natgillin/translations-raw huggingface dataset:
the import of tissues and cells referred to in Article 9(3)(b) of Directive 2004/23/EC which are directly authorised in case of emergencies;
uvoz tkiv in celic iz člena 9(3)(b) Direktive 2004/23/ES, ki so neposredno odobreni v nujnih primerih;
blood and blood components as defined by Directive 2002/98/EC;
kri in krvne komponente, kot so opredeljene v Direktivi 2002/98/ES;
organs or parts of organs, as defined in Directive 2004/23/EC.
organe ali dele organov, kot so opredeljeni v Direktivi 2004/23/ES.
‘emergency’ means any unforeseen situation in which there is no practical alternative other than to urgently import tissues and cells from a third country into the Union for immediate application to a known recipient or known recipients whose health would be seriously endangered without such an import;
„nujen primer“ pomeni kakršno koli nepredvideno situacijo, v kateri ni nobene druge praktične možnosti kot nujen uvoz tkiv in celic iz tretje države v Unijo za takojšnje zdravljenje znanih prejemnikov ali znanih prejemnikov, katerih zdravje bi bilo brez takega uvoza resno ogroženo;
‘importing tissue establishment’ means a tissue bank or a unit of a hospital or another body established within the Union which is a party to a contractual agreement with a third country supplier for the import into the Union of tissues and cells coming from a third country intended for human application;
„ustanova uvoznica za tkiva“ je banka tkiv ali enota bolnišnice ali drug organ s sedežem v Uniji, ki je v pogodbenem razmerju z dobaviteljem iz tretje države za uvoz tkiv in celic, namenjenih zdravljenju ljudi, iz tretje države v Unijo;
‘one-off import’ means the import of any specific type of tissue or cell which is for the personal use of an intended recipient or recipients known to the importing tissue establishment and the third country supplier before the importation occurs.
„enkratni uvoz“ pomeni uvoz katere koli določene vrste tkiva ali celice, namenjene osebni uporabi namembnih prejemnikov, ki so pred uvozom znani ustanovi uvoznici za tkiva in dobavitelju iz tretje države.
Such an import of any specific type of tissue or cell shall normally not occur more than once for any given recipient.
Tak uvoz katere koli določene vrste tkiva ali celice običajno ne poteka več kot enkrat za katerega koli prejemnika.
Imports from the same third country supplier taking place on a regular or repeated basis shall not be considered to be ‘one-off imports’;
Uvoz, ki ga isti dobavitelj iz tretje države opravlja redno ali večkrat, se ne šteje za „enkratni uvoz“;
‘third country supplier’ means a tissue establishment or another body, established in a third country, which is responsible for the export to the Union of tissues and cells it supplies to an importing tissue establishment.
„dobavitelj iz tretje države“ pomeni ustanovo za tkiva ali drug organ, ustanovljen v tretji državi, ki je pristojen za izvoz v Unijo tkiv in celic, ki jih dobavlja ustanovi uvoznici za tkiva.
A third country supplier may also carry out one or more of the activities, which take place outside of the Union, of donation, procurement, testing, processing, preservation, storage or distribution of tissues and cells imported into the Union.
Dobavitelj iz tretje države lahko opravlja tudi eno ali več dejavnosti, ki se izvajajo zunaj Unije, in sicer darovanje, pridobivanje, testiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje tkiv in celic, uvoženih v Unijo.
OBLIGATIONS ON MEMBER STATES' AUTHORITIES
OBVEZNOSTI ORGANOV DRŽAV ČLANIC
Accreditation, designation, authorisation or licensing of importing tissue establishments
Akreditacija, imenovanje, odobritev ali dovoljenje ustanove uvoznice za tkiva
Without prejudice to Article 1(3), Member States shall ensure that all imports of tissues and cells from third countries are undertaken by importing tissue establishments accredited, designated, authorised or licensed by a competent authority or authorities for the purposes of these activities.
Države članice brez poseganja v člen 1(3) zagotovijo, da celoten uvoz tkiv in celic iz tretjih držav opravljajo ustanove uvoznice za tkiva, ki jih pristojni organi, pristojni za te dejavnosti, akreditirajo in imenujejo oz. zanje izdajo odobritev ali dovoljenje.
The competent authority or authorities, having obtained the information set out in Annex I to this Directive and, having verified that the importing tissue establishment complies with the requirements of this Directive, shall accredit, designate, authorise or license the importing tissue establishment to import tissues and cells and indicate any conditions which apply such as any restrictions of the types of tissues and cells to be imported or the third country suppliers to be used.
Pristojni organi po pridobitvi informacij iz Priloge I k tej direktivi in po tem, ko preverijo, ali ustanova uvoznica za tkiva izpolnjuje zahteve iz te direktive, akreditirajo ali imenujejo ustanovo uvoznico za tkiva oz. zanjo izdajo odobritev ali dovoljenje za uvoz tkiv in celic ter navedejo kakršne koli pogoje, ki se uporabljajo, kot so morebitne omejitve za vrste tkiv in celic, namenjenih uvozu, ali dobavitelje iz tretjih držav.
The competent authority or authorities shall issue the accredited, designated, authorised or licensed importing tissue establishment with the certificate set out in Annex II to this Directive.
Pristojni organi akreditirajo, imenujejo oz. izdajo odobritev ali dovoljenje ustanovi uvoznici za tkiva s potrdilom iz Priloge II k tej direktivi.
The importing tissue establishment shall not undertake any substantial changes to its import activities without the prior written approval of the competent authority or authorities.
Ustanova uvoznica za tkiva ne uvede bistvenih sprememb svojih uvoznih dejavnosti brez predhodne pisne odobritve pristojnih organov.
In particular, any changes to the type of tissues and cells imported, the activities undertaken in third countries which may have an influence on the quality and safety of imported tissues and cells or the third country suppliers used shall be considered as substantial changes.
Za bistvene spremembe se zlasti štejejo vse spremembe uvoženih vrst tkiv in celic, in dejavnosti, ki se izvajajo v tretjih državah, ki bi lahko vplivale na kakovost in varnost uvoženih tkiv in celic ali uporabljenih dobaviteljev iz tretjih držav.
Where an importing tissue establishment undertakes a one-off import of tissues or cells originating from a third country supplier not covered by its existing accreditation, designation, authorisation or licence, such an import shall not be considered as a substantial change if the importing tissue establishment is authorised to import the same type of tissues or cells from another third country supplier or suppliers.
Kadar ustanova uvoznica za tkiva opravi enkratni uvoz tkiv ali celic od dobavitelja iz tretje države, ki ni vključen v njeno obstoječo akreditacijo, imenovanje, odobritev ali dovoljenje, se tak uvoz ne šteje za bistveno spremembo, če ima ustanova uvoznica za tkiva odobritev za uvoz iste vrste tkiv ali celic od drugih dobaviteljev iz tretje države.
The competent authority or authorities may suspend or revoke the accreditation, designation, authorisation, or licence, in part or in full, of an importing tissue establishment if, in particular, inspections or other control measures demonstrate that such an establishment no longer meets the requirements of this Directive.
Pristojni organi lahko deloma ali v celoti začasno ukinejo ali prekličejo akreditacijo, imenovanje, odobritev ali dovoljenje za ustanovo uvoznico za tkiva, zlasti če inšpekcijski pregledi ali drugi kontrolni ukrepi pokažejo, da taka ustanova ne izpolnjuje več zahtev iz te direktive.
Inspections and other control measures
Inšpekcijski pregledi in drugi kontrolni ukrepi
Member States shall ensure that the competent authority or authorities organise inspections and other control measures of importing tissue establishments and, where appropriate, their third country suppliers and that importing tissue establishments carry out appropriate controls in order to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC.
Države članice zagotovijo, da pristojni organi organizirajo inšpekcijske preglede in druge kontrolne ukrepe za ustanove uvoznice za tkiva in, kadar je to ustrezno, njihove dobavitelje iz tretjih držav ter da ustanove uvoznice za tkiva opravljajo ustrezne kontrole za zagotovitev ustreznosti standardov kakovosti in varnosti tkiv in celic, namenjenih uvozu, s standardi iz Direktive 2004/23/ES.
The interval between inspections of any given importing tissue establishment shall not exceed 2 years.
Časovni presledek med inšpekcijskimi pregledi katere koli ustanove uvoznice za tkiva ne sme biti daljši od dveh let.
