natgillin/translations-raw huggingface dataset:
‘outer packaging’ means packaging in which the immediate packaging is placed;
„izjava o dostopnosti podatkov“ pomeni izvorni dokument, ki ga podpiše lastnik podatkov ali njegov zastopnik in v katerem je navedeno, da se podatki lahko uporabljajo v korist predlagatelja v zvezi s pristojnimi organi, Evropsko agencijo za zdravila, ustanovljeno z Uredbo (ES) št. 726/2004 (v nadaljnjem besedilu: Agencija), ali Komisijo za namene te uredbe;
‘package leaflet’ means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;
„omejeni trg“ pomeni trg za eno od naslednjih vrst zdravil:
‘letter of access’ means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of the applicant in relation to the competent authorities, the European Medicines Agency established by Regulation (EC) No 726/2004 (‘the Agency’) or the Commission for the purposes of this Regulation;
zdravila za uporabo v veterinarski medicini za zdravljenje ali preprečevanje bolezni, ki se pojavljajo redko ali na omejenih geografskih območjih;
‘limited market’ means a market for one of the following medicinal product types:
zdravila za uporabo v veterinarski medicini za živalske vrste, ki niso govedo, ovce za proizvodnjo mesa, prašiči, piščanci, psi in mačke;
veterinary medicinal products for the treatment or prevention of diseases that occur infrequently or in limited geographical areas;
„farmakovigilanca“ pomeni znanost in dejavnosti, povezane z odkrivanjem, ocenjevanjem, razumevanjem in preprečevanjem domnevnih neželenih dogodkov ali drugih težav, povezanih z zdravilom;
veterinary medicinal products for animal species other than cattle, sheep for meat production, pigs, chickens, dogs and cats;
„glavni dosje o sistemu farmakovigilance“ pomeni podroben opis sistema farmakovigilance, ki ga uporabljajo imetniki dovoljenj za promet v zvezi z enim ali več zdravili za uporabo v veterinarski medicini, za katera je izdano dovoljenje za promet;
‘pharmacovigilance’ means the science and activities relating to the detection, assessment, understanding and prevention of suspected adverse events or any other problem related to a medicinal product;
„nadzor“ pomeni vsako nalogo, ki jo opravi pristojni organ za preverjanje skladnosti s to uredbo;
‘pharmacovigilance system master file’ means a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised veterinary medicinal products;
„veterinarski recept“ pomeni dokument, ki ga izda veterinar za zdravilo za uporabo v veterinarski medicini ali za zdravilo za uporabo v humani medicini za njegovo uporabo pri živalih;
‘control’ means any task performed by a competent authority for the verification of compliance with this Regulation;
„karenca“ pomeni najkrajše obdobje med zadnjim dajanjem zdravila za uporabo v veterinarski medicini pri živali in proizvodnjo živil iz te živali, ki je v običajnih pogojih uporabe potrebno, da se zagotovi, da ta živila ne vsebujejo ostankov v količinah, ki so škodljivi za javno zdravje;
‘veterinary prescription’ means a document issued by a veterinarian for a veterinary medicinal product or a medicinal product for human use for its use in animals;
„dajanje v promet“ pomeni, da je prvič omogočena dostopnost zdravila za uporabo v veterinarski medicini na vsem trgu Unije ali na trgu ene ali več držav članic, kakor je ustrezno;
‘withdrawal period’ means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health;
„promet na debelo“ pomeni vse dejavnosti nabave, hrambe, dobave ali izvoza zdravil za uporabo v veterinarski medicini za dobiček ali ne, razen dobave zdravil za uporabo v veterinarski medicini na drobno;
‘placing on the market’ means the first making available of a veterinary medicinal product on the whole of the Union market or in one or more Member States, as applicable;
„vodna vrsta“ pomeni vrsto iz točke (3) člena 4 Uredbe (EU) 2016/429 Evropskega parlamenta in Sveta;
‘wholesale distribution’ means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products whether for profit or not, apart from retail supply of veterinary medicinal products to the public;
„živali za proizvodnjo živil“ pomeni živali za proizvodnjo živil, kot so opredeljene v točki (b) člena 2 Uredbe (ES) št. 470/2009;
