natgillin/translations-raw huggingface dataset:
In that way, the effective enforcement of Regulation (EC) No 726/2004 would be ensured by an appropriate management of the resources available at Community and national level.
Na ta način bi se z ustreznim upravljanjem sredstev, ki so na voljo v Skupnosti in na nacionalni ravni, zagotovilo učinkovito izvrševanje Uredbe (ES) št. 726/2004.
As a result of the system of parallel powers in relation to supervision and enforcement by the Community and the Member States with regard to marketing authorisations granted in accordance with Regulation (EC) No 726/2004, the provisions of this Regulation can be effectively enforced only in a framework of close cooperation, in accordance with Article 10 of the Treaty, between the Member States, the Agency and the Commission.
Posledica sistema vzporednih pooblastil Skupnosti in držav članic za nadzor in izvrševanje v zvezi z dovoljenji za promet, izdanimi v skladu z Uredbo (ES) št. 726/2004, je, da je mogoče določbe te uredbe učinkovito izvrševati le s tesnim sodelovanjem med državami članicami, Agencijo in Komisijo v skladu s členom 10 Pogodbe.
For that purpose it is necessary to set up arrangements for consultation and cooperation between them.
V ta namen je treba vzpostaviti ureditve za posvetovanje in medsebojno sodelovanje.
It is appropriate that, for the purposes of the initiation and conduct of the infringement procedure and the quantification of financial penalties, the Agency and the Commission should take into account any procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts.
Zaradi začetka in vodenja postopka za ugotavljanje kršitev in zaradi določitve višine denarnih kazni je primerno, da bi Agencija in Komisija upoštevali morebitni postopek države članice proti istemu imetniku dovoljenja za promet ter na podlagi istih zakonskih razlogov in istih dejstev.
In order to ensure the effective conduct of the inquiry stage of alleged infringements, the Agency and the Commission should have recourse to the competent authorities of the Member States, designated as the supervisory authorities of medicinal products authorised through the centralised procedure by Regulation (EC) No 726/2004, to carry out the necessary measures of inquiry and to obtain information relating to infringements falling within the scope of this Regulation.
Da bi zagotovili učinkovito vodenje preiskovalne faze domnevnih kršitev, bi se morali Agencija in Komisija obrniti na pristojne organe držav članic, imenovane za nadzorne organe za zdravila, ki so odobrena po centraliziranem postopku po Uredbi (ES) št. 726/2004, da izvedejo potrebne preiskovalne ukrepe in pridobijo informacije v zvezi s kršitvami na področju uporabe te uredbe.
To that end, it is appropriate that the supervisory authorities conduct the inspection and surveillance activities for which they are competent in accordance with the provisions of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [2] and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [3] and their implementing provisions.
V ta namen je primerno, da nadzorni organi vodijo dejavnosti inšpekcije in nadzorovanja, za katere so pristojni, v skladu z določbami Uredbe (ES) št. 726/2004, Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [2] in Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [3] ter njihovimi izvedbenimi določbami.
The obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 falling within the scope of this Regulation should be enforceable by means of two types of financial penalties: fines and periodic penalty payments.
Obveznosti v zvezi z dovoljenji za promet, izdanimi v skladu z Uredbo (ES) št. 726/2004, ki spadajo v področje uporabe te uredbe, bi morale biti izvršljive z dvema vrstama denarnih kazni: z globami in periodičnimi denarnimi kaznimi.
Maximum amounts for both categories should be established.
Treba bi bilo določiti najvišje zneske za obe kategoriji.
The decision to initiate an infringement procedure under this Regulation should be taken by the Agency, which should first inform the Commission and the Member States.
Odločitev o začetku postopka za ugotavljanje kršitev po tej uredbi bi morala sprejeti Agencija, ki naj najprej obvesti Komisijo in države članice.
In the course of an inquiry, the Agency should be empowered to require such information to be supplied as is necessary to detect any infringement.
V teku preiskave bi morala biti Agencija pooblaščena, da zahteva predložitev tistih informacij, ki so potrebne za odkrivanje katere koli kršitve.
It should also be able to rely on the cooperation of national competent authorities.
Morala bi tudi imeti možnost, da se zanese na sodelovanje nacionalnih pristojnih organov.
Any supervisory powers entrusted to the Agency by Community law as regards marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004 may be used by it in the course of the investigation of an infringement.
Vse pristojnosti nadzora, ki jih ima Agencija po pravu Skupnosti v zvezi z dovoljenji za promet z zdravili, izdanimi v skladu z Uredbo (ES) št. 726/2004, lahko izkoristi v teku preiskave kršitve.
The decisions by the Commission imposing penalties should be based on the inquiry by the Agency, the observations of the marketing authorisation holder subject to the infringement procedure and, where appropriate, other information submitted to it.
