natgillin/translations-raw huggingface dataset:
Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers
Uredba Komisije (ES) št. 2141/96 z dne 7. novembra 1996 o pregledu vloge za prenos odobritve za trženje zdravil, ki spada na področje Uredbe Sveta (ES) št. 2309/93
Approximated on 11 June 2013
Uredba (ES) št. 469/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o dodatnem varstvenem certifikatu za zdravila
Drug precursors
Za namene te priloge in člena 173(2) tega sporazuma sklicevanja na pravni red Unije ali zakonodajo ali določene akte Unije zajemajo tudi vse pretekle ali prihodnje spremembe ustreznih aktov ter vse izvedbene ukrepe v zvezi s temi akti.
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors
PRILOGA XVII
Good laboratory practice
ZAJETI UKREPI
Application of principles and verification for tests on chemicals, inspection and verification of good laboratory practice
PRILOGA XVIII
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
SEZNAMI BOLEZNI ŽIVALI IN ŽIVALI IZ AKVAKULTURE, KI JIH JE TREBA PRIJAVITI, IN ŠKODLJIVIH ORGANIZMOV, ZA KATERE SE LAHKO PRIZNA REGIONALNA NENAPADENOST
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)
PRILOGA XIX
PHARMACEUTICALS
REGIONALIZACIJA ALI DOLOČANJE OBMOČIJ, OBMOČJA BREZ ŠKODLJIVIH ORGANIZMOV IN VAROVANA OBMOČJA
Medicinal products for human use
A. Bolezni živali in živali iz ribogojstva
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems
Bolezni živali
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Podlaga za priznavanje statusa za živalske bolezni na ozemlju ali v regiji pogodbenice je Zoosanitarni kodeks OIE za kopenske živali.
Transposition: 2015
Podlaga za sklepe o regionalizaciji za živalsko bolezen je Zoosanitarni kodeks OIE za kopenske živali.
Medicinal products for veterinary use
Bolezni živali iz ribogojstva
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
Podlaga za sklepe o regionalizaciji za bolezni živali iz ribogojstva je Kodeks OIE o zdravju vodnih živali.
Approximation: 2013
B. Škodljivi organizmi
Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription
Merila za oblikovanje območij brez škodljivih organizmov ali varovanih območij za nekatere škodljive organizme so v skladu z določbami:
Miscellaneous
Mednarodnega standarda FAO za fitosanitarne ukrepe št. 4 o „zahtevah za vzpostavitev območij brez škodljivih organizmov“ in ustreznimi opredelitvami Mednarodnih standardov za fitosanitarne ukrepe ali
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products
Člen 2(1)(h) Direktive 2000/29/ES z dne 8. maja 2000 o varstvenih ukrepih proti vnosu organizmov, škodljivih za rastline ali rastlinske proizvode, v Skupnost in proti njihovemu širjenju v Skupnosti
Directive 2001/18/ЕС of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms
C. Merila za priznavanje posebnega statusa za živalske bolezni na ozemlju ali v regiji pogodbenice
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products
Kadar pogodbenica uvoznica meni, da je njeno ozemlje ali del njenega ozemlja prosto živalske bolezni, razen bolezni iz Priloge XVIII-A k temu sporazumu, pogodbenici izvoznici predloži ustrezno dodatno dokumentacijo, ki navaja zlasti naslednja merila:
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms
naravo bolezni in zgodovino njenega pojavljanja na njenem ozemlju,
Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93
rezultate nadzornega testiranja na podlagi seroloških, mikrobioloških, patoloških ali epidemioloških preiskav ter dejstva, da je treba bolezen v skladu z zakonom priglasiti pristojnim organom,
Commission Regulation (EC) No 1662/95 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use
obdobje, v katerem se je izvajal nadzor,
Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorisation for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93
kjer je to ustrezno, obdobje, v katerem je bilo prepovedano cepljenje proti bolezni, in zemljepisno območje, ki ga je prepoved zadevala,
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products
režim za preverjanje odsotnosti bolezni.
For the purposes of this Annex and of Article 173(2) of this Agreement, references to the Union acquis or legislation or to specific Union acts shall be understood to cover any past or future revisions of the relevant acts as well as any implementation measures related to those acts.
Dodatna splošna ali posebna jamstva, ki jih lahko zahteva pogodbenica uvoznica, ne smejo presegati jamstev, ki jih pogodbenica uvoznica izvaja na domačem trgu.
ANNEX XVII
Pogodbenici se medsebojno obvestita o vseh spremembah meril iz odstavka 1 te točke, ki se nanašajo na bolezen.
