natgillin/translations-raw huggingface dataset:
The use of such registered homeopathic veterinary medicinal products is therefore subject to national law which is also the case as regards homeopathic medicinal products registered in accordance with Directive 2001/83/EC of the European Parliament and of the Council.
Zato se za uporabo teh registriranih homeopatskih zdravil za uporabo v veterinarski medicini uporablja nacionalno pravo, kar velja tudi za homeopatska zdravila, registrirana v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta.
In order to protect public and animal health and the environment, the activities, services and tasks attributed to the Agency in this Regulation should be adequately funded.
Za varovanje javnega zdravja in zdravja živali ter okolja bi bilo treba ustrezno financirati dejavnosti, storitve in naloge, ki so določene za Agencijo v tej uredbi.
Those activities, services and tasks should be funded through fees charged by the Agency to undertakings.
Navedene dejavnosti, storitve in naloge bi bilo treba financirati s pristojbinami, ki jih Agencija zaračuna podjetjem.
Those fees, however, should not affect the right of Member States to charge fees for activities and tasks carried out at national level.
Vendar te pristojbine ne bi smele vplivati na pravico držav članic, da zaračunavajo pristojbine za dejavnosti in naloge, ki se izvajajo na nacionalni ravni.
It is generally accepted that the existing requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products presented when applying for a marketing authorisation in Annex I to Directive 2001/82/EC as last amended by Commission Directive 2009/9/EC work sufficiently well in practice.
Na splošno velja, da veljavne zahteve iz Priloge I k Direktivi 2001/82/ES, kakor je bila nazadnje spremenjena z Direktivo Komisije 2009/9/ES, v zvezi s tehnično dokumentacijo o kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini, ki se priložijo k vlogi za izdajo dovoljenja za promet, v praksi dovolj dobro delujejo.
There is no urgent need, therefore, to substantially change those requirements.
Zato ni nujno, da se navedene zahteve bistveno spremenijo.
However, there is a need to adjust those requirements in order to respond to the identified discrepancies with the international scientific progress or latest developments, including guidance from VICH, WHO, the Organisation for Economic Cooperation and Development (OECD) standards, and taking into account also the need to develop specific requirements for novel therapy veterinary medicinal products while avoiding major overhaul of the current provisions, in particular not altering their structure.
Vendar pa je navedene zahteve treba prilagoditi, da bi odpravili ugotovljena neskladja z mednarodnim znanstvenim napredkom ali najnovejšim razvojem, tudi s smernicami VICH, SZO ter standardi Organizacije za gospodarsko sodelovanje in razvoj (OECD), pri čemer je treba upoštevati tudi potrebo po razvoju posebnih zahtev za zdravila za uporabo v veterinarski medicini za nove terapije, in se hkrati izogniti obsežni prenovi trenutnih določb, zlasti njihove strukture.
When providing services in another Member State, veterinarians should follow any national rules present in the host Member State pursuant to Directive 2005/36/EC of the European Parliament and of the Council and Directive 2006/123/EC of the European Parliament and of the Council.
Pri opravljanju storitev v drugih državah članicah bi morali veterinarji v skladu z Direktivo 2005/36/ES Evropskega parlamenta in Sveta in Direktivo 2006/123/ES Evropskega parlamenta in Sveta upoštevati nacionalna pravila države članice gostiteljice.
Taking into account the main changes that should be made to the existing rules, and aiming to improve the functioning of the internal market, a regulation is the appropriate legal instrument to replace Directive 2001/82/EC in order to lay down clear, detailed and directly applicable rules.
Ob upoštevanju bistvenih sprememb, ki bi jih bilo treba vnesti v obstoječa pravila in ki bi naj izboljšala delovanje notranjega trga, je uredba ustrezen pravni instrument za nadomestitev Direktive 2001/82/ES za določitev jasnih in podrobnih pravil, ki se neposredno uporabljajo.
Moreover, a regulation ensures that legal requirements are implemented at the same time and in a harmonised manner throughout the Union.
Poleg tega uredba zagotavlja hkratno in harmonizirano izvajanje pravnih zahtev po vsej Uniji.
Since the objectives of this Regulation, namely to establish rules on veterinary medicinal products ensuring the protection of human and animal health and the environment as well as the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, by reason of its effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker države članice ne morejo zadovoljivo doseči ciljev te uredbe, in sicer določiti pravil o zdravilih za uporabo v veterinarski medicini, ki zagotavljajo varovanje zdravja ljudi in živali ter okolja in delovanje notranjega trga, temveč se te cilje zaradi njihovega učinka lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
This Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products.
Ta uredba določa pravila za dajanje v promet, proizvodnjo, uvoz, izvoz, dobavo, distribucijo, farmakovigilanco, nadzor in uporabo zdravil za uporabo v veterinarski medicini.
This Regulation shall apply to veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market.
Ta uredba se uporablja za zdravila za uporabo v veterinarski medicini, ki so pripravljena industrijsko ali po metodi, ki vključuje industrijski postopek, in so namenjena za dajanje v promet.
In addition to the products referred to in paragraph 1 of this Article, Articles 94 and 95 shall also apply to active substances used as starting materials in veterinary medicinal products.
Poleg zdravil iz odstavka 1 tega člena se člena 94 in 95 uporabljata tudi za učinkovine, ki se uporabljajo kot vhodne snovi v zdravilih za uporabo v veterinarski medicini.
In addition to the products referred to in paragraph 1 of this Article, Articles 94, 105, 108, 117, 120, 123 and 134 shall also apply to 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.
Poleg zdravil iz odstavka 1 tega člena se členi 94, 105, 108, 117, 120, 123 in 134 uporabljajo tudi za inaktivirana imunološka zdravila 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 ali teh živali v isti epidemiološki enoti ali za zdravljenje ene živali ali živali v enoti, ki je potrdila epidemiološko povezavo.
By way of derogation from paragraphs 1 and 2 of this Article, only Articles 55, 56, 94, 117, 119, 123, 134 and Section 5 of Chapter IV shall apply to veterinary medicinal products authorised in accordance with Article 5(6).
Z odstopanjem od odstavkov 1 in 2 tega člena se za zdravila za uporabo v veterinarski medicini, odobrena v skladu s členom 5(6), uporabljajo samo členi 55, 56, 94, 117, 119, 123, 134 in oddelek 5 poglavja IV.
By way of derogation from paragraph 1 of this Article, Articles 5 to 15, 17 to 33, 35 to 54, 57 to 72, 82 to 84, 95, 98, 106, 107, 110, 112 to 116, 128, 130 and 136 shall not apply to homeopathic veterinary medicinal products which are registered in accordance with Article 86.
Z odstopanjem od odstavka 1 tega člena se členi 5 do 15, 17 do 33, 35 do 54, 57 do 72, 82 do 84, 95, 98, 106, 107, 110, 112 do 116, 128, 130 in 136 ne uporabljajo za homeopatska zdravila za uporabo v veterinarski medicini, registrirana v skladu s členom 86.
In addition to the products referred to in paragraph 1 of this Article, Chapter VII shall also apply to:
Poleg zdravil iz odstavka 1 tega člena se poglavje VII uporablja tudi za:
substances that have anabolic, anti-infectious, antiparasitic, anti-inflammatory, hormonal, narcotic or psychotropic properties and that may be used in animals;
snovi z anabolnimi, protiinfekcijskimi, antiparazitnimi, protivnetnimi, hormonalnimi, narkotičnimi ali psihotropnimi lastnostmi ter ki se lahko uporabijo pri živalih;
veterinary medicinal products prepared in a pharmacy or by a person permitted to do so under national law, in accordance with a veterinary prescription for an individual animal or a small group of animals (‘magistral formula’);
zdravila za uporabo v veterinarski medicini, pripravljena v lekarni ali ki jih pripravi oseba, ki ji to dovoljuje nacionalno pravo, po veterinarskem receptu za posamezno žival ali manjšo skupino živali (magistralna zdravila);
This Regulation shall not apply to:
zdravila za uporabo v veterinarski medicini na podlagi radioaktivnih izotopov;
veterinary medicinal products containing autologous or allogeneic cells or tissues that have not been subjected to an industrial process;
krmne dodatke, kot so opredeljeni v točki (a) člena 2(2) Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003;
veterinary medicinal products based on radio-active isotopes;
zdravila za uporabo v veterinarski medicini, namenjena za raziskave in razvoj;
feed additives as defined in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council;
medicirano krmo in vmesne proizvode, kot so opredeljeni v točkah (a) in (b) člena 3(2) Uredbe (EU) 2019/4.
veterinary medicinal products intended for research and development;
Ta uredba ne posega v nacionalne določbe o pristojbinah, razen ko gre za postopek za pridobitev centraliziranega dovoljenja za promet.
medicated feed and intermediate products as defined in points (a) and (b) of Article 3(2) of Regulation (EU) 2019/4.
Ta uredba državam članicam ne preprečuje, da bi na svojem ozemlju za narkotične in psihotropne snovi ohranile ali uvedle nacionalne nadzorne ukrepe, ki se jim zdijo ustrezni.
This Regulation shall, except as regards the centralised marketing authorisation procedure, be without prejudice to national provisions on fees.
Člen 3
Nothing in this Regulation shall prevent a Member State from maintaining or introducing on its territory any national control measure it deems appropriate regarding narcotic and psychotropic substances.
Kolizija zakonov
Article 3
Kadar zdravilo za uporabo v veterinarski medicini iz člena 2(1) te uredbe prav tako spada v področje uporabe Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta ali Uredbe (ES) št. 1831/2003 ter obstaja kolizija med to uredbo in Uredbo (EU) št. 528/2012 ali Uredbo (ES) št. 1831/2003, se uporablja ta uredba.
Conflict of laws
Za namen odstavka 1 tega člena lahko Komisija z izvedbenimi akti sprejme sklepe o tem, ali se določen proizvod ali skupina proizvodov šteje za zdravilo za uporabo v veterinarski medicini.
Where a veterinary medicinal product referred to in Article 2(1) of this Regulation also falls within the scope of Regulation (EU) No 528/2012 of the European Parliament and of the Council or Regulation (EC) No 1831/2003, and there is a conflict between this Regulation and Regulation (EU) No 528/2012 or Regulation (EC) No 1831/2003, this Regulation shall prevail.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 145(2).
For the purpose of paragraph 1 of this Article, the Commission may, by means of implementing acts, adopt decisions on whether a specific product or group of products is to be considered as a veterinary medicinal product.
Člen 4
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Opredelitev pojmov
Definitions
„zdravilo za uporabo v veterinarski medicini“ pomeni katero koli snov ali kombinacijo snovi, ki izpolnjuje vsaj enega od naslednjih pogojev:
For the purposes of this Regulation, the following definitions apply:
predstavljeno je z lastnostmi za zdravljenje ali preprečevanje bolezni pri živalih;
‘veterinary medicinal product’ means any substance or combination of substances which fulfils at least one of the following conditions:
njegov namen je, da se uporablja za živali ali daje živalim za ponovno vzpostavitev, izboljšanje ali spremembo fizioloških funkcij prek farmakološkega, imunološkega ali presnovnega delovanja;
it is presented as having properties for treating or preventing disease in animals;
njegov namen je, da se uporablja pri živalih, da bi se določila diagnoza;
its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;
njegov namen je, da se uporablja za evtanazijo živali;
its purpose is to be used in animals with a view to making a medical diagnosis;
„snov“ pomeni katero koli snov:
its purpose is to be used for euthanasia of animals;
človeškega izvora,
‘substance’ means any matter of the following origin:
živalskega izvora,
human;
rastlinskega izvora,
animal;
kemičnega izvora;
vegetable;
„učinkovina“ pomeni katero koli snov ali mešanico snovi, namenjeno za uporabo v proizvodnji zdravila za uporabo v veterinarski medicini, ki z uporabo pri njegovi proizvodnji postane aktivna sestavina tega zdravila;
chemical;
„pomožna snov“ pomeni katero koli sestavino zdravila za uporabo v veterinarski medicini, ki ni učinkovina ali ovojnina;
‘active substance’ means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product that, when used in its production, becomes an active ingredient of that product;
„imunološko zdravilo za uporabo v veterinarski medicini“ pomeni zdravilo za uporabo v veterinarski medicini, namenjeno dajanju živalim za ustvarjanje aktivne ali pasivne imunosti ali diagnosticiranju stanja njihove imunosti;
‘excipient’ means any constituent of a veterinary medicinal product other than an active substance or packaging material;
„biološko zdravilo za uporabo v veterinarski medicini“ pomeni zdravilo za uporabo v veterinarski medicini, v katerem je učinkovina biološka snov;
‘immunological veterinary medicinal product’ means a veterinary medicinal product intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;
„biološka snov“ pomeni snov, ki se proizvaja ali ekstrahira iz biološkega vira ter za katere opis značilnosti in določitev kakovosti je potrebna kombinacija fizikalno-kemijskih-bioloških testiranj, skupaj s poznavanjem proizvodnega postopka in njegovega nadzora;
‘biological veterinary medicinal product’ means a veterinary medicinal product where an active substance is a biological substance;
„referenčno zdravilo za uporabo v veterinarski medicini“ pomeni zdravilo za uporabo v veterinarski medicini, odobreno v skladu s členom 44, 47, 49, 52, 53 ali 54, kot je navedeno v členu 5(1) na podlagi vloge, predložene v skladu s členom 8;
‘biological substance’ means a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with knowledge of the production process and its control;
„generično zdravilo za uporabo v veterinarski medicini“ pomeni zdravilo za uporabo v veterinarski medicini, ki ima enako kakovostno in količinsko sestavo učinkovin in enako farmacevtsko obliko kot referenčno zdravilo za uporabo v veterinarski medicini in za katerega je dokazana bioekvivalenca z referenčnim zdravilom za uporabo v veterinarski medicini;
‘reference veterinary medicinal product’ means a veterinary medicinal product authorised in accordance with Article 44, 47, 49, 52, 53 or 54 as referred to in Article 5(1) on the basis of an application submitted in accordance with Article 8;
„homeopatsko zdravilo za uporabo v veterinarski medicini“ pomeni zdravilo za uporabo v veterinarski medicini, pripravljeno iz homeopatskih surovin v skladu s homeopatskim proizvodnim postopkom po določilih Evropske farmakopeje ali, če Evropska farmakopeja tega ne določa, po določilih farmakopej, ki se uradno uporabljajo v državah članicah;
‘generic veterinary medicinal product’ means a veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference veterinary medicinal product, and with regard to which bioequivalence with the reference veterinary medicinal product has been demonstrated;
„odpornost mikrobov proti protimikrobnim snovem (v nadaljnjem besedilu: mikrobna odpornost)“ pomeni sposobnost mikroorganizmov za preživetje ali rast v prisotnosti koncentracije protimikrobnega sredstva, ki je običajno dovolj, da lahko zavre rast ali ubije mikroorganizme iste vrste;
‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
„protimikrobna snov“ pomeni katero koli snov z neposrednim učinkom na mikroorganizme, ki se uporablja za zdravljenje ali preprečevanje okužb ali nalezljivih bolezni, vključno z antibiotiki, protivirusnimi zdravili, antimikotiki in antiprotozoiki;
‘antimicrobial resistance’ means the ability of micro-organisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill micro-organisms of the same species;
„antiparazitik“ pomeni snov, ki ubije ali prekine razvoj zajedavcev in se uporablja za zdravljenje ali preprečevanje okužb, infestacij ali bolezni, ki jih povzročajo ali prenašajo zajedavci, vključno s snovmi z repelentnim delovanjem;
‘antimicrobial’ means any substance with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and anti-protozoals;
„antibiotik“ pomeni katero koli snov z neposrednim učinkom na bakterije, ki se uporablja za zdravljenje ali preprečevanje okužb ali nalezljivih bolezni;
‘antiparasitic’ means a substance that kills or interrupts the development of parasites, used for the purpose of treating or preventing an infection, infestation or disease caused or transmitted by parasites, including substances with a repelling activity;
„metafilaksa“ pomeni dajanje zdravila skupini živali po tem, ko je za del skupine postavljena klinična diagnoza bolezni, in sicer, da bi se zdravile klinično bolne živali in bi se nadzorovalo širjenje bolezni na živali, ki so v tesnem stiku in ogrožene ter so mogoče tudi že subklinično okužene;
‘antibiotic’ means any substance with a direct action on bacteria that is used for treatment or prevention of infections or infectious diseases;
„profilaksa“ pomeni dajanje zdravila živali ali skupini živali, preden se pojavijo klinični znaki bolezni, da bi preprečili nastanek bolezni ali okužbe.
‘metaphylaxis’ means the administration of a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk and which may already be subclinically infected;
„klinično preskušanje“ pomeni študijo, katere namen je v terenskih pogojih preučiti varnost ali učinkovitost zdravila za uporabo v veterinarski medicini v normalnih pogojih reje živali ali kot del običajne veterinarske prakse za pridobitev ali spremembo dovoljenja za promet;
‘prophylaxis’ means the administration of a medicinal product to an animal or group of animals before clinical signs of a disease, in order to prevent the occurrence of disease or infection;
„predklinična študija“ pomeni študijo, ki ni zajeta v opredelitvi kliničnega preskušanja in katere cilj je preučiti varnost ali učinkovitost zdravila za uporabo v veterinarski medicini za pridobitev ali spremembo dovoljenja za promet;
‘clinical trial’ means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof;
„razmerje med tveganji in koristmi“ pomeni vrednotenje pozitivnih učinkov zdravila za uporabo v veterinarski medicini glede na naslednja tveganja v zvezi z uporabo navedenega zdravila:
‘pre-clinical study’ means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;
vsako tveganje, ki se nanaša na kakovost, varnost in učinkovitost zdravila za uporabo v veterinarski medicini, v zvezi z zdravjem ljudi ali živali;
‘benefit-risk balance’ means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:
vsako tveganje neželenih vplivov na okolje;
any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health;
vsako tveganje v zvezi z razvojem odpornosti;
any risk of undesirable effects on the environment;
„splošno ime“ pomeni mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija (SZO) za snov, ali, če to ne obstaja, ime, ki se na splošno uporablja;
any risk relating to the development of resistance;
„ime zdravila za uporabo v veterinarski medicini“ pomeni bodisi izmišljeno ime, ki ga ni mogoče zamenjati s splošnim imenom, bodisi splošno ali znanstveno ime z blagovno znamko ali imenom imetnika dovoljenja za promet;
‘common name’ means the international non-proprietary name recommended by the World Health Organization (WHO) for a substance or, if one does not exist, the name generally used;
„jakost“ pomeni vsebnost učinkovin v zdravilu za uporabo v veterinarski medicini, izraženo količinsko na enoto odmerka, na enoto prostornine ali enoto mase, v skladu s farmacevtsko obliko;
‘name of the veterinary medicinal product’ means either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;
„pristojni organ“ pomeni organ, ki ga v skladu s členom 137 določi država članica;
‘strength’ means the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form;
„označevanje“ pomeni informacije na stični ali zunanji ovojnini;
‘competent authority’ means an authority designated by a Member State in accordance with Article 137;
„stična ovojnina“ pomeni vsebnik ali drugo obliko ovojnine, ki je v neposrednem stiku z zdravilom za uporabo v veterinarski medicini;
‘labelling’ means information on the immediate packaging or the outer packaging;
„zunanja ovojnina“ pomeni ovojnino, v katero je vložena stična ovojnina;
‘immediate packaging’ means the container or any other form of packaging that is in direct contact with the veterinary medicinal product;
„navodilo za uporabo“ pomeni dokumentacijo o zdravilu za uporabo v veterinarski medicini, ki zajema informacije za zagotovitev varne in učinkovite uporabe zdravila;