natgillin/translations-raw huggingface dataset:
Minimum requirements concerning the information and documentation to be provided by importing tissue establishment applicants when applying to be accredited, designated, authorised or licensed for the purpose of import activities
A. Splošne informacije o ustanovi uvoznici za tkiva (Importing Tissue Establishment – ITE)
When applying for an accreditation, designation, authorisation or licence for the purpose of import activities, the importing tissue establishment applicant shall, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as a tissue establishment or importing tissue establishment, provide the most up-to-date information and, for part F, documentation on the following:
Ime ITE (ime družbe).
A. General Information on the Importing Tissue Establishment (ITE)
Naslov za obiske pri ITE.
Name of the ITE (Company name).
Poštni naslov ITE (če je drugačen).
Visiting address of the ITE.
Status vložnice ITE: navesti je treba, če je to prva vloga za akreditacijo, imenovanje, odobritev ali dovoljenja za ITE oz., kadar je primerno, ali gre za vlogo za podaljšanje.
Postal address of the ITE (if different).
Kadar ustanova vložnica že ima akreditacijo, imenovanje, odobritev ali dovoljenje za ustanovo za tkiva, bi bilo treba predložiti kodo iz kompendija ustanov za tkiva.
Status of the applicant ITE: It should be indicated if this is the first application for accreditation, designation, authorisation or licensing as an ITE or, where applicable, whether this is a renewal application.
Ime enote vložnice (če je drugačno od imena podjetja).
Where the applicant is already accredited, designated, authorised or licensed as a tissue establishment, the TE compendium code should be provided.
Naslov za obiske pri enoti vložnici.
Name of the applying unit (if different from the company name).
Poštni naslov enote vložnice (če je drugačen).
Visiting address of the applying unit.
Ime kraja sprejema uvoza (če je drugačno od imena podjetja in enote vložnice).
Postal address of the applying unit (if different).
Naslov za obiske na kraju sprejema.
Name of the site of reception of imports (if different from the company name and applying unit).
Poštni naslov na kraju sprejema (če je drugačen).
Visiting address of the site of reception.
B. Kontaktni podatki za vlogo
Postal address of the site of reception (if different).
Ime kontaktne osebe za vlogo.
B. Contact Details for the Application
Telefonska številka.
Name of contact person for the application.
Elektronski naslov.
Telephone number.
Ime odgovorne osebe (če je drugačno od kontaktne osebe).
E-mail address.
URL spletne strani ITE (če je na voljo).
Name of Responsible Person (if different from contact person).
C. Podatki o tkivih in celicah, namenjenih uvozu
URL of ITE website (if available).
Seznam vrst tkiv in celic, namenjenih uvozu, vključno z enkratnim uvozom določenih vrst tkiv ali celic.
C. Details of Tissues and Cells to be Imported
Ime izdelka (kadar je ustrezno, v skladu z generičnim seznamom EU) za vse vrste tkiv in celic, namenjenih uvozu.
A list of the types of tissues and cells to be imported, including one-off imports of specific types of tissues or cells.
Trgovsko ime (če je drugačno od imena izdelka) vseh vrst tkiv in celic, namenjenih uvozu.
The product name (where applicable, in accordance with the EU generic list) of all types of tissues and cells to be imported.
Ime dobavitelja iz tretje države za vsako vrsto tkiv in celic, namenjenih uvozu.
The trade name (if different to the product name) of all types of tissues and cells to be imported.
D. Kraj dejavnosti
The name of the third country supplier for each type of tissue and cell to be imported.
Seznam, v katerem je navedeno, katere dejavnosti, in sicer darovanje, pridobivanje, testiranje, predelava, konzerviranje in skladiščenje, dobavitelj iz tretje države izvaja pred uvozom za vsako vrsto tkiv ali celic.
D. Location of Activities
Seznam, v katerem je navedeno, katere dejavnosti, in sicer darovanje, pridobivanje, testiranje, predelava, konzerviranje in skladiščenje, podizvajalci dobavitelja iz tretje države izvajajo pred uvozom za vsako vrsto tkiv ali celic.
A list specifying which of the activities of donation, procurement, testing, processing, preservation or storage are carried out prior to import by the third country supplier per type of tissue or cell.
Seznam vseh dejavnosti, ki jih ITE izvaja po uvozu za vsako vrsto tkiv ali celic.
A list specifying which of the activities of donation, procurement, testing, processing, preservation or storage are carried out prior to import by sub-contractors of the third country supplier per type of tissue or cell.
Imena tretjih držav, v katerih se dejavnosti izvajajo pred uvozom za vsako vrsto tkiv ali celic.
A list of all activities carried out by the ITE subsequent to import per type of tissue or cell.
E. Podrobnosti o dobaviteljih iz tretje države
The names of the third countries in which the activities prior to import take place per type of tissue or cell.
Ime dobaviteljev iz tretje države (ime družbe).
E. Details of Third Country Suppliers
Ime kontaktne osebe.
Name of third country supplier(s) (company name).
Naslov za obiske.
Name of contact person.
Poštni naslov (če je drugačen).
Visiting address.
Telefonska številka, vključno z mednarodno klicno številko.
Postal address (if different).
Telefonska številka za nujne primere (če je drugačna).
Telephone number including international dialling code.
F. Dokumentacija, ki se priloži vlogi
Emergency contact number (if different)
Kopija pisnega sporazuma z dobavitelji iz tretje države.
F. Documentation to Accompany the Application
Podroben opis poti uvoženih tkiv in celic od njihove pridobitve do njihovega sprejema v ustanovi uvoznici za tkiva.
A copy of the written agreement with the third country supplier(s).
Kopija potrdila o odobritvi izvoza dobavitelja iz tretje države ali, kadar specifično potrdilo o odobritvi izvoza ni izdano, potrdilo pristojnih organov zadevne tretje države, s katerim se odobrijo dejavnosti dobavitelja iz tretje države v sektorju tkiv in celic, vključno z izvozom.
A detailed description of the flow of imported tissues and cells from their procurement to their reception at the importing tissue establishment.
Ta dokumentacija vključuje tudi kontaktne podatke pristojnih organov tretje države.
A copy of the third country supplier's export authorisation certificate or, where a specific export authorisation certificate is not issued, certification from the relevant third country competent authority or authorities authorising the third country supplier's activities in the tissue and cells sector including exports.
V tretjih državah, v katerih takšne dokumentacije ni na voljo, se predložijo alternativne oblike dokumentacije, kot so poročila o revizijah dobavitelja iz tretje države.
This documentation shall also include the contact details of the third country competent authority or authorities.
PRILOGA II
In third countries where such documentation is not available, alternative forms of documentation shall be provided such as reports of audits of the third country supplier.
Potrdilo o akreditaciji, imenovanju, odobritvi ali dovoljenju ustanove uvoznice za tkiva s strani pristojnih organov
ANNEX II
Potrdilo o akreditaciji, imenovanju, odobritvi ali dovoljenju za ustanovo uvoznico za tkiva
Certificate of Accreditation, Designation, Authorisation or Licence to be issued by the competent authority or authorities to importing tissue establishments
Podrobnosti o ustanovi uvoznici za tkiva (Importing Tissue Establishment – ITE)
Certificate of Accreditation, Designation, Authorisation or Licence of an Importing Tissue Establishment
Ime ITE
Importing Tissue Establishment (ITE) Details
Koda iz EU-kompendija ustanov za tkiva
Name of ITE
Naslov ITE in poštni naslov (če je drugačen)
EU Tissue Establishment Compendium Code
Kraj sprejema uvoza (če je drugačen od zgornjega naslova)
ITE Address and postal address (if different)
Ime imetnika akreditacije, imenovanja, odobritve ali dovoljenja
Site of reception of imports (if different from the above address)
Naslov imetnika akreditacije, imenovanja, odobritve ali dovoljenja
Name of accreditation, designation, authorisation or licence holder
Telefonska številka imetnika akreditacije, imenovanja, odobritve ali dovoljenja (neobvezno)
Address of accreditation, designation, authorisation or licence holder
Elektronski naslov imetnika akreditacije, imenovanja, odobritve ali dovoljenja (neobvezno)
Telephone number of accreditation, designation, authorisation or licence holder (optional)
URL spletne strani ITE
E-mail address of accreditation, designation, authorisation or licence holder (optional)
Področje uporabe dejavnosti
URL of ITE website
Vrsta tkiv in celic
Scope of Activities
(spodnji seznam vključuje kategorije tkiv in celic iz EU-kompendija ustanov za tkiva, po potrebi dodati vrstice)
Type of Tissues and Cells
Dejavnosti v tretjih državah
(list below using categories of tissues and cells listed in the EU Tissue Establishment Compendium adding rows as necessary)
Status akreditacije, imenovanja, odobritve ali dovoljenja za uvoz
Activities in third countries
Darovanje
Import Accreditation, Designation, Authorisation or Licence Status
Pridobivanje
Donation
Testiranje
Procurement
Konzerviranje
Testing
Predelava
Preservation
Shranjevanje
Processing
dobavitelj iz tretje države
Storage
SC – podizvajalec dobavitelja iz tretje države
Third country supplier
G – odobreno
SC — Sub-contractor of third country supplier
S – začasna ukinitev, R – preklic, C – prenehanje
G — Granted
Enkratni uvoz
S — Suspended R — Revoked C — Cessation
Imena izdelkov za uvožena tkiva in celice
One-off imports
Kakršni koli pogoji, uvedeni za uvoz, ali pojasnjevalne opombe
Product name(s) of imported tissues and cells
Tretje države pridobivanja (za vsak uvoz tkiv in celic)
Any conditions placed on the import or clarifying remarks
Tretje države, v katerih se izvajajo druge dejavnosti (če so drugačne)
Third country or countries of procurement (per tissue and cell import)
Ime in država dobaviteljev iz tretje države (za vsak uvoz tkiv in celic)
Third country or countries in which other activities take place (if different)
Države članice EU, v katerih se bodo razdeljevali uvožena tkiva in celice (če so znane)
Name and country of third country supplier(s) (per tissue and cell import)
Akreditacija, imenovanje, odobritev ali dovoljenje pristojnega organa
EU Member States in which imported tissues and cells will be distributed (if known)
Nacionalna številka akreditacije, imenovanja, odobritve ali dovoljenja
Competent Authority (CA) Accreditation, Designation, Authorisation or Licence
Pravna podlaga akreditacije, imenovanja, odobritve ali dovoljenja
National accreditation, designation, authorisation or licence number
Datum izteka akreditacije, imenovanja, odobritve ali dovoljenja (če obstaja)
Legal basis of accreditation, designation, authorisation or licence
Prva akreditacija, imenovanje, odobritev ali dovoljenje za ITE ali podaljšanje
Date of expiry of accreditation, designation, authorisation or licence (if any)
Prvič
First accreditation, designation, authorisation or licence as ITE or renewal
Podaljšanje
First time
Dodatne opombe
Renewal
Ime pristojnega organa
Additional remarks
Ime uradnika pristojnega organa
Name of CA
Podpis uradnika pristojnega organa (elektronski ali drug)
Name of CA Officer
Datum akreditacije, imenovanja, odobritve ali dovoljenja
Signature of CA Officer (electronic or otherwise)
Žig pristojnega organa
Date of accreditation, designation, authorisation or licence
PRILOGA III
CA Stamp
Minimalne zahteve glede dokumentacije, ki jo pristojnim organom dajo na voljo ustanove za tkiva, ki nameravajo uvoziti tkiva in celice iz tretjih držav
ANNEX III
Z izjemo enkratnega uvoza, kot je opredeljen v členu 2 te direktive, ki je izvzet iz teh zahtev glede dokumentacije, ustanova uvoznica za tkiva, ki vlaga vlogo, na zahtevo pristojnih organov da na voljo najnovejšo različico spodaj navedenih dokumentov v zvezi z ustanovo vložnico in njenimi dobavitelji iz tretje države, razen če so že zagotovljene kot del prejšnjih vlog za akreditacijo, imenovanje, odobritev ali dovoljenje za ustanovo uvoznico za tkiva.
Minimum requirements concerning the documentation to be made available to the competent authority or authorities by tissue establishments intending to import tissues and cells from third countries
A. Dokumentacija v zvezi z ustanovo uvoznico za tkiva
With the exception of one-off imports as defined in Article 2 of this Directive which have been exempted from these documentation requirements, the applicant importing tissue establishment shall make available and, unless already provided as part of previous applications for accreditation, designation, authorisation or licensing as an importing tissue establishment or tissue establishment, shall provide when requested by the competent authority or authorities the most up-to-date version of the following documents regarding the applicant and its third country supplier(s).
Opis delovnih nalog pristojne osebe in podrobnosti o njegovih/njenih zadevnih kvalifikacijah in izobrazbi, kot so določene v Direktivi 2004/23/ES.
A. Documentation relating to the importing tissue establishment
Kopija primarne nalepke, nalepke o ponovnem pakiranju, zunanje ovojnine in embalaže za prevoz.
A job description of the Responsible Person and details of his/her relevant qualifications and training record as laid down in Directive 2004/23/EC;
Seznam ustreznih in posodobljenih različic standardnih operativnih postopkov (SOP) v zvezi z uvoznimi dejavnostmi ustanove, vključno s SOP v zvezi z uporabo enotne evropske kode, sprejemom in shranjevanjem uvoženih tkiv in celic v ustanovi uvoznici za tkiva, obravnavanjem neželenih dogodkov in reakcij, upravljanjem preklicev in sledljivostjo od darovalca do prejemnika.
A copy of the primary label, repackage label, external package and transport container;
B. Dokumentacija v zvezi z dobavitelji iz tretje države
A list of relevant and up-to-date versions of standard operating procedures (SOPs) relating to the establishment's import activities including SOPs on applying the Single European Code, reception and storage of imported tissues and cells at the importing tissue establishment, management of adverse events and reactions, management of recalls and traceability from donor to recipient.
Podroben opis meril, uporabljenih za identifikacijo in ocenitev darovalcev, informacije, ki se predložijo darovalcu ali njegovi družini, kako je pridobljeno soglasje darovalca ali njegove družine in ali je bilo darovanje prostovoljno in neplačano ali ne.
B. Documentation relating to the third country supplier or suppliers
Podrobne informacije o centrih za testiranje, ki jih uporabljajo dobavitelji iz tretjih držav, in testih, ki jih taki centri izvajajo.
A detailed description of the criteria used for donor identification and evaluation, information provided to the donor or donor family, how consent is obtained from the donor or donor family and whether the donation was voluntary and unpaid or not;
Podrobne informacije o metodah, uporabljenih pri predelavi tkiv in celic, vključno s podrobnostmi o potrditvi za ključne postopke predelave.
Detailed information on the testing centre(s) used by third country suppliers and the tests performed by such centres;
Podroben opis prostorov, ključne opreme in materialov ter meril, ki se uporabljajo za nadzor kakovosti in nadzor okolja za vsako dejavnost, ki jo opravlja dobavitelj iz tretje države.
Detailed information on the methods used during the processing of the tissues and cells including details of the validation for the critical processing procedure;
Podrobne informacije o pogojih za sprostitev tkiv in celic s strani dobaviteljev iz tretje države.
A detailed description of the facilities, critical equipment and materials and criteria used for quality control and control of the environment for each activity carried out by the third country supplier;
Podrobnosti o morebitnih podizvajalcih dobaviteljev iz tretje države, vključno z imenom, lokacijo in izvedeno dejavnostjo.
Detailed information on the conditions for release of tissues and cells by the third country supplier or suppliers;
Povzetek zadnjega inšpekcijskega pregleda dobavitelja iz tretje države, ki ga opravijo pristojni organi tretje države, vključno z datumom, vrsto in glavnimi ugotovitvami inšpekcijskega pregleda.
Details of any sub-contractors used by the third country suppliers including the name, location and activity undertaken;
Povzetek zadnje revizije dobavitelja iz tretje države, ki jo opravi ustanova uvoznica za tkiva ali se opravi v njenem imenu.
A summary of the most recent inspection of the third country supplier by the third country competent authority or authorities including the date of the inspection, type of inspection and main conclusions;
Vse zadevne nacionalne ali mednarodne akreditacije.
A summary of the most recent audit of the third country supplier carried out by, or on behalf of, the importing tissue establishment;
PRILOGA IV
Any relevant national or international accreditation.
Minimalne zahteve glede vsebine pisnih sporazumov med ustanovami uvoznicami za tkiva in njihovimi dobavitelji iz tretjih držav
ANNEX IV
Z izjemo enkratnega uvoza, kot je opredeljen v členu 2 te direktive, ki je izvzet iz teh zahtev, pisni sporazum med ustanovo uvoznico za tkiva in dobaviteljem iz tretje države zajema vsaj naslednje določbe.
Minimum requirements concerning the contents of written agreements between importing tissue establishments and their third country suppliers
Podrobne informacije o specifikacijah ustanove uvoznice za tkiva, katerih cilj je zagotoviti, da so izpolnjeni standardi kakovosti in varnosti iz Direktive 2004/23/ES, in vzajemno dogovorjene pristojnosti in odgovornosti obeh strani pri zagotavljanju ustreznih standardov kakovosti in varnosti uvoženih tkiv in celic.
With the exception of one-off imports as defined in Article 2 of this Directive which have been exempted from these requirements, the written agreement between the importing tissue establishment and the third country supplier shall contain at least the following provisions.
Klavzula, ki zagotavlja, da dobavitelj iz tretje države ustanovi uvoznici za tkiva predloži informacije iz Priloge III B k tej direktivi.
Detailed information on the specifications of the importing tissue establishment aimed at ensuring that the quality and safety standards laid down in Directive 2004/23/EC are met and the mutually agreed roles and responsibilities of both parties in ensuring that imported tissues and cells are of equivalent standards of quality and safety;
Klavzula, ki zagotavlja, da dobavitelj iz tretje države ustanovo uvoznico za tkiva obvesti o vseh domnevnih ali dejanskih resnih neželenih dogodkih in reakcijah, ki bi lahko vplivale na kakovost in varnost tkiv in celic, ki jih ustanova uvoznica za tkiva uvaža ali jih namerava uvoziti.