Odločbe Komisije o naložitvi kazni bi morale temeljiti na preiskavi Agencije, pripombah imetnika dovoljenja za promet v postopku za ugotavljanje kršitev in, če je primerno, drugih prejetih informacij.
Any supervisory powers entrusted to the Commission by Community law as regards marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004 may be used by it in the course of the decision-making stage of an infringement procedure.
Vse pristojnosti nadzora, ki jih ima Komisija po pravu Skupnosti v zvezi z dovoljenji za promet z zdravili, izdanimi v skladu z Uredbo (ES) št. 726/2004, lahko izkoristi pri sprejemanju odločitve v teku postopka za ugotavljanje kršitev.
It is appropriate that decisions imposing penalties be based exclusively on objections on which the marketing authorisation holder concerned has been able to comment.
Primerno je, da odločbe o naložitvi kazni temeljijo izključno na ugovorih, na katere so zadevni imetniki dovoljenj za promet lahko dali pripombe.
The penalties imposed should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case.
Naložene kazni bi morale biti učinkovite, sorazmerne in odvračilne glede na okoliščine posameznega primera.
It appears appropriate to provide for a specific procedure in cases where the Commission intends to impose a fine for failure by a marketing authorisation holder subject to an infringement procedure to comply with a request for information from the Agency or the Commission.
Zdi se, da je smiselno predvideti poseben postopek v primerih, ko namerava Komisija v postopku za ugotavljanje kršitev naložiti kazen imetniku dovoljenja za promet, ki ni izpolnil zahteve Agencije ali Komisije za predložitev podatkov.
When carrying out an infringement procedure, the Agency and the Commission must ensure the respect of the rights of defence and of the principle of confidentiality in accordance with the general principles of law, and the case-law of the Court of Justice of the European Communities.
Pri izvajanju postopka za ugotavljanje kršitev morata Agencija in Komisija zagotoviti spoštovanje pravic obrambe in načela zaupnosti v skladu s splošnimi načeli prava in sodne prakse Sodišča Evropskih skupnosti.
In particular, the marketing authorisation holder subject to the infringement procedure should have the right to be heard by the Agency during the inquiry stage and by the Commission once it has been notified a statement of objections, as well as to access the file compiled by the Agency and the Commission.
Še posebno bi moral imetnik dovoljenja za promet v postopku za ugotavljanje kršitev imeti pravico, da ga zasliši Agencija v preiskovalni fazi in Komisija, potem ko je obveščen o ugotovitvah o možnih kršitvah, kakor tudi imeti dostop do spisa, ki sta ga sestavili Agencija in Komisija.
While the Commission should be entitled to compel marketing authorisation holders to provide the necessary information and documents relating to a presumed infringement, the right to silence in situations where the holder would be compelled to provide answers which may involve an admission on its part of the existence of an infringement, as developed by the Court of Justice, should also be respected.
Komisija bi morala imeti pravico prisiliti imetnike dovoljenj za promet, da zagotovijo potrebne informacije in dokumente, ki se nanašajo na domnevno kršitev, vendar pa je treba spoštovati tudi pravico do molka v razmerah, ko bi bil imetnik prisiljen dati odgovore, ki bi lahko vključevali priznanje o obstoju kršitve, kakor to razlaga Sodišče.
For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to lay down detailed rules for the computation of time-limits and limitation periods for the imposition and enforcement of penalties.
Za namene zagotavljanja pravne varnosti pri vodenju postopka za ugotavljanje kršitev je treba določiti natančna pravila za računanje rokov in zastaralnih rokov za odreditev in izvršitev kazni.
Decisions imposing penalties are to be enforced in accordance with Article 256 of the Treaty and are subject to review by the Court of Justice.
Odločbe o naložitvi kazni je treba izvršiti v skladu s členom 256 Pogodbe, pregledati pa jih mora Sodišče.
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.
