use the repositories system for purposes which are outside the scope of this Regulation.
Čeprav ta delegirana uredba ne zahteva shranjevanja nobenih osebnih podatkov v sistem arhivov, bi bilo treba zagotoviti varstvo osebnih podatkov v primeru, če uporabniki arhivov uporabljajo sistem arhivov za namene, ki ne spadajo na področje uporabe te uredbe.
The information referred to in Article 33(2) of this Regulation and the information on the status of a unique identifier should stay accessible to all parties required to verify the authenticity of medicinal products, as such information is necessary for the proper performing of those verifications.
Informacije iz člena 33(2) te uredbe in informacije o statusu edinstvene oznake bi morale še vedno biti dostopne vsem stranem, ki morajo preverjati avtentičnost zdravil, saj so take informacije nujne za pravilno izvajanje navedenih preverjanj.
In order to avoid potential ambiguities and authentication errors, no unique identifiers having the same product code and serial number should be present in the repositories system at the same time.
Da bi preprečili morebitne nejasnosti in napake pri preverjanju avtentičnosti, ne bi smele biti v sistemu arhivov hkrati shranjene edinstvene oznake z isto šifro proizvoda in serijsko številko.
In accordance with Article 54a(1) of Directive 2001/83/EC, medicinal products subject to prescription are to bear the safety features while medicinal products not subject to prescription are not allowed to.
V skladu s členom 54a(1) Direktive 2001/83/ES morajo imeti zdravila na recept nameščene zaščitne elemente, zdravila brez recepta pa ne smejo imeti nameščenih zaščitnih elementov.
However, whether a medicinal product is subject to prescription is most often decided nationally and may vary across Member States.
Vendar pa se odločitev glede tega, ali se bo zdravilo izdajalo na recept ali ne, najpogosteje sprejme na nacionalni ravni, zato so lahko med državami članicami razlike.
In addition, Member States may extend the scope of application of the safety features in accordance with Article 54a(5) of Directive 2001/83/EC.
Poleg tega lahko države članice v skladu s členom 54a(5) Direktive 2001/83/ES razširijo področje uporabe zaščitnih elementov.
As a result, the same medicinal product may be required to bear the safety features in one Member State but not in another.
Zato morda mora zdravilo v eni državi članici imeti nameščene zaščitne elemente, v drugi pa ne.
In order to ensure the correct application of this Regulation, national competent authorities should, when requested, make available the information on the medicinal products placed on the market on their territory which shall bear the safety features, including those for which the scope of application of the unique identifier or of the anti-tampering device has been extended in accordance with Article 54a(5) of Directive 2001/83/EC, to the marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public.
Za zagotovitev pravilne uporabe te uredbe bi morali pristojni nacionalni organi na zahtevo dati informacije o zdravilih, ki so dana v promet na njihovem ozemlju in morajo imeti nameščene zaščitne elemente, vključno s tistimi, za katera je bilo področje uporabe edinstvene oznake ali pripomočka za zaščito pred poseganjem v zdravilo razširjeno v skladu s členom 54a(5) Direktive 2001/83/ES, na voljo imetnikom dovoljenj za promet z zdravili, proizvajalcem, trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti.
Since a repository may use servers physically located in different Member States, or may be physically located in a Member State which is not the Member State it serves, national competent authorities should be allowed to perform or observe inspections in other Member States, subject to certain conditions.
Ker lahko arhiv uporablja strežnike, ki se fizično nahajajo v različnih državah članicah, ali se lahko arhiv fizično nahaja v državi članici, ki ni država članica, ki ga uporablja, bi bilo treba pristojnim nacionalnim organom dovoliti, da pod nekaterimi pogoji opravijo ali opazujejo preglede v drugih državah članicah.
The lists containing the medicinal products or product categories which, in the case of prescription medicinal products shall not bear the safety features, and in the case of non-prescription medicinal products shall bear the safety features, should be established considering the risk of and the risk arising from falsification of the medicinal products or product categories, in accordance with Article 54a(2)(b) of Directive 2001/83/EC, as amended.
Sezname zdravil ali kategorij zdravil, ki – če gre za zdravila na recept –, ne smejo imeti nameščenih zaščitnih elementov in ki – če gre za zdravila brez recepta –, morajo imeti nameščene zaščitne elemente, bi bilo treba pripraviti ob upoštevanju tveganja ponarejanja zdravil ali kategorij zdravil in tveganja, ki izhaja iz ponarejanja zdravil ali kategorij zdravil, v skladu s členom 54a(2)(b) Direktive 2001/83/ES, kakor je bila spremenjena.
Those risks should be assessed on the basis of the criteria referred to in the said Article.
Navedena tveganja bi bilo treba oceniti na podlagi meril iz navedenega člena.
In order to avoid disruptions in the supply of medicinal products, transitional measures for medicinal products which have been released for sale or distribution without the safety features before the date of application of this Regulation in the Member State or Member States where the product is placed on the market are necessary.
Da bi se izognili motnjam pri dobavi zdravil, je treba uvesti prehodne ukrepe za zdravila, ki so bila dana v promet ali distribucijo brez zaščitnih elementov pred datumom začetka uporabe te uredbe v državi članici ali državah članicah, kjer se izdelek da v promet.
At the time of entry into force of Directive 2011/62/EU of the European Parliament and of the Council, Belgium, Greece and Italy already had systems in place for the verification of the authenticity of medicinal products and for the identification of individual packs.
Ko je začela veljati Direktiva 2011/62/EU Evropskega parlamenta in Sveta, so Belgija, Grčija in Italija že imele vzpostavljene sisteme za preverjanje avtentičnosti zdravil in za identifikacijo posameznih pakiranj.
Directive 2011/62/EU granted such Member States an additional transitional period for adapting to the harmonised Union system for safety features introduced by that Directive for the same purposes, by allowing them to defer their application of the Directive as regards that system.
Direktiva 2011/62/EU je tem državam članicam odobrila dodatno prehodno obdobje za prilagoditev harmoniziranemu sistemu Unije na področju zaščitnih elementov, ki je bil uveden z navedeno direktivo za iste namene, tako da jim je dovolila, da odložijo uporabo Direktive v zvezi z navedenim sistemom.
In order to ensure consistency between the national transposition measures adopted pursuant to the Directive, on the one hand, and the rules of this Regulation, on the other hand, those Member States should be allowed the same additional transitional period for the application of the rules of this Regulation regarding that system.
Da bi se zagotovila skladnost med nacionalnimi ukrepi za prenos Direktive, sprejetimi na podlagi Direktive, na eni strani in pravili iz te uredbe na drugi strani, bi bilo treba državam članicam dovoliti enako dodatno prehodno obdobje glede uporabe pravil v zvezi z navedenim sistemom iz te uredbe.