natgillin/translations-raw huggingface dataset:
In the interest of legal certainty and legal clarity with regard to the applicable rules in those Member States which benefit from an additional transitional period in accordance with this Regulation, each of those Member States should be required to notify the Commission of the date from which the provisions of this Regulation subject to the additional transitional period apply in its territory in order for the Commission to publish the date of application in that Member State in the Official Journal of the European Union sufficiently in advance,
Zaradi zagotavljanja pravne varnosti in pravne jasnosti glede pravil, ki se uporabljajo v državah članicah, ki jim je bilo odobreno dodatno prehodno obdobje v skladu s to uredbo, bi bilo treba od vsake od navedenih držav članic zahtevati, da Komisijo obvesti o datumu, od katerega se določbe te uredbe, za katere velja dodatno prehodno obdobje, uporabljajo na njenem ozemlju, da lahko Komisija v Uradnem listu Evropske unije pravočasno objavi datum začetka uporabe te uredbe v navedeni državi članici –
the characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified;
značilnosti in tehnične specifikacije edinstvene oznake, ki omogoča preverjanje avtentičnosti zdravil in identifikacijo posameznih pakiranj;
the modalities for the verification of the safety features;
načine preverjanja zaščitnih elementov;
the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;
določbe o vzpostavitvi, upravljanju in dostopnosti sistema arhivov, v katerih se shranjujejo informacije o zaščitnih elementih;
the list of medicinal products and product categories subject to prescription which shall not bear the safety features;
seznam zdravil in kategorij zdravil na recept, ki ne smejo imeti nameščenih zaščitnih elementov;
the list of medicinal products and product categories not subject to prescription which shall bear the safety features;
seznam zdravil in kategorij zdravil brez recepta, ki morajo imeti nameščene zaščitne elemente;
the procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification in accordance with the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC;
postopke, ki jih morajo upoštevati pristojni nacionalni organi pri obveščanju Komisije o zdravilih brez recepta, ki so bila ocenjena kot zdravila s tveganjem ponarejanja, in o zdravilih na recept, ki niso bila ocenjena kot zdravila s tveganjem ponarejanja, v skladu z merili iz člena 54a(2)(b) Direktive 2001/83/ES;
the procedures for a rapid evaluation of and decision on the notifications referred to in point (f) of this Article.
postopke za hitro oceno obvestil iz točke (f) tega člena in hitro odločitev o njih.
medicinal products subject to prescription which shall bear safety features on their packaging pursuant to Article 54a(1) of Directive 2001/83/EC, unless included in the list set out in Annex I to this Regulation;
zdravila na recept, ki morajo imeti na ovojnini nameščene zaščitne elemente v skladu s členom 54a(1) Direktive 2001/83/ES, razen če so vključena na seznam iz Priloge I k tej uredbi;
medicinal products not subject to prescription included in the list set out in Annex II to this Regulation;
zdravila brez recepta, ki so vključena na seznam iz Priloge II k tej uredbi;
medicinal products to which Member States have extended the scope of application of the unique identifier or of the anti-tampering device in accordance with Article 54a(5) of Directive 2001/83/EC.
zdravila, za katera so države članice razširile področje uporabe edinstvene oznake ali pripomočka za zaščito pred poseganjem v zdravilo v skladu s členom 54a(5) Direktive 2001/83/ES.
For the purposes of this Regulation, where reference is made to the packaging in a provision of this Regulation, the provision shall apply to outer packaging or to the immediate packaging if the medicinal product has no outer packaging.
V tej uredbi se sklicevanje na ovojnino v določbah te uredbe razume kot sklicevanje na zunanjo ovojnino ali na stično ovojnino, če zdravilo nima zunanje ovojnine.
For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply.
V tej uredbi se uporabljajo opredelitve pojmov iz člena 1 Direktive 2001/83/ES.