A clause ensuring that the third country supplier provides the information set out in Annex III B to this Directive to the importing tissue establishment;
Klavzula, ki zagotavlja, da dobavitelj iz tretje države ustanovo uvoznico za tkiva obvesti o vseh bistvenih spremembah svojih dejavnosti, vključno z vsakim delnim ali popolnim preklicem ali začasno prekinitvijo svoje odobritve za izvoz tkiv in celic ali drugo takšno odločitvijo zaradi neskladnosti s strani pristojnih organov tretje države, ki bi lahko vplivala na kakovost in varnost tkiv in celic, ki jih ustanova uvoznica za tkiva uvaža ali jih namerava uvoziti.
A clause ensuring that the third country supplier informs the importing tissue establishment of any suspected or actual serious adverse events or reactions which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;
Klavzula, ki pristojnim organom zagotavlja pravico, da opravijo inšpekcijski pregled dejavnosti dobavitelja iz tretje države, vključno z inšpekcijskimi pregledi na kraju samem, če to želijo opraviti kot del svojih inšpekcijskih pregledov ustanove uvoznice za tkiva.
A clause ensuring that the third country supplier informs the importing tissue establishment of any substantial changes to its activities, including any revocation or suspension, in part or in full, of its authorisation to export tissue and cells or other such decisions of non-compliance by the third country competent authority or authorities, which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;
Ta klavzula mora ustanovi uvoznici za tkiva prav tako zagotavljati pravico, da redno opravlja revizijo svojega dobavitelja iz tretje države.
A clause guaranteeing the competent authority or authorities the right to inspect the activities of the third country supplier, including on-site inspections, should it wish to do so as part of its inspection of the importing tissue establishment.
Dogovorjeni pogoji, ki morajo biti izpolnjeni za prevoz tkiv in celic med dobaviteljem iz tretje države in ustanovo uvoznico za tkiva.
The clause should also guarantee the importing tissue establishment the right to regularly audit its third country supplier;
Klavzula, ki zagotavlja, da dobavitelj iz tretje države ali njegov podizvajalec v skladu s pravili EU o varstvu podatkov evidenco o darovalcu v zvezi z uvoženimi tkivi in celicami hrani 30 let po pridobitvi, ter da so uvedene ustrezne določbe za njihovo hrambo, če dobavitelj iz tretje države preneha delovati.
The agreed conditions to be met for the transport of tissues and cells between the third country supplier and importing tissue establishment;
Določbe za redni pregled in po potrebi revizijo pisnega sporazuma, da se upoštevajo kakršne koli spremembe zahtev v standardih EU za kakovost in varnost iz Direktive 2004/23/ES.
A clause ensuring that donor records relating to imported tissues and cells are kept by the third country supplier or its sub-contractor, in line with EU data protection rules, for 30 years following procurement and that suitable provision is made for their retention should the third country supplier cease to operate;
Seznam vseh standardnih operativnih postopkov dobavitelja iz tretje države v zvezi s kakovostjo in varnostjo uvoženih tkiv in celic ter zavezo, da bodo le-ti predloženi na zahtevo.
Provisions for the regular review and, where necessary, revision of the written agreement including in order to reflect any changes in the requirements of the EU quality and safety standards laid out in Directive 2004/23/EC;
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje 29. oktobra 2016.
A list of all standard operating procedures of the third country supplier relating to the quality and safety of imported tissues and cells and a commitment to provide these on request.
Komisiji nemudoma sporočijo besedilo navedenih predpisov.
amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices
o spremembi Priloge IV k Direktivi 2011/65/EU Evropskega parlamenta in Sveta glede izjeme pri uporabi svinca v polivinilkloridnih senzorjih v diagnostičnih in vitro medicinskih pripomočkih zaradi prilagoditve tehničnemu napredku
Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures.
Analizatorji krvi, telesnih tekočin in telesnih plinov so pomemben analitični instrument številnih diagnostičnih in terapevtskih postopkov.
Lead is required as a stabiliser in the processing of the PVC for the sensor cards.
Svinec je potreben kot stabilizator v predelavi PVC za senzorske kartice.
Although research of substitutes is ongoing, a suitable alternative is not yet available.
Čeprav raziskave nadomestkov že potekajo, ustrezne alternative še niso na voljo.
The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.
Rezultati testiranih alternativ, tako za svinec v PVC kot za sam PVC, ne izpolnjujejo posebnih tehničnih zahtev.