natgillin/translations-raw huggingface dataset:
implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation
o izvajanju Uredbe (ES) št. 1774/2002 Evropskega parlamenta in Sveta v zvezi z uvozom in tranzitom nekaterih vmesnih proizvodov, pridobljenih iz snovi kategorije 3 in namenjenih za tehnično uporabo v medicinskih pripomočkih, in vitro diagnostičnih medicinskih pripomočkih in laboratorijskih reagentih, ter o spremembi te uredbe
Having regard to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption [1], and in particular Article 32(1) and point 4 of Chapter IV(A) of Annex VIII thereof,
ob upoštevanju Uredbe (ES) št. 1774/2002 Evropskega parlamenta in Sveta z dne 3. oktobra 2002 o določitvi zdravstvenih pravil za živalske stranske proizvode, ki niso namenjeni prehrani ljudi [1], ter zlasti člena 32(1) in točke 4 Poglavja IV(A) Priloge VIII k Uredbi,
Regulation (EC) No 1774/2002 provides that certain animal by-products may be imported into the Community for the production of technical products provided that they comply with that Regulation.
Uredba (ES) št. 1774/2002 določa, da se lahko nekateri stranski živalski proizvodi uvažajo v Skupnost za pridobivanje tehničnih proizvodov, pod pogojem, da so ti proizvodi skladni s to uredbo.
Annex VIII to Regulation (EC) No 1774/2002 sets out the requirements for the placing on the market of certain technical products including starting materials to be used for or in the production of technical products which may include medical devices, in vitro diagnostics and laboratory reagents.
Priloga VIII k Uredbi (ES) št. 1774/2002 določa zahteve za dajanje na trg nekaterih tehničnih proizvodov, vključno z vhodnimi snovmi, ki se uporabljajo za tehnične proizvode ali pri proizvodnji tehničnih proizvodov, ki lahko vključujejo medicinske pripomočke, in vitro diagnostične medicinske pripomočke in laboratorijske reagente.
However, certain Member States, trading partners and operators have expressed concerns over the importation of certain products sourced from Category 3 material intended for the production of medical devices, in vitro diagnostics and laboratory reagents (‘the intermediate products’).
Vendar pa so nekatere države članice, trgovinski partnerji in upravljavci zaskrbljeni zaradi uvoza nekaterih proizvodov, ki izvirajo iz snovi kategorije 3 in so namenjeni za proizvodnjo medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov in laboratorijskih reagentov („vmesnih proizvodov“).
It is therefore necessary to clarify the importation requirements and to lay down specific conditions for those intermediate products.
Zato je treba pojasniti uvozne zahteve in določiti posebne pogoje za te vmesne proizvode.
Although the intermediate products concerned may have been subjected to preliminary processing, the way in which they are transported to the Community does not make it possible to differentiate them from other types of animal by-products intended for other technical uses, except by taking into account their intended destination and uses.
Čeprav so zadevni vmesni proizvodi predhodno predelani, način njihovega prevoza v Skupnost ne omogoča razlikovanja od drugih vrst živalskih stranskih proizvodov za druge vrste tehnične uporabe, razen če se upoštevajo njihov namembni kraj in načini uporabe.
The monitoring of their intended destination and uses under other Community legislation should be sufficient to ensure that they are not diverted into the food and feed chains at a later stage, provided that risk-appropriate channelling, recording and control measures are put in place.
Spremljanje njihovega namembnega kraja in načinov uporabe v skladu z drugo zakonodajo Skupnosti mora zadoščati za preprečevanje njihovega preusmerjanja za uporabo v hrani in prehranjevalni verigi na poznejši stopnji, pod pogojem, da so vzpostavljeni ustrezni ukrepi za usmerjanje, evidenco in nadzor tveganja.
The placing on the market of the intermediate products concerned should therefore be channelled in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries [2], and subjected to specific identification and control measures, in order to reduce the risk of diversion into the food and feed chains and other unintended uses.
Dajanje zadevnih vmesnih proizvodov na trg je zato treba usmerjati v skladu z Direktivo Sveta 97/78/ES z dne 18. decembra 1997 o določitvi načel, ki urejajo organizacijo veterinarskih pregledov proizvodov, ki vstopajo v Skupnost iz tretjih držav [2], pri tem pa morajo veljati ukrepi posebne identifikacije in nadzora za zmanjšanje tveganj preusmerjanja za uporabo v hrani in prehranjevalni verigi ter za drug nenameren način uporabe.
Annex VIII to Regulation (EC) No 1774/2002 sets out the requirements for the placing on the market of technical products.
