natgillin/translations-raw huggingface dataset:
the common logo established in accordance with paragraph 6 of this Article is clearly displayed on every page of the website that relates to the offer for sale at a distance of veterinary medicinal products and contains a hyperlink to the entry of the retailer in the list of permitted retailers referred to in point (c) of paragraph 8 of this Article.
Vsaka država članica vzpostavi spletno mesto v zvezi s prodajo zdravil za uporabo v veterinarski medicini na daljavo, ki vsebuje vsaj naslednje informacije:
The Commission shall establish a common logo pursuant to paragraph 7 that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance is established.
informacije o nacionalnem pravu, ki se uporablja za ponujanje zdravil za uporabo v veterinarski medicini za promet na daljavo prek storitev informacijske družbe v skladu z odstavkoma 1 in 2, vključno z informacijami o tem, da lahko med državami članicami obstajajo razlike v razvrščanju zdravil za uporabo v veterinarski medicini glede na to, kako so pridobljena;
The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.
informacije o skupnem logotipu;
The Commission shall, by means of implementing acts, adopt the design of the common logo referred to in paragraph 6 of this Article.
seznam trgovcev na drobno s sedežem v državi članici, ki jim je dovoljeno ponujati zdravila za uporabo v veterinarski medicini za promet na daljavo prek storitev informacijske družbe v skladu z odstavkoma 1 in 2, ter tudi spletne naslove navedenih trgovcev na drobno.
Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:
Agencija vzpostavi spletno mesto, ki zagotavlja informacije o skupnem logotipu.
information on its national law applicable to the offering of veterinary medicinal products for sale at a distance by means of information society services, in accordance with paragraphs 1 and 2, including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;
Na spletnem mestu Agencije je izrecno navedeno, da spletna mesta držav članic vsebujejo informacije o osebah, ki jim je dovoljeno ponujati zdravila za uporabo v veterinarski medicini za promet na daljavo prek storitev informacijske družbe v relevantni državi članici.
information on the common logo;
Države članice lahko postavijo pogoje za promet na drobno zdravil za uporabo v veterinarski medicini, ki se ponujajo za promet na daljavo prek storitev informacijske družbe na njihovem ozemlju, ki so upravičeni na podlagi varovanja javnega zdravja.
a list of retailers established in the Member State permitted to offer veterinary medicinal products for sale at a distance by means of information society services in accordance with paragraphs 1 and 2 as well as the website addresses of those retailers.
Spletna mesta, ki jih vzpostavijo države članice, vsebujejo hiperpovezavo do spletnega mesta Agencije, vzpostavljenega v skladu z odstavkom 9.
The Agency shall set up a website providing information on the common logo.
Člen 105
The Agency’s website shall explicitly mention that the websites of Member States contain information on persons permitted to offer veterinary medicinal products for sale at a distance by means of information society services in the relevant Member State.
Veterinarski recepti
Members States may impose conditions, justified on grounds of public health protection, for the retail, on their territory, of veterinary medicinal products offered for sale at a distance by means of information society services.
Veterinarski recept za protimikrobna zdravila za metafilakso se izda samo po tem, ko je veterinar postavil diagnozo nalezljive bolezni.
The websites set up by Member States shall contain a hyperlink to the website of the Agency set up in accordance with paragraph 9.
Veterinar je zmožen utemeljiti veterinarski recept za protimikrobna zdravila, zlasti za metafilakso in profilakso.
Article 105
Veterinarski recept se izda samo po kliničnem pregledu ali kakršni koli drugi ustrezni oceni zdravstvenega stanja živali ali skupine živali, ki jo opravi veterinar.
Veterinary prescriptions
Z odstopanjem od točke (33) člena 4 in odstavka 3 tega člena lahko država članica dovoli, da veterinarski recept izda strokovna oseba, ki ni veterinar, in je za to usposobljena v skladu z veljavnim nacionalnim pravom ob začetku veljavnosti te uredbe.
A veterinary prescription for an antimicrobial medicinal product for metaphylaxis shall only be issued after a diagnosis of the infectious disease by a veterinarian.
Taki recepti so veljavni le v tej državi članici in ne vključujejo predpisovanja protimikrobnih zdravil in vseh drugih zdravil za uporabo v veterinarski medicini, za katera je potrebna diagnoza veterinarja.