COVERAGE
Dodatna jamstva, opredeljena v skladu z odstavkom 2 te točke, lahko zaradi take priglasitve Pododbor za sanitarne in fitosanitarne ukrepe spremeni ali umakne.
ANNEX XVIII
PRILOGA XX
LIST OF NOTIFIABLE ANIMAL AND AQUACULTURE DISEASES AND REGULATED PESTS FOR WHICH REGIONAL FREEDOM CAN BE RECOGNISED
ZAČASNA ODOBRITEV OBRATOV
ANNEX XIX
Pogoji in določila za začasno odobritev obratov
REGIONALISATION/ZONING, PEST-FREE AREAS AND PROTECTED ZONES
Začasna odobritev obratov pomeni, da pogodbenica uvoznica za namen uvoza začasno odobri obrate v pogodbenici izvoznici na podlagi ustreznih jamstev, ki jih zagotovi navedena pogodbenica, ne da bi pogodbenica uvoznica pred tem izvedla inšpekcije posameznih obratov v skladu z določbami odstavka 4 te priloge.
A. Animal and aquaculture diseases
Postopek in pogoji iz odstavka 4 te priloge se uporabijo za spreminjanje ali dopolnjevanje seznamov iz odstavka 2 te priloge, da se upoštevajo novi načini uporabe in prejeta jamstva.
Animal diseases
Preverjanje je v skladu z določbami odstavka 4(d) lahko del postopka, vendar samo kar zadeva izhodiščni seznam obratov.
The basis for recognition of the animal disease status of the territory or of a region of a Party shall be the Terrestrial Animal Health Code of the OIE.
Začasna odobritev se na začetku uporablja za naslednje kategorije obratov.
The basis for regionalisation decisions for an animal disease shall be the Terrestrial Animal Health Code of the OIE.
Obrati za proizvode živalskega izvora, namenjene za prehrano ljudi:
Aquaculture diseases
klavnice za sveže meso domačih kopitarjev, perutnine in lagomorfov ter gojene divjadi (Priloga XVII-A, del 1);
The basis for regionalisation decisions for aquaculture diseases shall be the Aquatic Animal Health Code of the OIE.
obrati za predelavo divjadi;
B. Pests
razsekovalnice;
The criteria for the establishment of pest free areas or protected zones for certain pests shall comply with the provisions of either:
obrati za mleto meso, mesne pripravke, mehansko izkoščeno meso in mesne proizvode;
the FAO International Standard for Phytosanitary Measures No 4 on Requirements for the establishment of pest free areas and the definitions of the relevant ISPMs, or
centri za čiščenje in centri za razpošiljanje živih školjk;
Article 2(1)(h) of Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
Obrati za:
C. Criteria for the recognition of the special status for animal diseases of the territory or a region of a Party
jajčne proizvode,
Where the importing Party considers that its territory or part of its territory is free from an animal disease other than a disease listed in Annex XVIII-A to this Agreement, it shall present to the exporting Party appropriate supporting documentation, setting out in particular the following criteria:
mlečne proizvode,
the nature of the disease and the history of its occurrence in its territory;
ribiške proizvode,
the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation and on the fact that the disease must by law be notified to the competent authorities;
obdelane želodce, mehurje in čreva,
the period over which the surveillance was carried out;
želatino in kolagen,
where applicable, the period during which vaccination against the disease has been prohibited and the geographical area concerned by the prohibition;
ribje olje;
the arrangements for verifying the absence of the disease.
predelovalna plovila;
The additional guarantees, general or specific, which may be required by the importing Party must not exceed those, which the importing Party implements nationally.
zamrzovalna plovila.
The Parties shall notify each other of any change in the criteria specified in paragraph 1 of this point which relate to the disease.
Odobreni ali registrirani obrati za proizvodnjo živalskih stranskih proizvodov in glavne kategorije proizvodov živalskega izvora za prehrano ljudi
The additional guarantees defined in accordance with paragraph 2 of this point may, in the light of such notification, be amended or withdrawn by the SPS Sub-Committee.
Vrsta odobrenega ali registriranega obrata in objektov
ANNEX XX
Proizvod
PROVISIONAL APPROVAL OF ESTABLISHMENTS
Klavnice
Conditions and provisions for provisional approval of establishments
Živalski stranski proizvodi za krmljenje kožuharjev
Provisional approval of establishments means that for the purpose of import the importing Party approves provisionally the establishments in the exporting Party on the basis of appropriate guarantees provided by that Party without prior inspection by the importing Party of the individual establishments in accordance with the provisions of paragraph 4 of this Annex.
