natgillin/translations-raw huggingface dataset:
Place of procurement
datum pridobitve
Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)
kraj pridobitve
Product identification that will include at least:
vrsto darovanja (npr. eno- ali večplastno tkivo; avtologno ali alogensko; živo ali mrtvo)
Identification of the tissue establishment
Identifikacija izdelka, ki zajema vsaj naslednje podatke:
Type of tissue and cell/product (basic nomenclature)
identifikacijo ustanove za tkiva
Pool number (in case of pooling)
vrsto tkiva in celice/izdelka (osnovna nomenklatura)
Split number (if applicable)
številko združitve (v primeru združevanja)
Expiry date (if applicable)
številko podskupine lotov (če je ustrezno)
Tissue/cell status (i.e. quarantined, suitable for use, etc.)
datum izteka roka uporabnosti (če je ustrezno)
Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety.
status tkiva/celice (tj. v karanteni, primerno za uporabo itd.)
Identification of the facility issuing the final label
opis in poreklo izdelkov, uporabljene stopnje predelave, materiale in dodatke, ki so bili v stiku s tkivi in celicami ter so vplivali na njihovo kakovost in/ali varnost
Single European Code (if applicable)
identifikacijo ustanove, ki je izdala končno nalepko
Human application identification that will include at least:
Enotna evropska koda (če je ustrezno)
Date of distribution/disposal
Identifikacija za zdravljenje ljudi, ki zajema vsaj naslednje podatke:
Identification of the clinician or end-user/facility
datum razdeljevanja/odstranitve
B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
Identifikacija kliničnega zdravnika ali končnega uporabnika/ustanove
Identification of the supplier tissue establishment
B. PODATKI, KI JIH HRANIJO ORGANIZACIJE, PRISTOJNE ZA ZDRAVLJENJE LJUDI
Type of tissues and cells
Identifikacija ustanove dobaviteljice za tkiva
Product identification
Vrsta tkiv in celic
Identification of the recipient
Identifikacija izdelka
Date of application
Identifikacija prejemnika
ANNEX VII
Datum zdravljenja
THE STRUCTURE OF THE SINGLE EUROPEAN CODE
PRILOGA VII
DONATION IDENTIFICATION SEQUENCE
STRUKTURA ENOTNE EVROPSKE KODE
PRODUCT IDENTIFICATION SEQUENCE
IDENTIFIKACIJSKO ZAPOREDJE DAROVANJA
EU TISSUE ESTABLISHMENT CODE
IDENTIFIKACIJSKO ZAPOREDJE IZDELKA
UNIQUE DONATION NUMBER
EU-KODA USTANOVE ZA TKIVA
SPLIT NUMBER
KODA IZDELKA
EXPIRY DATE
ŠTEVILKA PODSKUPINE LOTOV
(YYYYMMDD)
DATUM IZTEKA ROKA UPORABNOSTI
Tissue establishment number
številka ustanove za tkiva
Product Coding System identifier
identifikator sistema kodiranja izdelkov
Product number
številka izdelka
2 alphabetic characters
2 črkovna znaka
6 alpha-numeric characters
6 alfanumeričnih znakov
13 alpha-numeric characters
13 alfanumeričnih znakov
1 alphabetic character
1 črkovni znak
7 alpha-numeric characters
7 alfanumeričnih znakov
3 alpha-numeric characters
3 alfanumerični znaki
8 numeric characters
8 numeričnih znakov
Data to be recorded in the EU Tissue Establishment Compendium
Podatki, ki jih je treba evidentirati v EU-kompendiju ustanov za tkiva
A. Tissue establishment information
A. Informacije o ustanovi za tkiva
Name of the tissue establishment
Ime ustanove za tkiva
National or international code of tissue establishment
Nacionalna ali mednarodna koda ustanove za tkiva
Name of the organisation in which the tissue establishment is located (if applicable)
Ime organizacije, znotraj katere se nahaja ustanova za tkiva (če je ustrezno)
Address of the tissue establishment
Naslov ustanove za tkiva
Publishable contact details: functional e-mail address, phone and fax
Kontaktni podatki za objavo: namenski elektronski poštni predal, telefon in telefaks
B. Details on the authorisation, accreditation, designation, or license of the tissue establishment
B. Podrobnosti v zvezi z odobritvijo, akreditacijo, imenovanjem ali dovoljenjem ustanove za tkiva
Name of the authorising, accrediting, designating or licensing competent authority or authorities
Ime pristojnega organa ali organov za odobritev, akreditacijo, imenovanje ali dovoljenje
Name of the national competent authority or authorities responsible for maintenance of the EU Tissue Establishment Compendium
Ime pristojnega nacionalnega organa ali organov, odgovornih za urejanje EU-kompendija ustanov za tkiva
Name of the authorisation, accreditation, designation or licence holder (if applicable)
Ime imetnika odobritve, akreditacije, imenovanja ali dovoljenja (če je ustrezno)
Tissues and cells for which the authorisation, accreditation, designation or license was granted
Tkiva in celice, za katera je izdano/izdana odobritev, akreditacija, imenovanje ali dovoljenje
