natgillin/translations-raw huggingface dataset:
The competent authorities may, in accordance with the applicable national law, prohibit the manufacture, import, distribution, possession, sale, supply or use of immunological veterinary medicinal products on their territory or in a part of it if at least one of the following conditions is fulfilled:
Z odstopanjem od člena 106(1) te uredbe, kadar je bilo imunološko zdravilo za uporabo v veterinarski medicini odobreno, vendar v Uniji ni več na voljo, lahko pristojni organ v interesu zdravja živali ter dobrobiti in javnega zdravja za bolezen, ki ni navedena v členu 5 ali 6 Uredbe (EU) 2016/429, vendar je že prisotna v Uniji, dovoli uporabo imunološkega zdravila za uporabo v veterinarski medicini, ki ni odobreno v Uniji, za vsak primer posebej.
the administration of the product to animals may interfere with the implementation of a national programme for the diagnosis, control or eradication of animal disease;
Pristojni organi brez odlašanja obvestijo Komisijo o uporabi odstavkov 1, 2 in 3 in obenem podajo informacije o pogojih, določenih za izvajanje navedenih odstavkov.
the administration of the product to animals may cause difficulties in certifying the absence of disease in live animals or contamination of foodstuffs or other products obtained from treated animals;
Če se žival izvozi v tretjo državo in zato zanjo veljajo posebni obvezujoči zdravstveni predpisi te tretje države, lahko pristojni organ samo za zadevno žival dovoli uporabo imunološkega zdravila za uporabo v veterinarski medicini, ki nima dovoljenja za promet v relevantni državi članici, vendar je njegova uporaba dovoljena v tretji državi, v katero se žival izvozi.
the strains of disease agents to which the product is intended to confer immunity is largely absent in terms of geographic spread from the territory concerned.
Člen 111
By way of derogation from Article 106(1) of this Regulation, and in the absence of a veterinary medicinal product as referred to in Article 116 of this Regulation, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EU) 2016/429 or an emerging disease as referred to in Article 6 of that Regulation, a competent authority may allow the use of an immunological veterinary medicinal product not authorised within the Union.
Uporaba zdravil za uporabo v veterinarski medicini pri veterinarjih, ki opravljajo storitve v drugih državah članicah
By way of derogation from Article 106(1) of this Regulation, when an immunological veterinary medicinal product has been authorised but is no longer available within the Union for a disease which is not referred to in Article 5 or 6 of Regulation (EU) 2016/429 but which is already present in the Union, a competent authority may, in the interest of animal health and welfare and public health, allow the use of an immunological veterinary medicinal product not authorised within the Union on a case by case basis.
Veterinar, ki opravlja storitve v državi članici, ki ni država članica, v kateri ima sedež (v nadaljnjem besedilu: država članica gostiteljica), lahko poseduje in daje zdravila za uporabo v veterinarski medicini, ki niso odobrena v državi članici gostiteljici, živalim ali skupinam živali, ki so v njegovi oskrbi, v količini, ki ne presega količine, potrebne za zdravljenje, ki ga je predpisal veterinar, če so izpolnjeni naslednji pogoji:
The competent authorities shall inform the Commission without delay when paragraphs 1, 2 and 3 are applied, together with information on the conditions imposed within the implementation of those paragraphs.
pristojni organi države članice, v kateri ima veterinar sedež, ali Komisija so izdali dovoljenje za promet z zdravilom za uporabo v veterinarski medicini, ki se daje živalim;
If an animal is to be exported to a third country and thereby subject to specific binding health rules in that third country, a competent authority may permit the use, solely for that animal concerned, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the relevant Member State but its use is allowed in the third country to where the animal is to be exported.
veterinar prevaža zadevna zdravila za uporabo v veterinarski medicini v njihovem originalnem pakiranju;
Article 111
veterinar upošteva dobro veterinarsko prakso, ki se uporablja v državi članici gostiteljici;
Use of veterinary medicinal products by veterinarians providing services in other Member States
veterinar določi karenco, določeno na označevanju ali v navodilih za uporabo zdravila za uporabo v veterinarski medicini;
A veterinarian providing services in a Member State other than the one in which the veterinarian is established (‘host Member State’) shall be allowed to possess and administer veterinary medicinal products which are not authorised in the host Member State to animals or groups of animals which are under the veterinarian’s care in the necessary quantity not exceeding the amount required for the treatment prescribed by the veterinarian, provided that the following conditions are met:
veterinar lastniku ali imetniku živali, ki se zdravi v državi članici gostiteljici, ne proda nobenega zdravila za uporabo v veterinarski medicini na drobno, razen če je to dovoljeno v skladu s pravili države članice gostiteljice.
