FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In particular, Member States may require the maintenance of a record giving at least the following information:
Slovenian: Še posebno lahko države članice zahtevajo hranjenje evidence z najmanj naslednjimi podatki:
English: name of the veterinary medicinal product;
Slovenian: ime zdravila za uporabo v veterinarski medicini;
English: quantity;
Slovenian: količino;
English: name and address of the supplier of the medicinal product;
Slovenian: ime in naslov dobavitelja zdravila;
English: identification of the animals treated.
Slovenian: identifikacijo zdravljene živali.
English: Article 70
Slovenian: Člen 70
English: Notwithstanding Articles 9 and 67, Member States shall ensure that veterinarians providing services in another Member State can take with them and administer to animals small quantities of ready-made veterinary medicinal products not exceeding daily requirements other than immunological veterinary medicinal products which are not authorized for use in the Member State in which the services are provided (hereinafter:
Slovenian: Ne glede na člena 9 in 67, morajo države članice zagotoviti, da smejo veterinarji, ki nudijo usluge v drugi državi članici, s sabo nositi ter dajati živalim majhne količine že pripravljenih zdravil za uporabo v veterinarski medicini, katerih količina na sme presegati dnevne potrebe, razen za imunološka zdravila za uporabo v veterinarski medicini, ki jih ni dovoljeno uporabljati v državi članici, v kateri se nudijo usluge (v nadaljnjem besedilu:
English: host Member State), providing that the following conditions are satisfied:
Slovenian: država članica gostiteljica), pod pogojem, da so izpolnjeni naslednji pogoji:
English: the authorization to place the product on the market provided for in Articles 5, 7 and 8 has been issued by the competent authorities of the Member State in which the veterinarian is established;
Slovenian: da je pristojni organ države članice, od koder izhaja veterinar, izdal dovoljenje za promet s zdravilom iz členov 5, 7 in 8;
English: the veterinary medicinal products are transported by the veterinarian in the original manufacturer's packaging;
Slovenian: da veterinar prenaša zdravila za uporabo v veterinarski medicini v originalni ovojnini izdelovalca;
English: the veterinary medicinal products intended for administration to food-producing animals have the same qualitative and quantitative composition in terms of active substances as the medicinal products authorized in accordance with Articles 5, 7 and 8 in the host Member State;
Slovenian: da imajo zdravila za uporabo v veterinarski medicini, ki so namenjena živalim za proizvodnjo živil, v pogledu zdravilnih učinkovin isto kakovostno in količinsko sestavo kot zdravila, ki imajo dovoljenje za promet v skladu s členi 5, 7 in 8 v državi članici gostiteljici;
English: the veterinarian providing services in another Member State acquaints himself with the good veterinary practices applied in that Member State and ensures that the withdrawal period specified on the labelling of the veterinary medicinal product concerned is complied with, unless he could reasonably be expected to know that a longer withdrawal period should be specified to comply with these good veterinary practices;
Slovenian: da se veterinar, ki nudi usluge v drugi državi članici, seznani z načeli dobre veterinarske prakse, ki se uporablja v tej državi članici in zagotovi, da se upošteva karenca, ki je navedena na ovojnini zdravila za uporabo v veterinarski medicini, razen če se od veterinarja lahko razumno pričakuje, da ve, da je treba odrediti daljšo karenco, da bi se skladala z načeli te dobre veterinarske prakse;
English: the veterinarian shall not furnish any veterinary medicinal product to the owner or keeper of the animals treated in the host Member State unless this is permissible on the basis of the rules of the host Member State;
Slovenian: da veterinar ne bo dajal nobenih zdravil za uporabo v veterinarski medicini lastniku ali rejcu zdravljene živali v državi članici gostiteljici, razen če je to dovoljeno na podlagi pravil države članice gostiteljice;
English: in this case he shall, however, supply only in relation to animals under his care and only the minimum quantities of veterinary medicinal product necessary to complete the treatment of animals concerned on that occasion;
Slovenian: v tem primeru sme dajati živalim, ki so v njegovi oskrbi samo minimalne količine zdravila za uporabo v veterinarski medicini, potrebne za zaključek zdravljenja zadevne živali;
English: the veterinarian shall be required to keep detailed records of the animals treated, the diagnosis, the veterinary medicinal products administered, the dosage administered, the duration of treatment and the withdrawal period applied.
Slovenian: da mora veterinar hraniti podrobne evidence o zdravljenih živali, o diagnozi, o uporabljenih zdravilih za uporabo v veterinarski medicini, o danih odmerkih zdravil, o trajanju zdravljenja ter o karenci.
English: These records shall be available for inspection by the competent authorities of the host Member State for a period of at least three years;
Slovenian: Ti podatki morajo biti na voljo za pregled pristojnih organov v državi članici gostiteljici najmanj za dobo treh let;
English: the overall range and quantity of veterinary medicinal products carried by the veterinarian shall not exceed that generally required for the daily needs of good veterinary practice.
Slovenian: da vrste in količina zdravil za uporabo v veterinarski medicini, ki jih prenaša veterinar ne presegajo običajnih dnevnih potreb v skladu z načeli dobre veterinarske prakse.
English: Article 71
Slovenian: Člen 71
English: In the absence of specific Community legislation concerning the use of immunological veterinary medicinal products for the eradication or control of animal disease, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: V primeru odsotnosti posebne zakonodaje Skupnosti, glede uporabe imunoloških zdravil za uporabo v veterinarski medicini za izkoreninjenje ali kontrolo živalskih bolezni, lahko država članica, v skladu z nacionalno zakonodajo, prepove izdelavo, uvoz, posedovanje, prodajo, dobavo in/ali uporabo imunoloških zdravil za uporabo v veterinarski medicini na celotnem ali delnem območju svoje države, če ugotovi, da:
English: the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals;
Slovenian: je dajanje zdravila živalim v neskladju z izvajanjem nacionalnega programa za diagnosticiranje, kontrolo in izkoreninjanje živalske bolezni, ali če bi to povzročilo težave pri zagotavljanju odsotnosti kontaminacije pri živih živalih, ali v živilih, ali drugih proizvodih iz zdravljenih živali;
English: the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: da je bolezen, za katero je zdravilo za vzpostavljanje imunosti namenjeno, na zadevnem območju v glavnem odsotna.
English: The competent authorities of the Member States shall inform the Commission of all instances in which the provisions of paragraph 1 are applied.
Slovenian: Pristojni organi države članice morajo obvestiti Komisijo o primerih, v katerih se uporabljajo določila odstavka 1.
English: TITLE VII
Slovenian: NASLOV VII
English: PHARMACOVIGILANCE
Slovenian: FARMAKOVIGILANCA
English: Article 72
Slovenian: Člen 72
English: Member States shall take all appropriate measures to encourage the reporting to the competent authorities of suspected adverse reactions to veterinary medicinal products.
Slovenian: Države članice uvedejo ustrezne ukrepe za spodbujanje poročanja pristojnim organom o sumu neželenih škodljivih učinkov zdravila za uporabo v veterinarski medicini.
English: The Member States may impose specific requirements on veterinary practitioners and other health care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions, in particular where such reporting is a condition of the marketing authorization.
Slovenian: Države članice lahko uvedejo specifične zahteve za veterinarje in strokovnjake na področju varovanja zdravja glede njihovega poročanja o sumu resnih ali nepričakovanih neželenih škodljivih učinkov ter neželenih škodljivih učinkov pri ljudeh, še posebno v primerih, ko je poročanje pogoj iz dovoljena za promet z zdravilom.
English: Article 73
Slovenian: Člen 73
English: In order to ensure the adoption of appropriate regulatory decisions concerning the veterinary medicinal products authorised within the Community, having regard to information obtained about suspected adverse reactions to veterinary medicinal products under normal conditions of use, the Member States shall establish a veterinary pharmacovigilance system.
Slovenian: Da bi se zagotovil sprejem ustreznih regulatornih odločitev glede zdravil za uporabo v veterinarski medicini z dovoljenjem za promet znotraj Skupnosti glede na pridobljene informacije o sumu neželenih škodljivih učinkov zdravil za uporabo v veterinarski medicini, morajo države članice vzpostaviti sistem veterinarske farmakovigilance.
English: This system shall be used to collect information useful in the surveillance of veterinary medicinal products, with particular reference to adverse reactions in animals and in human beings related to the use of veterinary medicinal products, and to evaluate such information scientifically.
Slovenian: Sistem se mora uporabljati za zbiranje informacij, ki so koristne za nadzor zdravil za uporabo v veterinarski medicini, s poudarkom na neželenih škodljivih učinkih pri živalih ter ljudeh v povezavi z uporabo zdravil za uporabo v veterinarski medicini, ter za znanstveno ovrednotenje teh informacij.
English: Such information shall be collated with available data on the sale and prescription of veterinary medicinal products.
Slovenian: Tovrstne informacije je treba primerjati z razpoložljivimi podatki o prodaji in predpisovanju zdravil za uporabo v veterinarski medicini.
English: This system also takes into account any available information related to the lack of expected efficacy, off-label use, investigations of the validity of the withdrawal period and on potential environmental problems, arising from the use of the product, interpreted in accordance with the Commission guidelines referred to in Article 77(1), which may have an impact on the evaluation of their benefits and risks.
Slovenian: Ta sistem tudi upošteva vse razpoložljive informacije, ki se nanašajo na izostanek pričakovane učinkovitosti, izjemno uporabo, raziskave o veljavnosti karence ter na morebitne okoljske probleme, ki so posledica uporabe zdravila in ki se tolmačijo v skladu s smernicami Komisije iz člena 77(1) in ki imajo lahko vpliv na oceno koristi in tveganj.
English: Article 74
Slovenian: Člen 74
English: The marketing authorization holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora imeti stalno in neprekinjeno na voljo ustrezno usposobljeno osebo, odgovorno za farmakovigilanco.
English: That qualified person shall be responsible for the following:
Slovenian: Ta usposobljena oseba mora biti odgovorna za naslednje:
English: the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, including its representatives, is collected and collated in order to be accessible at least at one point within the Community;
Slovenian: vzpostavitev in vzdrževanje sistema, ki bo zagotavljal, da bodo vsi sumljivi neželeni škodljivi učinki, o katerih so bila podana poročila osebju podjetja, vključno z njegovim vodstvom, zbrana in primerjana, da bi bila na voljo najmanj na enem mestu znotraj Skupnosti;
English: the preparation for the competent authorities of the reports referred to in Article 75, in such form as may be laid down by those authorities, in accordance with the guidance referred to in Article 77(1);
Slovenian: pripravo poročil za pristojne organe iz člena 75, v obliki, ki jo določijo ti organi, v skladu s smernicami iz člena 77(1);
English: ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the veterinary medicinal product concerned;
Slovenian: popoln in takojšen odgovor pristojnim organom, kadar zahtevajo, da so posredovane dodatne informacije, potrebne za oceno koristi in tveganj zaradi zdravila za uporabo v veterinarski medicini, vključno s posredovanjem informacij o obsegu prodaje ali izdanih receptov za zadevna zdravila za uporabo v veterinarski medicini;
English: the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies.
Slovenian: zagotavljanje ostalih informacij pristojnim organom, ki so primerna za oceno koristi in tveganj v zvezi z zdravilom za uporabo v veterinarski medicini, kar vključuje ustrezne informacije o študijah o varnosti zdravila po pridobitvi dovoljenja za promet.
English: Article 75
Slovenian: Člen 75
English: The marketing authorization holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country.
Slovenian: Od imetnika dovoljenja za promet z zdravilom se zahteva, da vzdržuje podrobne evidence o vseh sumljivih neželenih škodljivih učinkih, ki se pojavijo bodisi v Skupnosti ali v tretji državi.
English: The marketing authorization holder shall be required to record and to report all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products, of which he can reasonably be expected to have knowledge, or which are brought to his attention, immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zabeležiti in takoj, vsekakor pa ne pozneje kakor v 15 koledarskih dneh po prejetju informacije, poročati pristojnemu organu države članice, na ozemlju katere je do dogodka prišlo, o sumljivih resnih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh v zvezi z uporabo zdravil za uporabo v veterinarski medicini, za katere se lahko logično pričakuje, da jih pozna, ali za katere izve.
English: The marketing authorization holder shall ensure that the suspected serious and unexpected adverse reactions and human adverse reactions, occurring in the territory of a third country, are reported immediately in accordance with the guidance referred to in Article 77(1), so that they are available to the Agency and to the competent authorities in the Member State(s) where the veterinary medicinal product is authorized, and in no case later than 15 calendar days following the receipt of the information.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da takoj, vsekakor pa ne pozneje kakor v 15 koledarskih dneh po prejetju informacije, poroča o sumljivih resnih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh, ki se dogajajo na ozemlju tretje države, v skladu s smernicami iz člena 77(19), da so poročila na voljo agenciji ter pristojnim organom v državi(ah) članici(ah), kjer ima zdravilo za uporabo v veterinarski medicini dovoljenje za promet.
English: In the case of veterinary medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition under Articles 21, 22 and 32(4) of this Directive and veterinary medicinal products for which there has been a referral to the procedures under Articles 36, 37 and 38 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions, occurring in the Community, are reported in the format and at intervals to be agreed with the reference Member State or a competent authority designated as reference Member State, in such a way so as to be accessible to the reference Member State.
Slovenian: V primeru zdravil za uporabo v veterinarski medicini, ki so obravnavana v obsegu uporabe Direktive 87/22/EGS, ali ki so izkoristila postopke medsebojnega priznavanja iz členov 21, 22 ter 32(4) te direktive ter zdravil za uporabo v veterinarski medicini, ki so bila predana v postopke iz členov 36, 37 ter 38 te direktive, mora imetnik dovoljenja za promet z zdravilom dodatno zagotoviti, da o vseh sumljivih resnih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh, do katerih prihaja znotraj Skupnosti, poroča v obliki ter v intervalih, ki jih je treba sporazumno določiti z referenčno državo članico, ali pristojnim organom, ki je določen kot referenčna država članica, na način, da bo poročilo dostopno referenčni državi članici.
English: Unless other requirements have been laid down as condition of the granting of authorization, records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows:
Slovenian: Če ni drugih zahtev, ki so pogoj za izdajo dovoljenja za promet, se morajo podatki o vseh neželenih škodljivih učinkih posredovati pristojnim organom v obliki periodičnega posodobljenega varnostnega poročila, bodisi na zahtevo takoj, ali periodično kakor sledi:
English: six monthly for the first two years after authorization, annually for the subsequent two years, and at the same time of the first renewal.
Slovenian: vsakih šest mesecev v prvih dveh letih po izdaji dovoljenja za promet, letno za nadaljnji dve leti, ter hkrati s prvim podaljšanjem dovoljenja za promet.
English: Thereafter, the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorization.
Slovenian: Po tem je treba periodična posodobljena varnostna poročila posredovati v petletnih intervalih, skupaj z vlogo za podaljšanje dovoljenja za promet.
English: The periodic safety update report shall include a scientific evaluation of the benefits and risks afforded by the veterinary medicinal product.
Slovenian: Periodično posodobljeno varnostno poročilo mora vsebovati znanstveno ovrednotenje koristi ter tveganj zaradi zdravila za uporabo v veterinarski medicini.
English: Following the granting of a marketing authorization, the marketing authorization holder may request the amendment of the periods referred to in this Article according to the procedure laid down by the Commission Regulation (EC) No 541/95(14), if applicable.
Slovenian: Po izdaji dovoljenja za promet z zdravilom lahko imetnik dovoljenja za promet z zdravilom, če je primerno, zahteva spremembo obdobij iz tega člena v skladu s postopkom, določenim z Uredbo Komisije (ES) št. 541/95 [14], kjer je to primerno.
English: Article 76
Slovenian: Člen 76
English: The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community.
Slovenian: Agencija mora v sodelovanju z državo članico in Komisijo vzpostaviti informacijsko mrežo za izmenjavo podatkov o farmakovigilanci za zdravila, ki so v prometu v Skupnosti.
English: Making use of the network foreseen in the first paragraph, Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, in accordance with the guidance referred to in Article 77(1), that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
Slovenian: Z uporabo mreže, predvidene v prvem odstavku, bodo države članice lahko zagotovile, v skladu s smernicami iz člena 77(1), da bodo poročila o sumljivih resnih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh, do katerih je prišlo na njihovem ozemlju, takoj dostopna agenciji ter drugim državam članicam, vsekakor pa najpozneje v roku 15 koledarskih dni od dneva prijave.
English: The Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification at the latest.
Slovenian: Države članice morajo zagotoviti, da bodo poročila o sumljivih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh, do katerih je prišlo na njihovem ozemlju, takoj dostopna imetniku dovoljenja za promet z zdravilom, vsekakor pa najpozneje v roku 15 koledarskih dni od prijave.
English: Article 77
Slovenian: Člen 77
English: In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and the interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information in accordance with internationally agreed terminology.
Slovenian: Za olajšanje izmenjave informacij o farmakovigilanci v Skupnosti, mora Komisija, po posvetu agencijo, državami članicami ter zainteresiranimi strankami, izdelati smernice za zbiranje, preverjanje ter predstavitev poročil o neželenih škodljivih učinkih, skupaj s tehničnimi zahtevami za elektronsko izmenjavo informacij o veterinarski farmakovigilanci v skladu z mednarodno sprejeto terminologijo.
English: This guidance shall be published in Volume 9 of the Rules governing medicinal products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance.
Slovenian: Smernice morajo biti objavljene v zvezku 9 Pravil, ki urejajo zdravila v Evropski skupnosti ter morajo upoštevati rezultate mednarodnega usklajevanja na področju farmakovigilance.
English: For the interpretation of the definitions referred to in Article 1 points 10 to 16 and principles outlined in this title, the marketing authorisation holder and the competent authorities shall refer to the detailed guidance referred to in paragraph 1.
Slovenian: Za tolmačenje opredelitev iz točk 10 do 16 člena 1 in načel, opisanih pod tem naslovom, mora imetnik dovoljenja za promet z zdravilom ter pristojni organi, uporabljati podrobne smernice iz odstavka 1.
English: Article 78
Slovenian: Člen 78
English: Where, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorization should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure, it shall forthwith inform the Agency, the other Member States and the marketing authorization holder.
Slovenian: Če država članica na osnovi rezultata ovrednotenja podatkov veterinarske farmakovigilance meni, da bi bilo treba dovoljenje za promet z zdravilom preklicati, ukiniti ali spremeniti zato, da bi se omejile indikacije ali dostopnost, spremenili načini dajanja in odmerki, dodalo kontraindikacijo ali dodal nov previdnostni ukrep, mora o tem nemudoma obvestiti agencijo, druge države članice ter imetnika dovoljenja za promet z zdravilom.