Activities actually carried out for which the authorisation, accreditation, designation or licence was granted
Dejansko izvedene dejavnosti, za katere je izdano/izdana odobritev, akreditacija, imenovanje ali dovoljenje
Status of the authorisation, accreditation, designation or license (authorised, suspended, revoked, in part or in full, voluntary cessation of activities)
Status odobritve, akreditacije, imenovanja ali dovoljenja (izdaja, začasna ukinitev, preklic, delno ali v celoti, prostovoljno prenehanje dejavnosti)
implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
o izvajanju Direktive 2004/23/ES v zvezi s postopki za preverjanje ustreznosti standardov kakovosti in varnosti uvoženih tkiv in celic
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [1], and in particular Article 9(4) thereof,
ob upoštevanju Direktive 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic [1] ter zlasti člena 9(4) Direktive,
Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of all human tissues and cells intended for human application, and for the donation, procurement, and testing of human tissues and cells contained in manufactured products intended for human application where those products are covered by other Union legislation, so as to ensure a high level of human health protection in the Union.
Direktiva 2004/23/ES določa standarde kakovosti in varnosti za darovanje, pridobivanje, testiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje vseh človeških tkiv in celic, namenjenih za zdravljenje ljudi, ter za darovanje, pridobivanje in testiranje človeških tkiv in celic, ki jih vsebujejo industrijski izdelki, namenjeni za zdravljenje ljudi, kadar navedene izdelke obravnava druga zakonodaja Unije, da se zagotovi visoka raven varovanja zdravja ljudi v Uniji.
Exchanges of tissues and cells increasingly take place on a worldwide basis and Directive 2004/23/EC therefore requires that imports of tissues and cells are undertaken by tissue establishments accredited, designated, authorised or licensed by Member States for that purpose.
Tkiva in celice se vse pogosteje izmenjujejo na svetovni ravni, zato Direktiva 2004/23/ES zahteva, da tkiva in celice uvažajo ustanove za tkiva, ki jih države članice akreditirajo in imenujejo oz. zanje izdajo odobritev ali dovoljenje za navedeni namen.
Exceptions to that requirement are laid down in Article 9(3) of Directive 2004/23/EC allowing competent authorities to directly authorise the import of specific tissues and cells under the conditions laid down in Article 6 of Commission Directive 2006/17/EC [2] or in case of emergency.
Izjeme od navedene zahteve so določene v členu 9(3) Direktive 2004/23/ES in pristojnim organom omogočajo, da neposredno odobrijo uvoz določenih tkiv in celic v skladu s pogoji iz člena 6 Direktive Komisije 2006/17/ES [2] ali v nujnem primeru.
These exceptions are regularly used, but not limited to, allowing the import of haematopoietic stem cells from bone marrow, peripheral blood or cord blood which is used in the treatment of a number of life-threatening conditions.
Te izjeme se redno uporabljajo za omogočanje uvoza krvotvornih matičnih celic iz kostnega mozga, periferne krvi ali popkovnične krvi, ki se uporablja pri zdravljenju številnih smrtno nevarnih bolezni, vendar niso omejene na navedeni uvoz.
Directive 2004/23/EC, furthermore, requires Member States and importing tissue establishments to ensure that imports of tissue and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and calls for the establishment of procedures to verify the equivalency of the quality and safety standards of imports of tissues and cells.
Direktiva 2004/23/ES poleg tega zahteva, da države članice in ustanove uvoznice za tkiva zagotovijo, da uvoz tkiv in celic ustreza standardom kakovosti in varnosti, kot jih določa Direktiva 2004/23/ES, in poziva k vzpostavitvi postopkov za preverjanje ustreznosti standardov kakovosti in varnosti uvoza tkiv in celic.
Those procedures should be laid down in this Directive without prejudice to the Union legislation on customs.
Navedene postopke bi bilo treba določiti v tej direktivi brez poseganja v zakonodajo Unije na področju carine.
In particular, it is appropriate to establish authorisation and inspection schemes mirroring the verification process in place for activities related to tissues and cells carried out within the Union.
Zlasti je primerno vzpostaviti sisteme za odobritve in za inšpekcijske preglede, ki odražajo postopek preverjanja v Uniji opravljenih dejavnosti v zvezi s tkivi in celicami.