Such inspections shall be carried out by officials representing the competent authority or authorities who shall:
Takšne inšpekcijske preglede opravljajo uradne osebe, ki zastopajo pristojne organe, ki:
be empowered to inspect importing tissue establishments and, where appropriate, the activities of any third country suppliers;
so pooblaščeni za inšpekcijski pregled ustanove uvoznice za tkiva ter, kadar je ustrezno, dejavnosti katerih koli dobaviteljev iz tretjih držav;
evaluate and verify the procedures and activities carried out in importing tissue establishments and the facilities of third country suppliers that are relevant to ensuring the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC;
ocenijo in preverijo postopke in dejavnosti, ki se opravljajo v ustanovah uvoznicah za tkiva, ter prostore dobaviteljev iz tretjih držav, ki so pomembni za zagotavljanje ustreznosti standardov kakovosti in varnosti tkiv in celic, namenjenih uvozu, s standardi iz Direktive 2004/23/ES;
examine any documents or other records that are relevant for this evaluation and verification.
preučijo kakršne koli dokumente ali druge evidence, bistvene za to ocenjevanje in preverjanje.
Member States shall, upon a duly justified request from another Member State or the Commission, provide information on the results of inspections and other control measures relating to importing tissue establishments and third country suppliers.
Države članice na upravičeno zahtevo druge države članice ali Komisije predložijo informacije o rezultatih inšpekcijskega pregleda in drugih kontrolnih ukrepov, povezanih z ustanovami uvoznicami za tkiva ter dobavitelji iz tretjih držav.
Member States into which tissues and cells are imported shall, upon a duly justified request from another Member State into which imported tissues and cells are subsequently distributed, consider carrying out inspections or other control measures on importing tissue establishments and the activities of any third country suppliers.
Države članice, v katere se tkiva in celice uvažajo, na ustrezno utemeljeno zahtevo druge države članice, v kateri se nato razdelijo uvožena tkiva in celice, razmislijo o izvedbi inšpekcijskih pregledov ali drugih kontrolnih ukrepov v zvezi z ustanovami uvoznicami za tkiva ter dejavnostmi katerih koli dobaviteljev iz tretje države.
The Member State in which the importing tissue establishment is located shall decide on the appropriate measures to take following consultation with the Member State which made such a request.
Država članica, v kateri se nahaja ustanova uvoznica za tkiva, sprejme odločitev o ustreznih ukrepih, ki se sprejmejo po posvetovanju z državo članico, ki je vložila tako zahtevo.
Where an on-site inspection takes place following such a request, the competent authority or authorities of the Member State in which the importing tissue establishment is located shall agree with the competent authority or authorities of the Member State which made such a request on whether and how the Member State which made such a request shall participate in the inspection.
Kadar se inšpekcijski pregled na kraju samem opravi na podlagi takšne zahteve, se pristojni organi države članice, v kateri se ustanova uvoznica za tkiva nahaja, s pristojnimi organi države članice, ki je vložila takšno zahtevo, dogovorijo, ali in kako bo država članica, ki je vložila takšno zahtevo, sodelovala pri inšpekcijskem pregledu.
The final decision on any such participation shall rest with the Member State in which the importing tissue establishment is located.
Končno odločitev o vsakem takem sodelovanju sprejme država članica, v kateri se nahaja ustanova uvoznica za tkiva.
The reasons for any decision to refuse such participation shall be explained to the Member State which made such a request.
Državi članici, ki je vložila takšno zahtevo, se pojasnijo razlogi za vsako odločitev o zavrnitvi takšnega sodelovanja.
OBLIGATIONS ON IMPORTING TISSUE ESTABLISHMENTS
OBVEZNOSTI ZA USTANOVE UVOZNICE ZA TKIVA
Applications for accreditation, designation, authorisation or licensing as an importing tissue establishment
Vloge za akreditacijo, imenovanje oz. odobritev ali dovoljenje za ustanovo uvoznico za tkiva
Importing tissue establishments, having taken measures to ensure that any imports of tissues and cells meet standards of quality and safety equivalent to the ones laid down in Directive 2004/23/EC and that imported tissues and cells can be traced from the donor to the recipient and vice versa, shall apply for an accreditation, designation, authorisation or licence as an importing tissue establishment by:
Ustanove uvoznice za tkiva ob sprejetju ukrepov za zagotovitev, da vsakršen uvoz tkiv in celic ustreza standardom kakovosti in varnosti, kot jih določa Direktiva 2004/23/ES, ter da je uvoženim tkivom in celicam mogoče slediti od darovalca do prejemnika in obratno, zaprosijo za akreditacijo, imenovanje, odobritev ali dovoljenje za ustanovo uvoznico za tkiva:
providing to the competent authority or authorities the required information and documentation as set out in Annex I to this Directive;
s predložitvijo zahtevanih informacij in dokumentacije iz Priloge I k tej direktivi pristojnim organom;
making available and, when requested by the competent authority or authorities, providing the documentation listed in Annex III to this Directive.
z omogočanjem dostopnosti do dokumentacije iz Priloge III k tej direktivi in na zahtevo pristojnih organov s predložitvijo takšne dokumentacije.
