natgillin/translations-raw huggingface dataset:
If the competent authority in the reference Member State has not been able to find an agreement with the competent authorities in the Member States concerned and additional Member States concerned at the latest within 60 days from the date on which the objections referred to in paragraph 4 of this Article were raised, it shall refer the application together with the updated assessment report referred to in paragraph 2 of this Article and the objections of the competent authorities in the additional Member States concerned to the coordination group in accordance with the review procedure laid down in Article 54.
Člen 54
Review procedure
Če pristojni organ v zadevni državi članici v skladu s členom 49(5), 52(6), 53(8) ali 66(8) izrazi pripombe k poročilu o oceni ali k posodobljenemu poročilu o oceni, potem pristojnemu organu v referenčni državi članici, pristojnim organom v zadevnih državah članicah in predlagatelju ali imetniku dovoljenja za promet z zdravilom brez odlašanja predloži podrobno izjavo o razlogih za vsako pripombo.
Article 54
Pristojni organ v referenčni državi članici sporne točke nemudoma pošlje usklajevalni skupini.
If the competent authority in a Member State concerned raises, in accordance with Article 49(5), 52(6), 53(8) or 66(8) an objection as referred to in those Articles to, respectively, the assessment report or the updated assessment report, it shall provide without delay a detailed statement of the reasons for any such objection to the competent authority in the reference Member State, to the competent authorities in the Member States concerned and to the applicant or the marketing authorisation holder.
Pristojni organ v referenčni državi članici v 90 dneh od prejetja pripomb sprejme vse ustrezne korake za dosego dogovora glede sporočenih pripomb.
The competent authority in the reference Member State shall refer the points of disagreement without delay to the coordination group.
Pristojni organ v referenčni državi članici da predlagatelju ali imetniku dovoljenja za promet možnost, da ustno ali pisno predstavi svoje stališče kar zadeva sporočene pripombe.
The competent authority in the reference Member State shall take, within 90 days of receipt of the objection, any appropriate steps in order to seek an agreement as regards the objection raised.
Kadar je dosežen dogovor med pristojni organi iz členov 49(1), 52(1), 53(1) in 66(1), pristojni organ v referenčni državi članici zaključi postopek in o tem obvesti predlagatelja ali imetnika dovoljenja za promet.
The competent authority in the reference Member State shall provide the applicant or the marketing authorisation holder with the opportunity to provide, orally or in writing, their point of view as regards the objection raised.
Pristojni organi v zadevni državi članici izdajo ali spremenijo dovoljenje za promet.
Where an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) is reached, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder.
Kadar pristojni organi iz členov 49(1), 52(1), 53(1) in 66(1) dosežejo soglasni dogovor, da se dovoljenje za promet ali sprememba zavrne, pristojni organ v referenčni državi članici zaključi postopek in o tem obvesti predlagatelja ali imetnika dovoljenja za promet ter ustrezno utemelji zavrnitev.
The competent authorities in the Member States concerned shall grant or vary a marketing authorisation.
Pristojni organi v zadevnih državah članicah nato zavrnejo izdajo dovoljenja ali spremembo.
When the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) reach an agreement by consensus to refuse the marketing authorisation or to reject the variation, the competent authority in the reference Member State shall close the procedure and inform the applicant or the marketing authorisation holder thereof, duly justifying the refusal or the rejection.
Če ni mogoče doseči soglasnega dogovora med pristojnimi organi iz členov 49(1), 52(1), 53(1) in 66(1), usklajevalna skupina najpozneje v 90 dneh od datuma, ko so bile sporočene pripombe iz odstavka 1 tega člena, pošlje Komisiji poročilo o oceni iz člena 49(5), 52(6), 53(4) oziroma 66(3) skupaj z informacijami o spornih točkah.
The competent authorities in the Member States concerned shall thereafter refuse the marketing authorisation or reject the variation.
Komisija v 30 dneh po prejemu poročila in informacij iz člena 6 pripravi osnutek sklepa, ki se sprejme v zvezi z vlogo.
If an agreement among the competent authorities referred to in Articles 49(1), 52(1), 53(1) and 66(1) cannot be reached by consensus, the coordination group shall provide the Commission with the assessment report referred to in Articles 49(5), 52(6), 53(2) and 66(3), respectively, together with information on the points of disagreement at the latest within a period of 90 days from the date on which the objection referred to in paragraph 1 of this Article was raised.
Komisija osnutek sklepa pošlje pristojnim organom in predlagatelju ali imetniku dovoljenja za promet.
Within 30 days of receipt of the report and information referred to in paragraph 6, the Commission shall prepare a draft decision to be taken in respect of the application.
Komisija lahko pristojne organe ali Agencijo zaprosi za pojasnila.
The Commission shall forward the draft decision to the competent authorities and to the applicant or the marketing authorisation holder.
Rok iz odstavka 7 se odloži, dokler se ta pojasnila ne pridobijo.
The Commission may request clarifications from the competent authorities or the Agency.
Za namene postopka delitve dela pri spremembah, za katere je v skladu s členom 66 potrebna ocena, se sklici v tem členu na pristojni organ v referenčni državi članici štejejo kot sklici na pristojni organ, določen v skladu s členom 65(3), sklici na zadevne države članice pa kot sklici na relevantne države članice.
The time limit laid down in paragraph 7 shall be suspended until the clarifications have been provided.
Komisija z izvedbenimi akti sprejme sklep o izdaji, spremembi, zavrnitvi ali preklicu dovoljenja za promet ali o zavrnitvi spremembe.
For the purpose of the work-sharing procedure in respect of variations requiring assessment in accordance with Article 66, references in this Article to a competent authority in the reference Member State shall be understood as references to a competent authority agreed upon in accordance with Article 65(3), and references to Member States concerned as references to relevant Member States.
POGLAVJE IV
The Commission shall, by means of implementing acts, take a decision to grant, change, refuse or revoke a marketing authorisation or to reject a variation.
UKREPI PO IZDAJI DOVOLJENJA ZA PROMET
CHAPTER IV
Zbirka podatkov Unije o zdravilih
POST-MARKETING AUTHORISATION MEASURES
Člen 55
Union product database
Zbirka podatkov Unije o zdravilih za uporabo v veterinarski medicini
Article 55
Agencija vzpostavi in v sodelovanju z državami članicami vzdržuje zbirko podatkov Unije o zdravilih za uporabo v veterinarski medicini (v nadaljnjem besedilu: zbirka podatkov o zdravilih).
Union database on veterinary medicinal products
Zbirka podatkov o zdravilih vsebuje vsaj naslednje informacije:
The Agency shall establish and, in collaboration with the Member States, maintain, a Union database on veterinary medicinal products (‘product database’).
za zdravila za uporabo v veterinarski medicini, ki jih Komisija in pristojni organi odobrijo znotraj Unije:
The product database shall contain at least the following information:
ime zdravila za uporabo v veterinarski medicini;
for veterinary medicinal products authorised within the Union by the Commission and by the competent authorities:
učinkovino ali učinkovine in jakost zdravila za uporabo v veterinarski medicini;
name of the veterinary medicinal product;
povzetek glavnih značilnosti zdravila;
active substance or substances, and the strength of the veterinary medicinal product;
navodila za uporabo;
summary of product characteristics;
poročilo o oceni;
package leaflet;
seznam obratov, kjer se zdravilo za uporabo v veterinarski medicini proizvaja in
the assessment report;
datume, ko je zdravilo za uporabo v veterinarski medicini dano v promet v državi članici;
list of sites where the veterinary medicinal product is manufactured; and
za homeopatska zdravila za uporabo v veterinarski medicini, ki jih pristojni organi v skladu s poglavjem V registrirajo v Uniji:
the dates of the placing of the veterinary medicinal product on the market in a Member State;
ime registriranega homeopatskega zdravila za uporabo v veterinarski medicini;
for homeopathic veterinary medicinal products registered in accordance with Chapter V within the Union by the competent authorities:
navodila za uporabo in
name of the registered homeopathic veterinary medicinal product;
sezname obratov, kjer se registrirano homeopatsko zdravilo za uporabo v veterinarski medicini proizvaja;
package leaflet; and
zdravila za uporabo v veterinarski medicini, ki se v skladu s členom 5(6) lahko uporabljajo v posamezni državi članici;
lists of sites where the registered homeopathic veterinary medicinal product is manufactured;
letni obseg prodaje in informacije o razpoložljivosti vsakega zdravila za uporabo v veterinarski medicini.
veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6);
Komisija z izvedbenimi akti sprejme potrebne ukrepe in praktično ureditev, s katerimi določi:
the annual volume of sales and information on the availability for each veterinary medicinal product.
tehnične specifikacije zbirke podatkov o zdravilih, vključno z mehanizmom za elektronsko izmenjavo podatkov z že obstoječimi nacionalnimi sistemi in formatom za elektronsko pošiljanje;
The Commission shall, by means of implementing acts, adopt the necessary measures and practical arrangements laying down:
praktično ureditev za delovanje zbirke podatkov o zdravilih, predvsem zato, da se zagotovi varstvo poslovno zaupnih informacij in varna izmenjava informacij;
the technical specifications of the product database including the electronic data exchange mechanism for exchanging with the existing national systems and the format for electronic submission;
natančne specifikacije, katere informacije je treba vključiti, posodabljati in si izmenjavati v zbirki podatkov o zdravilih in kdo ima lahko dostop do njih;
the practical arrangements for the functioning of the product database, in particular to ensure protection of commercially confidential information and security of exchange of information;
izredne ukrepe, ki se uporabijo, kadar katera od funkcij zbirke podatkov o zdravilih ni na voljo;
detailed specifications of the information to be included, updated and shared in the product database and by whom;
po potrebi, katere podatke je treba dodati v zbirko podatkov o zdravilih poleg informacij iz odstavka 2 tega člena.
contingency arrangements to be applied in case of unavailability of any of the functionalities of the product database;
Člen 56
where appropriate, data to be included in the product database in addition to the information referred to in paragraph 2 of this Article.
Dostop do zbirke podatkov o zdravilih
Article 56
Pristojni organi, Agencija in Komisija imajo neomejen dostop do informacij v zbirki podatkov o zdravilih.
Access to the product database
Imetniki dovoljenj za promet imajo v zbirki podatkov o zdravilih neomejen dostop do informacij, ki zadevajo njihova dovoljenja za promet.
The competent authorities, the Agency and the Commission shall have full access to the information in the product database.
Splošna javnost ima dostop do informacij v zbirki podatkov o zdravilih, ne more pa spreminjati informacij iz zbirke podatkov o zdravilih, in sicer ima dostop do seznama zdravil za uporabo v veterinarski medicini, njihovih povzetkov glavnih značilnosti, navodil za uporabo in, potem ko pristojni organ zbriše vse poslovno zaupne informacije, poročil o oceni.
Marketing authorisation holders shall have full access to the information in the product database as regards their marketing authorisations.
Zbiranje podatkov v državah članicah in odgovornosti imetnikov dovoljenj za promet
The general public shall have access to information in the product database, without the possibility to change the information therein, as regards the list of the veterinary medicinal products, the summary of product characteristics, package leaflets and, after the deletion of any commercially confidential information by the competent authority, assessment reports.
Člen 57
Collection of data by Member States and responsibilities of marketing authorisation holders
Zbiranje podatkov o protimikrobnih zdravilih, ki se uporabljajo pri živalih
Article 57
Države članice v skladu s tem členom in v rokih iz odstavka 5 zbirajo ustrezne in primerljive podatke o obsegu in uporabi protimikrobnih zdravil za uporabo v veterinarski medicini, ki se uporabljajo pri živalih, da omogočijo neposredno ali posredno vrednotenje uporabe pri živalih za proizvodnjo živil na kmetijskih gospodarstvih.
Collection of data on antimicrobial medicinal products used in animals
Države članice v skladu z odstavkom 5 in v rokih, ki so v njem določeni, pošljejo Agenciji zbrane podatke o obsegu prodaje in uporabi po živalskih vrstah in po vrstah protimikrobnih zdravil, ki se pri njih uporabljajo.
Member States shall collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used in animals, to enable in particular the direct or indirect evaluation of the use of such products in food-producing animals at farm level, in accordance with this Article and within the time limits set out in paragraph 5.
Agencija sodeluje z državami članicami in drugimi agencijami Unije ter te podatke analizira in objavi letno poročilo.
Member States shall send collated data on the volume of sales and the use per animal species and per types of antimicrobial medicinal products used in animals to the Agency in accordance with paragraph 5 and within the time limits referred to therein.
Agencija upošteva te podatke pri sprejemanju ustreznih smernic in priporočil.
The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report.
Komisija sprejme delegirane akte v skladu s členom 147, da dopolni ta člen z določitvijo zahtev glede naslednjega:
The Agency shall take into account those data when adopting any relevant guidelines and recommendations.
za katere vrste protimikrobnih zdravil, ki se uporabljajo pri živalih, se zbirajo podatki;
The Commission shall adopt delegated acts in accordance with Article 147, in order to supplement this Article, establishing the requirements as regards:
kako bodo države članice in Agencija zagotavljale kakovost in primerljivost podatkov ter
the types of antimicrobial medicinal products used in animals for which data shall be collected;
pravil o metodah zbiranja podatkov o uporabi protimikrobnih zdravil, ki se uporabljajo pri živalih, in o načinu posredovanja teh podatkov Agenciji.
the quality assurance that Member States and the Agency shall put in place to ensure quality and comparability of data; and
Komisija z izvedbenimi akti določi obliko podatkov, ki jih je treba zbrati v skladu s tem členom.
the rules on the methods of gathering data on the use of the antimicrobial medicinal products used in animals and on the method of transfer of those data to the Agency.
Države članice smejo v zvezi z obveznostmi tega člena uporabiti postopen pristop, tako da:
The Commission shall, by means of implementing acts, set up the format for the data to be collected in accordance with this Article.
se v dveh letih od 28. januarja 2022 zbirajo podatki vsaj za živalske vrste in kategorije živil iz Izvedbenega sklepa Komisije 2013/652/EU, različica z dne 11. decembra 2018;
Member States shall be allowed to apply a progressive stepwise approach regarding the obligations set out in this Article so that:
se v petih letih od 28. januarja 2022 zberejo podatki za vse živalske vrste, ki uporabljajo za proizvodnjo živil;
within two years from 28 January 2022, data shall be collected at least for the species and categories included in Commission Implementing Decision 2013/652/EU in its version of 11 December 2018;
se v osmih letih od 28. januarja 2022 zberejo podatki za druge živali, ki se vzrejajo ali gojijo.
within five years from 28 January 2022, data shall be collected for all food-producing animal species;
Točka (c) odstavka 5 ne nalaga obveznosti zbiranja podatkov o fizičnih osebah, ki imajo hišne živali.
within eight years from 28 January 2022, data shall be collected for other animals which are bred or kept.
Člen 58
Nothing in point (c) of paragraph 5 shall be understood to include an obligation to collect data from natural persons keeping companion animals.
Odgovornosti imetnikov dovoljenj za promet
Article 58
Za trženje zdravila za uporabo v veterinarski medicini je odgovoren imetnik dovoljenja za promet s tem zdravilom.
Responsibilities of the marketing authorisation holders
Tudi če imetnik dovoljenja imenuje zastopnika, ga to ne razbremeni pravne odgovornosti.
The marketing authorisation holder shall be responsible for the marketing of its veterinary medicinal products.
Imetnik dovoljenja v okviru svojih odgovornosti zagotovi ustrezno in neprekinjeno dobavo svojega zdravila za uporabo v veterinarski medicini.
The designation of a representative shall not relieve the marketing authorisation holder of legal responsibility.
Po izdaji dovoljenja za promet imetnik dovoljenja v zvezi z metodami v proizvodnem postopku in metodami nadzora, navedenimi v vlogi za pridobitev tega dovoljenja za promet, upošteva znanstveni in tehnični napredek in uvede vse spremembe, ki so potrebne, da se zdravilo za uporabo v veterinarski medicini proizvaja in nadzoruje s splošno sprejetimi znanstvenimi metodami.
The marketing authorisation holder shall, within the limits of its responsibilities, ensure appropriate and continued supplies of its veterinary medicinal products.
Za uvedbo teh sprememb veljajo postopki iz oddelka 3 tega poglavja.
After a marketing authorisation has been granted, the marketing authorisation holder shall, in respect of the methods of manufacture and control stated in the application for that marketing authorisation, take account of scientific and technical progress and introduce any changes that may be required to enable the veterinary medicinal product to be manufactured and controlled by means of generally accepted scientific methods.
Imetnik dovoljenja za promet zagotovi, da so povzetek glavnih značilnosti zdravila, navodila za uporabo in označevanje posodobljeni v skladu z aktualnimi znanstvenimi dognanji.
The introduction of such changes shall be subject to the procedures laid down in Section 3 of this Chapter.
Imetnik dovoljenja za promet ne da v promet generičnih in hibridnih zdravil za uporabo v veterinarski medicini, dokler se ne izteče obdobje varstva tehnične dokumentacije za referenčno zdravilo za uporabo v veterinarski medicini, kakor je določeno v členih 39 in 40.
The marketing authorisation holder shall ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge.
Imetnik dovoljenja za promet v zbirki podatkov o zdravilih evidentira datume, ko se zdravila za uporabo v veterinarski medicini dajo v promet, informacije o razpoložljivosti vsakega zdravila v vseh relevantnih državah članicah, po potrebi pa tudi datume o začasnih odvzemih ali odvzemih zadevnih dovoljenj za promet.
The marketing authorisation holder shall not place generic veterinary medicinal products and hybrid veterinary medicinal products on the Union market until the period of the protection of technical documentation for the reference veterinary medicinal product, as set out in Articles 39 and 40, has elapsed.
Imetnik dovoljenja za promet pristojnim organom na njihovo zahtevo zagotovi zadostne količine vzorcev za izvajanje nadzora v zvezi z zdravili za uporabo v veterinarski medicini, ki jih je dal v promet na trgu Unije.
The marketing authorisation holder shall record in the product database the dates when its authorised veterinary medicinal products are placed on the market, information on the availability for each veterinary medicinal product in each relevant Member State and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned.
Na zahtevo pristojnega organa imetnik dovoljenja za promet zagotovi tehnično strokovno znanje za lažje izvajanje analizne metode za detekcijo ostankov zdravil za uporabo v veterinarski medicini v referenčnem laboratoriju Evropske unije, določenem v skladu z Uredbo (EU) 2017/625.
On the request of the competent authorities, the marketing authorisation holder shall provide them with sufficient quantities of samples to enable controls to be made on its veterinary medicinal products placed on the Union market.
Imetnik dovoljenja za promet na zahtevo pristojnega organa ali Agencije v roku, določenem v tej zahtevi, predloži podatke, ki dokazujejo, da razmerje med tveganjem in koristmi ostaja pozitivno.
On the request of a competent authority, the marketing authorisation holder shall provide technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the European Union reference laboratory designated under Regulation (EU) 2017/625.
Imetnik dovoljenja za promet z zdravilom pristojni organ, ki je izdal dovoljenje za promet, ali Komisijo, kakor je ustrezno, brez odlašanja obvesti o vsaki prepovedi ali omejitvi, ki jo naloži pristojni organ ali organ tretje države, in o vseh drugih novih informacijah, ki bi utegnile vplivati na oceno tveganj in koristi posameznega zdravila za uporabo v veterinarski medicini, vključno z izidom postopka obravnave signala, ki se izvede v skladu s členom 81.
On the request of a competent authority or the Agency, the marketing authorisation holder shall, within the time limit set in that request, provide data demonstrating that the benefit-risk balance remains positive.
Imetnik dovoljenja za promet z zdravilom v zahtevanem roku predloži pristojnemu organu, Komisiji ali Agenciji, kakor je ustrezno, vse podatke v zvezi z obsegom prodaje zadevnega zdravila za uporabo v veterinarski medicini.
The marketing authorisation holder shall without delay inform the competent authority which has granted the marketing authorisation or the Commission, as applicable, of any prohibition or restriction imposed by a competent authority or by an authority of a third country and of any other new information which might influence the assessment of the benefits and risks of the veterinary medicinal product concerned, including from the outcome of the signal management process carried out in accordance with Article 81.
Imetnik dovoljenja za promet v zbirki podatkov o zdravilih vpiše letni obseg prodaje za vsa zdravila za uporabo v veterinarski medicini.
The marketing authorisation holder shall provide the competent authority, the Commission or the Agency, as applicable, within the time limit set, with all data in its possession relating to the volume of sales of the veterinary medicinal product concerned.
Imetnik dovoljenja za promet brez odlašanja obvesti pristojni organ, ki je izdal dovoljenje za promet, ali Komisijo, kakor je ustrezno, o vseh svojih ukrepih za ustavitev prometa z zdravilom za uporabo v veterinarski medicini, skupaj z razlogi za te ukrepe, in to še pred izvedbo teh ukrepov.
The marketing authorisation holder shall record in the product database the annual volume of sales for each of its veterinary medicinal products.
Člen 59
The marketing authorisation holder shall without delay inform the competent authority which has granted the marketing authorisation or the Commission, as applicable, of any action which the holder intends to take in order to cease the marketing of a veterinary medicinal product prior to taking such action, together with the reasons for such action.
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