natgillin/translations-raw huggingface dataset:
If an applicant withdraws the application for a marketing authorisation submitted to a competent authority or the Agency, as applicable, before the examination of the application as referred to in Article 28 has been completed, the applicant shall communicate the reasons for doing so to the competent authority or the Agency, as applicable, to which the application was submitted in accordance with Article 6.
Člen 33
The competent authority or the Agency, as applicable, shall make publicly available the information that the application has been withdrawn, together with the report or the opinion, as applicable, if already drawn up, after deletion of any commercially confidential information.
Rezultat ocene
Article 33
Ko pristojni organ ali Agencija, kakor je ustrezno, pregleda vlogo v skladu s členom 28, pripravi poročilo o oceni ali mnenje.
Outcome of the assessment
V primeru pozitivne ocene vključuje to poročilo o oceni ali mnenje naslednje:
The competent authority or the Agency, as applicable, examining the application in accordance with Article 28, shall prepare, respectively, an assessment report or an opinion.
povzetek glavnih značilnosti zdravila, ki zajemajo informacije, določene v členu 35;
In case of a favourable assessment, that assessment report or opinion shall include the following:
podrobnosti o morebitnih pogojih ali omejitvah, ki jih je treba uvesti v zvezi z dobavo ali varno in učinkovito uporabo zadevnega zdravila za uporabo v veterinarski medicini, vključno z razvrstitvijo zdravila za uporabo v veterinarski medicini v skladu s členom 34;
a summary of the product characteristics containing the information laid down in Article 35;
besedilo označevanja in navodila za uporabo, določeno v členih 10 do 14.
details of any conditions or restrictions to be imposed as regards the supply or safe and effective use of the veterinary medicinal product concerned, including the classification of a veterinary medicinal product in accordance with Article 34;
V primeru negativne ocene poročilo o oceni ali mnenje iz odstavka 1 vsebuje obrazložitev za tako ugotovitev.
the text of the labelling and package leaflet referred to in Articles 10 to 14.
Člen 34
In the case of an unfavourable assessment, the assessment report or the opinion referred to in paragraph 1 shall contain the justification for its conclusions.
Razvrstitev zdravil za uporabo v veterinarski medicini
Article 34
Pristojni organ ali Komisija, kakor je ustrezno, pri izdaji dovoljenja za promet iz člena 5(1) razvrsti naslednja zdravila za uporabo v veterinarski medicini kot zdravila na veterinarski recept:
Classification of veterinary medicinal products
zdravila za uporabo v veterinarski medicini, ki vsebujejo narkotike ali psihotropne snovi ali snovi, ki se pogosto uporabljajo pri nezakoniti proizvodnji teh drog ali snovi, vključno s tistimi, ki so zajeti v Enotno konvencijo Združenih narodov o narkotikih iz leta 1961, kot je bila spremenjena s Protokolom iz leta 1972, Konvencijo Združenih narodov o psihotropnih substancah iz leta 1971, Konvencijo Združenih narodov zoper nezakoniti promet z mamili in psihotropnimi snovmi iz leta 1988 ali z zakonodajo Unije o predhodnih sestavinah za prepovedane droge;
The competent authority or the Commission, as applicable, granting a marketing authorisation as referred to in Article 5(1) shall classify the following veterinary medicinal products as subject to veterinary prescription:
zdravila za uporabo v veterinarski medicini za živali, namenjene proizvodnji živil;
veterinary medicinal products which contain narcotic drugs or psychotropic substances, or substances frequently used in the illicit manufacture of those drugs or substances, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the United Nations Convention on Psychotropic Substances of 1971, the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 or by Union legislation on drug precursors;
protimikrobna zdravila za uporabo v veterinarski medicini;
veterinary medicinal products for food-producing animals;
zdravila za uporabo v veterinarski medicini, namenjena zdravljenju patoloških procesov, ki zahtevajo podrobno predhodno diagnozo ali uporaba katerih bi lahko ovirala ali vplivala na poznejše diagnostične ali terapevtske ukrepe;
antimicrobial veterinary medicinal products;
zdravila za uporabo v veterinarski medicini, ki se uporabljajo za evtanazijo živali;
veterinary medicinal products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;
zdravila za uporabo v veterinarski medicini, ki vsebujejo učinkovino, za katero je izdano dovoljenje za manj kot pet let v Uniji;
veterinary medicinal products used for euthanasia of animals;
imunološka zdravila za uporabo v veterinarski medicini;
veterinary medicinal products containing an active substance that has been authorised for less than five years in the Union;
brez poseganja v Direktivo Sveta 96/22/ES, zdravila za uporabo v veterinarski medicini, ki vsebujejo učinkovine s hormonskim ali tirostatičnim delovanjem ali beta-agoniste.