‘unique identifier’ means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;
„edinstvena oznaka“ pomeni zaščitni element, ki omogoča preverjanje avtentičnosti in identifikacijo posameznega pakiranja zdravila;
‘anti-tampering device’ means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with;
„pripomoček za zaščito pred poseganjem v zdravilo“ pomeni zaščitni element, s katerim se lahko preveri, ali se je posegalo v ovojnino zdravila;
‘decommissioning of a unique identifier’ means the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;
„deaktiviranje edinstvene oznake“ pomeni spremembo aktivnega statusa edinstvene oznake, shranjene v sistemu arhivov iz člena 31 te uredbe, v status, ki preprečuje kakršno koli nadaljnje uspešno preverjanje avtentičnosti navedene edinstvene oznake;
‘active unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned;
„aktivna edinstvena oznaka“ pomeni edinstveno oznako, ki ni bila deaktivirana oziroma ki ni več deaktivirana;
‘active status’ means the status of an active unique identifier stored in the repositories system referred to in Article 31;
„aktivni status“ pomeni status aktivne edinstvene oznake, shranjene v sistemu arhivov iz člena 31;
‘healthcare institution’ means a hospital, in- or outpatient clinic or health centre.
„zdravstvena ustanova“ pomeni bolnišnico, ambulanto ali zdravstveni dom.
TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER
TEHNIČNE SPECIFIKACIJE EDINSTVENE OZNAKE
Composition of the unique identifier
Sestava edinstvene oznake
The manufacturer shall place on the packaging of a medicinal product a unique identifier which complies with the following technical specifications:
Proizvajalec na ovojnino zdravila namesti edinstveno oznako, ki je v skladu z naslednjimi tehničnimi specifikacijami:
The unique identifier shall be a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product.
Edinstvena oznaka je zaporedje številk oziroma številk in črk, ki je za dano pakiranje zdravila edinstveno.
The unique identifier shall consist of the following data elements:
Edinstvena oznaka vsebuje naslednje elemente:
a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier (‘product code’);
šifro, ki omogoča identifikacijo vsaj imena, splošnega imena, farmacevtske oblike, jakosti, velikosti in vrste ovojnine zdravila, ki mora imeti nameščeno edinstveno oznako (v nadaljnjem besedilu: šifra proizvoda);
a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm (‘serial number’);
zaporedje največ 20 številk oziroma številk in črk, ki ga določi deterministični ali nedeterministični algoritem za generiranje naključnih številk (v nadaljnjem besedilu: serijska številka);
a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market;
nacionalno številko zdravila na pozitivni listi zdravil ali drugo nacionalno številko zdravila, če tako zahteva država članica, v kateri je zdravilo namenjeno dajanju v promet;
the batch number;
številko serije;
the expiry date.
datum izteka roka uporabnosti zdravila.
The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand.
Verjetnost, da se serijska številka ugane, mora biti zanemarljiva in v vsakem primeru manjša od ena proti deset tisoč.
The character sequence resulting from the combination of the product code and the serial number shall be unique to a given pack of a medicinal product until 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.
Zato mora biti zaporedje znakov, ki izhaja iz kombinacije šifre proizvoda in serijske številke, za posamezno pakiranje zdravila edinstveno, in sicer vsaj še eno leto po datumu izteka roka uporabnosti navedenega pakiranja ali pet let po dajanju zdravila v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje.
Where the national reimbursement number or other national number identifying the medicinal product is contained in the product code, it is not required to be repeated within the unique identifier.
Če je nacionalna številka zdravila na pozitivni listi zdravil ali druga nacionalna številka zdravila vključena v šifro proizvoda, je ni treba ponoviti v edinstveni oznaki.
Carrier of the unique identifier
Nosilec edinstvene oznake
Manufacturers shall encode the unique identifier in a two-dimensional barcode.
Proizvajalci zakodirajo edinstveno oznako v dvodimenzionalno črtno kodo.
The barcode shall be a machine-readable Data Matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200.
Črtna koda je strojno berljiva koda Data Matrix, ki ima stopnjo prepoznavanja in popravljanja napak višjo ali enako kot Data Matrix ECC200.
Barcodes conforming to the International Organization for Standardisation/International Electrotechnical Commission standard (‘ISO/IEC’) 16022:2006 shall be presumed to fulfil the requirements set out in this paragraph.
Za črtne kode, ki ustrezajo standardu 16022:2006 Mednarodne organizacije za standardizacijo/Mednarodne elektrotehniške komisije (v nadaljnjem besedilu: ISO/IEC), se šteje, da izpolnjujejo zahteve iz tega odstavka.
