natgillin/translations-raw huggingface dataset:
MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS
NAČINI, KAKO PROIZVAJALCI PREVERJAJO ZAŠČITNE ELEMENTE IN DEAKTIVIRAJO EDINSTVENO OZNAKO
Verification of the two-dimensional barcode
Preverjanje dvodimenzionalne črtne kode
The manufacturer placing the safety features shall verify that the two-dimensional barcode carrying the unique identifier complies with Articles 5 and 6, is readable and contains the correct information.
Proizvajalec, ki namesti zaščitne elemente, preveri, ali dvodimenzionalna črtna koda, v kateri je zapisana edinstvena oznaka, izpolnjuje zahteve iz členov 5 in 6, jo je mogoče prebrati in vsebuje pravilne informacije.
The manufacturer placing the safety features shall keep records of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack 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, and shall provide those records to competent authorities on request.
Proizvajalec, ki namesti zaščitne elemente, vodi evidenco vsake dejavnosti, ki jo opravi v zvezi z edinstveno oznako na pakiranju zdravila, in sicer vsaj še eno leto po datumu izteka roka uporabnosti pakiranja ali pet let po dajanju pakiranja v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje, in to evidenco na zahtevo predloži pristojnim organom.
Verifications to be performed before removing or replacing the safety features
Preverjanja, ki jih je treba opraviti pred odstranitvijo ali nadomestitvijo zaščitnih elementov
Before removing or covering, either fully or partially, the safety features in accordance with Article 47a of Directive 2001/83/EC, the manufacturer shall verify the following:
Pred delno ali popolno odstranitvijo ali prekritjem zaščitnih elementov v skladu s členom 47a Direktive 2001/83/ES proizvajalec preveri naslednje:
the integrity of the anti-tampering device;
celovitost pripomočka za zaščito pred poseganjem v zdravilo;
the authenticity of the unique identifier and decommission it if replaced.
avtentičnost edinstvene oznake, ki jo v primeru nadomestitve deaktivira.
Manufacturers holding both a manufacturing authorisation according to Article 40 of Directive 2001/83/EC and an authorisation to manufacture or import investigational medicinal products to the Union as referred to in Article 61 of Regulation (EU) No 536/2014 of the European Parliament and of the Council [3] shall verify the safety features and decommission the unique identifier on a pack of medicinal product before repackaging or re-labelling it for the purpose of using it as authorised investigational medicinal product or authorised auxiliary medicinal product.
Proizvajalci z dovoljenjem za proizvodnjo v skladu s členom 40 Direktive 2001/83/ES in dovoljenjem za proizvodnjo in uvoz zdravil v preskušanju v Unijo v skladu s členom 61 Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta [3] preverijo zaščitne elemente in deaktivirajo edinstveno oznako na pakiranju zdravila, preden ga prepakirajo ali ponovno označijo, da ga lahko uporabijo kot odobreno zdravilo v preskušanju ali odobreno pomožno zdravilo.
Equivalent unique identifier
Enakovredna edinstvena oznaka
When placing an equivalent unique identifier for the purposes of complying with Article 47a(1)(b) of Directive 2001/83/EC, the manufacturer shall verify that the structure and composition of the unique identifier placed on the packaging complies, with regard to the product code and the national reimbursement number or other national number identifying the medicinal product, with the requirements of the Member State where the medicinal product is intended to be placed on the market, so that that unique identifier can be verified for authenticity and decommissioned.
Proizvajalec pri nameščanju enakovredne edinstvene oznake za namene zagotavljanja skladnosti s členom 47a(1)(b) Direktive 2001/83/ES preveri, ali sta struktura in sestava edinstvene oznake na ovojnini, kar zadeva šifro proizvoda in nacionalno številko zdravila na pozitivni listi zdravil ali drugo nacionalno številko zdravila, v skladu z zahtevami države članice, v kateri je zdravilo namenjeno dajanju v promet, tako da je mogoče preveriti avtentičnost navedene edinstvene oznake in jo deaktivirati.
Actions to be taken by manufacturers in case of tampering or suspected falsification
Ukrepi, ki jih sprejmejo proizvajalci v primeru nedovoljenega poseganja v zdravilo ali suma na ponarejanje
Where a manufacturer has reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features shows that the product may not be authentic, the manufacturer shall not release the product for sale or distribution and shall immediately inform the relevant competent authorities.
Kadar proizvajalec utemeljeno domneva, da se je nedovoljeno posegalo v ovojnino zdravila, ali kadar se pri preverjanju zaščitnih elementov pokaže, da zdravilo morda ni avtentično, proizvajalec zdravila ne da v promet ali distribucijo ter nemudoma obvesti zadevne pristojne organe.
Provisions applicable to a manufacturer distributing his products by wholesale
Določbe za proizvajalca, ki svoja zdravila distribuira prek trgovcev na debelo
Where a manufacturer distributes his products by wholesale, Article 20(a), and Articles 22, 23 and 24 shall apply to him in addition to Articles 14 to 18.
Kadar proizvajalec svoja zdravila distribuira prek trgovcev na debelo, se zanj poleg členov 14 do 18 uporabljajo še člen 20(a) ter členi 22, 23 in 24.
MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS
NAČINI, KAKO TRGOVCI NA DEBELO PREVERJAJO ZAŠČITNE ELEMENTE IN DEAKTIVIRAJO EDINSTVENO OZNAKO
Verification of the authenticity of the unique identifier by wholesalers
Preverjanje avtentičnosti edinstvene oznake s strani trgovcev na debelo
A wholesaler shall verify the authenticity of the unique identifier of at least the following medicinal products in his physical possession:
Trgovec na debelo preveri avtentičnost edinstvene oznake vsaj naslednjih zdravil, ki jih ima v fizični posesti:
medicinal products returned to him by persons authorised or entitled to supply medicinal products to the public or by another wholesaler;
zdravil, ki so mu jih vrnile osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ali drug trgovec na debelo;
medicinal products he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is 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.
zdravil, ki jih prejme od trgovca na debelo, ki ni niti proizvajalec niti trgovec na debelo z dovoljenjem za promet niti trgovec na debelo, ki ga imetnik dovoljenja za promet s pisno pogodbo imenuje za skladiščenje in distribucijo zdravil, zajetih v njegovem dovoljenju za promet, v svojem imenu.
Derogations from Article 20(b)
Odstopanja od člena 20(b)
Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following situations:
Preverjanje avtentičnosti edinstvene oznake zdravila na podlagi člena 20(b) ni potrebno v nobenem od naslednjih primerov:
that medicinal product changes ownership but remains in the physical possession of the same wholesaler;
lastnik navedenega zdravila se spremeni, vendar zdravilo ostane v fizični posesti istega trgovca na debelo;
that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.
navedeno zdravilo se distribuira na ozemlju države članice med dvema skladiščema, ki pripadata istemu trgovcu na debelo ali isti pravni osebi, vendar pa se ne prodaja.
Decommissioning of unique identifiers by wholesalers
Deaktiviranje edinstvenih oznak s strani trgovcev na debelo
A wholesaler shall verify the authenticity of and decommission the unique identifier of the following medicinal products:
Trgovec na debelo preveri avtentičnost edinstvene oznake in jo deaktivira pri naslednjih zdravilih:
products which he intends to distribute outside of the Union;
pri zdravilih, ki jih namerava distribuirati zunaj Unije;
products which have been returned to him by persons authorised or entitled to supply medicinal products to the public or another wholesaler and cannot be returned to saleable stock;
pri zdravilih, ki so mu jih vrnile osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ali drug trgovec na debelo ter ki jih ni mogoče vrniti v prodajno zalogo;
products which are intended for destruction;
pri zdravilih, ki so namenjena za uničenje;
products which, while in his physical possession, are requested as a sample by competent authorities;
pri zdravilih, ki jih pristojni organi zahtevajo kot vzorec, medtem ko so v njegovi fizični posesti;
products which he intends to distribute to the persons or institutions referred to in Article 23, where required by national legislation in accordance with the same Article.
pri zdravilih, ki jih namerava distribuirati osebam ali ustanovam iz člena 23, če tako zahteva nacionalna zakonodaja v skladu z istim členom.