It is also appropriate to lay down the procedures to be followed by importing tissue establishments in their relations with their third country suppliers.
Primerno je tudi določiti postopke, ki jih morajo uporabljati ustanove uvoznice za tkiva pri odnosih s svojimi dobavitelji iz tretjih držav.
With the exception of imports directly authorised by competent authorities pursuant to Article 9(3) of Directive 2004/23/EC, all imports of tissues and cells from third countries must be undertaken by importing tissue establishments.
Z izjemo uvoza, ki ga neposredno odobrijo pristojni organi v skladu s členom 9(3) Direktiva 2004/23/ES, morajo celoten uvoz tkiv in celic iz tretjih držav opraviti ustanove uvoznice za tkiva.
Where competent authorities do directly authorise imports pursuant to Article 9(3) of Directive 2004/23/EC, the responsibility to ensure that such imports meet quality and safety standards equivalent to those laid down in that Directive falls upon the competent authorities.
Kadar pristojni organi neposredno odobrijo uvoz v skladu s členom 9(3) Direktive 2004/23/ES, odgovornost za zagotovitev, da tak uvoz izpolnjuje standarde kakovosti in varnosti, kot so določeni v navedeni direktivi, prevzamejo pristojni organi.
Tissues and cells should normally be imported by tissue banks or units of hospitals which are accredited, designated, authorised or licensed as importing tissue establishments for the purpose of their import activities.
Tkiva in celice bi običajno morale uvažati banke tkiv ali enote bolnišnic, ki so akreditirane, imenovane oz. imajo odobritev ali dovoljenje kot ustanove uvoznice za tkiva za namene njihovih uvoznih dejavnosti.
Tissue banks or units of hospitals should be considered to be importing tissue establishments where they are a party to a contractual agreement with a third country supplier for the import of tissues and cells.
Banke tkiv ali enote bolnišnic bi bilo treba obravnavati kot ustanove uvoznice za tkiva, kadar so v pogodbenem razmerju z dobaviteljem iz tretje države za uvoz tkiv in celic.
Where an organisation offering brokerage services is a party to a contractual agreement with a third country supplier to facilitate the import of tissues and cells but not for the import itself, it should not be considered to be an importing tissue establishment.
Kadar je organizacija, ki ponuja posredniške storitve, v pogodbenem razmerju z dobaviteljem iz tretje države za olajšanje uvoza tkiv in celic, ne pa tudi za sam uvoz, se ne bi smela obravnavati kot ustanova uvoznica za tkiva.
Member States may choose to regulate such services outside the scope of this Directive.
Države članice se lahko odločijo, da bodo takšne storitve urejale zunaj področja uporabe te direktive.
Where other bodies such as organisations responsible for human application, manufacturers of advanced therapy medicinal products, clinical practitioners or individuals are a party to a contractual agreement with a third country supplier for the import of tissues and cells, they should be considered to be an importing tissue establishment.
Kadar so drugi organi, na primer organizacije, pristojne za zdravljenje ljudi, proizvajalci zdravil za napredno zdravljenje, klinični zdravniki ali posamezniki, v pogodbenem razmerju z dobaviteljem iz tretje države za uvoz tkiv in celic, bi jih bilo treba obravnavati kot ustanove uvoznice za tkiva.
They must comply with the requirements of this Directive as well as with all relevant provisions of Directive 2004/23/EC and be accredited, designated, authorised or licensed as importing tissue establishments for the purpose of their import activities by their relevant competent authorities.
Izpolnjevati morajo zahteve iz te direktive in vse zadevne določbe iz Direktive 2004/23/ES, njihovi zadevni pristojni organi pa jih morajo akreditirati, imenovati oz. jim izdati odobritev ali dovoljenje za ustanove uvoznice za tkiva za namene njihovih uvoznih dejavnosti.
Where, subsequent to the import, they also undertake testing, processing, preservation, storage or distribution of the imported tissues and cells they must also be accredited, designated, authorised or licensed by their relevant competent authorities for the purpose of those activities and comply with the requirements of Directive 2004/23/EC.
Kadar po uvozu izvajajo tudi testiranje, predelavo, konzerviranje, shranjevanje ali razdeljevanje uvoženih tkiv in celic, jih morajo njihovi zadevni pristojni organi prav tako akreditirati, imenovati oz. jim izdati odobritev ali dovoljenje za namene navedenih dejavnosti, izpolnjevati pa morajo tudi zahteve iz Direktive 2004/23/ES.
Alternatively they may obtain tissues and cells originating from third countries from tissue banks or units of hospitals located within the Union which are accredited, designated, authorised or licensed as importing tissue establishments by their relevant competent authorities.
Kot drugo možnost lahko tkiva in celice s poreklom iz tretjih držav pridobijo iz bank tkiv ali enot bolnišnic v Uniji, ki so jih njihovi zadevni pristojni organi akreditirali, imenovali oz. jim izdali odobritev ali dovoljenje za ustanove uvoznice za tkiva.
Where importing tissue establishments are also accredited, designated, authorised or licensed as tissue establishments for the activities they carry out within the Union, Member States may align their authorisation, inspection and reporting procedures provided the procedures laid down in this Directive are followed.
Kadar so ustanove uvoznice za tkiva akreditirane, imenovane oz. imajo odobritev ali dovoljenje kot ustanove za tkiva za dejavnosti, ki jih izvajajo v Uniji, lahko države članice uskladijo svoje postopke za odobritve, inšpekcijske preglede in poročanje, pod pogojem, da se upoštevajo postopki iz te direktive.
In order to facilitate the distribution within the Union of imported tissues and cells including where such distribution is cross-border in nature, the competent authority or authorities should issue the certificate attesting the accreditation, designation, authorisation, or licence of the importing tissue establishment.
Za olajšanje razdeljevanja uvoženih tkiv in celic v Uniji, tudi kadar je takšno razdeljevanje čezmejne narave, bi pristojni organi morali izdati potrdilo o akreditaciji, imenovanju, odobritvi ali dovoljenju ustanove uvoznice za tkiva.
Inspection measures play an important role in the verification of the equivalency of imported tissues and cells with the quality and safety standards laid down in Directive 2004/23/EC.
Inšpekcijski pregledi imajo pomembno vlogo pri preverjanju ustreznosti uvoženih tkiv in celic s standardi kakovosti in varnosti iz Direktive 2004/23/ES.
Member States are therefore encouraged, where appropriate to also inspect third country suppliers and cooperate with other Member States into which imported tissues and cells are likely to be distributed.
Zato so države članice pozvane, kadar je ustrezno, da opravijo inšpekcijske preglede tudi pri dobaviteljih iz tretjih držav in sodelujejo z drugimi državami članicami, v katerih se bodo uvožena tkiva in celice najverjetneje razdeljevala.
Member States in which the importing tissue establishments are located retain the responsibility for deciding on the most appropriate measures to be undertaken and for decisions on whether on-site inspections of third country suppliers are needed.
Države članice, v katerih se nahajajo ustanove uvoznice za tkiva, so še naprej pristojne za sprejemanje odločitev o najustreznejših ukrepih, ki jih je treba sprejeti, in odločitev o tem, ali so potrebni inšpekcijski pregledi dobaviteljev iz tretjih držav na kraju samem.
The Operational Manual for Competent Authorities on inspections has been updated to take into account inspections of importing tissue establishments and their third country suppliers and is available to Member States as a guidance document when undertaking such inspection measures.
Operativni priročnik za pristojne organe v zvezi z inšpekcijskimi pregledi je bil posodobljen tako, da upošteva inšpekcijske preglede ustanov uvoznic za tkiva in njihovih dobaviteljev iz tretjih držav, ter je na voljo državam članicam kot dokument s smernicami pri izvajanju takšnih inšpekcijskih pregledov.
Importing tissue establishments should verify that the standards of quality and safety of the tissues and cells they import into the Union are equivalent to the standards of quality and safety laid down in Directive 2004/23/EC.
Ustanove uvoznice za tkiva bi morale preveriti, ali standardi kakovosti in varnosti tkiv in celic, ki jih uvažajo v Unijo, ustrezajo standardom kakovosti in varnosti iz Direktive 2004/23/ES.
Written agreements with third country suppliers and the documentation to be provided and made available to competent authorities are key elements in ensuring such verification takes place and in particular providing traceability back to the donor and ensuring that the principle of voluntary and unpaid donation is adhered to in line with Directive 2004/23/EC.
Pisni sporazumi z dobavitelji iz tretjih držav in dokumentacija, ki jo je treba predložiti in dati na voljo pristojnim organom, so ključni elementi pri zagotavljanju takšnega preverjanja ter zlasti pri omogočanju sledljivosti do darovalca in zagotavljanju upoštevanja načela prostovoljnega in neplačanega darovanja v skladu z Direktivo 2004/23/ES.
Importing tissue establishments are also encouraged to audit their third country suppliers as part of this verification process.
Ustanove uvoznice za tkiva so tudi pozvane, da v okviru tega postopka preverjanja opravijo revizijo svojih dobaviteljev iz tretjih držav.
Importing tissue establishments should ensure that the Single European Code is applied to imported tissues and cells in line with Commission Directive 2006/86/EC [3], either by carrying out this task themselves or delegating it to third country suppliers as part of the terms of their written agreements with such suppliers.
Ustanove uvoznice za tkiva bi morale zagotoviti, da se za uvožena tkiva in celice uporablja enotno evropsko kodo v skladu z Direktivo Komisije 2006/86/ES [3], bodisi tako, da same opravijo to nalogo, bodisi to nalogo prenesejo na dobavitelje iz tretjih držav v okviru pogojev njihovih pisnih sporazumov s takšnimi dobavitelji.
Member States should be allowed to exempt one-off imports from the requirements laid down in this Directive in respect of documentation and written agreements.
Države članice bi morale imeti možnost, da enkratni uvoz izvzamejo iz zahtev v zvezi z dokumentacijo in pisnimi sporazumi iz te direktive.
Such one-off imports should, however, be carried out by accredited, designated, authorised or licensed importing tissue establishments and as a general rule should not take place on a regular or repeated basis from the same third country supplier.
Vendar pa bi tak enkratni uvoz morale opravljati ustanove uvoznice za tkiva, ki so akreditirane, imenovane oz. imajo odobritev ali dovoljenje, in praviloma tak uvoz ne bi smel redno ali večkrat izvajati isti dobavitelj iz tretje države.
The use of such exemptions should be limited to situations where a person or persons has or have had tissues and cells stored in a third country for their future use, in particular in cases of partner donations of reproductive cells, of autologous donations, or donations directed to close relatives, and subsequently, wishes to have such tissues or cells imported into the Union on their behalf.
Uporaba takšne izjeme bi morala biti omejena na primere, v katerih osebe, katerih tkiva in celice so shranjene v tretji državi za njihovo prihodnjo uporabo, zlasti v primeru darovanj reproduktivnih celic med partnerjema, avtolognih darovanj ali darovanj za bližnje sorodnike, nato pa želijo taka tkiva ali celice v svojem imenu uvoziti v Unijo.
Such an import of any specific type of tissue or cell should normally not occur more than once for any given recipient and should not include tissues or cells for third parties.
Tak uvoz katerih koli določenih vrst tkiv ali celic običajno se ne bi smel izvajati več kot enkrat za katerega koli prejemnika in ne bi smel zajemati tkiv ali celic za tretje osebe.
This Directive does not prevent Member States from maintaining or introducing more stringent measures relating to imports of tissues and cells, in particular in order to ensure the principle of voluntary and unpaid donation is respected, provided that the provisions of the Treaty are met.
Ta direktiva državam članicam ne preprečuje, da ohranijo ali uvedejo strožje ukrepe za uvoz tkiv in celic, zlasti za zagotovitev načela prostovoljnega in neplačanega darovanja, pod pogojem, da se upoštevajo določbe iz Pogodbe.
The measures provided for in this Directive are in accordance with the opinion of the Tissues and Cells Regulatory Committee established by Article 29(3) of Directive 2004/23/EC,
Ukrepi iz te direktive so v skladu z mnenjem Regulativnega odbora za tkiva in celice, ustanovljenega v skladu s členom 29(3) Direktive 2004/23/ES –
This Directive shall apply to the import into the Union of:
Ta direktiva se uporablja za uvoz v Unijo:
human tissues and cells intended for human application; and
človeških tkiv in celic, namenjenih zdravljenju ljudi, ter
manufactured products derived from human tissues and cells intended for human applications, where those products are not covered by other Union legislation.
industrijskih izdelkov, izdelanih na podlagi človeških tkiv in celic, namenjenih zdravljenju ljudi, kadar navedenih izdelkov ne obravnava druga zakonodaja Unije.
Where the human tissues and cells to be imported are intended to be used exclusively in manufactured products which are covered by other Union legislation, this Directive shall only apply to the donation, procurement and testing which takes place outside of the Union as well as to contributing to ensuring traceability from donor to recipient and vice versa.
Kadar so človeška tkiva in celice za uvoz namenjeni izključno uporabi v industrijskih izdelkih, ki jih obravnava druga zakonodaja Unije, se ta direktiva uporablja le za darovanje, pridobivanje in testiranje zunaj Unije ter za zagotavljanje sledljivosti od darovalca do prejemnika in obratno.
the import of tissues and cells referred to in Article 9(3)(a) of Directive 2004/23/EC which are directly authorised by the competent authority or authorities;
uvoz tkiv in celic iz člena 9(3)(a) Direktive 2004/23/ES, ki jih neposredno odobrijo pristojni organi;