Živalski stranski proizvodi za proizvodnjo hrane za hišne živali
The procedure and conditions set out in paragraph 4 of this Annex shall be used for modifying or completing the lists provided for in paragraph 2 of this Annex to take account of new applications and guarantees received.
Kri in proizvodi iz krvi enoprstih kopitarjev za uporabo zunaj krmne verige
Verification may be part of the procedure, only as regards the initial list of establishments, in accordance with the provisions of paragraph 4(d).
Sveže ali ohlajene kože kopitarjev
The provisional approval shall initially be applied to the following categories of establishments
Živalski stranski proizvodi za proizvodnjo pridobljenih proizvodov za uporabo zunaj krmne verige
Establishments for products of animal origin for human consumption:
Mlekarne
Slaughterhouses for fresh meat of domestic ungulates, poultry, lagomorphs and farm game (Annex XVII-A, Part 1)
Mleko, mlečni izdelki in izdelki, pridobljeni iz mleka
Game handling establishments
Kolostrum in proizvodi iz kolostruma
Cutting plants
Drugi obrati za zbiranje živalskih stranskih proizvodov in ravnanje z njimi (tj. nepredelani/neobdelani materiali)
Establishments for minced meat, meat preparation, mechanically separated meat and meat products
Neobdelani proizvodi iz krvi, razen iz krvi enoprstih kopitarjev, za pridobljene proizvode, ki se uporabljajo zunaj krmne verige za farmsko gojene živali
Purification centres and dispatched centres for live bivalve molluscs
Obdelani proizvodi iz krvi, razen iz krvi enoprstih kopitarjev, za proizvodnjo pridobljenih proizvodov, ki se uporabljajo zunaj krmne verige za farmsko gojene živali
Establishments for:
Ščetine prašičev iz tretjih držav ali njihovih regij, proste afriške prašičje kuge
eggs products
Kosti in proizvodi iz kosti (razen kostne moke), rogovi in proizvodi iz rogov (razen moke iz rogov) ter kopita in proizvodi iz kopit (razen moke iz kopit) za druge vrste uporabe kakor za posamična krmila, organska gnojila in sredstva za izboljšanje tal
dairy products
Rogovi in proizvodi iz rogov (razen moke iz rogov) ter kopita in proizvodi iz kopit (razen moke iz kopit) za proizvodnjo organskih gnojil ali sredstev za izboljšanje tal
fishery products
Želatina, ki ni namenjena za prehrano ljudi, za uporabo v fotografski industriji
treated stomachs, bladders and intestines
Volna in dlake
gelatine and collagen
Obdelano perje, deli peres in puh
fish oil
Predelovalni obrati
Factory vessels
Predelane živalske beljakovine, vključno z mešanicami in proizvodi, ki niso hrana za hišne živali, ki vsebujejo take beljakovine
Freezer vessels
Proizvodi iz krvi, ki se lahko uporabljajo kot posamična krmila
Approved or registered establishments producing animal by-products and main categories of animal by-products not for human consumption
Obdelane kože kopitarjev
Type of approved or registered establishment and plants
Obdelane kože prežvekovalcev in enoprstih kopitarjev (21 dni)
Product
Ščetine prašičev iz tretjih držav ali njihovih regij, ki niso proste afriške prašičje kuge
Slaughterhouses
Ribje olje za uporabo kot posamična krmila ali za namene zunaj krmne verige
Animal by-products to be fed to fur animals
Topljena maščoba za uporabo kot posamična krmila
Animal by-products for the manufacture of pet food
Topljena maščoba za nekatere uporabe zunaj krmne verige za farmsko gojene živali
Blood and blood products from equidae to be used outside the feed chain
Želatina ali kolagen za uporabo kot posamična krmila ali za namene zunaj krmne verige
Fresh or chilled hides and skins of ungulates
Hidrolizirane beljakovine, dikalcijev fosfat ali trikalcijev fosfat za uporabo kot posamična krmila ali za namene zunaj krmne verige
Animal by-products for the manufacture of derived products for uses outside the feed chain
Čebelarski stranski proizvodi, namenjeni izključno za uporabo v čebelarstvu
Dairy plants
Maščobni derivati za uporabo zunaj krmne verige
Milk, milk-based products and milk-derived products
Maščobni derivati za uporabo kot krmilo ali zunaj krmne verige
Colostrum and colostrum products
Jajčni proizvodi, ki se lahko uporabljajo kot posamična krmila
Other facility for the collection or handling of animal by-products (i.e. unprocessed/untreated materials