Priloga VIII k Uredbi (ES) št. 1774/2002 določa zahteve za dajanje na trg tehničnih proizvodov.
A comprehensive review and clarification of that Annex is to be undertaken once the transitional regime provided for in that Regulation has expired.
Izčrpen pregled in pojasnitev Priloge bosta opravljena po izteku prehodne ureditve, ki jo določa ta uredba.
It is therefore, appropriate to lay down in the meantime the rules required for the importation of intermediate products intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents in a specific regulation complementing the rules already laid down in that Annex.
Zato je primerno, da se medtem določijo pravila, potrebna za uvoz vmesnih proizvodov, namenjenih za tehnično uporabo v medicinskih pripomočkih, in vitro diagnostičnih medicinskih pripomočkih in laboratorijskih reagentih, v posebni uredbi, ki dopolnjuje pravila, že določena v omenjeni Prilogi.
Until a full review and clarification has been undertaken, it is necessary to clarify the scope of Chapters IV and XI of Annex VIII to Regulation (EC) No 1774/2002 to take into account this specific Regulation being laid down.
Do popolnega pregleda in pojasnitve je treba pojasniti področje uporabe Poglavij IV in XI Priloge VIII k Uredbi (ES) št. 1774/2002, da se bo upoštevala ta posebna uredba, ki se določa.
The rules set out in Chapter IV should concern blood used for all technical purposes and blood products other than the serum of equidae used for technical purposes other than medical devices, in vitro diagnostics or laboratory reagents.
Pravila, določena v Poglavju IV, morajo veljati za kri, uporabljeno v katere koli tehnične namene, in krvne proizvode, razen seruma kopitarjev, uporabljene v tehnične namene, razen za medicinske pripomočke, in vitro diagnostiko ali laboratorijske reagente.
The rules set out in Chapter V should continue to concern the serum of equidae intended for any technical purposes, including medical devices, in vitro diagnostics or laboratory reagents, and thus such rules do not need to be amended.
Pravila, določena v Poglavju V, morajo še naprej veljati za serum kopitarjev, namenjen za uporabo v katere koli tehnične namene, vključno z medicinskimi pripomočki, in vitro diagnostičnimi medicinskimi pripomočki ali laboratorijskimi reagenti, zato teh pravil ni treba spreminjati.
The rules set out in Chapter XI should concern the importation of other non-processed animal by-products, which are not covered by this Regulation, imported for any purposes, including medical devices, in vitro diagnostics or laboratory reagents.
Pravila, določena v Poglavju XI, morajo veljati za uvoz drugih nepredelanih živalskih stranskih proizvodov, ki jih ne zajema ta uredba in se uvažajo za kateri koli namen, vključno z medicinskimi pripomočki, in vitro diagnostičnimi medicinskimi pripomočki ali laboratorijskimi reagenti.
As a consequence of such clarification, some amendments need to be made to certain model health certificates laid down in Annex X to Regulation (EC) No 1774/2002.
Zaradi te pojasnitve je treba spremeniti nekatera vzorčna zdravstvena spričevala iz Priloge X k Uredbi (ES) št. 1774/2002.
This Regulation shall apply to the importation and transit through the Community of an ‘intermediate product’, as defined in Article 2 of this Regulation.
Ta uredba velja za uvoz „vmesnih proizvodov“, kakor so opredeljeni v členu 2 te uredbe, in njihov tranzit prek Skupnosti.
An ‘intermediate product’ means a product derived from Category 3 material intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents, and whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify the material for that purpose, except for the fact that it requires some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make it suitable for placing on the market or putting into service in accordance with the Community legislation applicable to the final products concerned.
„Vmesni proizvod“ pomeni proizvod, ki je pridobljen iz snovi kategorije 3, namenjen za proizvodnjo medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov ali laboratorijskih reagentov in katerega stopnje oblikovanja, predelave in proizvodnje so bile ustrezno dokončane, da se proizvod šteje za predelanega in da ustreza temu namenu, razen dejstva, da je potrebna še nadaljnja obdelava ali predelava, kot je mešanje, premazovanje, sestavljanje, pakiranje ali označevanje, da je primeren za dajanje na trg ali v uporabo v skladu z zakonodajo Skupnosti, ki velja za zadevne končne proizvode.
Member States shall authorise imports of the intermediate products that comply with the following conditions:
Države članice dovolijo uvoz vmesnih proizvodov, ki izpolnjujejo naslednje pogoje:
they come from a third country listed as member of the World Organisation for Animal Health (OIE) in the OIE Bulletin;
izvirajo iz tretje države, navedene v biltenu OIE kot članice Svetovne organizacije za zdravje živali (OIE);
they come from a plant registered or approved by the competent authority of a third country referred to in point (a) of this Article in accordance with the conditions set out in Annex I to this Regulation;
izvirajo iz obrata, ki so ga registrirali ali odobrili pristojni organi tretje države, navedene v točki (a) tega člena, v skladu s pogoji, določenimi v Prilogi I k tej uredbi;
they are derived exclusively from Category 3 material;
pridobljeni so izključno iz snovi kategorije 3;
each consignment must be accompanied by a commercial document indicating:
opremljeni so s trgovinskim dokumentom, v katerem je navedeno naslednje:
the country of origin,
država porekla,
the name of the establishment of production; and
ime proizvodnega obrata in
that the outer packaging of intermediate products is labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’.
da je zunanja embalaža vmesnega proizvoda opremljena z oznako „SAMO ZA MEDICINSKE PRIPOMOČKE/IN VITRO DIAGNOSTIKO/LABORATORIJSKE REAGENTE“.
The commercial document must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination.
Trgovinski dokument mora biti pripravljen v najmanj enem uradnem jeziku države članice EU, v kateri se bo opravil inšpekcijski pregled na mejni kontrolni točki, in v jeziku namembne države članice EU.
These Member States may allow other languages, if necessary, accompanied by an official translation.
Zadevni državi članici lahko po potrebi dovolita uporabo drugih jezikov, priložen pa mora biti uradni prevod.
they are accompanied by a declaration of the importer in accordance with the model declaration set out in Annex II to this Regulation.
opremljeni so z izjavo uvoznika, v skladu z vzorcem izjave iz Priloge II k tej uredbi.
The declaration must be in at least one of the official languages of the EU Member State in which the inspection at the border inspection post shall be carried out and of the EU Member State of destination.
Izjava mora biti pripravljena v najmanj enem uradnem jeziku države članice EU, v kateri se bo opravil inšpekcijski pregled na mejni kontrolni točki, in v jeziku namembne države članice EU.
Checks, transport and labelling
Pregledi, prevoz in označevanje
The intermediate products imported into the Community shall be checked at the border inspection post of first entry in accordance with Article 4 of Directive 97/78/EC and transported directly from the border inspection post of entry into the Community either:
Vmesni proizvodi, ki se uvažajo v Skupnost, se pregledajo na mejni kontrolni točki prvega vstopa v skladu s členom 4 Direktive 97/78/ES in se prevažajo neposredno od mejne kontrolne točke vstopa v Skupnost do:
to a technical plant approved in accordance with Article 18 of Regulation (EC) No 1774/2002, where the intermediate products shall be further mixed, used for coating, assembled, packaged or labelled before they are placed on the market or put into services in accordance with the Community legislation applicable to the final product; or
tehničnega obrata, odobrenega v skladu s členom 18 Uredbe (ES) št. 1774/2002, kjer se vmesni proizvodi še naprej mešajo, uporabijo za premazovanje, sestavijo, zapakirajo ali označijo, preden se dajo na trg ali v uporabo v skladu z zakonodajo Skupnosti, ki velja za končni proizvod, ali
to a Category 3 intermediate plant or storage plant approved in accordance with Article 10(3) or with Article 11 of Regulation (EC) No 1774/2002.
vmesnega ali skladiščnega obrata kategorije 3, odobrenega v skladu s členom 10(3) ali členom 11 Uredbe (ES) št. 1774/2002.
Intermediate products in transit through the Community shall be transported in accordance with Article 11 of Directive 97/78/EC.
Vmesni proizvodi v tranzitu prek Skupnosti se prevažajo v skladu s členom 11 Direktive 97/78/ES.
The official veterinarian at the border inspection post concerned shall inform the authority in charge of the plant at the place of destination of the consignment via the TRACES system.
Uradni veterinar na zadevni mejni kontrolni točki obvesti pristojni organ obrata v namembnem kraju pošiljke preko sistema TRACES.
The outer packaging of intermediate products shall be labelled: ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’.
Zunanjo embalažo vmesnih proizvodov je treba opremiti z oznako: „SAMO ZA MEDICINSKE PRIPOMOČKE/IN VITRO DIAGNOSTIIČNE MEDICINSKE PRIPOMOČKE/LABORATORIJSKE REAGENTE“.
Use and dispatch
Uporaba in odprema
The operator or owner of the plant of destination or his representative shall use and/or dispatch the intermediate products exclusively for the technical purposes specified in the approval of the plant, as referred to in point (a) of Article 4(1).
Upravljavec ali lastnik namembnega obrata ali njegov zastopnik uporabi in/ali odpremi vmesne proizvode izključno za tehnične namene, opredeljene v odobritvi obrata iz točke (a) člena 4(1).
Records on use and dispatch
Evidence o uporabi in odpremi
The operator or owner of the plant of destination or his representative shall keep records in accordance with Article 9(1) of Regulation (EC) No 1774/2002 and shall provide the competent authority on request with the necessary details of purchases, sales, uses, stocks and disposals of surplus of the intermediate products for the purposes of checking compliance with this Regulation.
Upravljavec ali lastnik namembnega obrata ali njegov zastopnik vodi evidence v skladu s členom 9(1) Uredbe (ES) št. 1774/2002 in pristojnemu organu na zahtevo zagotovi ustrezne podrobnosti o nakupu, prodaji, uporabi, zalogi in razpolaganju s presežki vmesnih proizvodov za preverjanje skladnosti s to uredbo.
The competent authority shall ensure, in accordance with Directive 97/78/EC, that the consignments of intermediate products are sent from the EU Member State in which the inspection at the border inspection post shall be carried out to the plant of destination, as referred to in Article 4(1) of this Regulation, or in the case of transit, to the post of exit.
Pristojni organ v skladu z Direktivo 97/78/ES zagotovi, da so pošiljke vmesnih proizvodov poslane iz države članice EU, v kateri se opravi inšpekcijski pregled na mejni kontrolni točki do namembnega obrata, kakor je navedeno v členu 4(1) te uredbe, ali, v primeru tranzita, do točke izstopa.
The competent authority shall carry out documentary checks at regular intervals for the purpose of reconciliation of the quantities of intermediate products imported on the one hand, and stocked, used, dispatched or disposed of on the other, in order to check compliance with this Regulation.
Pristojni organ v rednih časovnih razmikih izvaja preglede dokumentov za usklajevanje količine uvoženih vmesnih proizvodov na eni strani in vmesnih proizvodov, ki so na zalogi, uporabljeni, odposlani ali odstranjeni, na drugi strani, da se preveri skladnost s to uredbo.
For consignments of intermediate products in transit, the competent authorities responsible for the border inspection posts of entry and of exit respectively shall cooperate as necessary to ensure that effective checks are carried out and to ensure the traceability of such consignments.
Pri pošiljkah vmesnih proizvodov v tranzitu pristojni organi, odgovorni za mejne kontrolne točke vstopa in izstopa, po potrebi sodelujejo, da zagotovijo učinkovito izvajanje preverjanja in sledljivost takih pošiljk.
Amendment to Annexes VIII and X of Regulation (EC) No 1774/2002
Sprememba Prilog VIII in X k Uredbi (ES) št. 1774/2002
Annexes VIII and X to Regulation (EC) No 1774/2002 are amended in accordance with Annex III to this Regulation.
Prilogi VIII in X k Uredbi (ES) št. 1774/2002 se spremenita v skladu s Prilogo III k tej uredbi.
Regulation as last amended by Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25-31).
Uredba, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 208/2006 (UL L 36, 8.2.2006, str. 25–31).
Conditions for the registration or approval of the plant of origin in accordance with point (b) of Article 3
Pogoji za registracijo ali odobritev obrata porekla v skladu s točko (b) člena 3
The operator or owner of the plant or his representative shall:
Upravljavec ali lastnik obrata ali njegov zastopnik:
ensure that the plant has adequate facilities for the transformation of Category 3 material, to ensure the completion of the design, transformation and manufacturing stages referred to in Article 2;
zagotovi, da ima obrat ustrezne objekte in naprave za predelavo snovi iz kategorije 3, ki zagotavljajo zaključek stopenj oblikovanja, predelave in proizvodnje iz člena 2;
establish and implement methods of monitoring and checking the critical control points on the basis of the process used;
uvede in izvaja metode spremljanja in obvladovanja kritičnih kontrolnih točk na podlagi uporabljenega postopka;
keep a record of the information obtained pursuant to (b) for a period of at least two years for submission to the competent authority;
najmanj dve leti vodi evidenco podatkov, pridobljenih v skladu s točko (b), da jih predloži pristojnemu organu;
inform the competent authority if any available information reveals the existence of a serious animal health or public health hazard.
obvesti pristojni organ, če kateri koli razpoložljiv podatek razkrije obstoj resne nevarnosti za zdravje živali in ljudi.
The competent authority of the third country shall at regular intervals carry out inspections of and supervise the plants registered or approved in accordance with this Regulation.
Pristojni organ tretje države v rednih časovnih razmikih opravlja inšpekcijske preglede obratov, registriranih in odobrenih v skladu s to uredbo, in te obrate nadzira.
The frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered, based on the principles of the system of HACCP.
Pogostost inšpekcijskih pregledov in nadzora je odvisna od velikosti obrata, vrste proizvedenih proizvodov, ocene tveganja in jamstev, zagotovljenih na podlagi načel sistema HACCP.
If the inspection carried out by the competent authority reveals that the provisions of this Regulation are not being complied with, the competent authority shall take appropriate action.
Če inšpekcijski pregled, ki ga izvede pristojni organ, razkrije, da določbe te uredbe niso izpolnjene, pristojni organ ustrezno ukrepa.
The competent authority shall draw up a list of plants approved in accordance with this Regulation within its territory.
Pristojni organ sestavi seznam obratov na svojem ozemlju, odobrenih v skladu s to uredbo.
It shall assign an official number to each plant, which identifies the plant with respect to the nature of its activities.
Vsakemu obratu določi uradno številko, ki obrat identificira glede na vrsto njegovih dejavnosti.
The list and subsequent amendments shall be submitted to the EU Member State in which the inspection at the border inspection post shall be carried out and to the Member State of destination.
Seznam in naknadne spremembe se predložijo državi članici EU, v kateri se opravi inšpekcijski pregled na mejni kontrolni točki, in namembni državi članici.
Model declaration for the importation from third countries and for the transit through the European Community of intermediate products to be used for medical devices, in vitro diagnostics and laboratory reagents
Vzorec izjave za uvoz vmesnih proizvodov iz tretjih držav in za tranzit skozi Skupnost za uporabo v medicinskih pripomočkih, in vitro diagnostičnih medicinskih pripomočkih in laboratorijskih reagentih
Model declaration
Vzorec Izjave
Document reference number
Referenčna številka spričevala
Technical use Other
Tehnična uporaba Drugo
MODEL DECLARATION FOR INTERMEDIATE PRODUCTS TO BE USED FOR MEDICAL DEVICES, IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS, FOR DISPATCH TO OR FOR TRANSIT THROUGH THE EUROPEAN COMMUNITY
VZOREC IZJAVE ZA VMESNE PROIZVODE, KI SE UPORABLJAJO ZA MEDICINSKE PRIPOMOČKE, IN VITRO DIAGNOSTIČNE MEDICINSKE PRIPOMOČKE IN LABORATORIJSKE REAGENTE ZA ODPOŠILJANJE ALI TRANZIT SKOZI EVROPSKO SKUPNOST
I, the undersigned, declare that the intermediate products referred to above are intended to be imported by me into the Community and that:
Spodaj podpisani izjavljam, da so vmesni proizvodi, navedeni zgoraj, namenjeni za uvoz v Skupnost, in da:
they are derived from Category 3 material referred to in Article 6 of Regulation (EC) No 1774/2002 [1] and are intended for the manufacture of medical devices, in vitro diagnostics or laboratory reagents;
so pridobljenih iz snovi kategorije 3 iz člena 6 Uredbe (ES) št. 1774/2002 [1] in so namenjeni za proizvodnjo medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov ali laboratorijskih reagentov;
their design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as processed products and to qualify them for that purpose, except for the fact that they require some further handling or transformation such as mixing, coating, assembling, packaging or labelling to make them suitable for placing on the market or putting into service in accordance with the Community legislation applicable to the final products concerned;
so bile njihove stopnje oblikovanja, predelave in proizvodnje ustrezno dokončane, da se snov proizvod šteje za predelanega in da ustreza temu namenu, razen dejstva, da je potrebna še nadaljnja obdelava ali predelava, kot je mešanje, premazovanje, sestavljanje, pakiranje ali označevanje, da je primeren za dajanje na trg ali v uporabo v skladu z zakonodajo Skupnosti, ki velja za zadevne končne proizvode;
their outer packaging is labelled ‘FOR MEDICAL DEVICES/IN VITRO DIAGNOSTICS/LABORATORY REAGENTS ONLY’; and
ima njihova zunanja embalaža oznako „SAMO ZA MEDICINSKE PRIPOMOČKE/IN VITRO DIAGNOSTIČNE MEDICINSKE PRIPOMOČKE/LABORATORIJSKE REAGENTE“ in