The veterinarian shall be able to provide justification for a veterinary prescription of antimicrobial medicinal products, in particular for metaphylaxis and for prophylaxis.
Za veterinarske recepte, ki jih izda strokovna oseba, ki ni veterinar, se smiselno uporabljajo odstavki 5, 6, 8, 9 in 11 tega člena.
A veterinary prescription 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.
Veterinarski recept zajema vsaj naslednje elemente:
By way of derogation from point (33) of Article 4 and paragraph 3 of this Article, a Member State may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this Regulation.
identifikacijo živali ali skupine živali, ki se zdravi;
Such prescriptions shall be valid only in that Member State and shall exclude prescriptions of antimicrobial medicinal products and any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.
polno ime in kontaktne podatke lastnika ali imetnika živali;
Veterinary prescriptions issued by a professional, other than a veterinarian shall be, mutatis mutandis, subject to paragraphs 5, 6, 8, 9 and 11 of this Article.
datum izdaje;
A veterinary prescription shall contain at least the following elements:
polno ime in kontaktne podatke veterinarja, vključno s poklicno številko, če je na voljo;
identification of the animal or groups of animals to be treated;
podpis ali enakovredno elektronsko identifikacijo veterinarja;
full name and contact details of the animal owner or keeper;
ime predpisanega zdravila, vključno z njegovimi učinkovinami;
issue date;
farmacevtsko obliko in jakost;
full name and contact details of the veterinarian including, if available, the professional number;
predpisano količino ali število pakiranj, vključno z velikostjo pakiranj;
signature or an equivalent electronic form of identification of the veterinarian;
režim odmerjanja;
name of the prescribed medicinal product, including its active substances;
za živalske vrste za proizvodnjo hrane, karenco, tudi če je nič;
pharmaceutical form and strength;
vsa opozorila, ki so potrebna za zagotovitev pravilne uporabe, vključno za zagotovitev preudarne rabe protimikrobnih snovi, kjer je ustrezno;
quantity prescribed, or the number of packs, including pack size;
če se zdravilo predpiše v skladu s členi 112, 113 in 114, izjavo o tem;
dosage regimen;
če se zdravilo predpiše v skladu s členom 107(3) in (4), izjavo o tem.
for food-producing animal species, withdrawal period even if such period is zero;
Predpisana količina zdravil se omeji na količino, ki je potrebna za zadevno zdravljenje ali terapijo.
any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;
Protimikrobna zdravila za metafilakso ali profilakso se predpišejo le za omejeno obdobje, dokler je prisotno tveganje.
if a medicinal product is prescribed in accordance with Articles 112, 113 and 114, a statement to that effect;
Veterinarski recepti, izdani v skladu z odstavkom 3, so priznani po vsej Uniji.
if a medicinal product is prescribed in accordance with Article 107(3) and (4), a statement to that effect.
Komisija lahko z izvedbenimi akti določi vzorec obrazca za zahteve iz odstavka 5 tega člena, ki je na voljo tudi v elektronski obliki.
The quantity of the medicinal products prescribed shall be limited to the amount required for the treatment or therapy concerned.
Predpisana zdravila za uporabo v veterinarski medicini se izdajo v skladu z veljavnim nacionalnim pravom.
As regards antimicrobial medicinal products for metaphylaxis or prophylaxis, they shall be prescribed only for a limited duration to cover the period of risk.
Veterinarski recept za protimikrobna zdravila velja pet dni od datuma izdaje.
Veterinary prescriptions issued in accordance with paragraph 3 shall be recognised throughout the Union.
Poleg zahtev, določenih v tem členu, lahko države članice določijo pravila o vodenju evidenc za veterinarje pri izdajanju veterinarskih receptov.
The Commission may, by means of implementing acts, set a model format for the requirements set in paragraph 5 of this Article.
Ne glede na člen 34 lahko zdravilo za uporabo v veterinarski medicini, za katerega je v skladu z navedenim členom potreben veterinarski recept, daje veterinar sam brez veterinarskega recepta, razen če je v veljavnem nacionalnem pravu določeno drugače.
That model format shall also be made available in electronic version.
Veterinar o takšnem svojem dajanju zdravila brez recepta vodi evidenco v skladu z veljavnim nacionalnim pravom.
The medicinal product prescribed shall be supplied in accordance with applicable national law.