Provisions to accommodate specific characteristics of Member States' supply chains
Določbe v zvezi s posebnimi značilnostmi dobavne verige v državah članicah
Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions:
Države članice lahko zahtevajo, kadar je to potrebno zaradi upoštevanja posebnih značilnosti dobavne verige na svojem ozemlju, da trgovec na debelo preveri zaščitne elemente in deaktivira edinstveno oznako zdravila, preden ga dobavi kateri od naslednjih oseb ali ustanov:
persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;
osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti, ki svoje dejavnosti ne izvajajo v zdravstveni ustanovi ali v lekarni;
veterinarians and retailers of veterinary medicinal products;
veterinarjem in trgovcem na drobno z zdravili za uporabo v veterinarski medicini;
dental practitioners;
zobozdravnikom;
optometrists and opticians;
optometristom in optikom;
paramedics and emergency medical practitioners;
reševalcem in zdravnikom specialistom urgentne medicine;
armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;
oboroženim silam, policiji in drugim vladnim ustanovam z zalogami zdravil za civilno zaščito in obvladovanje nesreč;
universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;
univerzam in drugim visokošolskim ustanovam, ki zdravila uporabljajo za raziskovalne in izobraževalne namene, z izjemo zdravstvenih ustanov;
prisons;
zaporom;
schools;
šolam;
hospices;
hospicem;
nursing homes.
domovom za nego.
Actions to be taken by wholesalers in case of tampering or suspected falsification
Ukrepi, ki jih morajo sprejeti trgovci na debelo v primeru nedovoljenega poseganja v zdravilo ali suma na ponarejanje
A wholesaler shall not supply or export a medicinal product where he has reason to believe that its packaging has been tampered with, or where the verification of the safety features of the medicinal product indicates that the product may not be authentic.
Trgovec na debelo ne dobavlja niti ne izvaža zdravila, kadar utemeljeno domneva, da se je posegalo v ovojnino zdravila, ali kadar se pri preverjanju zaščitnih elementov zdravila pokaže, da zdravilo morda ni avtentično.
He shall immediately inform the relevant competent authorities.
Takoj obvesti ustrezne pristojne organe.
MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC
NAČINI, KAKO OSEBE Z DOVOLJENJEM ALI PRAVICO DO IZDAJANJA ZDRAVIL JAVNOSTI PREVERJAJO ZAŠČITNE ELEMENTE IN DEAKTIVIRAJO EDINSTVENO OZNAKO
Obligations of persons authorised or entitled to supply medicinal products to the public
Obveznosti oseb z dovoljenjem ali pravico do izdajanja zdravil javnosti
Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.
Osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ob izdaji katerega koli zdravila z zaščitnimi elementi javnosti preverijo zaščitne elemente in deaktivirajo edinstveno oznako tega zdravila.
Notwithstanding paragraph 1, persons authorised or entitled to supply medicinal products to the public operating within a healthcare institution may carry out that verification and decommissioning at any time the medicinal product is in the physical possession of the healthcare institution, provided that no sale of the medicinal product takes place between the delivery of the product to the healthcare institution and the supplying of it to the public.
Ne glede na odstavek 1 lahko osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti, ki svojo dejavnost izvajajo v zdravstveni ustanovi, navedeno preverjanje in deaktiviranje opravijo kadar koli, ko je zdravilo v fizični posesti zdravstvene ustanove, pod pogojem, da se zdravilo od dobave zdravstveni ustanovi do izdaje javnosti ne prodaja.
In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the Member State in which they are authorised or entitled.
Zaradi preverjanja avtentičnosti edinstvene oznake zdravila in deaktiviranja navedene edinstvene oznake se osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti povežejo s sistemom arhivov iz člena 31 prek nacionalnega ali nadnacionalnega arhiva za ozemlje države članice, v kateri so pridobile dovoljenje ali pravico.
They shall also verify the safety features and decommission the unique identifier of the following medicinal products bearing the safety features:
Navedene osebe prav tako preverijo zaščitne elemente in deaktivirajo edinstveno oznako naslednjih zdravil, ki morajo imeti nameščene zaščitne elemente:
medicinal products in their physical possession that cannot be returned to wholesalers or manufacturers;
zdravil v svoji fizični posesti, ki jih ni mogoče vrniti trgovcem na debelo ali proizvajalcem;
medicinal products that, while in their physical possession, are requested as samples by competent authorities, in accordance with national legislation;
zdravil, ki jih, ko so v fizični posesti navedenih oseb, pristojni organi v skladu z nacionalno zakonodajo zahtevajo kot vzorce;
medicinal products which they supply for subsequent use as authorised investigational medicinal products or authorised auxiliary medicinal products as defined in Articles 2(2)(9) and (10) of Regulation (EU) No 536/2014.
zdravil, ki jih izdajo za nadaljnjo uporabo kot odobrena zdravila v preskušanju ali odobrena pomožna zdravila, kot so opredeljena v členu 2(2)(9) in (10) Uredbe (EU) št. 536/2014.
Derogations from Article 25
Odstopanja od člena 25
Persons authorised or entitled to supply medicinal products to the public are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products provided to them as free samples in accordance with Article 96 of Directive 2001/83/EC.
Osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti so izvzete od obveznosti preverjanja zaščitnih elementov in deaktiviranja edinstvene oznake zdravil, ki jih dobijo kot brezplačne vzorce v skladu s členom 96 Direktive 2001/83/ES.
Persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products where that obligation has been placed on wholesalers by national legislation in accordance with Article 23.
Osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti, ki svoje dejavnosti ne izvajajo v zdravstveni ustanovi ali lekarni, so izvzete od obveznosti preverjanja zaščitnih elementov in deaktiviranja edinstvene oznake zdravil, če nacionalna zakonodaja to obveznost nalaga trgovcem na debelo v skladu s členom 23.
Notwithstanding Article 25, Member States may decide, where necessary to accommodate the particular characteristics of the supply chain on their territory, to exempt a person authorised or entitled to supply medicinal products to the public operating within a healthcare institution from the obligations of verification and decommissioning of the unique identifier, provided that the following conditions are met:
Ne glede na člen 25 se lahko države članice odločijo, kadar je to potrebno zaradi upoštevanja posebnih značilnosti dobavne verige na svojem ozemlju, da izvzamejo osebo z dovoljenjem ali pravico do izdajanja zdravil javnosti, ki svojo dejavnost izvaja v zdravstveni ustanovi, od obveznosti preverjanja in deaktiviranja edinstvene oznake, pod pogojem, da so izpolnjeni naslednji pogoji:
the person authorised or entitled to supply medicinal products to the public obtains the medicinal product bearing the unique identifier through a wholesaler belonging to the same legal entity as the healthcare institution;
oseba z dovoljenjem ali pravico do izdajanja zdravil javnosti je zdravilo z edinstveno oznako priskrbela pri trgovcu na debelo, ki pripada isti pravni osebi kot zdravstvena ustanova;
the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution;
edinstveno oznako preveri in deaktivira trgovec na debelo, ki zdravilo dobavlja zdravstveni ustanovi;
no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution;
med trgovcem na debelo, ki dobavi zdravilo, in navedeno zdravstveno ustanovo ne pride do prodaje;
the medicinal product is supplied to the public within that healthcare institution.
zdravilo se izda javnosti v navedeni zdravstveni ustanovi.
Obligations when applying the derogations
Obveznosti pri uporabi odstopanj
Where the verification of the authenticity and decommissioning of the unique identifier is carried out earlier than referred to in Article 25(1), pursuant to Articles 23 or 26, the integrity of the anti-tampering device shall be verified at the time the medicinal product is supplied to the public.
Če se preverjanje avtentičnosti in deaktiviranje edinstvene oznake v skladu s členom 23 ali 26 izvede prej, kot je navedeno v členu 25(1), se celovitost pripomočka za zaščito pred poseganjem v zdravilo preveri ob izdaji zdravila javnosti.
Obligations when supplying only part of a pack
Obveznosti pri izdaji le dela pakiranja zdravila
Notwithstanding Article 25(1), where persons authorised or entitled to supply medicinal products to the public supply only part of a pack of a medicinal product the unique identifier of which is not decommissioned, they shall verify the safety features and decommission that unique identifier when the pack is opened for the first time.
Ne glede na člen 25(1) v primeru, kadar osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti izdajo le del pakiranja zdravila, katerega edinstvena oznaka ni deaktivirana, preverijo zaščitne elemente in deaktivirajo navedeno edinstveno oznako ob prvem odpiranju pakiranja.
Obligations in case of inability to verify the authenticity and decommission the unique identifier
Obveznosti v primeru, kadar preverjanje avtentičnosti in deaktiviranje edinstvene oznake nista mogoča
Notwithstanding Article 25(1), where technical problems prevent persons authorised or entitled to supply medicinal products to the public from verifying the authenticity of and decommissioning a unique identifier at the time the medicinal product bearing that unique identifier is supplied to the public, those persons authorised or entitled to supply medicinal products to the public shall record the unique identifier and, as soon as the technical problems are solved, verify the authenticity of and decommission the unique identifier.
Ne glede na člen 25(1) v primeru, kadar osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti zaradi tehničnih težav ne morejo preveriti avtentičnosti edinstvene oznake in je deaktivirati ob izdaji zdravila z navedeno edinstveno oznako javnosti, si jo zapišejo in takoj, ko so tehnične težave odpravljene, preverijo njeno avtentičnost ter jo deaktivirajo.
Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification
Ukrepi, ki jih osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti sprejmejo v primeru suma na ponarejeno zdravilo
Where persons authorised or entitled to supply medicinal products to the public have reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features of the medicinal product indicates that the product may not be authentic, those persons authorised or entitled to supply medicinal products to the public shall not supply the product and shall immediately inform the relevant competent authorities.
Kadar osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti utemeljeno domnevajo, da se je posegalo v ovojnino zdravila, ali se pri preverjanju zaščitnih elementov zdravila pokaže, da zdravilo morda ni avtentično, osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti ne izdajo zdravila in nemudoma obvestijo ustrezne pristojne organe.
ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM
VZPOSTAVITEV, UPRAVLJANJE IN DOSTOPNOST SISTEMOV ARHIVOV
Establishment of the repositories system
Vzpostavitev sistema arhivov
The repositories system where the information on the safety features shall be contained, pursuant to Article 54a(2)(e) of Directive 2001/83/EC, shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.
Sistem arhivov, v katerih so v skladu s členom 54a(2)(e) Direktive 2001/83/ES shranjene informacije o zaščitnih elementih, vzpostavi in upravlja nepridobitna pravna oseba ali nepridobitne pravne osebe, ki so jih v Uniji ustanovili proizvajalci in imetniki dovoljenj za promet z zdravili, ki morajo imeti nameščene zaščitne elemente.
In setting up the repositories system, the legal entity or entities referred to in paragraph 1 shall consult at least wholesalers, persons authorised or entitled to supply medicinal products to the public and relevant national competent authorities.
Pri vzpostavitvi sistema arhivov se pravna oseba ali pravne osebe iz odstavka 1 posvetujejo vsaj s trgovci na debelo, osebami z dovoljenjem ali pravico do izdajanja zdravil javnosti in z ustreznimi pristojnimi nacionalnimi organi.
Wholesalers and persons authorised or entitled to supply medicinal products to the public are entitled to participate in the legal entity or entities referred to in paragraph 1, on a voluntary basis, at no cost.
Trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti imajo pravico do prostovoljne in brezplačne udeležbe v pravni osebi ali pravnih osebah iz odstavka 1.