a marketing authorisation for the veterinary medicinal product to be administered to the animals has been granted by the competent authorities of the Member State in which the veterinarian is established or by the Commission;
Odstavek 1 se ne uporablja za imunološka zdravila za uporabo v veterinarski medicini, razen za toksine in serume.
the veterinary medicinal products concerned are transported by the veterinarian in their original packaging;
Člen 112
the veterinarian follows the good veterinary practice applied in the host Member State;
Uporaba zdravil, ki ni zajeta v pogojih dovoljenja za promet, pri živalskih vrstah, ki niso namenjene proizvodnji živil
the veterinarian sets the withdrawal period specified on the labelling or package leaflet of the veterinary medicinal product used;
Kadar v državi članici ni nobenega odobrenega zdravila za uporabo v veterinarski medicini za indikacijo, ki se nanaša na živalske vrste, ki niso namenjene proizvodnji živil, lahko odgovorni veterinar z odstopanjem od člena 106(1) na svojo neposredno osebno odgovornost in zlasti, da bi preprečil nesprejemljivo trpljenje živali, zadevno žival izjemoma zdravi z naslednjim zdravilom:
the veterinarian does not retail any veterinary medicinal product to an owner or keeper of animals treated in the host Member State unless this is permissible under the rules of the host Member State.
zdravilom za uporabo v veterinarski medicini, ki je v skladu s to uredbo odobreno v relevantni državi članici ali drugi državi članici za uporabo pri isti ali drugi živalski vrsti za isto ali drugo indikacijo;
Paragraph 1 shall not apply to immunological veterinary medicinal products except in the case of toxins and sera.
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) tega odstavka, z zdravilom za uporabo v humani medicini, ki je odobreno v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004;
Article 112
če ni na voljo nobenega zdravila iz točke (a) ali (b) tega odstavka, z zdravilom za uporabo v veterinarski medicini, ki ga veterinar pripravi ex tempore v skladu s pogoji veterinarskega recepta.
Use of medicinal products outside the terms of the marketing authorisation in non-food-producing animal species
Razen v zvezi z imunološkimi zdravili za uporabo v veterinarski medicini, če ni na voljo nobenega zdravila iz odstavka 1, lahko pristojni veterinar na svojo neposredno odgovornost in zlasti, da se prepreči nesprejemljivo trpljenje živali, izjemoma zdravi žival, ki ni namenjena za proizvodnjo živil, z zdravilom za uporabo v veterinarski medicini, ki ima dovoljenje za promet v tretji državi za iste živalske vrste in isto indikacijo.
By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a non-food-producing animal species, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product:
Veterinar lahko zdravilo da osebno ali dovoli drugi osebi, da to stori v okviru veterinarjeve odgovornosti in v skladu z nacionalnimi določbami.
a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same species or another animal species for the same indication or for another indication;
Ta člen se uporablja tudi za veterinarsko zdravljenje živali iz vrste enoprstih kopitarjev, pod pogojem, da je navedeno, da je v enotnem identifikacijskem dokumentu za celotno življenjsko dobo živali iz člena 8(4) navedeno, da ni namenjena za zakol za prehrano ljudi.
if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004;
Ta člen se uporablja tudi, kadar odobreno zdravilo za uporabo v veterinarski medicini ni na voljo v relevantni državi članici.
if there is no medicinal product as referred to in point (a) or (b) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.
Člen 113
Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraph 1, the veterinarian responsible may under his or her direct responsibility and in particular to avoid causing unacceptable suffering exceptionally treat a non-food-producing animal with a veterinary medicinal product authorised in a third country for the same animal species and same indication.
Uporaba zdravil, ki ni vključena v pogojih dovoljenja za promet, pri kopenskih živalskih vrstah za proizvodnjo živil
The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian’s responsibility, in accordance with national provisions.
Kadar v državi članici ni nobenega odobrenega zdravila za uporabo v veterinarski medicini za indikacijo, ki se nanaša na kopenske živalske vrste za proizvodnjo živil, lahko odgovorni veterinar z odstopanjem od člena 106(1) na svojo neposredno osebno odgovornost in zlasti, da bi preprečil nesprejemljivo trpljenje živali, zadevno žival izjemoma zdravi z naslednjim zdravilom:
This Article shall also apply to the treatment by a veterinarian of an animal of the equine species provided that it is declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in Article 8(4).
z zdravilom za uporabo v veterinarski medicini, ki je v skladu s to uredbo odobreno v relevantni državi članici ali drugi državi članici za uporabo pri isti ali drugi kopenski živalski vrsti za proizvodnjo živil za isto ali drugo indikacijo;
This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State.
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) tega odstavka, z zdravilom za uporabo v veterinarski medicini, ki je v skladu s to uredbo odobreno v relevantni državi članici za uporabo pri živalski vrsti, ki ni namenjena proizvodnji živil, za isto indikacijo;
Article 113
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) ali (b) tega odstavka, z zdravilom za uporabo v humani medicini, ki je odobreno v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004, ali
Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species
če ni na voljo nobenega zdravila iz točke (a), (b) ali (c) tega odstavka, z zdravilom za uporabo v veterinarski medicini, ki ga v skladu s pogoji veterinarskega recepta pripravi veterinar.
By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing terrestrial animal species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product:
Razen v zvezi z imunološkimi zdravili za uporabo v veterinarski medicini, kadar ni na voljo nobenega zdravila iz odstavka 1, lahko pristojni veterinar na svojo neposredno odgovornost in zlasti da se prepreči nesprejemljivo trpljenje živali, izjemoma zdravi kopenske živali za proizvodnjo živil, z zdravilom za uporabo v veterinarski medicini, ki ima dovoljenje za promet v tretji državi za isto živalsko vrsto in isto indikacijo.
a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same or in another food-producing terrestrial animal species for the same indication, or for another indication;
Farmakološke učinkovine v zdravilu, ki se uporablja v skladu z odstavkoma 1 in 2 tega člena, so dovoljene v skladu z Uredbo (ES) št. 470/2009 in morebitnimi akti, sprejetimi na podlagi te uredbe.
if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a veterinary medicinal product authorised under this Regulation in the relevant Member State for use in a non-food-producing animal species for the same indication;
Člen 114
if there is no veterinary medicinal product as referred to in point (a) or (b) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004; or
Uporaba zdravil pri vodnih vrstah za proizvodnjo živil
if there is no medicinal product as referred to in point (a), (b) or (c) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.
Kadar v državi članici ni nobenega odobrenega zdravila za uporabo v veterinarski medicini za indikacije pri vodnih vrstah za proizvodnjo živil, lahko odgovorni veterinar z odstopanjem od člena 106(1) na svojo neposredno osebno odgovornost in zlasti, da bi preprečil nesprejemljivo trpljenje živali, zadevno žival zdravi z naslednjim zdravilom:
Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraph 1, the veterinarian responsible may under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing terrestrial animals with a veterinary medicinal product authorised in a third country for the same animal species and same indication.
z zdravilom za uporabo v veterinarski medicini, ki je v skladu s to uredbo odobreno v relevantni državi članici ali drugi državi članici za uporabo pri isti ali drugi vodni vrsti za proizvodnjo živil za isto ali drugo indikacijo;
Pharmacologically active substances included in the medicinal product used in accordance with paragraphs 1 and 2 of this Article shall be allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof.
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) tega odstavka, z zdravilom za uporabo v veterinarski medicini, ki je v skladu s to uredbo odobreno v relevantni državi članici ali drugi državi članici za uporabo pri isti ali drugi kopenski vrsti za proizvodnjo živil in ki vsebuje snov s seznama, pripravljenega v skladu z odstavkom 3;
Article 114
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) ali (b) tega odstavka, z zdravilom za uporabo v humani medicini, ki je odobreno v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004 in ki vsebuje snovi s seznama, pripravljenega v skladu z odstavkom 3 tega člena, ali
Use of medicinal products for food-producing aquatic species
Z odstopanjem od točk (b) in (c) odstavka 1 in dokler ni pripravljen seznam iz odstavka 3, lahko pristojni veterinar v okviru svoje neposredne osebne odgovornosti in predvsem, da prepreči nesprejemljivo trpljenje, vodne vrste za proizvodnjo živil na določeni posesti izjemoma zdravi z naslednjim zdravilom:
By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing aquatic species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, treat the animals concerned with the following medicinal product:
zdravilom za uporabo v veterinarski medicini, ki je odobreno v skladu s to uredbo v relevantni državi članici ali v drugi državi članici za uporabo pri kopenski živalski vrsti za proizvodnjo živil;
a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same or in another food-producing aquatic species and for the same indication or for another indication;
če ni na voljo nobenega zdravila za uporabo v veterinarski medicini iz točke (a) tega odstavka, z zdravilom za uporabo v humani medicini, ki je odobreno v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004.
if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use with a food-producing terrestrial species containing a substance present in the list established in accordance with paragraph 3;
Komisija z izvedbenimi akti najpozneje v petih letih od 28. januarja 2022 vzpostavi seznam snovi, ki se uporabljajo v zdravilih za uporabo v veterinarski medicini za kopenske živalske vrste za proizvodnjo živil z dovoljenjem za promet v Uniji, ali snovi, ki jih vsebuje zdravilo za uporabo v humani medicini z dovoljenjem za promet v Uniji v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004, ki jih je mogoče uporabiti pri vodnih vrstah za proizvodnjo živil v skladu z odstavkom 1 tega člena.
if there is no veterinary medicinal product as referred to in point (a) or (b) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 and containing substances present in the list established in accordance with paragraph 3 of this Article; or
Komisija pri sprejemanju teh izvedbenih aktov upošteva naslednja merila:
By way of derogation from points (b) and (c) of paragraph 1, and until the list referred to in paragraph 3 is established, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing aquatic species of a particular holding with the following medicinal product:
tveganja za okolje, če se vodne vrste za proizvodnjo živil zdravijo s temi snovmi;
a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use with a food-producing terrestrial animal species;
vpliv na zdravje živali in javno zdravje, če prizadete vodne vrste za proizvodnjo živil ne morejo prejeti protimikrobnih snovi, ki so na seznamu v skladu s členom 107(6);
if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.
razpoložljivost ali pomanjkanje drugih zdravil, zdravljenj ali ukrepov za preprečevanje ali zdravljenje bolezni ali nekaterih bolezenskih stanj pri vodnih vrstah za proizvodnjo živil.
The Commission shall, by means of implementing acts, at the latest within five years from 28 January 2022, establish a list of substances used in veterinary medicinal products authorised in the Union for use in food-producing terrestrial animal species or substances contained in a medicinal product for human use authorised in the Union in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, which may be used in food-producing aquatic species in accordance with paragraph 1 of this Article.
Razen v zvezi z imunološkimi zdravili za uporabo v veterinarski medicini, če ni na voljo zdravil iz odstavkov 1 in 2, lahko pristojni veterinar v okviru svoje neposredne osebne pristojnosti in zlasti da se prepreči nesprejemljivo trpljenje živali, izjemoma zdravi vodno vrsto za proizvodnjo živil z zdravilom za uporabo v veterinarski medicini, odobrenim v tretji državi za isto vrsto in isto indikacijo.
The Commission, when adopting those implementing acts, shall take account of the following criteria:
Farmakološke učinkovine, ki so prisotne v zdravilu, uporabljenem v skladu z odstavki 1, 2 in 4 tega člena, so dovoljene v skladu z Uredbo (ES) št. 470/2009 in z vsemi akti, sprejetimi na njeni podlagi.
risks to the environment if the food-producing aquatic species are treated with those substances;
Člen 115
impact on animal and public health if the food-producing aquatic species affected cannot receive an antimicrobial listed in accordance with Article 107(6);
Karenca za zdravila, katerih uporaba pri živalskih vrstah za proizvodnjo živil ni vključena v pogojih dovoljenja za promet
availability or lack of availability of other medicinal products, treatments or measures for prevention or treatment of diseases or certain indications in food-producing aquatic species.
Karenco za namene členov 113 in 114, razen če je karenca za uporabljeno zdravilo za zadevne živalske vrste določena v njegovem povzetku glavnih značilnosti, določi veterinar v skladu z naslednjimi merili:
Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraphs 1 and 2, the veterinarian responsible may, under his or her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing aquatic species with a veterinary medicinal product authorised in a third country for the same species and same indication.
za meso in drobovino sesalcev, ptic in gojenih divjih ptic za proizvodnjo živil karenca ne znaša manj kot:
Pharmacologically active substances included in the medicinal product used in accordance with paragraphs 1, 2 and 4 of this Article shall be allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof.
najdaljša karenca iz povzetka glavnih značilnosti zdravila za meso in drobovino, pomnožena s faktorjem 1,5;
Article 115
28 dni, če zdravilo ni odobreno za živali za proizvodnjo živil;
Withdrawal period for medicinal products used outside the terms of the marketing authorisation in food-producing animal species
en dan, če ima zdravilo karenco nič dni in se uporablja na drugi živalski družini kot tisti, za katero ima dovoljenje;
For the purpose of Articles 113 and 114, unless a medicinal product used has a withdrawal period provided in its summary of the product characteristics for the animal species in question, a withdrawal period shall be set by the veterinarian in accordance with the following criteria:
za mleko živali, katerih mleko je namenjeno za prehrano ljudi, karenca ne znaša manj kot:
for meat and offal from food-producing mammals and poultry and farmed game birds the withdrawal period shall not be less than:
najdaljša karenca za mleko iz povzetka glavnih značilnosti zdravila za katero koli živalsko vrsto, pomnožena s faktorjem 1,5;
the longest withdrawal period provided in its summary of the product characteristics for meat and offal multiplied by factor 1,5;
sedem dni, če zdravilo ni odobreno za živali, katerih mleko je namenjeno za prehrano ljudi;
28 days if the medicinal product is not authorised for food-producing animals;
en dan, če ima zdravilo karenco nič;
one day, if the medicinal product has a zero withdrawal period and is used in a different taxonomic family than the target species authorised;
za jajca živali, katerih jajca so namenjena za prehrano ljudi, karenca ne znaša manj kot: