natgillin/translations-raw huggingface dataset:
Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers.
Medicirana krma in vmesni proizvodi se dajejo v promet le v zapečateni embalaži ali posodah.
Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.
Embalaža ali posode se zapečatijo tako, da se pečat pri odprtju embalaže ali posode poškoduje in se ne more ponovno uporabiti.
Packages shall not be reused.
Embalaža se ne sme ponovno uporabiti.
Paragraph 1 shall not apply to mobile mixers that supply medicated feed directly to the animal keeper.
Odstavek 1 se ne uporablja za mobilne mešalce, ki medicirano krmo dobavljajo neposredno imetnikom živali.
Advertising of medicated feed and intermediate products
Oglaševanje medicirane krme in vmesnih proizvodov
The advertising of medicated feed and intermediate products shall be prohibited.
Oglaševanje medicirane krme in vmesnih proizvodov je prepovedano.
That prohibition shall not apply to advertising made exclusively to veterinarians.
Ta prepoved ne velja za oglaševanje, namenjeno izključno veterinarjem.
The advertising shall not include information in any form which could be misleading or lead to incorrect use of the medicated feed.
Oglaševanje ne vključuje informacij v kakršni koli obliki, ki bi bile lahko zavajajoče ali bi povzročile nepravilno uporabo medicirane krme.
Medicated feed shall not be distributed for promotional purposes except for small quantities of samples.
Medicirana krma se ne distribuira v promocijske namene, razen v majhnih količinah vzorcev.
Medicated feed containing antimicrobial veterinary medicinal products shall not be distributed for promotional purposes as samples or in any other presentation.
Medicirana krma, ki vsebuje protimikrobna zdravila za uporabo v veterinarski medicini, se ne distribuira v promocijske namene v obliki vzorcev ali v kakršni koli drugi obliki.
The samples referred to in paragraph 3 shall be appropriately labelled indicating that they are samples and shall be given directly to veterinarians during sponsored events or by sales representatives during their visits.
Vzorci iz odstavka 3 se ustrezno označijo, da je razvidno, da so vzorci, in se dajo neposredno veterinarjem med sponzoriranimi dogodki ali s strani prodajnih zastopnikov med njihovimi obiski.
Intra-Union trade and import
Trgovanje znotraj Unije in uvoz
The feed business operator distributing medicated feed or intermediate products in a Member State which is different from the Member State where it was manufactured shall ensure that the veterinary medicinal products used for the manufacturing of that medicated feed or those intermediate products are allowed for use, in accordance with Regulation (EU) 2019/6, in the Member State of use.
Nosilec dejavnosti poslovanja s krmo, ki distribuira medicirano krmo ali vmesne proizvode v državi članici, ki ni država članica, v kateri je ta krma ali ta proizvod proizveden, zagotovi, da so zdravila za uporabo v veterinarski medicini, ki se uporabljajo za proizvodnjo te medicirane krme ali teh vmesnih proizvodov, v državi članici uporabe dovoljena za uporabo v skladu z Uredbo (EU) 2019/6.
The feed business operator importing medicated feed or intermediate products into the Union shall ensure that the veterinary medicinal products used for the manufacturing of that medicated feed or those intermediate products are allowed for use, in accordance with Regulation (EU) 2019/6, in the Member State of use.
Nosilec dejavnosti poslovanja s krmo, ki uvaža medicirano krmo ali vmesne proizvode v Unijo, zagotovi, da so zdravila za uporabo v veterinarski medicini, ki se uporabljajo za proizvodnjo te medicirane krme ali teh vmesnih proizvodov, v državi članici uporabe dovoljena za uporabo v skladu z Uredbo (EU) 2019/6.
APPROVAL OF ESTABLISHMENTS
ODOBRITEV OBRATOV
Approval obligations
Obveznosti odobritve
Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority.
Nosilci dejavnosti poslovanja s krmo, ki proizvajajo, skladiščijo, prevažajo ali dajejo v promet medicirano krmo ali vmesne proizvode, zagotovijo, da je obrate pod njihovim nadzorom odobril pristojni organ.
Paragraph 1 shall not apply to the following feed business operators:
Odstavek 1 se ne uporablja za naslednje nosilce dejavnosti poslovanja s krmo:
those who only buy, store or transport medicated feed for the exclusive use on their farm;
tiste, ki medicirano krmo kupujejo, skladiščijo ali prevažajo izključno za uporabo na svojem kmetijskem gospodarstvu;
those who act solely as traders, without holding the medicated feed or intermediate products in their premises;
tiste, ki delujejo samo kot trgovci, ne da bi hranili medicirano krmo ali vmesne proizvode v svojih prostorih;
those who only transport or store medicated feed or intermediate products exclusively in sealed packages or containers.
tiste, ki medicirano krmo ali vmesne proizvode prevažajo ali skladiščijo izključno v zapečateni embalaži ali posodah.
The competent authority shall approve establishments only where an on-site visit, prior to start-up of the relevant activity, has demonstrated that the system put in place for the manufacture, storage, transport or placing on the market of medicated feed or intermediate products meets the specific requirements of Chapter II.
Pristojni organ odobri obrate samo, če se pri obisku na kraju samem pred začetkom ustrezne dejavnosti ugotovi, da vzpostavljeni sistem za proizvodnjo, skladiščenje, prevoz ali dajanje v promet medicirane krme ali vmesnih proizvodov izpolnjuje posebne zahteve iz poglavja II.
In the event that mobile mixers place medicated feed on the market in a Member State different from the one where they are approved, such mobile mixers shall notify that activity to the competent authority in the Member State where the medicated feed is placed on the market.
Če mobilni mešalci dajejo medicirano krmo v promet v državi članici, ki ni država, v kateri so odobreni, taki mobilni mešalci o tej dejavnosti obvestijo pristojni organ v državi članici, v kateri dajejo medicirano krmo v promet.
In respect of retailers of medicated feed for pets and keepers of fur animals feeding animals with medicated feed, Member States shall have in place national procedures to ensure that relevant information regarding their activities is available to the competent authorities, while avoiding duplication and unnecessary administrative burden.
Države članice imajo v zvezi s trgovci na drobno z medicirano krmo za hišne živali in imetniki kožuharjev, ki živali krmijo z medicirano krmo, vzpostavljene nacionalne postopke za zagotovitev, da so pristojnim organom na voljo ustrezne informacije o njihovih dejavnostih, pri čemer se preprečita podvajanje in nepotrebno upravno breme.
The establishments approved in accordance with Article 13(1) of this Regulation shall be recorded in a national list, as referred to in Article 19(2) of Regulation (EC) No 183/2005, under an individual identifying number attributed in the form set out in Chapter II of Annex V to that Regulation.
Obrati, odobreni v skladu s členom 13(1) te uredbe se vnesejo na nacionalni seznam iz člena 19(2) Uredbe (ES) št. 183/2005 pod posamično identifikacijsko številko, dodeljeno v obliki, ki je določena v poglavju II Priloge V k navedeni uredbi.
Transitional measures concerning the implementation of the requirements for approval and registration
Prehodni ukrepi v zvezi z izvajanjem zahtev za odobritev in registracijo
Establishments falling within the scope of this Regulation which have already been approved in accordance with Directive 90/167/EEC or otherwise authorised by the competent authority for activities falling within the scope of this Regulation may continue their activities subject to the submission, by 28 July 2022, of a declaration to the relevant competent authority in the area where their facilities are located, in a form decided upon by that competent authority, that they meet the requirements for approval referred to in Article 13(3) of this Regulation.
Obrati, ki spadajo v področje uporabe te uredbe in so že bili odobreni v skladu z Direktivo 90/167/EGS ali ki jih je pristojni organ drugače pooblastil za dejavnosti, ki spadajo v področje uporabe te uredbe, lahko nadaljujejo svoje dejavnosti, če do 28. julija 2022 ustreznemu pristojnemu organu na območju, kjer se nahajajo njihovi prostori, predložijo izjavo v obliki, ki jo določi ta pristojni organ, da izpolnjujejo zahteve za odobritev iz člena 13(3) te uredbe.
Where the declaration referred to in paragraph 1 of this Article is not submitted within the period specified, the competent authority shall suspend the existing approval in accordance with the procedure referred to in Article 14 of Regulation (EC) No 183/2005.
Če se izjava iz odstavka 1 tega člena v opredeljenem roku ne predloži, pristojni organ začasno prekliče obstoječo odobritev v skladu postopkom iz člena 14 Uredbe (ES) št. 183/2005.
PRESCRIPTION AND USE
IZDAJANJE RECEPTOV IN UPORABA
Prescription
Izdajanje receptov
The supply of medicated feed to animal keepers shall be subject to:
Za dobavo medicirane krme imetnikom živali je treba:
the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription for medicated feed; and
predložiti oziroma v primeru proizvodnje mešalcev na kmetijskem gospodarstvu imeti veterinarski recept za medicirano krmo,
the conditions laid down in paragraphs 2 to 10.
izpolnjevati pogoje iz odstavkov 2 do 10.
A veterinary prescription for medicated feed shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian and only for a diagnosed disease.
Veterinarski recept za medicirano krmo se izda samo po kliničnem pregledu ali kakršni koli drugi ustrezni oceni zdravstvenega stanja živali ali skupine živali, ki jo opravi veterinar, in samo za diagnosticirano bolezen.
By way of derogation from paragraph 2, a veterinary prescription for medicated feed containing immunological veterinary medicinal products may be issued also in the absence of a diagnosed disease.
Z odstopanjem od odstavka 2 se lahko izda veterinarski recept za medicirano krmo, ki vsebuje imunološka zdravila za uporabo v veterinarski medicini, tudi če bolezen ni diagnosticirana.
By way of derogation from paragraph 2, if it is not possible to confirm the presence of a diagnosed disease, a veterinary prescription for medicated feed containing antiparasitics without antimicrobial effects may be issued based on the knowledge of the parasite infestation status in the animal or group of animals.
Z odstopanjem od odstavka 2 se lahko na podlagi poznavanja statusa okužbe s paraziti živali ali skupine živali izda veterinarski recept za medicirano krmo, ki vsebuje antiparazitike brez protimikrobnih učinkov, tudi če ni mogoče potrditi diagnosticirane bolezni.
By way of derogation from point (h) of Article 3(2) and paragraph 2 of this Article, a Member State may allow a veterinary prescription for medicated feed to be issued by a professional person qualified to do so in accordance with applicable national law on 27 January 2019.
Z odstopanjem od točke (h) člena 3(2) in odstavka 2 tega člena lahko država članica dovoli, da veterinarski recept izda strokovna oseba, ki je 27. januarja 2019 usposobljena za to v skladu z veljavnim nacionalnim pravom.
Such prescriptions shall exclude prescription of medicated feed containing antimicrobial veterinary medicinal products or any other veterinary medicinal products where a diagnosis by a veterinarian is necessary and shall be valid only in that Member State.
Taki recepti ne vključujejo predpisovanja medicirane krme, ki vsebuje protimikrobna zdravila ali katera koli druga zdravila za uporabo v veterinarski medicini, za katera je potrebna diagnoza veterinarja, ter so veljavni samo v tej državi članici.
The professional person referred to in the first subparagraph shall, when issuing such a prescription, make any necessary verifications in accordance with national law.
Strokovna oseba iz prvega pododstavka pri izdaji takega recepta opravi vsa potrebna preverjanja v skladu z nacionalnim pravom.
Paragraphs 6, 7, 8 and 10 of this Article shall apply, mutatis mutandis, to such prescriptions.
Za te recepte se smiselno uporabljajo odstavki 6, 7, 8 in 10 tega člena.
The veterinary prescription for medicated feed shall contain the information set out in Annex V.
Veterinarski recept za medicirano krmo vsebuje podatke, ki so določeni v Prilogi V.
The original veterinary prescription for medicated feed shall be kept by the manufacturer or, where appropriate, the feed business operator supplying the medicated feed to the animal keeper.
Originalni veterinarski recept za medicirano krmo hrani proizvajalec ali, kadar je to primerno, nosilec dejavnosti poslovanja s krmo, ki dobavlja medicirano krmo imetniku živali.
The veterinarian, or the professional person referred to in paragraph 5, issuing the prescription and the keeper of food-producing or fur animal shall keep a copy of the veterinary prescription for medicated feed.
Veterinar ali strokovna oseba iz odstavka 5, ki izda recept, in imetnik živali za proizvodnjo živil ali kožuharjev, hrani kopijo veterinarskega recepta za medicirano krmo.
The original and copies shall be kept for five years from the date of issuance.
Izvirnik in kopije se hranijo pet let od datuma izdaje.
With the exception of medicated feed for non-food-producing animals, other than fur animals, medicated feed shall not be used for more than one treatment under the same veterinary prescription for medicated feed.
Z izjemo medicirane krme za živali, ki niso namenjene proizvodnji živil, razen za kožuharje, se lahko medicirana krma na podlagi enega veterinarskega recepta za medicirano krmo uporabi samo za eno zdravljenje.
The duration of a treatment shall comply with the summary of product characteristics of the veterinary medicinal product incorporated in the feed and, where not specified, shall not exceed one month, or two weeks in case of a medicated feed containing antibiotic veterinary medicinal products.
Trajanje zdravljenja mora biti skladno s povzetkom glavnih značilnosti zdravila za uporabo v veterinarski medicini, ki je vsebovano v krmi in, kadar ni določeno, ne sme biti daljše od enega meseca ali dveh tednov v primeru medicirane krme, ki vsebuje zdravila za uporabo v veterinarski medicini z antibiotiki.
The veterinary prescription for medicated feed shall be valid from the date of its issuance for a maximum period of six months for non-food-producing animals other than fur animals and three weeks for food-producing animals and fur animals.
Veterinarski recept za medicirano krmo velja največ šest mesecev od datuma njegove izdaje za živali, ki niso namenjene proizvodnji živil, razen za kožuharje, in tri tedne za živali za proizvodnjo živil in za kožuharje.
In the case of medicated feed containing antimicrobial veterinary medicinal products, the prescription shall be valid from the date of its issuance for a maximum period of five days.
Če medicirana krma vsebuje protimikrobna zdravila za uporabo v veterinarski medicini, je recept veljaven največ pet dni od datuma njegove izdaje.
The veterinarian issuing the veterinary prescription for medicated feed shall verify that that medication is justified for the target animals on veterinary grounds.
Veterinar, ki je izdal veterinarski recept za medicirano krmo, preveri, da je uporaba zdravila za ciljne živali upravičena z veterinarskega stališča.
Furthermore that veterinarian shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Poleg tega ta veterinar zagotovi, da vnos zadevnega zdravila za uporabo v veterinarski medicini ni nezdružljivo z drugim zdravljenjem ali uporabo ter da v primeru uporabe več zdravil ni kontraindikacij ali medsebojnega delovanja.
In particular, the veterinarian shall not prescribe medicated feed with more than one veterinary medicinal product containing antimicrobials.
Veterinar zlasti ne sme predpisati medicirane krme z več kot enim veterinarskim zdravilom, ki vsebuje protimikrobne snovi.
The veterinary prescription for medicated feed shall:
Veterinarski recept za medicirano krmo:
comply with the summary of the product characteristics of the veterinary medicinal product, except for veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6;
mora biti skladen s povzetkom glavnih značilnosti zdravila za uporabo v veterinarski medicini, razen za zdravila za uporabo v veterinarski medicini, ki so namenjena uporabi v skladu s členom 112, členom 113 ali členom 114 Uredbe (EU) 2019/6;
indicate the daily dose of the veterinary medicinal product which is to be incorporated in a quantity of medicated feed that ensures the uptake of the dosage by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration;
navaja dnevni odmerek zdravila za uporabo v veterinarski medicini, ki se vključi v takšno količino medicirane krme, ki zagotavlja, da ciljna žival zaužije odmerek, ob upoštevanju, da se lahko količina krme, ki jo zaužije bolna žival, razlikuje od običajnega dnevnega obroka;
ensure that the medicated feed containing the dosage of the veterinary medicinal product corresponds to at least 50 % of the daily feed ration on a dry matter basis and that, for ruminants, the daily dose of the veterinary medicinal product is contained in at least 50 % of the complementary feed except for mineral feed;
zagotavlja, da medicirana krma, ki vsebuje odmerek zdravila za uporabo v veterinarski medicini, ustreza vsaj 50 % dnevnega obroka krme v suhi snovi ter da je za prežvekovalce dnevni odmerek zdravila za uporabo v veterinarski medicini v vsaj 50 % dopolnilne krmne mešanice, z izjemo mineralne krmne mešanice;
indicate the inclusion rate of the active substances, calculated on the basis of the relevant parameters.
navaja stopnjo vsebnosti učinkovin, izračunano na podlagi ustreznih parametrov.
Veterinary prescriptions for medicated feed issued in accordance with paragraphs 2, 3 and 4 shall be recognised throughout the Union.
Veterinarski recepti za medicirano krmo, izdani v skladu z odstavki 2, 3 in 4, se priznajo po vsej Uniji.
The Commission may, by means of implementing acts, set a model format for the information set out in Annex V. That model format shall also be made available in electronic version.
Komisija lahko z izvedbenimi akti določi vzorec obrazca za informacije iz Priloge V. Ta vzorec obrazca je na voljo tudi v elektronski obliki.
Use of medicated feed
Uporaba medicirane krme
The prescribed medicated feed shall be used only for animals for which the veterinary prescription for medicated feed has been issued in accordance with Article 16.
Predpisana medicirana krma se uporablja samo za živali, za katere je bil v skladu s členom 16 izdan veterinarski recept za medicirano krmo.
Animal keepers shall use medicated feed only in accordance with the veterinary prescription for medicated feed, take measures to avoid cross-contamination and shall ensure that only the identified animals in the veterinary prescription for medicated feed are administered with the medicated feed.
Imetniki živali uporabljajo medicirano krmo samo v skladu z veterinarskim receptom za medicirano krmo, sprejmejo ukrepe za preprečevanje navzkrižne kontaminacije in zagotovijo, da se medicirana krma vnese samo pri živalih, navedenih na veterinarskem receptu za medicirano krmo.
Animal keepers shall ensure that expired medicated feed is not used.
Imetniki živali zagotovijo, da se medicirana krma s pretečenim rokom uporabnosti ne uporabi.
Medicated feed containing antimicrobial veterinary medicinal products shall be used in accordance with Article 107 of Regulation (EU) 2019/6, except as regards paragraph 3 thereof, and shall not be used for prophylaxis.
Medicirana krma, ki vsebuje protimikrobna zdravila za uporabo v veterinarski medicini, se uporablja v skladu s členom 107 Uredbe (EU) 2019/6, razen kar zadeva odstavek 3 navedenega člena, in se ne uporablja za profilakso.
Medicated feed containing immunological veterinary medicinal products shall be used in accordance with Article 110 of Regulation (EU) 2019/6 and shall be used on the basis of a prescription in accordance with Article 16(3) of this Regulation.
Medicirana krma, ki vsebuje imunološka zdravila za uporabo v veterinarski medicini, se uporablja v skladu s členom 110 Uredbe (EU) 2019/6 in se uporablja na podlagi recepta v skladu s členom 16(3) te uredbe.
Medicated feed containing antiparasitics shall be used on the basis of a prescription in accordance with Article 16(4) of this Regulation.
Medicirana krma, ki vsebuje antiparazitike, se uporablja na podlagi recepta v skladu s členom 16(4) te uredbe.
When administering medicated feed, the keeper of food-producing animals shall ensure compliance with the withdrawal period provided for in the veterinary prescription for medicated feed.
Pri vnosu medicirane krme imetnik živali za proizvodnjo živil zagotovi skladnost s karenco, ki je določena v veterinarskem receptu za medicirano krmo.
The keeper of food-producing animals feeding them with medicated feed shall keep records in accordance with Article 108 of Regulation (EU) 2019/6.
Imetnik živali za proizvodnjo živil, ki živali krmi z medicirano krmo, vodi evidenco v skladu s členom 108 Uredbe (EU) 2019/6.
Those records shall be kept for at least five years after the date of administration of medicated feed, including when the food-producing animal is slaughtered during the five-year period.
Ta evidenca se hrani vsaj pet let od datuma vnosa medicirane krme, tudi če se žival za proizvodnjo živil v tem petletnem obdobju zakolje.
Collection or discard systems of unused or expired products
Sistemi zbiranja ali zavrženja neuporabljenih proizvodov ali proizvodov s pretečenim rokom uporabnosti
Member States shall ensure that appropriate collection or discard systems are in place for medicated feed and intermediate products that are expired or in case the animal keeper has received a bigger quantity of medicated feed than he actually used for the treatment referred to in the veterinary prescription for medicated feed.
Države članice zagotovijo, da se vzpostavijo ustrezni sistemi zbiranja ali zavrženja medicirane krme in vmesnih proizvodov s pretečenim rokom uporabnosti ali kadar imetnik živali dobi večjo količino medicirane krme, kot jo dejansko uporabi za zdravljenje na podlagi veterinarskega recepta za medicirano krmo.
Member States shall take measures to ensure that relevant stakeholders are consulted as regards such systems.
Države članice sprejmejo ukrepe, s katerimi zagotovijo posvetovanja z ustreznimi deležniki v zvezi s takšnimi sistemi.
Member States shall take measures to ensure that the location of collection or discard points as well as other relevant information is made available to farmers, animal keepers, veterinarians and other relevant persons.
Države članice sprejmejo ukrepe, s katerimi zagotovijo, da so kmetom, imetnikom živali, veterinarjem in drugim ustreznim osebam na voljo informacije o mestu zbiranja ali zavrženja in druge potrebne informacije.
The Commission is empowered to adopt delegated acts in accordance with Article 20 amending Annexes I to V, in order to take into account technical progress and scientific developments.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 20 za spremembo prilog I do V, da bi se upoštevala tehnični napredek in znanstveni razvoj.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Prenos pooblastila iz členov 7 in 19 lahko kadar koli prekliče Evropski parlament ali Svet.