natgillin/translations-raw huggingface dataset:
the identification of a pack of a medicinal product bearing a unique identifier and the verification of the authenticity and the decommissioning of that unique identifier in a Member State which is not the Member State where the medicinal product bearing that unique identifier was placed on the market;
identifikacijo pakiranja zdravila, ki mora imeti nameščeno edinstveno oznako, ter preverjanje avtentičnosti navedene edinstvene oznake in njeno deaktiviranje v državi članici, ki ni država, v kateri je bilo zdravilo z navedeno edinstveno oznako dano v promet;
the reading of the information contained in the two-dimensional barcode encoding the unique identifier, the identification of the medicinal product carrying the barcode and the verification of the status of the unique identifier, without triggering the alert referred to in point (b) of this Article;
branje informacij, ki jih vsebuje dvodimenzionalna črtna koda, v kateri je zakodirana edinstvena oznaka, identifikacijo zdravila, na katerem mora biti nameščena črtna koda, in preverjanje statusa edinstvene oznake, ne da bi to sprožilo opozorilo iz točke (b) tega člena;
without prejudice to Article 35(1)(h), the access by verified wholesalers to the list of wholesalers referred to in Article 33(2)(h) for the purposes of determining whether they have to verify the unique identifier of a given medicinal product.
brez poseganja v člen 35(1)(h) dostop preverjenih trgovcev na debelo do seznama trgovcev na debelo iz člena 33(2)(h), da ugotovijo, ali morajo preveriti edinstveno oznako zadevnega zdravila;
the verification of the authenticity of a unique identifier and its decommissioning by manually querying the system with the data elements of the unique identifier;
preverjanje avtentičnosti edinstvene oznake in njeno deaktiviranje z ročnim primerjanjem podatkovnih elementov edinstvene oznake v sistemu;
the immediate provision of information concerning a given unique identifier to the national competent authorities and the European Medicines Agency, upon request;
takojšnje posredovanje informacij o dani edinstveni oznaki pristojnim nacionalnim organom in Evropski agenciji za zdravila na zahtevo;
the creation of reports that allow competent authorities to verify compliance of individual marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public with the requirements of this Regulation or to investigate potential incidents of falsification;
ustvarjanje poročil, ki pristojnim organom omogočajo, da preverijo, ali posamezni imetniki dovoljenj za promet, proizvajalci, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti izpolnjujejo zahteve iz te uredbe, ali da raziščejo morebitne primere ponarejanja;
the reverting of the status of a unique identifier from decommissioned to active, subject to the conditions referred to in Article 13;
povrnitev statusa edinstvene oznake iz deaktiviranega v aktivnega pod pogoji iz člena 13;
the indication that a unique identifier has been decommissioned;
obvestilo, da je bila edinstvena oznaka deaktivirana;
the indication that a medicinal product has been recalled, withdrawn, stolen, exported, requested as a sample by national competent authorities, indicated as a free sample by the marketing authorisation holder, or is intended for destruction;
obvestilo, da je bilo zdravilo odpoklicano, umaknjeno, ukradeno, izvoženo ali da so ga pristojni nacionalni organi zahtevali kot vzorec, da ga je imetnik dovoljenja za promet označil kot brezplačni vzorec ali da je namenjeno za uničenje;
the linking, by batches of medicinal products, of the information on unique identifiers removed or covered to the information on the equivalent unique identifiers placed on those medicinal products for the purposes of complying with Article 47a of Directive 2001/83/EC.
povezovanje – po serijah zdravil – informacij o odstranjenih ali prekritih edinstvenih oznakah z informacijami o enakovrednih edinstvenih oznakah, ki so nameščene na navedena zdravila zaradi zagotavljanja skladnosti s členom 47a Direktive 2001/83/ES;
the synchronisation of the status of a unique identifier between the national or supranational repositories serving the territory of the Member States where that medicinal product is intended to be placed on the market.
sinhronizacijo statusa edinstvene oznake med nacionalnimi ali nadnacionalnimi arhivi za ozemlje držav članic, v katerih je zdravilo namenjeno dajanju v promet.
Obligations of legal entities establishing and managing a repository which is part of the repositories system
Obveznosti pravnih oseb, vzpostavitev in upravljanje arhiva, ki je del sistema arhivov
Any legal entity establishing and managing a repository which is part of the repositories system shall perform the following actions:
Vsaka pravna oseba, ki vzpostavi in upravlja arhiv, ki je del sistema arhivov, opravi naslednje dejavnosti:
inform the relevant national competent authorities of its intention to physically locate the repository or part of it in their territory and notify them once the repository becomes operational;
pristojne nacionalne organe obvesti o svoji nameri, da arhiv ali del arhiva fizično vzpostavi na ozemlju njihove države, in jih obvesti, ko arhiv začne delovati;
put in place security procedures ensuring that only users whose identity, role and legitimacy has been verified can access the repository or upload the information referred to in Article 33(2);
uvede varnostne postopke, ki zagotavljajo, da lahko samo uporabniki, katerih identiteta, vloga in legitimnost je bila preverjena, dostopajo do arhiva ali nalagajo informacije iz člena 33(2);
continuously monitor the repository for events alerting to potential incidents of falsification in accordance to Article 36(b);
stalno spremlja, ali se v arhivu morda pojavijo dogodki, ki kažejo na morebitne primere ponarejanja v skladu s členom 36(b);
provide for the immediate investigation of all potential incidents of falsification flagged in the system in accordance with Article 36(b) and for the alerting of national competent authorities, the European Medicines Agency and the Commission should the falsification be confirmed;
takoj preišče vse morebitne primere ponarejanja, ki so označeni v sistemu v skladu s členom 36(b), in opozori nacionalne pristojne organe, Evropsko agencijo za zdravila in Komisijo, če je primer ponarejanja potrjen;
carry out regular audits of the repository to verify compliance with the requirements of this Regulation.
redno izvaja revizije arhiva, da preveri skladnosti z zahtevami iz te uredbe.
Audits shall take place at least annually for the first five years after this Regulation becomes applicable in the Member State where the repository is physically located, and at least every three years thereafter.
Revizije se v državi članici, kjer se arhiv fizično nahaja, izvajajo vsaj enkrat letno v prvih petih letih po začetku veljavnosti te uredbe in nato vsaj vsaka tri leta.
The outcome of those audits shall be provided to competent authorities upon request;
Rezultati navedenih revizij se na zahtevo predložijo pristojnim organom;
make the audit trail referred to in Article 35(1)(g) immediately available to competent authorities upon their request;
revizijsko sled iz člena 35(1)(g) na zahtevo nemudoma da na voljo pristojnim organom;
make the reports referred to in Article 36(j) available to competent authorities upon their request.
poročila iz člena 36(j) na zahtevo da na voljo pristojnim organom.
Data protection and data ownership
Varstvo podatkov in lastništvo podatkov
Manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public shall be responsible for any data generated when they interact with the repositories system and stored in the audit trail.
Proizvajalci, imetniki dovoljenj za promet, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti so odgovorni za vse podatke, ki se ustvarijo pri uporabi sistema arhivov in se shranijo v revizijsko sled.
They shall only have ownership of and access to those data, with the exception of the information referred to in Article 33(2) and the information on the status of a unique identifier.
Lastništvo in dostop imajo samo do navedenih podatkov, razen informacij iz člena 33(2) in informacij o statusu edinstvene oznake.
The legal entity managing the repository where the audit trail is stored shall not access the audit trail and the data contained therein without the written agreement of the legitimate data owners except for the purpose of investigating potential incidents of falsification flagged in the system in accordance with Article 36(b).
Pravna oseba, ki upravlja arhiv, v katerem se hrani revizijska sled, ne dostopa do revizijske sledi in podatkov v njej brez pisnega soglasja zakonitih lastnikov podatkov, razen za namene preiskovanja morebitnih primerov ponarejanja, označenih v sistemu v skladu s členom 36(b).
Access by national competent authorities
Dostop pristojnih nacionalnih organov
A legal entity establishing and managing a repository used to verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in a Member State shall grant access to that repository and to the information contained therein, to competent authorities of that Member State for the following purposes:
Pravna oseba, ki vzpostavi in upravlja arhiv, ki se uporablja za preverjanje avtentičnosti ali deaktiviranje edinstvenih oznak zdravil, ki se dajejo v promet v državi članici, odobri dostop do navedenega arhiva in informacij v njem pristojnim organom navedene države članice za naslednje namene:
supervising the functioning of the repositories and investigating potential incidents of falsification;
nadzor delovanja arhivov in preiskovanje morebitnih primerov ponarejanja;
reimbursement;
povračila;
pharmacovigilance or pharmacoepidemiology.
farmakovigilanco ali farmakoepidemiologijo.
OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS
OBVEZNOSTI IMETNIKOV DOVOLJENJ ZA PROMET, VZPOREDNIH UVOZNIKOV IN VZPOREDNIH DISTRIBUTERJEV
Products recalled, withdrawn or stolen
Odpoklicana, umaknjena ali ukradena zdravila
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 promptly take all the following measures:
Imetnik dovoljenja za promet 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, nemudoma sprejme vse naslednje ukrepe:
ensure the decommissioning of the unique identifier of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place;
zagotovi, da se edinstvena oznaka zdravila, ki ga je treba odpoklicati ali umakniti, deaktivira v vsakem nacionalnem ali nadnacionalnem arhivu za ozemlje države članice ali držav članic, kjer se zdravilo odpokliče ali umakne;
ensure the decommissioning of the unique identifier, where known, of a medicinal product which has been stolen, in every national or supranational repository in which information on that product is stored;
zagotovi, da se edinstvena oznaka, če je znana, ukradenega zdravila deaktivira v vsakem nacionalnem ali nadnacionalnem arhivu, v katerem se shranjujejo informacije o navedenem zdravilu;
indicate in the repositories referred to in points (a) and (b) that that product has been recalled or withdrawn or stolen, where applicable.
v arhivih iz točk (a) in (b) označi, kjer je primerno, da je bilo zdravilo odpoklicano, umaknjeno oziroma ukradeno.
Products to be supplied as free samples
Zdravila, ki se dajejo kot brezplačni vzorci
The marketing authorisation holder intending to supply any of his medicinal products as a free sample in accordance with Article 96 of Directive 2001/83/EC shall, where that product bears the safety features, indicate it as a free sample in the repositories system and ensure the decommissioning of its unique identifier before providing it to the persons qualified to prescribe it.
Imetnik dovoljenja za promet z zdravilom, ki namerava katero od svojih zdravil, ki mora imeti nameščene zaščitne elemente, dati kot brezplačni vzorec v skladu s členom 96 Direktive 2001/83/ES, navedeno zdravilo v sistemu arhivov označi kot brezplačni vzorec in zagotovi deaktiviranje njegove edinstvene oznake, preden ga da osebam, pooblaščenim za njegovo predpisovanje.
Removal of unique identifiers from the repositories system
Odstranitev edinstvenih oznak iz sistema 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 not upload unique identifiers in the repositories system before having removed from therein, where present, older unique identifiers containing the same product code and serial number as the unique identifiers being uploaded.
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, ne naloži edinstvenih oznak v sistem arhivov, preden iz njega ne odstrani starejših edinstvenih oznak, če obstajajo, ki vsebujejo isto šifro proizvoda in serijsko številko kot edinstvene oznake, ki bodo naložene v arhiv.
OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES
OBVEZNOSTI PRISTOJNIH NACIONALNIH ORGANOV
Information to be provided by national competent authorities
Informacije, ki jih morajo predložiti pristojni nacionalni organi
National competent authorities shall make the following information available to the marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public, upon their request:
Pristojni nacionalni organi dajo imetnikom dovoljenj za promet, proizvajalcem, trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti na njihovo zahtevo na voljo naslednje informacije:
the medicinal products placed on the market on their territory which shall bear the safety features in accordance with Article 54(o) of Directive 2001/83/EC and this Regulation;
o zdravilih, danih v promet na ozemlju njihove države, ki morajo imeti nameščene zaščitne elemente v skladu s členom 54(o) Direktive 2001/83/ES in v skladu s to uredbo;
the medicinal products subject to prescription or subject to reimbursement for which the scope of the unique identifier is extended for the purposes of reimbursement or pharmacovigilance, in accordance with Article 54a(5) of Directive 2001/83/EC;
o zdravilih, ki se izdajajo na recept ali za katera velja povračilo stroškov, za katera se v skladu s členom 54a(5) Direktive 2001/83/ES zaradi povračila stroškov ali farmakovigilance razširi področje uporabe edinstvene oznake;
the medicinal products for which the scope of the anti-tampering device is extended for the purpose of patient safety, in accordance with Article 54a(5) of Directive 2001/83/EC.
o zdravilih, za katera se v skladu s členom 54a(5) Direktive 2001/83/ES zaradi varstva pacientov razširi področje uporabe pripomočka za zaščito pred poseganjem v zdravilo.
Supervision of the repositories system
Nadzor sistema arhivov
National competent authorities shall supervise the functioning of any repository physically located in their territory, in order to verify, if necessary by means of inspections, that the repository and the legal entity responsible for the establishment and management of the repository comply with the requirements of this Regulation.
Pristojni nacionalni organi nadzirajo delovanje vsakega arhiva, ki se fizično nahaja na ozemlju njihove države, da preverijo, po potrebi s pregledi, ali arhiv in pravna oseba, odgovorna za vzpostavitev in upravljanje arhiva, izpolnjujeta zahteve iz te uredbe.
A national competent authority may delegate any of its obligations under this Article to the competent authority of another Member State or to a third party, by means of a written agreement.
Nacionalni pristojni organ lahko s pisnim sporazumom prenese katero koli od svojih obveznosti iz tega člena na pristojni organ druge države članice ali na tretjo osebo.
Where a repository not physically located in the territory of a Member State is used for the purpose of verifying the authenticity of medicinal products placed on the market in that Member State, the competent authority of that Member State may observe an inspection of the repository or perform an independent inspection, subject to the agreement of the Member State in which the repository is physically located.
Če se arhiv, ki se fizično ne nahaja na ozemlju države članice, uporablja za preverjanje avtentičnosti zdravil, ki se dajejo v promet v navedeni državi članici, lahko pristojni organ navedene države članice opazuje pregled arhiva ali opravi neodvisen pregled v dogovoru z državo članico, v kateri se arhiv fizično nahaja.
A national competent authority shall communicate reports of supervision activities to the European Medicines Agency, which shall make them available to the other national competent authorities and the Commission.
Pristojni nacionalni organ poročila o nadzornih dejavnostih pošlje Evropski agenciji za zdravila, ki jih da na voljo drugim pristojnim nacionalnim organom in Komisiji.
National competent authorities may contribute to the management of any repository used to identify medicinal products and verify the authenticity of or decommission the unique identifiers of medicinal products placed on the market in the territory of their Member State.
Pristojni nacionalni organi lahko prispevajo k upravljanju katerega koli arhiva, ki se uporablja za identifikacijo zdravil in preverjanje avtentičnosti ali deaktiviranje edinstvenih oznak zdravil, ki se dajejo v promet na ozemlju njihove države članice.
National competent authorities may participate to the management board of the legal entities managing those repositories to the extent of up to one third of the members of the board.
Pristojni nacionalni organi lahko sodelujejo v upravnem odboru pravnih oseb, ki upravljajo navedene arhive, pri čemer predstavljajo največ eno tretjino članov odbora.
LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION
SEZNAM ODSTOPANJ IN OBVEŠČANJE KOMISIJE
Lists of derogations from bearing or not bearing the safety features
Seznam odstopanj v zvezi z zdravili, ki morajo imeti nameščene zaščitne elemente, ali z zdravili, ki ne smejo imeti nameščenih zaščitnih elementov
The list of medicinal products or product categories subject to prescription which shall not bear the safety features are set out in Annex I to this Regulation.
Seznam zdravil ali kategorij zdravil na recept, ki ne smejo imeti nameščenih zaščitnih elementov, je določen v Prilogi I k tej uredbi.
The list of medicinal products or product categories not subject to prescription which shall bear the safety features are set out in Annex II to this Regulation.
Seznam zdravil ali kategorij zdravil brez recepta, ki morajo imeti nameščene zaščitne elemente, je določen v Prilogi II k tej uredbi.
National competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification as soon as they become aware of such risk.
Pristojni nacionalni organi obvestijo Komisijo o zdravilih brez recepta, pri katerih menijo, da obstaja tveganje ponarejanja, takoj ko so seznanjeni s takim tveganjem.
For that purpose, they shall use the form set out in Annex III to this Regulation.
V ta namen uporabijo obrazec iz Priloge III k tej uredbi.
National competent authorities may inform the Commission of medicinal products which they deem not to be at risk of falsification.
Nacionalni pristojni organi lahko Komisijo obvestijo o zdravilih, pri katerih menijo, da ni tveganja ponarejanja.
For that purpose, they shall use the form set out in Annex IV to this Regulation.
V ta namen uporabijo obrazec iz Priloge IV k tej uredbi.
For the purposes of the notifications referred to in paragraphs 1 and 2, national competent authorities shall conduct an assessment of the risks of and arising from falsification of such products taking into account the criteria listed in Article 54a(2)(b) of Directive 2001/83/EC.
Za namene obveščanja iz odstavkov 1 in 2 pristojni nacionalni organi opravijo oceno tveganj ponarejanja zdravil in tveganj, ki izhajajo iz takih zdravil, ob upoštevanju meril iz člena 54a(2)(b) Direktive 2001/83/ES.
When submitting to the Commission the notification referred to in paragraph 1, national competent authorities shall provide the Commission with evidence and documentation supporting the presence of incidents of falsification.
Pristojni nacionalni organi Komisiji skupaj z obvestilom iz odstavka 1 predložijo tudi dokaze in dokumentacijo o ugotovljenih primerih ponarejanja.
Evaluation of the notifications
Ocena obvestil
Where, following a notification as referred to in Article 46, the Commission or a Member State considers, on the basis of casualties or hospitalisations of citizens of the Union due to exposure to falsified medicinal products, that rapid action is required to protect public health, the Commission shall asses the notification without delay and at the latest within 45 days.
Kadar Komisija, potem ko je prejela obvestilo iz člena 46, ali država članica meni, da je na podlagi števila smrtnih žrtev ali hospitalizacij državljanov Unije zaradi ponarejenih zdravil potrebno hitro ukrepanje zaradi varovanja javnega zdravja, Komisija nemudoma oceni obvestilo, najpozneje pa v 45 dneh.
TRANSITIONAL MEASURES AND ENTRY INTO FORCE
PREHODNI UKREPI IN ZAČETEK VELJAVNOSTI
Medicinal products that have been released for sale or distribution without the safety features in a Member State before the date in which this Regulation becomes applicable in that Member State, and are not repackaged or relabelled thereafter, may be placed on the market, distributed and supplied to the public in that Member State until their expiry date.
Zdravila, ki so bila v državi članici dana v promet ali distribucijo brez zaščitnih elementov pred datumom začetka uporabe te uredbe v navedeni državi članici in po tem niso bila prepakirana ali ponovno označena, se lahko dajejo v promet, se distribuirajo in izdajajo javnosti v navedeni državi članici do izteka njihovega roka uporabnosti.
Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs
Uporaba v državah članicah z obstoječimi sistemi za preverjanje avtentičnosti zdravil in identifikacijo posameznih pakiranj
Each of the Member States referred to in Article 2, paragraph 2, second subparagraph, point (b), second sentence, of Directive 2011/62/EU shall notify the Commission of the date from which Articles 1 to 48 of this Regulation apply in its territory in accordance with the third subparagraph of Article 50.
Vsaka od držav članic, navedenih v drugem stavku točke (b) drugega pododstavka odstavka 2 člena 2 Direktive 2011/62/EU, Komisiji sporoči datum, ko se na njenem ozemlju začnejo uporabljati členi 1 do 48 te uredbe v skladu s tretjim pododstavkom člena 50.
The notification shall take place at the latest 6 months before that application.
Obvestilo pošlje najpozneje 6 mesecev pred začetkom uporabe.
The Commission shall publish a notice of each of the dates notified to it in accordance with paragraph 1 in the Official Journal of the European Union.
Komisija vsak datum, o katerem je bila obveščena v skladu z odstavkom 1, objavi v Uradnem listu Evropske unije.