‘aquatic species’ mean species referred to in point (3) of Article 4 of Regulation (EU) 2016/429 of the European Parliament and of the Council;
„sprememba“ pomeni spremembo pogojev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini iz člena 36;
‘food-producing animals’ mean food-producing animals as defined in point (b) of Article 2 of Regulation (EC) No 470/2009;
„oglaševanje zdravil za uporabo v veterinarski medicini“ pomeni izdelavo predstavitve za zdravilo za uporabo v veterinarski medicini v kateri koli obliki, da bi se spodbudili dobava, distribucija, prodaja, predpisovanje ali uporaba zdravila za uporabo v veterinarski medicini ter tudi z dobavo vzorcev in sponzorstvom;
‘variation’ means a change to the terms of the marketing authorisation for a veterinary medicinal product as referred to in Article 36;
„postopek obravnave signala“ pomeni postopek izvajanja dejavnega nadzora podatkov o farmakovigilanci, da se ti podatki ocenijo in se določi, ali je prišlo do sprememb v razmerju med tveganji in koristmi teh zdravil za uporabo v veterinarski medicini, zato da se odkrijejo tveganja za zdravje živali ali javno zdravje ali varstvo okolja;
‘advertising of veterinary medicinal products’ means the making of a representation in any form in connection with veterinary medicinal products in order to promote the supply, distribution, sale, prescription or use of veterinary medicinal products and comprising also the supply of samples and sponsorships;
„potencialno resno tveganje za zdravje ljudi ali živali ali za okolje“ pomeni okoliščine, ko obstaja znatno velika verjetnost, da bo z uporabo zdravila za uporabo v veterinarski medicini povzročena huda nevarnost, ki bo imela posledice za zdravje ljudi ali živali ali za okolje;
‘signal management process’ means a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment;
„zdravilo za uporabo v veterinarski medicini za nove terapije“ pomeni:
‘potential serious risk to human or animal health or to the environment’ means a situation where there is a significantly high probability that a serious hazard resulting from the use of a veterinary medicinal product will affect human or animal health or the environment;
zdravilo za uporabo v veterinarski medicini, ki je posebej izdelano za gensko terapijo, regenerativno medicino, tkivno inženirstvo, terapijo s krvnimi pripravki, bakterofagno terapijo;
‘novel therapy veterinary medicinal product’ means:
zdravilo za uporabo v veterinarski medicini, narejeno z nanotehnologijami, ali
a veterinary medicinal product specifically designed for gene therapy, regenerative medicine, tissue engineering, blood product therapy, phage therapy;
katero koli drugo terapijo, ki velja za novorazvijajoče se področje veterinarske medicine;
a veterinary medicinal product issued from nanotechnologies; or
„epidemiološka enota“ pomeni epidemiološko enoto, kot je opredeljena v točki 39 člena 4 Uredbe (EU) 2016/429.
any other therapy which is considered as a nascent field in veterinary medicine;
POGLAVJE II
‘epidemiological unit’ means an epidemiological unit as defined in point (39) of Article 4 of Regulation (EU) 2016/429.
DOVOLJENJA ZA PROMET – SPLOŠNE DOLOČBE IN PRAVILA O VLOGAH
CHAPTER II
Oddelek 1
MARKETING AUTHORISATIONS – GENERAL PROVISIONS AND RULES ON APPLICATIONS
Splošne določbe
General provisions
Dovoljenja za promet
Article 5
Zdravilo za uporabo v veterinarski medicini se da v promet samo, ko pristojni organ ali Komisija, kakor je ustrezno, za to zdravilo izda dovoljenje za promet v skladu s členom 44, 47, 49, 52, 53 ali 54.
Marketing authorisations
Dovoljenje za promet z zdravilom za uporabo v veterinarski medicini je veljavno za nedoločen čas.
A veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorisation for that product in accordance with Article 44, 47, 49, 52, 53 or 54.
Sklepi o izdaji, zavrnitvi, začasnem odvzemu, odvzemu ali spremembi dovoljenja za promet se objavijo.
A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.
Dovoljenje za promet za zdravilo za uporabo v veterinarski medicini se izda samo predlagatelju s sedežem v Uniji.
Decisions to grant, refuse, suspend, revoke or amend by way of a variation a marketing authorisation shall be made public.
Zahteva o sedežu v Uniji velja tudi za imetnike dovoljenj za promet.