immunological veterinary medicinal products;
Pristojni organ ali Komisija, kakor je ustrezno, lahko, ne glede na odstavek 1 tega člena, zdravilo za uporabo v veterinarski medicini razvrstita kot zdravilo na veterinarski recept, če je v skladu z nacionalnim pravom razvrščeno kot narkotična droga ali kadar so v povzetek glavnih značilnosti zdravila iz člena 35 vključeni posebni varnostni ukrepi.
without prejudice to Council Directive 96/22/EC, veterinary medicinal products containing active substances having a hormonal or thyrostatic action or beta-agonists.
Z odstopanjem od odstavka 1 pristojni organ ali Komisija, kakor je ustrezno, lahko razvrsti kot zdravila za uporabo v veterinarski medicini kot taka, za katera ni potreben veterinarski recept, kadar ne gre za zdravila za uporabo v veterinarski medicini iz točk (a), (c), (e) in (h) odstavka 1 in so izpolnjeni vsi naslednji pogoji:
The competent authority or the Commission, as applicable, may, notwithstanding paragraph 1 of this Article, classify a veterinary medicinal product as subject to veterinary prescription if it is classified as a narcotic drug in accordance with national law or where special precautions are contained in the summary of product characteristics referred to in Article 35.
dajanje zdravila za uporabo v veterinarski medicini je omejena na farmacevtske oblike, ki pri uporabi zdravila ne zahtevajo nobenega posebnega znanja ali spretnosti;
By way of derogation from paragraph 1, the competent authority or the Commission, as applicable, may, except as regards veterinary medicinal products referred to in points (a), (c), (e) and (h) of paragraph 1, classify a veterinary medicinal product as not subject to veterinary prescription if all of the following conditions are fulfilled:
zdravilo za uporabo v veterinarski medicini ne predstavlja neposrednega ali posrednega tveganja za žival ali zdravljeno žival ali druge živali, osebo, ki ga daje, ali okolje, tudi če je dano nepravilno;
the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;
povzetek glavnih značilnosti zdravila za uporabo v veterinarski medicini ne zajema nobenih opozoril o možnih neželenih dogodkih, ki izhajajo iz njegove pravilne uporabe;
the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated or to other animals, to the person administering it or to the environment;
niti za zdravilo za uporabo v veterinarski medicini niti za katero drugo zdravilo, ki vsebuje isto učinkovino, ni preteklih poročil o pogostih neželenih dogodkih;
the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;
povzetek glavnih značilnosti zdravila ne navaja kontraindikacij v zvezi z uporabo zadevnega zdravila v kombinaciji z drugimi zdravili za uporabo v veterinarski medicini, ki se običajno uporabljajo brez recepta;
neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;
kar zadeva ostanke v živilih, pridobljenih iz zdravljene živali, ni tveganja za javno zdravje, tudi kadar se zdravilo za uporabo v veterinarski medicini uporablja nepravilno;
the summary of the product characteristics does not refer to contra-indications related to the use of the product concerned in combination with other veterinary medicinal products commonly used without prescription;
kar zadeva razvoj odpornosti proti snovem, ni tveganja za javno zdravje ali zdravje živali, tudi kadar se zdravilo za uporabo v veterinarski medicini, ki vsebuje navedene snovi, uporablja nepravilno.
there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal product is used incorrectly;
Člen 35
there is no risk to public or animal health as regards the development of resistance to substances even where the veterinary medicinal product containing those substances is used incorrectly.