Manufacturers shall print the barcode on the packaging on a smooth, uniform, low-reflecting surface.
Proizvajalci črtno kodo natisnejo na ovojnino, na gladko, enotno in čim bolj neodsevno površino.
When encoded in a Data Matrix, the structure of the unique identifier shall follow an internationally-recognised, standardised data syntax and semantics (‘coding scheme’) which allows the identification and accurate decoding of each data element of which the unique identifier is composed, using common scanning equipment.
Ob prekodiranju v kodo Data Matrix mora biti struktura edinstvene oznake v skladu z mednarodno priznano in standardizirano sintakso in semantiko podatkov (v nadaljnjem besedilu: shema kodiranja), ki z običajno opremo za skeniranje omogoča identifikacijo in natančno dekodiranje vsakega podatkovnega elementa, iz katerega je sestavljena edinstvena oznaka.
The coding scheme shall include data identifiers or application identifiers or other character sequences identifying the beginning and the end of the sequence of each individual data element of the unique identifier and defining the information contained in those data elements.
Shema kodiranja vključuje podatkovne identifikatorje ali aplikacijske identifikatorje ali druga zaporedja znakov, ki določajo začetek in konec zaporedja vsakega posameznega podatkovnega elementa edinstvene oznake ter opredeljujejo informacije, ki jih vsebujejo navedeni podatkovni elementi.
Unique identifiers having a coding scheme conforming to ISO/IEC 15418:2009 shall be presumed to fulfil the requirements set out in this paragraph.
Za edinstvene oznake s shemami kodiranja, ki so v skladu s standardom ISO/IEC 15418:2009, se šteje, da izpolnjujejo zahteve iz tega odstavka.
When encoded in a Data Matrix as data element of a unique identifier, the product code shall follow a coding scheme and begin with characters specific to the coding scheme used.
Kadar se šifra proizvoda prekodira v kodo Data Matrix kot podatkovni element edinstvene oznake, mora biti šifra proizvoda v skladu s shemo kodiranja in se začeti z znaki, ki so specifični za uporabljeno shemo kodiranja.
It shall also contain characters or character sequences identifying the product as a medicinal product.
Vsebuje tudi znake ali zaporedja znakov, ki proizvod identificirajo kot zdravilo.
The resulting code shall be less than 50 characters and be globally unique.
Nastala koda ni daljša od 50 znakov in je globalno edinstvena.
Product codes which conform to the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 shall be presumed to fulfil the requirements set out in this paragraph.
Za šifre proizvodov, ki so v skladu s standardoma ISO/IEC 15459-3:2014 in ISO/IEC 15459-4:2014, se šteje, da izpolnjujejo zahteve iz tega odstavka.
Where necessary, different coding schemes may be used within the same unique identifier provided that the decoding of the unique identifier is not hindered.
Po potrebi se lahko pri isti edinstveni oznaki uporabijo različne sheme kodiranja, če to ne ovira dekodiranja edinstvene oznake.
In that case, the unique identifier shall contain standardised characters permitting the identification of the beginning and the end of the unique identifier as well as the beginning and the end of each coding scheme.
V tem primeru edinstvena oznaka vsebuje standardizirane znake, ki omogočajo določitev začetka in konca edinstvene oznake ter začetka in konca vsake sheme šifriranja.
Where containing multiple coding schemes, unique identifiers which conform to ISO/IEC 15434:2006 shall be presumed to fulfil the requirements set out in this paragraph.
Za edinstvene oznake z več shemami kodiranja, ki so v skladu s standardom ISO/IEC 15434:2006, se šteje, da izpolnjujejo zahteve iz tega odstavka.
Quality of the printing of the two-dimensional barcode
Kakovost tiskanja dvodimenzionalne črtne kode
Manufacturers shall evaluate the quality of the printing of the Data Matrix by assessing at least the following Data Matrix parameters:
Proizvajalci ocenjujejo kakovost tiskanja kode Data Matrix, tako da pregledajo vsaj naslednje parametre kode Data Matrix:
the contrast between the light and dark parts;
kontrast med svetlimi in temnimi deli;
the uniformity of the reflectance of the light and dark parts;
enakomernost odsevnosti svetlih in temnih delov;
the axial non-uniformity;
osno neprileganje;
the grid non-uniformity;
mrežno neprileganje;
the unused error correction;
neuporabo odpravljanja napak;
the fixed pattern damage;
poškodbe nespremenljivega vzorca;
the capacity of the reference decode algorithm to decode the Data Matrix.
zmogljivost algoritma za dekodiranje referenc dekodirati kodo Data Matrix.
Manufacturers shall identify the minimum quality of the printing which ensures the accurate readability of the Data Matrix throughout the supply chain until 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.
Proizvajalci opredelijo najnižjo kakovost tiskanja, ki zagotavlja natančno berljivost kode Data Matrix v celotni dobavni verigi, in sicer vsaj še eno leto po datumu izteka roka uporabnosti navedenega pakiranja ali pet let po dajanju pakiranja v promet ali distribucijo v skladu s členom 51(3) Direktive 2001/83/ES, kar je pozneje.
When printing the Data Matrix, manufacturers shall not use a quality of the printing lower than the minimum quality referred to in paragraph 2.
Pri tiskanju kode Data Matrix proizvajalci ne smejo uporabiti kakovosti tiskanja, ki je slabša od najnižje kakovosti iz odstavka 2.
A quality of printing rated at least 1,5 in accordance with ISO/IEC 15415:2011 shall be presumed to fulfil the requirements set out in this Article.
Za kakovost tiskanja z oceno vsaj 1,5 v skladu s standardom ISO/IEC 15415:2011 se šteje, da izpolnjuje zahteve iz tega člena.
Human-readable format
Človeku berljiva oblika zapisa
Manufacturers shall print the following data elements of the unique identifier on the packaging in human-readable format:
Proizvajalci natisnejo naslednje podatkovne elemente edinstvene oznake na ovojnini v človeku berljivi obliki zapisa:
the product code;
šifro proizvoda;
the serial number;
serijsko številko;
the national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market and not printed elsewhere on the packaging.
nacionalno številko zdravila na pozitivni listi zdravil ali drugo nacionalno številko zdravila, če tako zahteva država članica, v kateri je zdravilo namenjeno dajanju v promet, in če ni natisnjena drugje na ovojnini.
Paragraph 1 shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres.
Odstavek 1 se ne uporablja, kadar je vsota dveh najdaljših mer ovojnine enaka ali manjša od 10 centimetrov.
Where the dimensions of the packaging allow it, the human-readable data elements shall be adjacent to the two-dimensional barcode carrying the unique identifier.
Če mere ovojnine dovoljujejo, so človeku berljivi podatkovni elementi natisnjeni zraven dvodimenzionalne črtne kode, v kateri je zapisana edinstvena oznaka.
Additional information in the two-dimensional barcode
Dodatne informacije v dvodimenzionalni črtni kodi
Manufacturers may include information other than the unique identifier in the two-dimensional barcode carrying the unique identifier, where permitted by the competent authority in accordance with Title V of Directive 2001/83/EC.
Proizvajalci lahko v dvodimenzionalno črtno kodo, v kateri je zapisana edinstvena oznaka, vključijo tudi druge informacije, če to dovoli pristojni organ v skladu z naslovom V Direktive 2001/83/ES.
Barcodes on the packaging
Črtne kode na ovojnini
Medicinal products having to bear the safety features pursuant to Article 54a of Directive 2001/83/EC shall not bear on their packaging, for the purpose of their identification and verification of their authenticity, any other visible two-dimensional barcode than the two-dimensional barcode carrying the unique identifier.
Zdravila, ki morajo imeti v skladu s členom 54a Direktive 2001/83/ES nameščene zaščitne elemente, ne smejo imeti na ovojnini za namene identifikacije in preverjanja avtentičnosti teh zdravil nobene druge vidne dvodimenzionalne črtne kode, razen dvodimenzionalne črtne kode, v kateri je zapisana edinstvena oznaka.
GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES
SPLOŠNE DOLOČBE O PREVERJANJU ZAŠČITNIH ELEMENTOV
Verification of the safety features
Preverjanje zaščitnih elementov
When verifying the safety features, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify the following:
Proizvajalci, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti pri preverjanju zaščitnih elementov preverijo naslednje:
the authenticity of the unique identifier;
avtentičnost edinstvene oznake;
the integrity of the anti-tampering device.
celovitost pripomočka za zaščito pred poseganjem v zdravilo.
Verification of the authenticity of the unique identifier
Preverjanje avtentičnosti edinstvene oznake
When verifying the authenticity of a unique identifier, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall check the unique identifier against the unique identifiers stored in the repositories system referred to in Article 31.
Proizvajalci, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti pri preverjanju avtentičnosti edinstvene oznake primerjajo edinstveno oznako z edinstvenimi oznakami, shranjenimi v sistemu arhivov iz člena 31.
A unique identifier shall be considered authentic when the repositories system contains an active unique identifier with the product code and serial number that are identical to those of the unique identifier being verified.
Edinstvena oznaka se šteje za avtentično, kadar je v sistemu arhivov shranjena aktivna edinstvena oznaka s šifro proizvoda in serijsko številko, ki sta enaki tistima, ki ju ima edinstvena oznaka, ki se preverja.
Unique identifiers which have been decommissioned
Deaktivirane edinstvene oznake
A medicinal product bearing a unique identifier which has been decommissioned shall not be further distributed or supplied to the public except in any of the following situations:
Zdravilo z edinstveno oznako, ki je bila deaktivirana, se nadalje ne distribuira ali izdaja javnosti, razen v naslednjih primerih:
the unique identifier was decommissioned in accordance with Article 22(a) and the medicinal product is distributed for the purpose of exporting it outside the Union;
edinstvena oznaka je bila deaktivirana v skladu s členom 22(a) in zdravilo se distribuira za izvoz zunaj Unije;
the unique identifier was decommissioned earlier than the time of supplying the medicinal product to the public, pursuant to Articles 23, 26, 28 or 41;
edinstvena oznaka je bila deaktivirana pred izdajo zdravila javnosti v skladu s členi 23, 26, 28 ali 41;
the unique identifier was decommissioned in accordance with Article 22(b) or (c) or Article 40, and the medicinal product is provided to the person responsible for its disposal;
edinstvena oznaka je bila deaktivirana v skladu s členom 22(b) ali (c) ali členom 40 in zdravilo je bilo predloženo osebi, odgovorni za njegovo odstranitev;
the unique identifier was decommissioned in accordance with Article 22(d) and the medicinal product is provided to the national competent authorities.
edinstvena oznaka je bila deaktivirana v skladu s členom 22(d) in zdravilo je bilo predloženo pristojnim nacionalnim organom.
Reversing the status of a decommissioned unique identifier
Povrnitev statusa deaktivirane edinstvene oznake
Manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public may only revert the status of a decommissioned unique identifier to an active status if the following conditions are fulfilled:
Proizvajalci, trgovci na debelo in osebe z dovoljenjem ali pravico do izdajanja zdravil javnosti lahko status deaktivirane edinstvene oznake povrnejo v aktivni status le, če so izpolnjeni naslednji pogoji:
the person performing the reverting operation is covered by the same authorisation or entitlement and operates in the same premises as the person that decommissioned the unique identifier;
oseba, ki povrne aktivni status, ima isto dovoljenje ali pooblastilo in svojo dejavnost izvaja v istih prostorih kot oseba, ki je deaktivirala edinstveno oznako;
the reverting of the status takes place not more than 10 days after the unique identifier was decommissioned;
povrnitev statusa se izvede ne več kot deset dni po tem, ko je bila edinstvena oznaka deaktivirana;
the pack of medicinal product has not expired;
rok uporabnosti pakiranja zdravila ni potekel;
the pack of medicinal product has not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen and the person performing the reverting operation does not have knowledge that the pack is stolen;
pakiranje zdravila v sistemu arhivov ni bilo evidentirano kot odpoklicano, umaknjeno, namenjeno za uničenje ali ukradeno in po vedenju osebe, ki povrne status, ni bilo ukradeno;
the medicinal product has not been supplied to the public.
zdravilo ni bilo izdano javnosti.
Medicinal products bearing a unique identifier which cannot be reverted to an active status because the conditions set out in paragraph 1 are not fulfilled shall not be returned to saleable stock.
Zdravila z edinstveno oznako, katere statusa ni mogoče povrniti v aktivnega, ker pogoji iz odstavka 1 niso izpolnjeni, se ne vrnejo v prodajno zalogo.