A marketing authorisation for a veterinary medicinal product shall only be granted to an applicant established in the Union.
Dovoljenje za promet za zdravila za uporabo v veterinarski medicini, ki so namenjena za eno ali več živalskih vrst za proizvodnjo živil, se lahko izda samo, če je farmakološka učinkovina dovoljena v skladu z Uredbo (ES) št. 470/2009 in vsemi drugimi akti, sprejetimi na njeni podlagi za zadevne živalske vrste.
The requirement to be established in the Union shall also apply to marketing authorisation holders.
Države članice lahko na svojem ozemlju dovolijo izjeme glede tega člena za zdravila za uporabo v veterinarski medicini, ki so predvidena za živali, ki so izključno hišne, akvarijske ali ribniške živali, ptice v kletkah, domače golobe, terarijske živali, male glodavce, bele dihurje ter kunce, pod pogojem, da za ta zdravila za uporabo v veterinarski medicini ni potreben veterinarski recept ter da so bili izvedeni vsi potrebni ukrepi za preprečitev nedovoljene uporabe teh zdravil za druge živali.
A marketing authorisation for a veterinary medicinal product intended for one or more food-producing animal species may only be granted if the pharmacologically active substance is allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof for the animal species concerned.
Člen 6
In the case of veterinary medicinal products intended for animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits, Member States may allow exemptions from this Article, provided that such veterinary medicinal products are not subject to a veterinary prescription and that all necessary measures are in place in the Member State to prevent unauthorised use of those veterinary medicinal products for other animals.
Predložitev vlog za dovoljenja za promet
Article 6
Vloge za dovoljenja za promet se predložijo pristojnemu organu, kadar se nanašajo na izdajo dovoljenj za promet v skladu s katerim od naslednjih postopkov:
Submission of applications for marketing authorisations
nacionalnim postopkom iz členov 46 in 47;
Applications for marketing authorisations shall be submitted to the competent authority where they concern the granting of marketing authorisations in accordance with any of the following procedures:
decentraliziranim postopkom iz členov 48 in 49;
the national procedure laid down in Articles 46 and 47;
postopkom vzajemnega priznavanja iz členov 51 in 52.
the decentralised procedure laid down in Articles 48 and 49;
postopkom naknadnega priznavanja iz člena 53.
the mutual recognition procedure laid down in Articles 51 and 52;
Vloge za dovoljenja za promet se predložijo Agenciji, kadar se nanašajo na izdajo dovoljenj za promet v skladu s postopkom za pridobitev centraliziranega dovoljenja za promet iz členov 42 do 45.
the subsequent recognition procedure laid down in Article 53.
Vloge iz odstavkov 1 in 2 se predložijo v elektronski obliki in zanje se uporabijo formati ki jih določi Agencija.
Applications for marketing authorisations shall be submitted to the Agency where they concern the granting of marketing authorisations in accordance with the centralised marketing authorisation procedure laid down in Articles 42 to 45.
Predlagatelj je odgovoren za točnost informacij in dokumentacije, predloženih v zvezi z vlogo.
Applications referred to in paragraphs 1 and 2 shall be submitted electronically and the formats made available by the Agency shall be used.
Pristojni organ ali Agencija, kakor je ustrezno, v 15 dneh od prejema vloge predlagatelja obvesti o tem, ali so bile predložene vse informacije in dokumentacija, ki se zahtevajo v skladu s členom 8, in ali je vloga veljavna.
The applicant shall be responsible for the accuracy of the information and documentation submitted with respect to its application.
Kadar pristojni organ ali Agencija, kakor je ustrezno, meni, da je vloga nepopolna, o tem obvesti predlagatelja in določi rok za predložitev manjkajočih informacij in dokumentacije.
Within 15 days of receipt of the application, the competent authority or the Agency, as applicable, shall notify the applicant as to whether all the information and documentation required in accordance with Article 8 have been submitted and whether the application is valid.
Če predlagatelj ne predloži manjkajočih informacij in dokumentacije v določenem roku, se šteje, da je bila vloga umaknjena.
Where the competent authority or the Agency, as applicable, considers that the application is incomplete, it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation.
Če predlagatelj ne zagotovi popolnega prevoda zahtevane dokumentacije v obdobju šestih mesecev po tem, ko prejme informacije iz členov 49(7), 52(8) ali 53(2), se šteje, da je vloga umaknjena.
If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn.
Člen 7
If the applicant fails to provide a complete translation of the required documentation within a period of six months after having received the information referred to in Article 49(7), 52(8) or 53(2), the application shall be considered to have been withdrawn.
Jeziki
Article 7
Če država članica ne odloči drugače, je jezik oziroma so jeziki povzetka glavnih značilnosti zdravila in informacij na označevanju ali v navodilih za uporabo uradni jezik oziroma uradni jeziki države članice, v kateri se omogoči dostopnost na trgu za zdravilo za uporabo v veterinarski medicini.
Languages
Zdravilo za uporabo v veterinarski medicini je lahko označeno v več jezikih.
The language or languages of the summary of the product characteristics and the information on the labelling and on the package leaflet shall, unless the Member State determines otherwise, be an official language or languages of the Member State where the veterinary medicinal product is made available on the market.
Oddelek 2
Veterinary medicinal products may be labelled in several languages.
Zahteve glede dokumentacije
Section 2
Člen 8
Dossier requirements
Podatki, ki jih je treba predložiti z vlogo
Article 8
Vloge za pridobitev dovoljenja za promet zajemajo naslednje:
Data to be submitted with the application
informacije, določene v Prilogi I;
An application for a marketing authorisation shall contain the following:
tehnično dokumentacijo, ki je potrebna za dokazovanje kakovosti, varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini v skladu z zahtevami iz Priloge II;
the information set out in Annex I;
povzetek glavnega dosjeja o sistemu farmakovigilance.
technical documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in accordance with the requirements set out in Annex II;
Kadar se vloga nanaša na protimikrobno zdravilo za uporabo v veterinarski medicini, se poleg informacij, tehnične dokumentacije in povzetka iz odstavka 1 predloži naslednje:
a summary of the pharmacovigilance system master file.
dokumentacija o neposrednih ali posrednih tveganjih za javno zdravje, zdravje živali ali okolje zaradi uporabe protimikrobnega zdravila za uporabo v veterinarski medicini pri živalih;
Where the application concerns an antimicrobial veterinary medicinal product, the following shall be submitted in addition to the information, technical documentation and summary listed in paragraph 1:
informacije o ustreznih ukrepih za zmanjšanje tveganja za omejitev razvoja mikrobne odpornosti v zvezi z uporabo zdravil za uporabo v veterinarski medicini.
documentation on the direct or indirect risks to public or animal health or to the environment of use of the antimicrobial veterinary medicinal product in animals;
Kadar se vloga nanaša na zdravilo za uporabo v veterinarski medicini, ki je namenjeno za ciljne živalske vrste za proizvodnjo živil in vsebuje farmakološke učinkovine, ki niso dovoljene v skladu z Uredbo (ES) št. 470/2009 in vsemi drugimi akti, sprejetimi na njeni podlagi za zadevne živalske vrste, se poleg informacij, tehnične dokumentacije in povzetka iz odstavka 1 tega člena predloži dokument, ki potrjuje, da je bila Agenciji v skladu z navedeno uredbo predložena veljavna vloga za določitev mejnih vrednosti ostankov.
information about risk mitigation measures to limit antimicrobial resistance development related to the use of the veterinary medicinal product.
Odstavek 3 tega člena se ne uporablja za zdravila za uporabo v veterinarski medicini, namenjena za živali iz vrste enoprstih kopitarjev, ki so bile označene kot živali, ki niso namenjene za zakol za prehrano ljudi v enotnem identifikacijskem dokumentu za celotno življenjsko dobo iz točke (c) člena 114(1) Uredbe (EU) 2016/429 in vseh drugih aktov, sprejetih na njeni podlagi, in učinkovine, ki jih vsebujejo navedena zdravila za uporabo v veterinarski medicini, niso dovoljena v skladu z Uredbo (ES) št. 470/2009 ali s katerimi koli drugimi akti, sprejetimi na njeni podlagi.
Where the application concerns a veterinary medicinal product intended for food-producing animals and containing pharmacologically active substances that are not allowed in accordance with Regulation (EC) No 470/2009 and with any acts adopted on the basis thereof for the animal species concerned, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with that Regulation shall be submitted in addition to the information, technical documentation and summary listed in paragraph 1 of this Article.
Kadar se vloga nanaša na zdravilo za uporabo v veterinarski medicini, ki vsebuje gensko spremenjene organizme v smislu člena 2 Direktive 2001/18/ES Evropskega parlamenta in Sveta ali je sestavljeno iz takih organizmov, ji je treba poleg informacij, tehnične dokumentacije in povzetka iz odstavka 1 tega člena priložiti:
Paragraph 3 of this Article shall not apply to veterinary medicinal products intended for animals of the equine species that have been declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in point (c) of Article 114(1) of Regulation (EU) 2016/429 and in any acts adopted on the basis thereof and the active substances contained in those veterinary medicinal products are not allowed in accordance with Regulation (EC) No 470/2009 or with any acts adopted on the basis thereof.
kopijo pisnega soglasja pristojnih organov za namerno sprostitev gensko spremenjenih organizmov v okolje za namene raziskav in razvoja, kot je določeno v delu B Direktive 2001/18/ES;
Where the application concerns a veterinary medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council, the application shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, be accompanied by:
popolno tehnično dokumentacijo z informacijami, ki se zahtevajo v prilogah III in IV k Direktivi 2001/18/ES;
a copy of the written consent of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes, as provided for in Part B of Directive 2001/18/EC;
oceno tveganja za okolje v skladu z načeli Priloge II k Direktivi 2001/18/ES in
the complete technical file supplying the information required under Annexes III and IV to Directive 2001/18/EC;
rezultate vseh preiskovanj, izvedenih za namene raziskav ali razvoja.
the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and
Kadar je vloga predložena v skladu z nacionalnim postopkom iz členov 46 in 47, predlagatelj poleg informacij, tehnične dokumentacije in povzetka iz odstavka 1 tega člena predloži izjavo, da vloge za pridobitev dovoljenja za promet z istim zdravilom za uporabo v veterinarski medicini ni predložil v drugi državi članici ali v Uniji oziroma da za isto zdravilo ni bilo izdano dovoljenje za promet v drugi državi članici ali v Uniji.
the results of any investigations performed for the purposes of research or development.
Oddelek 3
Where the application is submitted in accordance with the national procedure set out in Articles 46 and 47, the applicant shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, submit a declaration stating that he or she has not submitted an application for a marketing authorisation for the same veterinary medicinal product in another Member State or in the Union and, if applicable, that no such marketing authorisation has been granted in another Member State or in the Union.
Klinična preskušanja
Section 3
Člen 9
Clinical trials
Vloga za odobritev kliničnega preskušanja se predloži v skladu z veljavnim nacionalnim pravom pristojnemu organu države članice, v kateri se klinično preskušanje izvaja.
Article 9
Klinična preskušanja se odobrijo pod pogojem, da živali za proizvodnjo živil, ki se uporabljajo pri kliničnih preskušanjih, ali njihovi proizvodi ne vstopijo v prehransko verigo, razen če pristojni organ določi primerno karenco.
An application for the approval of a clinical trial shall be submitted in accordance with the applicable national law to a competent authority of the Member State in which the clinical trial is to take place.
Pristojni organ izda sklep o odobritvi oziroma zavrnitvi kliničnega preskušanja v 60 dneh od prejema veljavne vloge.
Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the food chain unless an appropriate withdrawal period has been set by the competent authority.
Klinična preskušanja se izvajajo ob ustreznem upoštevanju mednarodnih smernic o dobri klinični praksi mednarodnega sodelovanja o harmonizaciji tehničnih zahtev za registracijo zdravil za uporabo v veterinarski medicini (VICH).
The competent authority shall issue a decision to approve or refuse a clinical trial within 60 days of the receipt of a valid application.
Podatki, ki izhajajo iz kliničnih preskušanj, se predložijo skupaj z vlogo za pridobitev dovoljenja za promet za zagotavljanje dokumentacije iz točke (b) člena 8(1).
The clinical trials shall be carried out taking due account of the international guidelines on good clinical practice of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (‘VICH’).
Podatki iz kliničnih preskušanj, izvedenih zunaj Unije, se lahko upoštevajo pri oceni vloge za pridobitev dovoljenja za promet samo, če so preskušanja zasnovana, izvedena in se o njih poroča v skladu z mednarodnimi smernicami o dobri klinični praksi mednarodnega sodelovanja VICH.