Member States may choose to not apply the documentation requirements of Annex I, part F and Annex III to this Directive to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such imports.
Države članice se lahko odločijo, da ne uporabijo zahtev glede dokumentacije iz dela F Priloge I in Priloge III k tej direktivi za enkratni uvoz, kot je opredeljen v členu 2 te direktive, pod pogojem, da so uvedle ustrezne nacionalne ukrepe za ureditev takšnega uvoza.
Those national measures shall ensure the following:
Navedeni nacionalni ukrepi zagotovijo naslednje:
traceability from donor to recipient and vice versa; and
sledljivost od darovalca do prejemnika in obratno ter
imported tissues and cells are not applied to anyone other than their intended recipients.
uvožena tkiva in celice se ne uporabljajo za druge osebe kot za namembne prejemnike.
Updated information
Posodobljene informacije
Importing tissue establishments shall seek the prior written approval of the competent authority or authorities for any planned substantial changes to their import activities, and in particular those substantial changes described in Article 3(3), and inform the competent authority or authorities of their decision to cease their import activities in part or in full.
Ustanove uvoznice za tkiva zaprosijo za predhodno pisno odobritev pristojnih organov za vsakršno načrtovano bistveno spremembo svojih uvoznih dejavnosti, zlasti bistvene spremembe, opisane v členu 3(3), ter pristojne organe obvestijo o svoji odločitvi, da bodo deloma ali v celoti prenehale opravljati svoje dejavnosti uvoza.
Importing tissue establishments shall notify, without delay, the competent authority or authorities of any suspected or actual serious adverse events or reactions, reported to them by third country suppliers and which may influence the quality and safety of the tissues and cells they import.
Ustanove uvoznice za tkiva nemudoma obvestijo pristojne organe o morebitnih domnevnih ali dejanskih resnih neželenih dogodkih ali reakcijah, ki so jim jih sporočili dobavitelji iz tretjih držav in ki bi lahko vplivali na kakovost in varnost tkiv in celic, ki jih uvažajo.
The information laid out in Annexes III and IV to Directive 2006/86/EC shall be included in such notifications.
V takšna obvestila se vključijo informacije iz prilog III in IV k Direktivi 2006/86/ES.
The importing tissue establishment shall notify, without delay, the competent authority or authorities of:
Ustanova uvoznica za tkiva pristojne organe nemudoma obvesti o:
any revocation or suspension, in part or full, of a third country supplier's authorisation to export tissues and cells; and
vsakršnem delnem ali popolnem preklicu ali začasni prekinitvi odobritve dobavitelja iz tretje države za izvoz tkiv in celic ter
any other decision taken for reasons of non-compliance by the competent authority or authorities of the country in which the third country supplier is based and which may be relevant to the quality and safety of imported tissues and cells.
o vsakršnih drugih odločitvah, ki jih zaradi neskladnosti sprejmejo pristojni organi države, v kateri ima sedež dobavitelj iz tretje države, in ki bi lahko bile pomembne za kakovost in varnost uvoženih tkiv in celic.
Written agreements
Pisni sporazumi
Importing tissue establishments shall have in place written agreements with third country suppliers where any of the activities of donation, procurement, testing, processing, preservation, storage or export to the Union of tissues and cells to be imported into the Union are carried out outside of the Union.
Ustanove uvoznice za tkiva sklenejo pisne sporazume z dobavitelji iz tretjih držav, kadar se katera koli dejavnost darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja ali izvoza v Unijo tkiv in celic, namenjenih uvozu v Unijo, izvaja zunaj Unije.
Member States may choose to not apply this requirement to one-off imports as defined in Article 2 of this Directive, provided they have suitable national measures in place to regulate such an imports.
Države članice se lahko odločijo, da ne uporabijo te zahteve za enkratni uvoz, kot je opredeljen v členu 2 te direktive, pod pogojem, da so uvedli ustrezne nacionalne ukrepe za ureditev takega uvoza.
The written agreement between the importing tissue establishment and the third country supplier shall specify the quality and safety requirements to be met to ensure the equivalency of the quality and safety standards of the tissues and cells to be imported with the standards laid down in Directive 2004/23/EC.
V pisnem sporazumu med ustanovo uvoznico za tkiva ter dobaviteljem iz tretje države se navedejo zahteve glede kakovosti in varnosti, ki jih je treba izpolniti za zagotovitev ustreznosti standardov kakovosti in varnosti tkiv in celic, namenjenih uvozu, s standardi iz Direktive 2004/23/ES.
In particular, the written agreement shall include, as a minimum, the contents listed in Annex IV to this Directive.
Pisni sporazum zlasti vključuje vsaj vsebine, navedene v Prilogi IV k tej direktivi.
The written agreement shall establish the right of the competent authority or authorities to inspect the activities, including the facilities, of any third country suppliers during the duration of the written agreement and for a period of 2 years following its termination.
V pisnem sporazumu se določi pravica pristojnih organov za inšpekcijski pregled dejavnosti, vključno s prostori katerih koli dobaviteljev iz tretje države v času trajanja pisnega sporazuma in za obdobje dveh let po prenehanju njegovega trajanja.
Importing tissue establishments shall provide copies of written agreements with third country suppliers to the competent authority or authorities as part of their application for accreditation, designation, authorisation or licensing.
Ustanove uvoznice za tkiva pristojnim organom predložijo kopije pisnih sporazumov z dobavitelji iz tretjih držav v okviru svoje vloge za akreditacijo, imenovanje, odobritev ali dovoljenje.
Register of importing tissue establishments
Register ustanov uvoznic za tkiva
Importing tissue establishments shall keep a record of their activities, including the types and quantities of tissues and cells imported, and on their origin and destination.
Ustanove uvoznice za tkiva vodijo evidence svojih dejavnosti, vključno z vrsto in količino uvoženih tkiv in celic ter njihovim izvorom in namembnim krajem.
This record shall also include the same information for any one-off imports carried out.
Te evidence vključujejo iste informacije tudi za kateri koli opravljeni enkratni uvoz.
The annual report referred to in Article 10(1) of Directive 2004/23/EC shall include information about those activities.
Letno poročilo iz člena 10(1) Direktive 2004/23/ES vključuje informacije o navedenih dejavnostih.
The competent authority or authorities shall include importing tissue establishments in the publicly accessible register of tissue establishments laid down in Article 10(2) of Directive 2004/23/EC.
Pristojni organi ustanove uvoznice za tkiva vključijo v javno dostopen register ustanov za tkiva, določen v členu 10(2) Direktive 2004/23/ES.
Information on the accreditations, designations, authorisations or licences of importing tissue establishments shall also be made available through the network of registers referred to in Article 10(3) of Directive 2004/23/EC.
Informacije o akreditacijah, imenovanjih, odobritvah ali dovoljenjih za ustanove uvoznice za tkiva in celice se dajo na voljo tudi prek mreže registrov iz člena 10(3) Direktive 2004/23/ES.
They shall apply those provisions from 29 April 2017.
Način sklicevanja določijo države članice.
Member States shall determine how such reference is to be made.
Člen 10
Addresses
V Bruslju, 8. aprila 2015
For the Commission
UL L 102, 7.4.2004, str. 48.
The President
Direktiva Komisije 2006/17/ES z dne 8. februarja 2006 o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o nekaterih tehničnih zahtevah za darovanje, pridobivanje in testiranje človeških tkiv in celic (UL L 38, 9.2.2006, str. 40).
OJ L 102, 7.4.2004, p. 48.
Direktiva Komisije 2006/86/ES z dne 24. oktobra 2006 o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o zahtevah po sledljivosti, obveščanju o hudih in neželenih reakcijah in pojavih ter nekaterih tehničnih zahtevah za kodiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic (UL L 294, 25.10.2006, str. 32).
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L 38, 9.2.2006, p. 40.)
PRILOGA I
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32.)
Minimalne zahteve glede informacij in dokumentacije, ki jih morajo predložiti ustanove uvoznice za tkiva, ko zaprosijo za akreditacijo, imenovanje, odobritev ali dovoljenje za namene uvoznih dejavnosti
ANNEX I
Ob vložitvi vloge za akreditacijo, imenovanje, odobritev ali dovoljenje za namene uvoznih dejavnosti ustanova uvoznica za tkiva, ki vlaga vlogo, predloži najnovejše informacije in, za del F, dokumentacijo o spodaj navedenem, razen če je to že predložila kot del prejšnjih vlog za akreditacijo, imenovanje, odobritev ali dovoljenje za ustanovo za tkiva ali ustanovo uvoznico za tkiva: