natgillin/translations-raw huggingface dataset:
The competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Articles 47, 49, 52 and 53.
Dokazilo o kakovosti zdravil za uporabo v veterinarski medicini
The competent authorities of the Member States in which the pharmacovigilance system master files are located shall carry out inspections of the pharmacovigilance systems master files.
Imetnik dovoljenja za promet ima dostop do rezultatov kontrolnih preskusov, izvedenih za zdravilo za uporabo v veterinarski medicini ali sestavine in vmesne proizvode v proizvodnem postopku v skladu z metodami, določenimi v dovoljenju za promet.
Notwithstanding paragraph 4 of this Article and pursuant to Article 80, a competent authority may enter into any work-sharing initiatives and delegation of responsibilities with other competent authorities to avoid the duplication of inspections of pharmacovigilance systems.
Če pristojni organ ugotovi, da serija zdravila za uporabo v veterinarski medicini ni v skladu s poročilom o nadzoru proizvajalca ali s specifikacijami iz dovoljenja za promet, sprejme ukrepe proti imetniku dovoljenja za promet in proizvajalcu ter o tem ustrezno obvesti pristojne organe drugih držav članic, v katerih je zdravilo za uporabo v veterinarski medicini odobreno, pa tudi Agencijo, kadar je zdravilo za uporabo v veterinarski medicini odobreno s centraliziranim postopkom.
The results of the pharmacovigilance inspections shall be recorded in the pharmacovigilance database as referred to in Article 74.
Člen 128
Article 127
Dokazilo o kakovosti imunoloških zdravil za uporabo v veterinarski medicini
Proof of the product quality for veterinary medicinal products
Za namene uporabe člena 127(1) lahko pristojni organi od imetnika dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini zahtevajo, naj jim predloži kopije vseh poročil o nadzoru, ki jih je podpisala usposobljena oseba v skladu s členom 97.
The marketing authorisation holder shall have at its disposal the results of the control tests carried out on the veterinary medicinal product or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down in the marketing authorisation.
Imetnik dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini zagotovi, da se ustrezno število reprezentativnih vzorcev vsake serije zdravila za uporabo v veterinarski medicini hrani na zalogi vsaj do datuma izteka roka uporabnosti, ter pristojnim organom na njihovo zahtevo nemudoma predloži te vzorce.
If a competent authority concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take measures in relation to the marketing authorisation holder and the manufacturer, and shall inform accordingly the competent authorities of other Member States in which the veterinary medicinal product is authorised, and also the Agency in case the veterinary medicinal product is authorised under the centralised procedure.
Kadar je to potrebno zaradi zdravja ljudi ali živali, lahko pristojni organ od imetnika dovoljenja za promet z imunološkim zdravilom za uporabo v veterinarski medicini zahteva, da predloži vzorce serij iz zbirnega vsebnika ali imunološkega zdravila za uporabo v veterinarski medicini za nadzor, ki ga izvede Uradni kontrolni laboratorij za preskušanje zdravil, preden se zdravilo da v promet.
Article 128
Na zahtevo pristojnega organa imetnik dovoljenja za promet nemudoma predloži vzorce iz odstavka 2, skupaj s poročili o nadzoru iz odstavka 1, za kontrolno preskušanje.
Proof of the product quality specific for immunological veterinary medicinal products
Pristojni organ o nameravani kontroli serij imunoloških zdravil za uporabo v veterinarski medicini obvesti pristojne organe v drugih državah članicah, v katerih je imunološko zdravilo za uporabo v veterinarski medicini odobreno, ter Evropski direktorat za kakovost zdravil in zdravstvenega varstva in Agencijo, če je imunološko zdravilo za uporabo v veterinarski medicini odobreno s centraliziranim postopkom.
For the purposes of application of Article 127(1), competent authorities may require the holder of a marketing authorisation for immunological veterinary medicinal products to submit to the competent authorities the copies of all the control reports signed by the qualified person in accordance with Article 97.
Na podlagi poročil o nadzoru iz tega poglavja laboratorij, ki je odgovoren za nadzor, na predloženih vzorcih ponovi vse teste, ki jih je izvedel proizvajalec na končanem imunološkem zdravilu za uporabo v veterinarski medicini, v skladu z zadevnimi specifikacijami iz njegove dokumentacije za dovoljenje za promet.
The holder of a marketing authorisation for immunological veterinary medicinal products shall ensure that an adequate number of representative samples of each batch of veterinary medical products is held in stock at least up to the expiry date, and provide samples promptly to the competent authorities on request.
Seznam testov, ki jih mora ponoviti laboratorij, odgovoren za nadzor, je omejen na upravičene teste, pod pogojem da pristojni organi v relevantnih državah članicah in, če je to ustrezno, Evropski direktorat za kakovost zdravil in zdravstvenega varstva, s to omejitvijo soglašata.
Where necessary for reasons of human or animal health, a competent authority may require the holder of a marketing authorisation for an immunological veterinary medicinal product to submit samples of batches of the bulk product or of the immunological veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is placed on the market.
Pri imunoloških zdravilih za uporabo v veterinarski medicini, odobrenih s centraliziranim postopkom, se seznam testov, ki jih mora kontrolni laboratorij ponoviti, lahko skrajša samo, če Agencija soglaša s tem.
On the request of a competent authority, the marketing authorisation holder shall promptly supply the samples referred to in paragraph 2, together with the control reports referred to in paragraph 1, for control testing.
Pristojni organi priznajo rezultate testov iz odstavka 5.
The competent authority shall inform the competent authorities in other Member States in which the immunological veterinary medicinal product is authorised, as well as the EDQM and the Agency in case the immunological veterinary medicinal product is authorised under the centralised procedure, of its intention to control batches of the immunological veterinary medicinal product.
Če Komisija ni obveščena, da je potrebno daljše obdobje za izvedbo testov, pristojni organi zagotovijo, da se ta nadzor dokonča v 60 dneh od prejema vzorcev in poročil o nadzoru.
On the basis of the control reports referred to in this Chapter, the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished immunological veterinary medicinal product, in accordance with the relevant specifications in its dossier for marketing authorisation.
Pristojni organ o rezultatih testov v istem roku obvesti pristojne organe v drugih relevantnih državah članicah, Evropski direktorat za kakovost zdravil in zdravstvenega varstva, imetnika dovoljenja za promet in, če je to ustrezno, proizvajalca.
The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all competent authorities in the relevant Member States, and, if appropriate, the EDQM, agree to such a restriction.
Pristojni organ preveri, ali so proizvodni procesi, ki se uporabljajo pri proizvodnji imunoloških zdravil za uporabo v veterinarski medicini, potrjeni in ali je zagotovljena konsistentnost med serijami.
For immunological veterinary medicinal products authorised under the centralised procedure, the list of tests to be repeated by the control laboratory may be reduced only upon agreement of the Agency.
POGLAVJE IX
The competent authorities shall recognise the results of the tests referred to in paragraph 5.
OMEJITVE IN KAZNI
Unless the Commission is informed that a longer period is necessary to conduct the tests, the competent authorities shall ensure that the control is completed within 60 days of receipt of the samples and control reports.
Člen 129
The competent authority shall notify the competent authorities of other relevant Member States, the EDQM, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time.
Začasne varnostne omejitve
The competent authority shall verify that the manufacturing processes used in the manufacture of immunological veterinary medicinal products are validated and that batch-to-batch consistency is ensured.
Pristojni organi in, kadar je zdravilo za uporabo v veterinarski medicini odobreno s centralnim postopkom, tudi Komisija lahko v primeru tveganja za javno zdravje, zdravje živali ali za okolje, zaradi katerega je potrebno nujno ukrepanje, uvedejo začasne varnostne omejitve za imetnika dovoljenja za promet in druge osebe, ki imajo obveznosti iz te uredbe.
CHAPTER IX
Te začasne varnostne omejitve lahko vključujejo:
RESTRICTIONS AND PENALTIES
omejitve glede dobave zdravila za uporabo v veterinarski medicini na zahtevo pristojnega organa in, če je zdravilo za uporabo v veterinarski medicini odobreno s centralnim postopkom, tudi če od pristojnega organa to zahteva Komisija;
Article 129
omejitve glede uporabe zdravila za uporabo v veterinarski medicini na zahtevo pristojnega organa in, če je zdravilo za uporabo v veterinarski medicini odobreno s centralnim postopkom, tudi če od pristojnega organa to zahteva Komisija;
Temporary safety restrictions
začasno odvzem dovoljenja za promet, ki jo naloži pristojni organ, ki je dovoljenje izdal, ali Komisija, če imajo zdravila za uporabo v veterinarski medicini centralizirano dovoljenje za promet.
The competent authority and, in the case of centrally authorised veterinary medicinal products, also the Commission may, in the event of a risk to public or animal health or to the environment that requires urgent action, impose temporary safety restrictions on the marketing authorisation holder and other persons having obligations under this Regulation.
Zadevni pristojni organ najpozneje naslednji delovni dan o vseh začasnih varnostnih omejitvah obvesti druge pristojne organe in Komisijo.
Those temporary safety restrictions may include:
V primeru centraliziranega dovoljenja za promet, Komisija v istem časovnem obdobju obvesti pristojne organe o vseh naloženih začasnih varnostnih omejitvah.
restriction of supply of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority;
Pristojni organi in Komisija lahko hkrati z določitvijo omejitve v skladu z odstavkom 1 tega člena uporabijo postopek napotitve Agenciji v skladu s členom 82.
restriction of the use of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority;
Kadar je to ustrezno, imetnik dovoljenja za promet predloži vlogo za spremembo pogojev dovoljenja za promet v skladu s členom 62.
suspension of a marketing authorisation by the competent authority having granted that marketing authorisation and, in the case of centrally authorised veterinary medicinal products, by the Commission.
Člen 130
The competent authority concerned shall inform, at the latest on the following working day, the other competent authorities and the Commission of any temporary safety restriction imposed.
Začasni odvzem, odvzem ali spremembe pogojev dovoljenj za promet
In the case of centralised marketing authorisations, the Commission shall inform, within the same time, the competent authorities of any temporary safety restriction imposed.
Pristojni organ ali v primeru centraliziranih dovoljenj za promet Komisija dovoljenje za promet začasno odvzame ali odvzame ali od imetnika dovoljenja zahteva, naj vloži vlogo za spremembo pogojev dovoljenja, če razmerje med tveganji in koristmi zdravila za uporabo v veterinarski medicini ni več pozitivno ali ne zadostuje za zagotavljanje varnosti živil.
Competent authorities and the Commission may, at the same time as imposing a restriction in accordance with paragraph 1 of this Article, refer the issue to the Agency in accordance with Article 82.
Pristojni organ ali v primeru centraliziranih dovoljenj za promet Komisija dovoljenje za promet odvzame, če dovoljenje ne izpolnjuje več zahteve glede sedeža v Uniji iz člena 5(4).
Where applicable, the marketing authorisation holder shall submit an application for a variation to the terms of the marketing authorisation in accordance with Article 62.
Pristojni organ ali v primeru centraliziranih dovoljenj za promet Komisija lahko začasno odvzame ali odvzame dovoljenje za promet ali od imetnika dovoljenja za promet zahteva, da predloži vlogo za spremembo pogojev dovoljenja za promet, kakor je ustrezno, zaradi enega ali več naslednjih razlogov:
Article 130
imetnik dovoljenja za promet ne izpolnjuje zahtev iz člena 58;
Suspending, revoking, or varying the terms, of marketing authorisations
imetnik dovoljenja za promet ne izpolnjuje zahtev iz člena 127;
The competent authority or, in the case of centralised marketing authorisations, the Commission shall suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation if the benefit-risk balance of the veterinary medicinal product is no longer positive or is insufficient to ensure food safety.
sistem farmakovigilance, vzpostavljen v skladu s členom 77(1), je neustrezen;
The competent authority or, in the case of centralised marketing authorisations, the Commission, shall revoke the marketing authorisation if the marketing authorisation holder no longer fulfils the requirement on establishment in the Union referred to in Article 5(4).
imetnik dovoljenja za promet ne izpolnjuje svojih obveznosti iz člena 77;
The competent authority or, in the case of centralised marketing authorisations, the Commission may suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation, as applicable, in the case of one or more of the following reasons:
usposobljena oseba, ki je pristojna za farmakovigilanco, ne izpolnjuje svojih nalog, kot določa člen 78.
the marketing authorisation holder does not comply with the requirements set out in Article 58;
Za namene odstavkov 1, 2 in 3 Komisija v primeru centraliziranih dovoljenj za promet pred sprejetjem ukrepov, kadar je to ustrezno, zahteva mnenje Agencije v roku, ki ga določi glede na nujnost zadeve, da bi lahko preučila razloge iz navedenih odstavkov.
the marketing authorisation holder does not comply with the requirements set out in Article 127;
Imetnika dovoljenja za promet z zdravilom za uporabo v veterinarski medicini se pozove k ustnim ali pisnim obrazložitvam v roku, ki ga določi Komisija.
the pharmacovigilance system established in accordance with Article 77(1) is inadequate;
Komisija lahko v skladu z mnenjem Agencije sprejme potrebne začasne ukrepe, ki se začnejo uporabljati takoj.
the marketing authorisation holder does not fulfil its obligations laid down in Article 77;
Komisija z izvedbenimi akti sprejme končni sklep.
the qualified person responsible for pharmacovigilance does not fulfil his or her tasks as laid down in Article 78.
Države članice določijo postopke za uporabo odstavkov 1, 2 in 3.
For the purpose of paragraphs 1, 2 and 3, in the case of centralised marketing authorisations, before taking action, the Commission shall request, where appropriate, the opinion of the Agency within a time limit which it shall determine in view of the urgency of the matter, in order to examine the reasons referred to in those paragraphs.
Člen 131
The holder of the marketing authorisation for the veterinary medicinal product shall be invited to provide oral or written explanations within a given time limit set by the Commission.
Začasni odvzem ali odvzem dovoljenja za promet na debelo
Following an opinion of the Agency, the Commission shall adopt, where necessary, provisional measures, which shall be applied immediately.
V primeru neizpolnjevanja zahtev iz člena 101(3) pristojni organ začasno odvzame ali odvzame dovoljenje za promet na debelo za zdravila za uporabo v veterinarski medicini.
The Commission shall, by means of implementing acts, take a final decision.
V primeru neizpolnjevanja zahtev iz drugih odstavkov člena 101, ki niso odstavek 3, lahko pristojni organ brez poseganja v druge ustrezne ukrepe na podlagi nacionalnega prava sprejme enega ali več naslednjih ukrepov:
Member States shall lay down procedures for application of paragraphs 1, 2 and 3.
začasni odvzem dovoljenja za promet na debelo;
Article 131
začasni odvzem dovoljenja za promet na debelo za eno ali več kategorij zdravil za uporabo v veterinarski medicini;
Suspending or revoking a wholesale distribution authorisation
odvzem dovoljenja za promet na debelo za eno ali več kategorij zdravil za uporabo v veterinarski medicini.
In the event of non-compliance with the requirements laid down in Article 101(3), the competent authority shall suspend or revoke the wholesale distribution authorisation of veterinary medicinal products.
Člen 132
In the event of non-compliance with the requirements laid down in Article 101, other than paragraph 3 thereof, the competent authority may, without prejudice to any other appropriate measures under national law, take one or more of the following measures:
Odstranitev uvoznikov, proizvajalcev in distributerjev učinkovin iz zbirke podatkov o proizvodnji in prometu na debelo
suspend the wholesale distribution authorisation;
V primeru, da uvozniki, proizvajalci in distributerji učinkovin ne izpolnjujejo zahtev iz člena 95, pristojni organ te uvoznike, proizvajalce in distributerje začasno ali dokončno odstrani iz zbirke podatkov o proizvodnji in prometu na debelo.
suspend the wholesale distribution authorisation for one or more categories of veterinary medicinal products;
Člen 133
revoke the wholesale distribution authorisation for one or more categories of veterinary medicinal products.
Začasni odvzem ali odvzem dovoljenj za proizvodnjo
Article 132
V primeru neizpolnjevanja zahtev iz drugih odstavkov člena 93 lahko pristojni organ brez poseganja v druge ustrezne ukrepe na podlagi nacionalnega prava sprejme enega ali več naslednjih ukrepov:
Removal of importers, manufacturers and distributors of active substance from the manufacturing and wholesale distribution database
začasno ustavi proizvodnjo zdravil za uporabo v veterinarski medicini;
In the event of non-compliance by importers, manufacturers and distributors of active substances with the requirements laid down in Article 95, the competent authority shall, temporarily or definitively, remove those importers, manufacturers and distributors from the manufacturing and wholesale distribution database.
začasno ustavi uvoz zdravil za uporabo v veterinarski medicini iz tretjih držav;
Article 133
začasno odvzame ali odvzame dovoljenje za proizvodnjo za eno ali več farmacevtskih oblik;
Suspending or revoking manufacturing authorisations
začasno odvzame ali odvzame dovoljenje za proizvodnjo za eno ali več dejavnosti na enem ali več proizvodnih krajih.
In the event of non-compliance with the requirements laid down in Article 93, the competent authority shall, without prejudice to any other appropriate measures under national law, take one or more of the following measures:
Člen 134
suspend the manufacture of veterinary medicinal products;
Prepoved dobave zdravil za uporabo v veterinarski medicini
suspend imports of veterinary medicinal products from third countries;
V primeru tveganja za javno zdravje, zdravje živali ali za okolje pristojni organ ali, v primeru centralno odobrenih zdravil za uporabo v veterinarski medicini, Komisija prepove dobavo zdravila za uporabo v veterinarski medicini in od imetnika dovoljenja za promet ali dobavitelja zahteva, da prekine dobavo zdravil za uporabo v veterinarski medicini ali da jih odpokličejo iz prometa, če je izpolnjen kateri koli od naslednjih pogojev:
suspend or revoke the manufacturing authorisation for one or more pharmaceutical forms;
razmerje med tveganji in koristmi zdravila za uporabo v veterinarski medicini ni več pozitivno;
suspend or revoke the manufacturing authorisation for one or more activities in one or more manufacturing sites.
kakovostna ali količinska sestava zdravila za uporabo v veterinarski medicini ni enaka navedeni v povzetku glavnih značilnosti zdravila iz člena 35;
Article 134
priporočena karenca ni dovolj dolga, da bi zagotovila varnost živil;
Prohibiting the supply of veterinary medicinal products
kontrolni preskusi iz člena 127(1) niso bili opravljeni ali
In the event of a risk to public or animal health or to the environment, the competent authority or, in the case of centrally authorised veterinary medicinal products, the Commission, shall prohibit the supply of a veterinary medicinal product and require the marketing authorisation holder or suppliers to cease the supply or recall of the veterinary medicinal product from the market if any of the following conditions apply:
nepravilno označevanje bi lahko povzročilo resno tveganje za zdravje živali ali javno zdravje.
the benefit-risk balance of the veterinary medicinal product is no longer positive;
Komisija ali pristojni organi lahko omejijo prepoved dobave in odpokličejo iz prometa samo oporečne proizvodne serije zadevnega zdravila za uporabo v veterinarski medicini.
the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the summary of the product characteristics referred to in Article 35;
Člen 135
the recommended withdrawal period is insufficient to ensure food safety;
Kazni, ki jih naložijo države članice
the control tests referred to in Article 127(1) have not been carried out; or
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve te uredbe, in sprejmejo vse potrebne ukrepe za zagotovitev, da se te kazni izvajajo.
the incorrect labelling might lead to a serious risk to animal or public health.
Te kazni so učinkovite, sorazmerne in odvračilne.
The competent authorities or the Commission may confine the prohibition on supply and recall from the market solely to the contested production batches of the veterinary medicinal product concerned.
Države članice o teh pravilih uradno obvestijo Komisijo do 28. januarja 2022 in jo brez odlašanja uradno obvestijo vsakršni naknadni spremembi, ki nanje vpliva.
Article 135
Pristojni organi zagotovijo objavo informacij o vrstah in številu primerov, v katerih so bile naložene denarne kazni, pri čemer se upošteva upravičen interes zadevnih strani za zaščito njihovih poslovnih skrivnosti.
Penalties imposed by Member States
Države članice nemudoma obvestijo Komisijo o vseh pravdnih postopkih proti imetnikom dovoljenja za promet za centralno odobrena zdravila za uporabo v veterinarski medicini zaradi kršitev te uredbe.
Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented.
Člen 136
The penalties provided for shall be effective, proportionate and dissuasive.
Denarne kazni, ki jih Komisija naloži imetnikom dovoljenja za promet za centralno odobrena zdravila za uporabo v veterinarski medicini