Obrati za proizvodnjo hrane za hišne živali (vključno z obrati, ki proizvajajo pasje žvečilke in aromatično drobovino)
Untreated blood products, excluding of equidae, for derived products for purposes outside the feed chain for farmed animals
Konzervirana hrana za hišne živali
Treated blood products, excluding of equidae, for the manufacture of derived products for purposes outside the feed chain for farmed animals
Predelana hrana za hišne živali, razen konzervirane hrane za hišne živali
Pig bristles from third countries or regions thereof that are free from African swine fever
Pasje žvečilke
Bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) for uses other than as feed material, organic fertiliser or soil improvers
Surova hrana za hišne živali za neposredno prodajo
Horns and horn products, excluding horn meal, and hooves and hoof products, excluding hoof meal, for the production of organic fertilisers or soil improvers
Aromatična drobovina za uporabo pri proizvodnji hrane za hišne živali
Gelatine not intended for human consumption to be used by the photographic industry
Obrati za izdelavo lovskih trofej
Wool and hair
Obdelane lovske trofeje in drugi preparati ptic in kopitarjev, ki vsebujejo samo kosti, rogove, kopita, kremplje, rogovje, zobovje ali kože
Treated feathers, parts of feathers and down
Lovske trofeje ali drugi preparati ptic in kopitarjev iz celih delov, ki niso bili obdelani
Processing plants
Obrati ali objekti, ki proizvajajo vmesne proizvode
Processed animal protein, including mixtures and products other than pet food containing such protein
Vmesni proizvodi
Blood products that could be used as feed material
Gnojila in sredstva za izboljšanje tal
Treated hides and skins of ungulates
Predelane živalske beljakovine, vključno z mešanicami in proizvodi, ki niso hrana za hišne živali, ki vsebujejo take beljakovine
Treated hides and skins of ruminants and of equidae (21 days)
Predelan gnoj, proizvodi, pridobljeni iz predelanega gnoja in gvana netopirjev
Pig bristles from third countries or regions thereof that are not free of African swine fever
Skladišča za pridobljene proizvode
Fish oil to be used as feed material or for purposes outside the feed chain
Vsi pridobljeni proizvodi
Rendered fats to be used as feed materials
Pogodbenica uvoznica sestavi sezname začasno odobrenih obratov iz odstavkov 2.1 in 2.2 in poskrbi, da so dostopni javnosti.
Rendered fats for certain purposes outside the feed chain for farmed animals
Pogoji in postopki za začasno odobritev:
Gelatine or Collagen to be used as feed material or for purposes outside the feed chain
če je pogodbenica uvoznica odobrila uvoz zadevnega živalskega proizvoda iz države izvoznice in so bili vzpostavljeni ustrezni uvozni pogoji in zahteve za izdajanje spričeval;
Hydrolysed protein, Dicalcium phosphate or Tricalcium phosphate to be used as feed material or for purposes outside the feed chain
če je pristojni organ pogodbenice izvoznice pogodbenici uvoznici predložil zadovoljiva jamstva, da obrati na njegovem seznamu ali seznamih izpolnjujejo ustrezne zdravstvene zahteve pogodbenice uvoznice in je uradno odobril obrate s seznamov za izvoz v pogodbenico uvoznico;
Apiculture by-products intended exclusively for use in apiculture
pristojni organ pogodbenice izvoznice mora imeti resnična pooblastila, da ob neizpolnjevanju jamstev začasno prekine vse dejavnosti izvoza v pogodbenico uvoznico iz obrata, za katerega je zagotovil jamstva;
Fat derivatives to be used outside the feed chain
preverjanje s strani pogodbenice uvoznice v skladu z določbami člena 188 tega sporazuma je lahko del postopka za začasno odobritev.
Fat derivatives to be used as feed or outside the feed chain
To preverjanje zadeva sestavo in organiziranost pristojnega organa, odgovornega za odobritev obrata, ter pooblastila, ki jih ima ta pristojni organ na voljo, in jamstva, ki jih lahko zagotovi v zvezi z izvajanjem pravil pogodbenice uvoznice.
Egg products that could be used as feed material
To preverjanje lahko vključuje preglede na kraju samem določenega reprezentativnega števila obratov s seznama ali seznamov, ki jih predloži pogodbenica izvoznica, na kraju samem.
