natgillin/translations-raw huggingface dataset:
for milk from animals producing milk for human consumption the withdrawal period shall not be less than:
najdaljša karenca za jajca iz povzetka glavnih značilnosti zdravila za živalske vrste za proizvodnjo jajc, pomnožena s faktorjem 1,5;
the longest withdrawal period for milk provided in the summary of the product characteristics for any animal species multiplied by factor 1,5;
10 dni, če zdravilo ni odobreno za živali, katerih jajca so namenjena za prehrano ljudi;
seven days, if the medicinal product is not authorised for animals producing milk for human consumption;
za vodne vrste, katerih meso je namenjeno za prehrano ljudi, karenca ne znaša manj kot:
one day, if the medicinal product has a zero withdrawal period;
najdaljša karenca iz povzetka glavnih značilnosti zdravila za katero koli vodno vrsto, pomnožena s faktorjem 1,5 in izražena s „stopinjskimi dnevi“;
for eggs from animals producing eggs for human consumption the withdrawal period shall not be less than:
če je zdravilo odobreno za kopenske živalske vrste za proizvodnjo živil, najdaljša karenca iz povzetka glavnih značilnosti zdravila za katero koli živalsko vrsto za proizvodnjo živil, pomnožena s faktorjem 50 in izražena v stopinjskih dneh, vendar ne več kot 500 stopinjskih dni;
the longest withdrawal period for eggs provided in the summary of the product characteristics for any animal species multiplied by factor 1,5;
500 stopinjskih dni, če zdravilo ni odobreno za živalske vrste za proizvodnjo živil;
10 days, if the product is not authorised for animals producing eggs for human consumption;
25 stopinjskih dni, če je najdaljša karenca za katero koli živalsko vrsto nič.
for aquatic species producing meat for human consumption the withdrawal period shall not be less than:
Če rezultat izračuna karence v skladu s točkami (a)(i), (b)(i), (c)(i), (d)(i) in (ii) odstavka 1 ni celo število dni, se karenca zaokroži navzgor na najbližje število dni.
the longest withdrawal period for any of the aquatic species indicated in the summary of the product characteristics multiplied by factor of 1,5 and expressed as degree-days;
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 147, da spremeni ta člen s spremembo pravil iz odstavkov 1 in 4 tega člena na podlagi novih znanstvenih dokazov.
if the medicinal product is authorised for food-producing terrestrial animal species, the longest withdrawal period for any of the food-producing animal species indicated in the summary of product characteristics multiplied by a factor of 50 and expressed as degree-days, but not exceeding 500 degree-days;
Za čebele veterinar določi ustrezno karenco tako, da oceni specifični položaj posameznega panja za vsak primer posebej in zlasti tveganje ostankov v medu ali v drugih živilih, ki se pridobijo iz panjev in so namenjeni za prehrano ljudi.
500 degree-days, if the medicinal product is not authorised for food-producing animal species;
Z odstopanjem od člena 113(1) in (4) Komisija z izvedbenimi akti določi seznam snovi, ki so bistvenega pomena za zdravljenje enoprstih kopitarjev ali pomenijo dodano klinično korist v primerjavi z drugimi možnostmi zdravljenja enoprstih kopitarjev in za katere karenca v primeru enoprstih kopitarjev znaša šest mesecev.
25 degree-days if the highest withdrawal period for any animal species is zero.
Člen 116
If the calculation of the withdrawal period according to points (a)(i), (b)(i), (c)(i), (d)(i) and (ii) of paragraph 1 results in a fraction of days, the withdrawal period shall be rounded up to the nearest number of days.
Zdravstveno stanje
The Commission shall adopt delegated acts in accordance with Article 147 in order to amend this Article by amending the rules laid down in paragraphs 1 and 4 thereof in the light of new scientific evidence.
Z odstopanjem od člena 106(1) pristojni organ na svojem ozemlju lahko dovoli uporabo zdravil za uporabo v veterinarski medicini, ki v navedeni državi članici niso odobrena, kadar je to potrebno zaradi zdravstvenega stanja živali ali javnega zdravja in je dajanje v promet navedenih zdravil za uporabo v veterinarski medicini odobreno v drugi državi članici.
For bees, the veterinarian shall determine the appropriate withdrawal period by assessing the specific situation of the particular beehive or beehives on a case-by-case basis and in particular the risk of residue in honey or in any other foodstuffs harvested from beehives intended for human consumption.
Člen 117
By way of derogation from Article 113(1) and (4), the Commission shall, by means of implementing acts, establish a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species shall be six months.
Zbiranje in odstranjevanje odpadkov zdravil za uporabo v veterinarski medicini
Article 116
Države članice zagotovijo ustrezne sisteme zbiranja in odstranjevanje odpadkov zdravil za uporabo v veterinarski medicini.
Health situation
Člen 118
By way of derogation from Article 106(1), a competent authority may allow the use in its territory of veterinary medicinal products not authorised in that Member State, where the situation of animal or public health so requires, and the marketing of those veterinary medicinal products is authorised in another Member State.
Živali ali proizvodi živalskega izvora, uvoženi v Unijo
Article 117
Člen 107(2) se smiselno uporablja za izvajalce iz tretjih držav, ki ne smejo uporabljati določenih protimikrobnih snovi iz člena 37(5), če je to smiselno za živali ali proizvode živalskega izvora, uvožene iz teh tretjih držav v Unijo.
Collection and disposal of waste of veterinary medicinal products
Komisija sprejme delegirane akte v skladu s členom 147, da ta člen dopolni z določitvijo potrebnih natančnih pravil o uporabi odstavka 1 tega člena.
Member States shall ensure that appropriate systems are in place for the collection and disposal of waste of veterinary medicinal products.
Oglaševanje
Animals or products of animal origin imported into the Union
Oglaševanje zdravil za uporabo v veterinarski medicini
Article 107(2) shall apply, mutatis mutandis, to operators in third countries and those operators shall not use the designated antimicrobials referred to in Article 37(5), insofar as relevant in respect of animals or products of animal origin exported from such third countries to the Union.
Samo zdravila za uporabo v veterinarski medicini, ki so odobrena ali registrirana v državi članici, se lahko oglašujejo v tej državi članici, razen če pristojni organ odloči drugače v skladu z veljavnim nacionalnim pravom.
The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Article by providing the necessary detailed rules on the application of paragraph 1 of this Article.
Iz oglaševanja zdravila za uporabo v veterinarski medicini je jasno razvidno, da je njegov namen spodbujanje dobave, prodaje, predpisovanja, distribucije ali uporabe zdravila za uporabo v veterinarski medicini.
Advertising
Oglaševanje se ne oblikuje tako, da bi se lahko razumelo, da je zdravilo za uporabo v veterinarski medicini lahko krma ali biocid.
Article 119
Oglaševanje je skladno s povzetkom glavnih značilnosti oglaševanega zdravila za uporabo v veterinarski medicini.
Advertising of veterinary medicinal products
Oglaševanje ne vključuje informacij v kakršni koli obliki, ki bi lahko bile zavajajoče ali bi povzročile nepravilno rabo zdravila za uporabo v veterinarski medicini.
Only veterinary medicinal products that are authorised or registered in a Member State may be advertised in that Member State, unless otherwise decided by the competent authority in accordance with applicable national law.
Oglaševanje spodbuja odgovorno uporabo zdravila za uporabo v veterinarski medicini, tako da ga predstavi objektivno in brez pretiravanja glede njegovih lastnosti.
The advertising of a veterinary medicinal product shall make it clear that it aims at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product.
Začasni odvzem dovoljenja za promet preprečuje vsakršno oglaševanje zdravila za uporabo v veterinarski medicini v obdobju tega začasnega odvzema v državi članici, v kateri se dovoljenje začasno odvzame.
The advertising shall not be formulated in such a way as to suggest that the veterinary medicinal product could be a feed or a biocide.
Zdravila za uporabo v veterinarski medicini se ne delijo v promocijske namene, razen v majhnih količinah vzorcev.
The advertising shall comply with the summary of the product characteristics of the advertised veterinary medicinal product.
Protimikrobna zdravila za uporabo v veterinarski medicini se ne delijo v promocijske namene kot vzorci ali v kakršni koli drugi obliki.
The advertising shall not include information in any form which could be misleading or lead to incorrect use of the veterinary medicinal product.
Vzorci iz odstavka 8 so ustrezno označeni, da je razvidno, da so vzorci, in se dajo neposredno veterinarjem ali drugim osebam, ki jim je dovoljena dobava takih zdravil za uporabo v veterinarski medicini med sponzoriranimi dogodki, ali s strani prodajnih zastopnikov med njihovimi obiski.
The advertising shall encourage the responsible use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties.
Člen 120
The suspension of a marketing authorisation shall preclude any advertising, during the period of that suspension, of the veterinary medicinal product in the Member State in which it is suspended.
Oglaševanje zdravil za uporabo v veterinarski medicini na veterinarski recept
Veterinary medicinal products shall not be distributed for promotional purposes except for small quantities of samples.
Oglaševanje zdravil za uporabo v veterinarski medicini, za katere je potreben veterinarski recept v skladu s členom 34, je dovoljeno le izrecno za:
Antimicrobial veterinary medicinal products shall not be distributed for promotional purposes as samples or in any other presentation.
veterinarjih;
The samples referred to in paragraph 8 shall be appropriately labelled indicating that they are samples and shall be given directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events or by sales representatives during their visits.
osebe, ki jim je v skladu v skladu z nacionalnim pravom dovoljena dobava zdravila za uporabo v veterinarski medicini.
Article 120
Z odstopanjem od odstavka 1 tega člena lahko država članica oglaševanje zdravil za uporabo v veterinarski medicini, za katere je v skladu s členim 34 potreben veterinarski recept, profesionalnim rejcem živali dovoli pod naslednjimi pogoji:
Advertising of veterinary medicinal products subject to veterinary prescription
če je oglaševanje omejeno na imunološka zdravila za uporabo v veterinarski medicini;
The advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 shall be allowed only when made exclusively to the following persons:
če oglaševanje vključuje izrecen poziv profesionalnim rejcem, naj se posvetujejo z veterinarjem glede imunološkega zdravila za uporabo v veterinarski medicini.
veterinarians;
Ne glede na odstavka 1 in 2 je prepovedano oglaševanje inaktiviranih imunoloških zdravil za uporabo v veterinarski medicini, ki se proizvajajo iz patogenih organizmov in antigenov, pridobljenih iz živali v epidemiološki enoti, in se uporabljajo za zdravljenje te živali ali teh živali v isti epidemiološki enoti ali za zdravljenje živali v enoti, ki ima potrjeno epidemiološko povezavo.
persons permitted to supply veterinary medicinal products in accordance with national law.
Člen 121
By way of derogation from paragraph 1 of this Article, advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 to professional keepers of animals may be permitted by the Member State provided the following conditions are met:
Promocija zdravil, ki se uporabljajo pri živalih
the advertising is limited to immunological veterinary medicinal products;
Kadar se zdravila v skladu s to uredbo promovirajo osebam, ki so usposobljene za njihovo predpisovanje ali dobavo, se takšnim osebam ne sme dajati, ponujati ali obljubljati daril, denarnih nadomestil ali koristi, razen če gre za darila, ki niso draga in so povezana s predpisovanjem ali dobavo zdravil.
the advertising includes an express invitation to the professional keepers of animal to consult the veterinarian about the immunological veterinary medicinal product.
Osebe, ki so usposobljene za predpisovanje ali dobavo zdravil iz odstavka 1, ne zahtevajo ali sprejmejo nobenih spodbud, ki so prepovedane s tem odstavkom.
Notwithstanding paragraphs 1 and 2, the advertising of inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link shall be prohibited.
Odstavek 1 ne preprečuje neposredne ali posredne gostoljubnosti na dogodkih, ki so v celoti strokovne in znanstvene narave.
Article 121
Takšna gostoljubnost je vedno strogo omejena na glavne cilje dogodka.
Promotion of medicinal products used in animals
Odstavki 1, 2 in 3 ne vplivajo na obstoječe ukrepe ali poslovno prakso držav članic v zvezi s cenami, maržami in popusti.
Where medicinal products are being promoted to persons qualified to prescribe or supply them in accordance with this Regulation, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products.
Člen 122
Persons qualified to prescribe or supply medicinal products as referred to in paragraph 1 shall not solicit or accept any inducement prohibited under that paragraph.
Izvajanje določb o oglaševanju
Paragraph 1 shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes.
Države članice lahko določijo postopke, za katere menijo, da so potrebni za izvajanje členov 119, 120 in 121.
Such hospitality shall always be strictly limited to the main objectives of the event.
POGLAVJE VIII
Paragraphs 1, 2 and 3 shall not affect existing measures or trade practice in Member States relating to prices, margins and discounts.
INŠPEKCIJSKI PREGLEDI IN NADZOR
Implementation of advertising provisions
Nadzor
Member States may lay down any procedures they deem necessary for the implementation of Articles 119, 120 and 121.
Pristojni organi izvajajo nadzor pri naslednjih osebah:
CHAPTER VIII
proizvajalcih in uvoznikih zdravil in učinkovin za uporabo v veterinarski medicini;
INSPECTIONS AND CONTROLS
distributerjih učinkovin;
Article 123
imetnikih dovoljenja za promet;
Controls
imetnikih dovoljenja za promet na debelo;
Competent authorities shall carry out controls of the following persons:
trgovcih na drobno;
manufacturers and importers of veterinary medicinal products and active substances;
lastnikih in imetnikih živali za proizvodnjo živil;
distributors of active substances;
imetnikih registracij za homeopatska zdravila za uporabo v veterinarski medicini;
marketing authorisation holders;
imetnikih zdravil za uporabo v veterinarski medicini iz člena 5(6) in
holders of a wholesale distribution authorisation;
vseh drugih osebah, ki imajo obveznosti na podlagi te uredbe.
retailers;
Nadzor iz odstavka 1 se izvajajo redno, na podlagi tveganja, da bi preverjali, da osebe iz odstavka 1 delujejo v skladu s to uredbo.
owners and keepers of food-producing animals;
Nadzor na podlagi tveganja iz odstavka 2 izvajajo pristojni organi ob upoštevanju vsaj:
holders of a registration for homeopathic veterinary medicinal products;
neizogibnih tveganj, povezanih z dejavnostmi oseb iz odstavka 1 in lokacijo njihovih dejavnosti;
holders of veterinary medicinal products referred to in Article 5(6); and
pretekle evidence oseb iz odstavka 1, kar zadeva rezultate nadzora, opravljenega pri njih in izpolnjevanje zahtev v preteklosti;
any other persons having obligations under this Regulation.
kakršnih koli informacij, ki bi lahko nakazovale neskladnost;
The controls referred to in paragraph 1 shall be carried out regularly, on a risk-basis, in order to verify that the persons referred to in paragraph 1 comply with this Regulation.
morebitnega vpliva neizpolnjevanja zahtev na javno zdravje, zdravje živali, dobrobit živali in okolje.
The risk-based controls referred to in paragraph 2 shall be carried out by the competent authorities taking account of at least:
Nadzor se lahko izvede tudi na zahtevo pristojnega organa druge države članice, Komisije ali Agencije.
the intrinsic risks associated with the activities of the persons referred to in paragraph 1 and the location of their activities;
Nadzor izvajajo predstavniki pristojnega organa.
the past record of the persons referred to paragraph 1 as regards the results of controls performed on them and their previous compliance;
Inšpekcijski pregledi se lahko izvajajo kot del nadzora.
any information that might indicate non-compliance;
Inšpekcijski pregledi so lahko nenapovedani.
the potential impact of non-compliance on public health, animal health, animal welfare and the environment.
V času teh inšpekcijskih pregledov imajo predstavniki pristojnega organa vsaj pooblastilo, da:
Controls may also be carried out on the request of a competent authority of another Member State, the Commission or the Agency.
pregledajo prostore, opremo, prevozna sredstva, evidence, dokumente in sisteme, povezane s predmetom inšpekcijskega pregleda;
Controls shall be carried out by representatives of the competent authority.
pregledajo in vzamejo vzorce z namenom, da jih predložijo za neodvisno analizo Uradnemu kontrolnemu laboratoriju za preskušanje zdravil ali laboratoriju, ki je bil za ta namen pooblaščen s strani države članice;
Inspections may be carried out as part of the controls.
dokumentirajo vse dokaze, ki se predstavnikom zdijo potrebni;
Such inspections may be made unannounced.
opravijo isti nadzor pri vseh straneh, ki opravljajo naloge, ki jih predvideva ta uredba, z ali za osebo iz odstavka 1 ali v njenem imenu.
During those inspections the representatives of a competent authority shall at least be empowered to:
Predstavniki pristojnih organov vodijo evidenco o vsakem nadzoru, ki ga opravijo, ter po potrebi pripravijo poročilo.
inspect the premises, equipment, means of transport, records, documents and systems, related to the objective of the inspection;
Pristojni organ osebe iz odstavka 1 nemudoma pisno obvesti o vseh primerih neskladnosti, ugotovljenih z nadzorom, te pa imajo možnost, da to komentirajo v roku, ki ga določi pristojni organ.
inspect and take samples with a view to submitting them for an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by a Member State;
Pristojni organi imajo vzpostavljene postopke ali ureditve, s katerimi zagotovijo, da osebje, ki izvaja nadzor, nima nasprotja interesov.
document any evidence deemed necessary by the representatives;
Člen 124
carry out the same controls on any parties performing the tasks required under this Regulation with, for or on behalf of the persons referred to in paragraph 1.
Revizije Komisije
The representatives of the competent authorities shall keep a record of every control that they carry out and where necessary shall draw up a report.
Komisija lahko v državah članicah izvaja revizije pristojnih organov, da bi potrdila ustreznost nadzora, ki ga izvajajo ti pristojni organi.
The person referred to in paragraph 1 shall be promptly informed in writing by the competent authority of any case of non-compliance identified through the controls and shall have the opportunity to submit comments within a time limit set by the competent authority.
Te revizije se uskladijo z relevantno državo članico in se izvajajo na način, ki ne povzroča dodatnega upravnega bremena.
The competent authorities shall have procedures or arrangements in place to ensure that staff performing controls are free from any conflict of interest.
Po vsaki reviziji Komisija pripravi poročilo, ki po potrebi vsebuje priporočila za relevantno državo članico.
Article 124
Komisija pošlje pristojnemu organu osnutek poročila za komentarje in vse komentarje upošteva pri pripravi končnega poročila.
Audits by the Commission
Komisija objavi končno poročilo in komentarje.
The Commission may carry out audits in Member States on their competent authorities for the purpose of confirming the appropriateness of the controls carried out by those competent authorities.
Člen 125
Such audits shall be coordinated with the relevant Member State and shall be carried out in a manner which avoids unnecessary administrative burden.
Potrdilo o ustreznosti
After each audit, the Commission shall draft a report containing, where appropriate, recommendations to the relevant Member State.
Zaradi preverjanja, ali so podatki, predloženi za pridobitev potrdila o ustreznosti, v skladu z monografijami Evropske farmakopeje, lahko standardizacijski organ za nomenklature in merila kakovosti v smislu Konvencije o izdelavi Evropske farmakopeje, sprejete s Sklepom Sveta 94/358/ES (Evropski direktorat za kakovost zdravil in zdravstvenega varstva), Komisijo ali Agencijo zaprosi, da zahteva inšpekcijski pregled, ki ga opravi pristojni organ, kadar je zadevna vhodna snov predmet monografije Evropske farmakopeje.
The Commission shall send the draft report to the competent authority for comments and shall take into account any such comments in drawing up the final report.
Člen 126
The final report and the comments shall be made public by the Commission.
Posebna pravila o inšpekcijskih pregledih farmakovigilance
Article 125
Pristojni organi in Agencija zagotovijo, da se vsi glavni dosjeji o sistemu farmakovigilance v Uniji redno preverjajo in da se sistemi farmakovigilance pravilno uporabljajo.
Certificate of suitability
Agencija koordinira in pristojni organi izvajajo inšpekcijske preglede sistemov farmakovigilance za zdravila za uporabo v veterinarski medicini z dovoljenjem v skladu s členom 44.
In order to verify whether the data submitted for obtaining a certificate of suitability complies with the monographs of the European Pharmacopoeia, the standardisation body for nomenclatures and quality norms within the meaning of the Convention on the elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC (European Directorate for the Quality of Medicines and Healthcare (‘EDQM’)) may ask the Commission or the Agency to request an inspection by a competent authority when the starting material concerned is subject to a European Pharmacopoeia monograph.
Pristojni organi izvajajo inšpekcijske preglede sistemov farmakovigilance za zdravila za uporabo v veterinarski medicini z dovoljenjem v skladu s členi 47, 49, 52 in 53.
Article 126
Pristojni organi držav članic, v katerih se nahaja glavni dosje o sistemu farmakovigilance, izvajajo inšpekcijske preglede glavnih dosjejev o sistemu farmakovigilance.
Specific rules on pharmacovigilance inspections
Ne glede na odstavek 4 tega člena in v skladu s členom 80 lahko pristojni organ sodeluje pri pobudah za delitev dela in delegiranju pristojnosti z drugimi pristojnimi organi, da se prepreči podvajanje inšpekcijskih pregledov sistemov farmakovigilance.
The competent authorities and the Agency shall ensure that all pharmacovigilance system master files in the Union are regularly checked and that the pharmacovigilance systems are being correctly applied.
Rezultati inšpekcijskih pregledov farmakovigilance se zabeležijo v zbirki podatkov o farmakovigilanci, kot določa člen 74.
The Agency shall coordinate and the competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Article 44.
Člen 127