Uporaba
A veterinary prescription for antimicrobial medicinal products shall be valid for five days from the date of its issue.
Člen 106
In addition to the requirements set out in this Article, Member States may lay down rules on record-keeping for veterinarians when issuing veterinary prescriptions.
Uporaba zdravil
Notwithstanding Article 34, a veterinary medicinal product classified as subject to veterinary prescription under that Article may be administered without a veterinary prescription by a veterinarian personally, unless otherwise provided for under applicable national law.
Zdravila za uporabo v veterinarski medicini se uporabljajo v skladu s pogoji dovoljenja za promet.
The veterinarian shall keep records of such personal administration without prescription in accordance with applicable national law.
Uporaba zdravil za uporabo v veterinarski medicini v skladu s tem oddelkom ne posega v člena 46 in 47 Uredbe (EU) 2016/429.
Use
Države članice lahko določijo vse postopke, ki se jim zdijo potrebni za izvajanje členov 110 do 114 in 116.
Article 106
Države članice lahko, če je to ustrezno utemeljeno, odločijo, da zdravilo za uporabo v veterinarski medicini lahko daje samo veterinar.
Use of medicinal products
Inaktivirana imunološka zdravila za uporabo v veterinarski medicini iz člena 2(3) se uporabljajo za živali iz navedenega člena samo v izjemnih okoliščinah v skladu z veterinarskim receptom in če ni imunološkega zdravila za uporabo v veterinarski medicini za ciljno živalsko vrsto in indikacije.
Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation.
Komisija sprejme delegirane akte v skladu s členom 147, da po potrebi dopolni ta člen, ki določajo pravila o ustreznih ukrepih za zagotovitev učinkovite in varne uporabe zdravil za uporabo v veterinarski medicini, ki so odobrena in predpisana za oralno uporabo po poti, ki ni medicirana krma, kot je mešanje vode za pitje z zdravilom za uporabo v veterinarski medicini ali ročno mešanje zdravil za uporabo v veterinarski medicini v krmo, ki jih živalim za proizvodnjo hrane daje v krmo njihov imetnik.
The use of veterinary medicinal products in accordance with this Section shall be without prejudice to Articles 46 and 47 of Regulation (EU) 2016/429.
Komisija pri sprejemanju teh delegiranih aktov upošteva znanstveni nasvet Agencije.
Member States may lay down any procedures they deem necessary for the implementation of Articles 110 to 114 and 116.
Člen 107
Member States may, if duly justified, decide that a veterinary medicinal product shall be administered only by a veterinarian.
Uporaba protimikrobnih zdravil za uporabo v veterinarski medicini
Inactivated immunological veterinary medicinal products referred to in Article 2(3) shall only be used in the animals referred to therein in exceptional circumstances, in accordance with a veterinary prescription, and if no immunological veterinary medicinal product is authorised for the target animal species and the indication.
Protimikrobna zdravila se ne uporabljajo rutinsko niti se ne uporabljajo kot nadomestilo za slabo higieno, neustrezno rejo živali ali slabo upravljanje kmetijskih gospodarstev.
The Commission shall adopt delegated acts in accordance with Article 147, in order to supplement this Article, as necessary, which establish the rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed, such as mixing of water for drinking with a veterinary medicinal product or as manual mixing of a veterinary medicinal product into feed and administered by the animal keeper to food-producing animals.
Protimikrobna zdravila se ne uporabljajo pri živalih z namenom spodbujanja rasti niti za povečanje donosa.
The Commission shall take into account the scientific advice of the Agency, when adopting those delegated acts.
Protimikrobna zdravila se ne uporabljajo za profilakso, razen v izjemnih primerih, ko se dajo posamezni živali ali omejenemu številu živali, kadar je tveganje za okužbo ali nalezljivo bolezen zelo veliko in je verjetno, da bodo posledice resne.
Article 107
V takih primerih je uporaba protimikrobnih zdravil za profilakso omejena na dajanje zdravila samo posamezni živali pod pogoji, določenimi v prvem pododstavku.
Use of antimicrobial medicinal products
Protimikrobna zdravila se uporabljajo za metafilakso le, kadar je tveganje za širjenje okužbe ali nalezljive bolezni v skupini živali visoko in kadar ni na voljo drugih ustreznih možnosti.
Antimicrobial medicinal products shall not be applied routinely nor used to compensate for poor hygiene, inadequate animal husbandry or lack of care or to compensate for poor farm management.
Države članice lahko zagotovijo smernice v zvezi s takimi drugimi ustreznimi možnostmi in dejavno podprejo razvoj in uporabo smernic, ki spodbujajo razumevanje dejavnikov tveganja, povezanih z metafilakso, in vključujejo merila za njeno izvajanje.
Antimicrobial medicinal products shall not be used in animals for the purpose of promoting growth nor to increase yield.
Zdravila, ki vsebujejo določene protimikrobne snovi iz člena 37(5), se ne uporabljajo v skladu s členi 112, 113 in 114.
Antimicrobial medicinal products shall not be used for prophylaxis other than in exceptional cases, for the administration to an individual animal or a restricted number of animals when the risk of an infection or of an infectious disease is very high and the consequences are likely to be severe.
Komisija lahko z izvedbenimi akti in ob upoštevanju znanstvenega mnenja Agencije določi seznam protimikrobnih snovi, ki:
In such cases, the use of antibiotic medicinal products for prophylaxis shall be limited to the administration to an individual animal only, under the conditions laid down in the first subparagraph.
se ne uporabljajo v skladu s členi 112, 113 in 114 ali
Antimicrobial medicinal products shall be used for metaphylaxis only when the risk of spread of an infection or of an infectious disease in the group of animals is high and where no other appropriate alternatives are available.
se ne uporabljajo v skladu s členi 112, 113 in 114 pod določenimi pogoji.
Member States may provide guidance regarding such other appropriate alternatives and shall actively support the development and application of guidelines which promote the understanding of risk factors associated with metaphylaxis and include criteria for its initiation.
Pri sprejemanju teh izvedbenih aktov Komisija upošteva naslednja merila:
Medicinal products which contain the designated antimicrobials referred to in Article 37(5) shall not be used in accordance with Articles 112, 113 and 114.
tveganja za zdravje živali ali javno zdravje, če se protimikrobna snov uporablja v skladu s členi 112, 113 in 114;
The Commission may, by means of implementing acts, and taking into consideration scientific advice of the Agency, establish a list of antimicrobials which:
tveganja za zdravje živali ali javno zdravje, če se razvije mikrobna odpornost;
shall not be used in accordance with Articles 112, 113 and 114; or
razpoložljivost drugih zdravljenj za živali;
shall only be used in accordance with Articles 112, 113 and 114 subject to certain conditions.
razpoložljivost drugih protimikrobnih zdravljenj za ljudi;
When adopting those implementing acts, the Commission shall take account of the following criteria:
vpliv na akvakulturo in gojenje, če se obolele živali ne zdravi.
risks to animal or public health if the antimicrobial is used in accordance with Articles 112, 113 and 114;
Država članica lahko na svojem ozemlju dodatno omeji ali prepove uporabo nekaterih protimikrobnih snovi pri živalih, če je dajanje takih protimikrobnih snovi živalim v nasprotju z izvajanjem nacionalne politike o preudarni rabi protimikrobnih snovi.
risk for animal or public health in case of development of antimicrobial resistance;
Ukrepi, ki jih države članice sprejmejo na podlagi odstavka 7, so sorazmerni in upravičeni.
availability of other treatments for animals;
Država članica obvesti Komisijo o vseh ukrepih, ki jih je sprejela na podlagi odstavka 7.
availability of other antimicrobial treatments for humans;
Člen 108
impact on aquaculture and farming if the animal affected by the condition receives no treatment.
Vodenje evidenc s strani lastnikov in imetnikov živali za proizvodnjo živil
A Member State may further restrict or prohibit the use of certain antimicrobials in animals on its territory if the administration of such antimicrobials to animals is contrary to the implementation of a national policy on prudent use of antimicrobials.
Lastniki ali, kadar živali ne redijo sami, imetniki živali za proizvodnjo hrane vodijo evidence o zdravilih, ki jih uporabljajo, ter, če je to ustrezno, hranijo kopijo veterinarskega recepta.
Measures adopted by the Member States on the basis of paragraph 7 shall be proportionate and justified.
Evidence iz odstavka 1 vključujejo:
The Member State shall inform the Commission of any measure it has adopted on the basis of paragraph 7.
datum, ko se zdravilo prvič da živalim;
Article 108
ime zdravila;
Record-keeping by owners and keepers of food-producing animals
količina danega zdravila;
Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the medicinal products they use and, if applicable, a copy of the veterinary prescription.
ime ali naziv podjetja in stalni naslov ali registrirani kraj poslovanja dobavitelja;
Records referred to in paragraph 1 shall include:
dokazilo o nakupu zdravila, ki ga uporabljajo;
date of the first administration of the medicinal product to the animals;
identifikacijo zdravljene živali ali skupine živali;
name of the medicinal product;
ime in kontaktne podatke veterinarja, ki je izdal recept, če je ustrezno;
quantity of the medicinal product administered;
karenco, tudi če je nič;
name or company name and permanent address or registered place of business of the supplier;
trajanje zdravljenja;
evidence of acquisition of the medicinal products they use;
Če so informacije, ki jih je treba evidentirati v skladu z odstavkom 2 tega člena, že na voljo na kopiji veterinarskega recepta, v evidenci, ki se hrani na kmetijskem gospodarstvu, ali za enoprste kopitarje v enotnem identifikacijskem dokumentu za celotno življenjsko dobo iz člena 8(4), jih ni treba posebej evidentirati.
identification of the animal or group of animals treated;
Države članice lahko določijo dodatne zahteve za vodenje evidenc s strani lastnikov in imetnikov živali za proizvodnjo živil.
name and contact details of the prescribing veterinarian, if applicable;
Informacije iz teh evidenc so na voljo za inšpekcijske preglede pristojnih organov v skladu s členom 123 vsaj za obdobje petih let.
withdrawal period even if such period is zero;
Člen 109
duration of treatment.
Obveznost vodenja evidenc za enoprste kopitarje
If the information to be recorded in accordance with paragraph 2 of this Article is already available on the copy of a veterinary prescription, in a record kept on the farm or for equine animals recorded in the single lifetime identification document referred to in Article 8(4), it does not need to be recorded separately.
Komisija sprejme delegirane akte v skladu s členom 147 za dopolnitev te uredbe glede vsebine in oblike informacij, potrebnih za uporabo členov 112(4) in 115(5) in ki jih mora vsebovati enotni identifikacijski dokument za celotno življenjsko dobo iz člena 8(4).
Member States may lay down additional requirements for record-keeping by owners and keepers of food-producing animals.
Komisija z izvedbenimi akti določi obrazce za vnos informacij, potrebnih za uporabo členov 112(4) in 115(5) in ki jih mora vsebovati enotni identifikacijski dokument za celotno življenjsko dobo iz člena 8(4).
The information contained in those records shall be available for inspections by the competent authorities in accordance with Article 123 for a period of at least five years.
Člen 110
Article 109
Uporaba imunoloških zdravil za uporabo v veterinarski medicini
Record-keeping obligations for equine animals
Pristojni organi v skladu z veljavnim nacionalnim pravom lahko prepovejo proizvodnjo, uvoz, distribucijo, posedovanje, prodajo, dobavo ali uporabo imunoloških zdravil za uporabo v veterinarski medicini na svojem ozemlju ali na njegovem delu, če je izpolnjen vsaj eden od naslednjih pogojev:
The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4).
dajanje zdravila živalim lahko ovira izvajanje nacionalnega programa za diagnosticiranje, nadzor in izkoreninjenje živalske bolezni;
The Commission shall, by means of implementing acts, lay down model forms for entering the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4).
dajanje zdravila živalim lahko povzroči težave pri potrjevanju odsotnosti bolezni pri živih živalih ali kontaminacijo v živilih ali drugih proizvodih iz zdravljenih živali;
Article 110
sevi povzročiteljev bolezni, za katero je namenjeno zdravilo za vzpostavljanje imunosti, so na zadevnem območju v veliki meri odsotni v smislu geografske razširjenosti.
Use of immunological veterinary medicinal products
Z odstopanjem od člena 106(1) te uredbe in če ni zdravila za uporabo v veterinarski medicini iz člena 116 te uredbe, lahko pristojni organ v primeru izbruha bolezni s seznama iz člena 5 Uredbe (EU) 2016/429 ali porajajoče se bolezni iz člena 6 navedene uredbe dovoli uporabo imunološkega zdravila za uporabo v veterinarski medicini, ki ni odobreno v Uniji.