Povzetek glavnih značilnosti zdravila
Article 35
Povzetek glavnih značilnosti zdravila iz točke (a) člena 33(1) zajema naslednje informacije v naslednjem zaporedju:
Summary of the product characteristics
ime zdravila za uporabo v veterinarski medicini in po potrebi seznam imen tega zdravila, kot so bila odobrena v različnih državah članicah;
The summary of the product characteristics referred to in point (a) of Article 33(1) shall contain, in the order indicated below, the following information:
kakovostna in količinska sestava učinkovin ali snovi ter kakovostna sestava pomožnih snovi in drugih sestavin z navedbo njihovega splošnega imena ali kemijskega opisa snovi, in njihovo količinsko sestavo, če je ta informacija bistvena za pravilno dajanje zdravila za uporabo v veterinarski medicini;
name of the veterinary medicinal product followed by its strength and pharmaceutical form and, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;
klinične informacije:
qualitative and quantitative composition of the active substance or substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product;
ciljne vrste;
clinical information:
indikacije za uporabo za vsako ciljno vrsto;
target species;
kontraindikacije;
indications for use for each target species;
posebna opozorila;
contra-indications;
posebni previdnostni ukrepi pri uporabi, zlasti posebni previdnostni ukrepi za varno uporabo pri posamezni ciljni vrsti, posebni previdnostni ukrepi, ki naj jih izvaja oseba, ki daje to veterinarsko zdravilo živalim, in posebni previdnostni ukrepi za varstvo okolja;
special warnings;
pogostost in resnost neželenih dogodkov;
special precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;
uporaba v obdobju brejosti, laktacije ali nesnosti;
frequency and seriousness of adverse events;
interakcija z drugimi zdravili ter druge oblike interakcije;
use during pregnancy, lactation or lay;
pot uporabe in odmerjanje;
interaction with other medicinal products and other forms of interaction;
simptomi prevelikega odmerjanja ter nujni postopki in protistrupi v primeru prevelikega odmerjanja, kadar je to ustrezno;
administration route and dosage;
posebne omejitve uporabe;
symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;
posebni pogoji za uporabo, vključno z omejitvami uporabe protimikrobnih in antiparazitskih zdravil za uporabo v veterinarski medicini, da se omeji tveganje za razvoj odpornosti;
special restrictions for use;
če je ustrezno, karence, tudi kadar karence ni;
special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;
farmakološke informacije:
if applicable, withdrawal periods, even if such periods are zero;
anatomsko-terapevtsko-kemijska veterinarska oznaka (ATCvet Code);
pharmacological information:
farmakodinamika;
Anatomical Therapeutic Chemical Veterinary Code (‘ATCvet Code’);
farmakokinetika.
pharmacodynamics;
Kadar gre za imunološko zdravilo za uporabo v veterinarski medicini, se namesto točk (i), (ii) in (iii) navedejo imunološke informacije;
pharmacokinetics.
farmacevtski podatki:
In case of an immunological veterinary medicinal product, instead of points (i), (ii) and (iii), immunological information;
glavne neskladnosti;
pharmaceutical particulars:
rok uporabnosti, kadar je ustrezno po rekonstituciji zdravila ali po prvem odpiranju stične ovojnine;
major incompatibilities;
posebni previdnostni ukrepi za shranjevanje;
shelf life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;
narava in sestava stične ovojnine;
special precautions for storage;
zahteva, da se uporabi sistem vračanja za zdravila za uporabo v veterinarski medicini za odstranitev neporabljenih zdravil za uporabo v veterinarski medicini ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil, ter po potrebi dodatni preventivni ukrepi za odstranitev nevarnih odpadnih neporabljenih zdravil za uporabo v veterinarski medicini ali odpadnih snovi, ki nastanejo pri njihovi uporabi;
nature and composition of immediate packaging;
ime imetnika dovoljenja za promet;
requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
številka ali številke dovoljenja za promet;
name of the marketing authorisation holder;
datum pridobitve dovoljenja za promet;
marketing authorisation number or numbers;
datum zadnje spremembe povzetka glavnih značilnosti zdravila;
date of the first marketing authorisation;
za zdravila za uporabo v veterinarski medicini iz člena 23 ali 25 po potrebi izjava:
date of the last revision of the summary of the product characteristics;
„dovoljenje za promet izdano za omejen trg, zato ocena temelji na prilagojenih zahtevah glede dokumentacije“ ali
if applicable, for veterinary medicinal products referred to in Article 23 or 25, the statement:
„dovoljenje za promet v izjemnih okoliščinah, zato ocena temelji na prilagojenih zahtevah glede dokumentacije“;
‘marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation’; or
razvrstitev zdravila za uporabo v veterinarski medicini, kot je navedeno v členu 34, za vsako državo članico, kjer je zdravilo odobreno.
‘marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation’;
V primeru generičnih zdravil za uporabo v veterinarski medicini se lahko opustijo tisti deli povzetka glavnih značilnosti referenčnega zdravila za uporabo v veterinarski medicini, ki se nanašajo na indikacije ali farmacevtske oblike, ki so v času dajanja generičnega zdravila za uporabo v veterinarski medicini v promet v posamezni državi članici zaščitene s patentnim pravom.
classification of the veterinary medicinal product as referred to in Article 34 for each Member State in which it is authorised.
Člen 36
In the case of generic veterinary medicinal products, the parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are protected by patent law in a Member State at the time of placing of the generic veterinary medicinal product on the market may be omitted.
Sklepi o izdaji dovoljenj za promet
Article 36
Sklepi o izdaji dovoljenj za promet iz člena 5(1) se sprejmejo na podlagi dokumentov, pripravljenih v skladu s členom 33(1), in se z njimi določijo morebitni pogoji za dajanje v promet za zdravilo za uporabo v veterinarski medicini ter povzetek glavnih značilnosti zdravila (v nadaljnjem besedilu: pogoji za dovoljenje za promet z zdravilom).
Decisions granting marketing authorisations
Kadar se vloga nanaša na protimikrobna zdravila za uporabo v veterinarski medicini, lahko pristojni organ ali Komisija, kakor je ustrezno, od imetnika dovoljenja za promet zahteva, da opravi študije po pridobitvi dovoljenja za promet in tako zagotovi, da je razmerje med tveganji in koristmi glede na morebitni razvoj mikrobne odpornosti še vedno pozitivno.
Decisions granting marketing authorisations referred to in Article 5(1) shall be taken on the basis of the documents prepared in accordance with Article 33(1) and shall set out any conditions attached to the placing on the market of the veterinary medicinal product and the summary of the product characteristics (‘terms of the marketing authorisation’).
Člen 37
Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.
Sklepi o zavrnitvi dovoljenj za promet
Article 37
Sklepi o zavrnitvi dovoljenj za promet iz člena 5(1) se sprejmejo na podlagi dokumentov, pripravljenih v skladu s členom 33(1), in vsebujejo ustrezno utemeljitev in razloge za zavrnitev.
Decisions refusing marketing authorisations
Dovoljenje za promet se zavrne, če je izpolnjen kateri koli od naslednjih pogojev:
Decisions refusing marketing authorisations referred to in Article 5(1) shall be taken on the basis of the documents prepared in accordance with Article 33(1) and shall be duly justified and include the reasons for refusal.
vloga ni skladna s tem poglavjem;
A marketing authorisation shall be refused if any of the following conditions are met:
razmerje med tveganji in koristmi zdravila za uporabo v veterinarski medicini je negativno;
the application does not comply with this Chapter;
predlagatelj ni predložil dovolj informacij o kakovosti, varnosti ali učinkovitosti zdravila za uporabo v veterinarski medicini;
the benefit-risk balance of the veterinary medicinal product is negative;
zdravilo za uporabo v veterinarski medicini je protimikrobno zdravilo za uporabo v veterinarski medicini, predstavljeno za uporabo kot sredstvo za povečanje proizvodnosti, da se spodbudi rast zdravljenih živali ali poveča donosnost zdravljenih živali;
the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;
predlagana karenca ni dovolj dolga, da bi zagotovila varnost živil, ali pa je nezadostno utemeljena;
the veterinary medicinal product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;
tveganje za javno zdravje v primeru razvoja mikrobne odpornosti ali odpornosti proti antiparazitikom je večje od koristi zdravila za uporabo v veterinarski medicini za zdravje živali;
the proposed withdrawal period is not long enough to ensure food safety or is insufficiently substantiated;
predlagatelj ni predložil zadostnih dokazov o učinkovitosti v zvezi s ciljnimi vrstami;
the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;
kakovostna in količinska sestava zdravila za uporabo v veterinarski medicini ni takšna, kot je navedena v vlogi;
the applicant has not provided sufficient proof of efficacy as regards the target species;
tveganja za javno zdravje ali zdravje živali ali za okolje niso zadostno obravnavana ali
the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;
učinkovina v zdravilu za uporabo v veterinarski medicini izpolnjuje merila za obstojno, bioakumulativno in strupeno snov ali zelo obstojno in zelo bioakumulativno, zdravilo za uporabo v veterinarski medicini pa je namenjeno za uporabo pri živalih za proizvodnjo živil, razen če se dokaže, da je ta učinkovina nujno potrebna za preprečevanje ali nadzorovanje resnega tveganja za zdravje živali.
risks to public or animal health or to the environment are not sufficiently addressed; or
Dovoljenje za promet s protimikrobnim zdravilom za uporabo v veterinarski medicini se zavrne, če je snov rezervirana za zdravljenje nekaterih okužb pri ljudeh, kakor je določeno v odstavku 5.
the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, and the veterinary medicinal product is intended to be used in food-producing animals, unless it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health.
Na Komisijo se v skladu s členom 147 prenese pooblastilo za sprejemanje delegiranih aktov, da dopolni to uredbo z določitvijo meril za opredelitev protimikrobnih snovi, ki jih je treba rezervirati za zdravljenje nekaterih okužb pri ljudeh, da se ohrani učinkovitost teh protimikrobnih snovi.
A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans as provided for in paragraph 5.
Komisija z izvedbenimi akti določi protimikrobne snovi ali skupino protimikrobnih snovi, rezerviranih za zdravljenje nekaterih okužb pri ljudeh.
The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation by establishing the criteria for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials.
Komisija pri sprejemanju aktov iz odstavkov 4 in 5 upošteva znanstvene napotke Agencije, EFSA in drugih ustreznih agencij Unije.
The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans.
Oddelek 8
The Commission shall, when adopting the acts referred to in paragraphs 4 and 5, take into account the scientific advice of the Agency, the EFSA and other relevant Union agencies.
Varstvo tehnične dokumentacije
Section 8
Člen 38
Protection of technical documentation
Brez poseganja v zahteve in obveznosti iz Direktive 2010/63/EU se drugi predlagatelji ne sklicujejo na tehnično dokumentacijo o kakovosti, varnosti in učinkovitosti, ki je bila prvotno predložena za pridobitev ali spremembo dovoljenja za promet, ko prosijo za dovoljenje za promet ali za spremembo pogojev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, razen če:
Article 38
se je obdobje varstva tehnične dokumentacije, kot je določeno v členih 39 in 40 te uredbe, izteklo ali se bo izteklo v manj kot dveh letih;
Without prejudice to the requirements and obligations laid down in Directive 2010/63/EU, technical documentation on quality, safety and efficacy originally submitted with a view to obtaining a marketing authorisation or a variation thereof shall not be referred to by other applicants for a marketing authorisation or a variation of the terms of a marketing authorisation for a veterinary medicinal product unless:
so predlagatelji v zvezi s to dokumentacijo prejeli pisno soglasje v obliki izjave o dostopnosti podatkov.