Pet food plants (including plants manufacturing dogchews and flavouring innards)
Ob upoštevanju specifične sestave in porazdelitve pristojnosti znotraj Unije lahko tako preverjanje v Uniji zadeva posamezne države članice;
Canned pet food
Na podlagi rezultatov preverjanja iz točke (d) tega odstavka lahko pogodbenica uvoznica spremeni obstoječi seznam obratov.
Processed pet food other than canned pet food
PRILOGA XXI
Dogchews
POSTOPEK PRIZNAVANJA ENAKOVREDNOSTI
Raw pet food for direct sale
Enakovrednost se lahko določi za posamezen ukrep ali skupino ukrepov ali sistem, povezan z določenim primarnim proizvodom ali kategorijami primarnih proizvodov ali obema;
Flavouring innards for use in the manufacture of pet food
če pogodbenica uvoznica pregleduje zahtevek za priznavanje enakovrednosti ukrepov v zvezi z določenim proizvodom pogodbenice izvoznice to ne sme biti razlog za oviranje trgovine ali ustavitev tekočega uvoza zadevnega proizvoda iz pogodbenice izvoznice;
Game trophies plants
postopek priznavanja enakovrednosti ukrepov je interaktiven proces med pogodbenico izvoznico in pogodbenico uvoznico.
Treated game trophies and other preparations of birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth, hides or skins
Ta postopek vključuje objektiven dokaz enakovrednosti posameznih ukrepov pogodbenice izvoznice in objektivno presojo enakovrednosti z namenom morebitnega priznavanja enakovrednosti v pogodbenici uvoznici;
Game trophies or other preparations of birds and ungulates consisting of entire parts not having been treated
končno priznavanje enakovrednosti ustreznih ukrepov pogodbenice izvoznice je v izključni pristojnosti pogodbenice uvoznice.
Plants or establishments manufacturing intermediate products
Predpogoji
Intermediate products
Uvrstitev na seznam je odvisna od zdravstvenega stanja ali stanja škodljivih organizmov, zakonodaje ter učinkovitosti sistema inšpekcij in nadzora, povezanega s proizvodom v pogodbenici izvoznici.
Fertiliser and soil improvers
V ta namen se upošteva zakonodaja v zadevnem sektorju in tudi sestava pristojnega organa države izvoznice, njena vodstvena hierarhija, pristojnosti, operativni postopki in viri ter učinkovitost pristojnih organov, kar zadeva inšpekcije in nadzorne sisteme, vključno s stopnjo izvrševanja v zvezi s proizvodom ter rednostjo in hitrostjo pri pošiljanju informacij pogodbenici uvoznici ob ugotovljenih tveganjih.
Processed animal protein including mixtures and products other than pet food containing such protein
Tako priznavanje je lahko utemeljeno z dokumentacijo, preverjanjem in dokumenti, poročili in informacijami, povezanimi s preteklimi izkušnjami, ocenami in preverjanjem;
Processed manure, derived products from processed manure and guano from bats
Pogodbenici lahko začneta postopek priznavanja enakovrednosti v skladu s členom 183 tega sporazuma po uspešno zaključni zakonodajnem približanju ukrepa, skupine ukrepov ali sistemov, vključenih v seznam zakonodaje, ki jo je treba približati, iz člena 181(4) tega sporazuma;
Storage of derived products
pogodbenica izvoznica postopek začne šele, ko pogodbenica uvoznica zanjo ne uporablja zaščitnih ukrepov za proizvod.
All derived products
Postopek
The importing Party shall draw up lists of provisionally approved establishments as referred to in paragraphs 2.1 and 2.2 and shall make these lists publicly available.
Pogodbenica izvoznica postopek začne tako, da pogodbenici uvoznici predloži zahtevek za priznavanje enakovrednosti posameznega ukrepa ali skupin ukrepov ali sistema za primarni proizvod ali kategorijo primarnih proizvodov v sektorju ali podsektorju ali v obeh;
Conditions and procedures for provisional approval:
Kadar je to primerno, ta zahtevek vključuje tudi zahtevek in potrebno dokumentacijo za odobritev s strani pogodbenice uvoznice na podlagi enakovrednosti kakšnega koli programa ali načrta pogodbenice izvoznice, ki ga pogodbenica uvoznica zahteva, in/ali statusa približanja v zvezi z ukrepi ali sistemi iz točke (a), kakor je določen v Prilogi XXIV tega sporazuma, kot pogoj za odobritev uvoza navedenega primarnega proizvoda ali kategorije primarnih proizvodov;
If import of the animal product concerned from the exporting Party has been authorised by the importing Party and the relevant import conditions and certification requirements for the products concerned have been established;
s tem zahtevkom pogodbenica izvoznica: