natgillin/translations-raw huggingface dataset:
The legal entity or entities referred to on paragraph 1 shall not require manufacturers, marketing authorisation holders, wholesalers or persons authorised or entitled to supply medicinal products to the public to be members of a specific organisation or organisations in order to use the repository system.
Pravna oseba ali pravne osebe iz odstavka 1 od proizvajalcev, imetnikov dovoljenj za promet, trgovcev na debelo ali oseb z dovoljenjem ali pravico do izdajanja zdravil javnosti ne zahtevajo, da so člani posebne organizacije ali organizacij, da bi lahko uporabljali sistem arhivov.
The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features, in accordance with Article 54a(2)(e) of Directive 2001/83/EC.
Stroške sistemov arhivov v skladu s členom 54a(2)(e) Direktive 2001/83/ES krijejo proizvajalci zdravil, ki morajo imeti nameščene zaščitne elemente.
Structure of the repositories system
Struktura sistema arhivov
The repositories system shall be composed of the following electronic repositories:
Sistem arhivov sestavljajo naslednji elektronski arhivi:
a central information and data router (‘hub’);
osrednji usmerjevalnik informacij in podatkov (v nadaljnjem besedilu: vozlišče);
repositories which serve the territory of one Member State (‘national repositories’) or the territory of multiple Member States (‘supranational repositories’).
arhivi za ozemlje ene države članice (v nadaljnjem besedilu: nacionalni arhivi) ali za ozemlja več držav članic (v nadaljnjem besedilu: nadnacionalni arhivi).
Those repositories shall be connected to the hub.
Navedeni arhivi so povezani z vozliščem.
The number of national and supranational repositories shall be sufficient to ensure that the territory of every Member State is served by one national or supranational repository.
Število nacionalnih in nadnacionalnih arhivov mora zadostovati za zagotovitev, da ozemlje vsake države članice pokriva nacionalni ali nadnacionalni arhiv.
The repositories system shall comprise the necessary information technology infrastructure, hardware and software to enable the execution of the following tasks:
Sistem arhivov vključuje potrebno infrastrukturo informacijske tehnologije ter programsko in strojno opremo za izvajanje naslednjih nalog:
upload, collate, process, modify and store the information on the safety features that enables the verification of the authenticity and identification of medicinal products;
nalaganje, zbiranje, obdelavo, spreminjanje in shranjevanje informacij o zaščitnih elementih, ki omogočajo preverjanje avtentičnosti in identifikacijo zdravil;
identify an individual pack of a medicinal product bearing the safety features and verify the authenticity of the unique identifier on that pack and decommission it at any point of the legal supply chain.
identifikacijo posameznega pakiranja zdravila, ki mora imeti nameščene zaščitne elemente, in preverjanje avtentičnosti edinstvene oznake na navedenem pakiranju ter njeno deaktiviranje v kateri koli točki v zakoniti dobavni verigi.
The repositories system shall include the application programming interfaces allowing wholesalers or persons authorised or entitled to supply medicinal products to the public to query the repositories system by means of software, for the purposes of verifying the authenticity of the unique identifiers and of decommissioning them in the repositories system.
Sistem arhivov vključuje vmesnike za programiranje aplikacij, ki omogočajo trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti, da s programsko opremo pošiljajo poizvedbe v sistem arhivov, da preverijo avtentičnost edinstvenih oznak in jih deaktivirajo v sistemu arhivov.
The application programming interfaces shall also allow national competent authorities to access the repositories system by means of software, in accordance with Article 39.
Vmesniki za programiranje aplikacij omogočajo tudi pristojnim nacionalnim organom dostop s programsko opremo do sistema arhivov v skladu s členom 39.
The repositories system shall also include graphical user interfaces providing direct access to the repositories system in accordance with Article 35(1)(i).
Sistem arhivov v skladu s členom 35(1)(i) vključuje tudi grafične uporabniške vmesnike, ki zagotavljajo neposreden dostop do tega sistema.
The repositories system shall not include the physical scanning equipment used for reading the unique identifier.
Sistem arhivov ne vključuje fizične opreme za skeniranje, ki se uporablja za branje edinstvene oznake.
Uploading of information in the repositories system
Nalaganje informacij v sistem arhivov
The marketing authorisation holder or, in case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of Directive 2001/83/EC, the person responsible for placing those medicinal products on the market, shall ensure that the information referred to in paragraph 2 is uploaded to the repositories system before the medicinal product is released for sale or distribution by the manufacturer, and that it is kept up to date thereafter.
Imetnik dovoljenja za promet z zdravilom ali v primeru vzporedno uvoženih ali vzporedno distribuiranih zdravil, ki morajo imeti zaradi zagotavljanja skladnosti s členom 47a Direktive 2001/83/ES nameščeno enakovredno edinstveno oznako, oseba, ki je odgovorna za dajanje navedenih zdravil v promet, zagotovi, da se informacije iz odstavka 2 naložijo v sistem arhivov, preden da proizvajalec zdravilo v promet ali distribucijo, ter da se te informacije pozneje redno posodabljajo.
The information shall be stored in all national or supranational repositories serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier is intended to be placed on the market.
Te informacije se hranijo v vseh nacionalnih ali nadnacionalnih arhivih za ozemlje države članice ali držav članic, kjer je zdravilo z edinstveno oznako namenjeno dajanju v promet.
The information referred to in paragraphs 2(a) to (d) of this Article, with the exception of the serial number, shall also be stored in the hub.
Informacije iz odstavka 2(a) do (d) tega člena, razen serijske številke, se shranijo tudi v vozlišče.
For a medicinal product bearing a unique identifier, at least the following information shall be uploaded to the repositories system:
Za zdravila z edinstveno oznako se vsaj naslednje informacije naložijo v sistem arhivov:
the data elements of the unique identifier in accordance with Article 4(b);
podatkovni elementi edinstvene oznake v skladu s členom 4(b);
the coding scheme of the product code;
shema kodiranja šifre proizvoda;
the name and the common name of the medicinal product, the pharmaceutical form, the strength, the pack type and the pack size of the medicinal product, in accordance with the terminology referred to in Article 25(1)(b) and (e) to (g) of the Commission Implementing Regulation (EU) No 520/2012 [4];
ime in splošno ime zdravila, farmacevtska oblika, jakost, vrsta in velikost pakiranja v skladu s terminologijo iz člena 25(1)(b) in (e) do (g) Izvedbene uredbe Komisije (EU) št. 520/2012 [4];
the Member State or Member States where the medicinal product is intended to be placed on the market;
država članica ali države članice, v katerih je zdravilo namenjeno dajanju v promet;
where applicable, the code identifying the entry corresponding to the medicinal product bearing the unique identifier in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 of the European Parliament and the Council [5];
kadar je primerno, identifikacijska koda vnosa, ki ustreza zdravilu z edinstveno oznako v podatkovni bazi iz člena 57(1)(l) Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [5];
the name and address of the manufacturer placing the safety features;
ime in naslov proizvajalca, ki namesti zaščitne elemente;
the name and address of the marketing authorisation holder;
ime in naslov imetnika dovoljenja za promet;
a list of wholesalers who are designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.
seznam trgovcev na debelo, ki jih je imetnik dovoljenja za promet s pisno pogodbo imenoval za skladiščenje in distribucijo zdravil, ki jih zajema njegovo dovoljenje za promet, v svojem imenu.
The information referred to in paragraph 2 shall be uploaded to the repositories system either through the hub or through a national or supranational repository.
Informacije iz odstavka 2 se naložijo v sistem arhivov prek vozlišča ali prek nacionalnega ali nadnacionalnega arhiva.
Where the upload is performed through the hub, the hub shall store a copy of the information referred to in paragraph 2(a) to (d), with the exception of the serial number, and transfer the complete information to all national or supranational repositories serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier is intended to be placed on the market.
Kadar nalaganje poteka prek vozlišča, ta shrani kopijo informacij iz odstavka 2(a) do (d), razen serijske številke, in prenese vse informacije v vse nacionalne ali nadnacionalne arhive za ozemlje države članice ali držav članic, kjer je zdravilo z edinstveno oznako namenjeno dajanju v promet.
Where the upload is performed through a national or supranational repository, that repository shall immediately transfer to the hub a copy of the information referred to in paragraph 2(a) to (d), with the exception of the serial number, using the data format and data exchange specifications defined by the hub.
Kadar nalaganje poteka prek nacionalnega ali nadnacionalnega arhiva, navedeni arhiv nemudoma prenese v vozlišče kopijo informacij iz odstavka 2(a) do (d), razen serijske številke, pri čemer se upošteva oblika zapisa podatkov in specifikacije za izmenjavo podatkov, ki so opredeljeni v vozlišču.
The information referred to in paragraph 2 shall be stored in the repositories where it was originally uploaded for at least one year after the expiry date of the medicinal product 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.
Informacije iz odstavka 2 se hranijo v arhivih, v katere so bile prvotno naložene, vsaj še eno leto po datumu izteka roka uporabnosti zdravila ali pet let po dajanju zdravila v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje.
Functioning of the hub
Delovanje vozlišča
Each national or supranational repository composing the repositories system shall exchange data with the hub using the data format and data exchange modalities defined by the hub.
Vsak nacionalni ali nadnacionalni arhiv, ki je vključen v sistem arhivov, si z vozliščem izmenjuje podatke v obliki zapisa in na podlagi specifikacij za izmenjavo, ki so določeni v vozlišču.
When the authenticity of the unique identifier cannot be verified because a national or supranational repository does not contain a unique identifier with the product code and serial number that are identical to those of the unique identifier being verified, the national or supranational repository shall transfer the query to the hub in order to verify whether that unique identifier is stored elsewhere in the repositories system.
Kadar avtentičnosti edinstvene oznake ni mogoče preveriti, ker nacionalni ali nadnacionalni arhiv ne vsebuje edinstvene oznake s šifro proizvoda in serijsko številko, ki sta enaki šifri proizvoda in serijski številki edinstvene oznake, ki se preverja, nacionalni ali nadnacionalni arhiv prenese poizvedbo na vozlišče, da se preveri, ali je navedena edinstvena oznaka shranjena drugje v sistemu arhivov.
When the hub receives the query, the hub shall identify, on the basis of the information contained therein, all national or supranational repositories serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier was intended to be placed on the market, and shall transfer the query to those repositories.
Ko vozlišče prejme poizvedbo, poišče na podlagi informacij, shranjenih v njem, vse nacionalne ali nadnacionalne arhive za ozemlje države članice ali držav članic, kjer je bilo zdravilo z edinstveno oznako namenjeno dajanju v promet, ter poizvedbo prenese na navedene arhive.
The hub shall subsequently transfer the reply of those repositories to the repository which initiated the query.
Vozlišče nato odgovor navedenih arhivov posreduje arhivu, iz katerega je bila poizvedba poslana.
Where notified by a national or supranational repository of the change of status of a unique identifier, the hub shall ensure the synchronisation of that status between those national or supranational repositories serving the territory of the Member State or Member States where the medicinal product bearing the unique identifier was intended to be placed on the market.
Kadar nacionalni ali nadnacionalni arhiv vozlišču pošlje obvestilo o spremembi statusa edinstvene oznake, vozlišče zagotovi sinhronizacijo navedenega statusa med navedenimi nacionalnimi ali nadnacionalnimi arhivi za ozemlje države članice ali držav članic, kjer je bilo zdravilo z edinstveno oznako namenjeno dajanju v promet.
When it receives the information referred to in Article 35(4), the hub shall ensure the electronic linking of the batch numbers before and after the repackaging or re-labelling operations with the set of unique identifiers decommissioned and with the set of equivalent unique identifiers placed.
Ko vozlišče prejme informacije iz člena 35(4), zagotovi elektronsko povezavo med številkami serij pred in po prepakiranju ali ponovnem označevanju in deaktiviranimi edinstvenimi oznakami ter nameščenimi enakovrednimi edinstvenimi oznakami.
Characteristics of the repositories system
Značilnosti sistema arhivov
Each repository in the repositories system shall satisfy all of the following conditions:
Vsak arhiv v sistemu arhivov mora izpolnjevati vse naslednje pogoje:
it shall be physically located in the Union;
fizično se nahaja v Uniji;
it shall be set up and managed by a non-profit legal entity established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public;
vzpostavi in upravlja ga nepridobitna pravna oseba, ki so jo v Uniji ustanovili proizvajalci in imetniki dovoljenja za promet z zdravili, ki morajo imeti nameščene zaščitne elemente, ter trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti, če se odločijo za udeležbo;
it shall be fully interoperable with the other repositories composing the repositories system;
je popolnoma interoperabilen z drugimi arhivi, ki so vključeni v sistem arhivov;
for the purposes of this Chapter, interoperability means the full functional integration of, and electronic data exchange between repositories regardless of the service provider used;
v tem poglavju interoperabilnost pomeni popolno funkcionalno integracijo arhivov in elektronsko izmenjavo podatkov med njimi, ne glede na ponudnika storitev;
it shall allow the reliable electronic identification and authentication of individual packs of medicinal products by manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public, in accordance with the requirements of this Regulation;
proizvajalcem, trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogoča zanesljivo elektronsko identifikacijo in preverjanje avtentičnosti posameznih pakiranj zdravil v skladu z zahtevami te uredbe;
it shall have application programming interfaces able to transfer and exchange data with the software used by wholesalers, persons authorised or entitled to supply medicinal products to the public and, where applicable, national competent authorities;
ima vmesnike za programiranje aplikacij, ki omogočajo prenos in izmenjavo podatkov s programsko opremo, ki jo uporabljajo trgovci na debelo, osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ter, če je primerno, pristojni nacionalni organi;
when wholesalers and persons authorised or entitled to supply medicinal products to the public query the repository for the purposes of verification of authenticity and decommissioning of a unique identifier, the response time of the repository, not considering the speed of the internet connection, shall be lower than 300 milliseconds in at least 95 % of queries.
kadar trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti v arhiv pošljejo poizvedbo, da bi preverili avtentičnost edinstvene oznake in jo deaktivirali, mora biti odzivni čas arhiva, ne glede na hitrost internetne povezave, pri 95 % poizvedb krajši od 300 milisekund.
The repository performance shall allow wholesalers and persons authorised or entitled to supply medicinal products to the public to operate without significant delay;
Zmogljivost arhiva omogoča trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti, da svoje dejavnosti opravljajo brez znatne zamude;
it shall maintain a complete record (‘audit trail’) of all operations concerning a unique identifier, of the users performing those operations and the nature of the operations;
hrani celotno evidenco (v nadaljnjem besedilu: revizijska sled) vseh dejavnosti v zvezi z edinstveno oznako, uporabnikov, ki so izvedli navedene dejavnosti, in naravo dejavnosti;
the audit trail shall be created when the unique identifier is uploaded to the repository and be maintained until at least one year after the expiry date of the medicinal product bearing the unique identifier 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;
revizijska sled se ustvari ob naložitvi edinstvene oznake v arhiv in se hrani vsaj še eno leto po datumu izteka roka uporabnosti zdravila z edinstveno oznako ali pet let po dajanju zdravila v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje;
in accordance with Article 38, its structure shall be such as to guarantee the protection of personal data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public interact with it;
v skladu s členom 38 mora biti njegova struktura taka, da zagotavlja varstvo osebnih podatkov in poslovno zaupnih informacij ter lastništvo in zaupnost podatkov, ustvarjenih, ko arhiv uporabljajo proizvajalci, imetniki dovoljenj za promet, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti;
it shall include graphical user interfaces providing direct access to it to the following users verified in accordance with Article 37(b):
vključuje tudi grafične uporabniške vmesnike, ki naslednjim uporabnikom, preverjenim v skladu s členom 37(b), zagotavljajo neposreden dostop do njega:
wholesalers and persons authorised or entitled to supply medicinal products to the public, for the purposes of verifying the authenticity of the unique identifier and decommissioning it in case of failure of their own software;
trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti za namene preverjanja avtentičnosti edinstvene oznake in njeno deaktiviranje v primeru nedelovanja njihove lastne programske opreme;
national competent authorities, for the purposes referred to in Article 39;
pristojnim nacionalnim organom za namene iz člena 39.
Where the status of a unique identifier on a medicinal product intended to be placed on the market in more than one Member State changes in a national or supranational repository, that repository shall immediately notify the change of status to the hub, except in case of decommissioning by marketing authorisation holders in accordance with Articles 40 or 41.
Če se status edinstvene oznake na zdravilu, ki je namenjeno dajanju v promet v več kot eni državi članici, spremeni v nacionalnem ali nadnacionalnem arhivu, navedeni arhiv takoj pošlje obvestilo o spremembi statusa vozlišču, razen če edinstveno oznako deaktivira imetnik dovoljenja za promet z zdravilom v skladu s členom 40 ali 41.
National or supranational repositories shall not allow the upload or storage of a unique identifier containing the same product code and serial number as another unique identifier already stored therein.
Nacionalni ali nadnacionalni arhivi ne dovoljujejo nalaganja ali shranjevanja edinstvene oznake, ki vsebuje isto šifro proizvoda in serijsko številko kot druga edinstvena oznaka, ki je že shranjena v arhivu.
For each batch of repackaged or relabelled packs of a medicinal product on which equivalent unique identifiers were placed for the purposes of complying with Article 47a of Directive 2001/83/EC, the person responsible for placing the medicinal product on the market shall inform the hub of the batch number or numbers of the packs which are to be repackaged or relabelled and of the unique identifiers on those packs.
Pri vsaki seriji prepakiranih ali ponovno označenih pakiranj zdravil, na katera so bile zaradi zagotavljanja skladnosti s členom 47a Direktive 2001/83/ES nameščene enakovredne edinstvene oznake, oseba, ki je odgovorna za dajanje zdravila v promet, v vozlišče pošlje številko serije ali številke serij na pakiranjih, ki bodo prepakirana ali ponovno označena, ter edinstvene oznake navedenih pakiranj.
He shall additionally inform the hub of the batch number of the batch resulting from the repackaging or re-labelling operations and the equivalent unique identifiers in that batch.
Ta oseba v vozlišče pošlje tudi številko nove serije, ki je nastala ob prepakiranju ali ponovnem označevanju, ter enakovredne edinstvene oznake v navedeni seriji.
Operations of the repositories system
Dejavnosti sistema arhivov
The repositories system shall provide for at least the following operations:
Sistem arhivov omogoča vsaj naslednje dejavnosti:
the repeated verification of the authenticity of an active unique identifier in accordance with Article 11;
večkratno preverjanje avtentičnosti aktivne edinstvene oznake v skladu s členom 11;
the triggering of an alert in the system and in the terminal where the verification of the authenticity of a unique identifier is taking place when such verification fails to confirm that the unique identifier is authentic in accordance with Article 11.
sprožitev opozorila v sistemu in terminalu, kjer se izvaja preverjanje avtentičnosti edinstvene oznake, kadar se pri takem preverjanju ne potrdi, da je edinstvena oznaka avtentična v skladu s členom 11.
Such an event shall be flagged in the system as a potential incident of falsification except where the product is indicated in the system as recalled, withdrawn or intended for destruction;
Takšen dogodek se v sistemu označi kot morebitni primer ponarejanja, razen če je zdravilo v sistemu označeno kot odpoklicano, umaknjeno ali namenjeno za uničenje;
the decommissioning of a unique identifier in accordance with the requirements of this Regulation;
deaktiviranje edinstvene oznake v skladu z zahtevami te uredbe;
the combined operations of identification of a pack of a medicinal product bearing a unique identifier and verification of the authenticity and decommissioning of that unique identifier;
kombinacijo dejavnosti za identifikacijo pakiranja zdravila, na katerem mora biti nameščena edinstvena oznaka, ter preverjanje avtentičnosti navedene edinstvene oznake in njeno deaktiviranje;