Ta uredba spoštuje temeljne pravice in upošteva sprejeta načela, zlasti načela Listine Evropske unije o temeljnih pravicah.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use and the Standing Committee for Veterinary Medicinal Products,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za humano uporabo in Stalnega odbora za zdravila za veterinarsko uporabo –
This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations, granted under Regulation (EC) No 726/2004, in respect of infringements of the following obligations, in cases where the infringement concerned may have significant public health implications in the Community, or where it has a Community dimension by taking place or having its effects in more than one Member State, or where interests of the Community are involved:
Ta uredba določa pravila o uporabi denarnih kazni za imetnike dovoljenj za promet, izdanih na podlagi Uredbe (ES) št. 726/2004, v zvezi s kršitvami naslednjih obveznosti, kadar lahko zadevne kršitve znatno vplivajo na javno zdravje v Skupnosti ali kadar imajo razsežnost Skupnosti, če se pojavljajo ali imajo vpliv v več kakor eni državi članici ali kadar je vpleten kateri koli interes Skupnosti:
the completeness and the accuracy of the particulars and documents contained in an application for marketing authorisation under Regulation (EC) No 726/2004, or of any other documents and data submitted to the European Medicines Agency established by that Regulation, hereinafter ‘the Agency’, in response to obligations laid down in that Regulation;
popolnost in točnost podatkov in dokumentov, ki jih vsebuje vloga za dovoljenje za promet na podlagi Uredbe (ES) št. 726/2004, ali katerih koli drugih dokumentov in podatkov, predloženih Evropski agenciji za zdravila, v nadaljnjem besedilu „Agenciji“, kot odziv na obveznosti, določene v navedeni uredbi;
conditions or restrictions included in the market authorisation and concerning the supply or use of the medicinal product, as referred to in Article 9(4)(b), the second subparagraph of Article 10(1), Article 34(4)(c) and the second subparagraph of Article 35(1) of Regulation (EC) No 726/2004;
pogoji ali omejitve, ki jih vsebuje dovoljenje za promet in se nanašajo na dobavo ali uporabo zdravila, kot je navedeno v členu 9(4)(b), v drugem pododstavku člena 10(1), v členu 34(4)(c) in drugem pododstavku člena 35(1) Uredbe (ES) št. 726/2004;
conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product, as referred to in Article 9(4)(c), Article 10(1), Article 34(4)(d) and Article 35(1) of Regulation (EC) No 726/2004;
pogoji ali omejitve, ki jih vsebuje dovoljenje za promet v zvezi z varno in učinkovito uporabo zdravila, kot je navedeno v členu 9(4)(c), členu 10(1), členu 34(4)(d) in členu 35(1) Uredbe (ES) št. 726/2004;
the introduction of any necessary variations to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods, as referred to in Article 16(1) and Article 41(1) of Regulation (EC) No 726/2004;
uvedba vseh potrebnih sprememb pogojev za dovoljenje za promet zaradi upoštevanja tehničnega in znanstvenega napredka in omogočanja, da se zdravila proizvajajo in preverjajo s splošno sprejetimi znanstvenimi metodami, kot je navedeno v členu 16(1) in členu 41(1) Uredbe (ES) št. 726/2004;
the supply of any new information which may entail a variation to the terms of the marketing authorisation, the notification of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed, or the supply of any information that may influence the evaluation of the risks and benefits of the product, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004;
predložitev kakršnih koli novih informacij, ki bi lahko privedle do spremembe pogojev za dovoljenje za promet, obvestilo o prepovedih ali omejitvah, ki so jih uvedli pristojni organi katere koli države, v kateri je zdravilo v prometu, ali predložitev katerih koli informacij, ki bi lahko vplivale na oceno tveganj in koristi zdravila, kot je navedeno v členu 16(2) in členu 41(4) Uredbe (ES) št. 726/2004;
the supply at the request of the Agency of any data demonstrating that the risk-benefit balance remains favourable, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004;
na zahtevo Agencije predložitev kakršnih koli podatkov, ki dokazujejo, da ostaja razmerje med tveganjem in koristmi ugodno, kot je navedeno v členu 16(2) in členu 41(4) Uredbe (ES) št. 726/2004;
the detection of residues in the case of veterinary medicinal products, as referred to in Article 41(2) and (3) of Regulation (EC) No 726/2004;
odkrivanje ostankov v primeru veterinarskih zdravil, kot je navedeno v členu 41(2) in (3) Uredbe (ES) št. 726/2004;
placing on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation;
dajanje na trg v skladu z vsebino povzetka značilnosti zdravila ter ovojnine in navodila za uporabo, kot je navedena v dovoljenju za promet;
the specific obligations referred to in Article 14(7) of Regulation (EC) No 726/2004 or in any other provisions adopted pursuant thereto;
posebne obveznosti, navedene v členu 14(7) Uredbe (ES) št. 726/2004 ali v kateri koli drugi določbi, sprejeti na tej podlagi;
the specific procedures referred to in Article 14(8) and Article 39(7) of Regulation (EC) No 726/2004;
posebni postopki, navedeni v členu 14(8) in členu 39(7) Uredbe (ES) št. 726/2004;
notification to the Agency of the dates of actual marketing and of the date when the product ceases to be on the market, and provision to the Agency of data relating to the volume of sales and the volume of prescriptions of the product, as referred to in Article 13(4) and Article 38(4) of Regulation (EC) No 726/2004;
obvestilo Agenciji o datumih dejanskega prometa in datumu, ko je zdravilo umaknjeno iz prometa, ter zagotavljanje podatkov Agenciji o obsegu prodaje in receptov za zdravilo, kot je navedeno v členu 13(4) in členu 38(4) Uredbe (ES) št. 726/2004;
the appropriately qualified person responsible for pharmacovigilance, as referred to in Article 23 and Article 48 of Regulation (EC) No 726/2004;
primerno usposobljena oseba, ki je odgovorna za farmakovigilanco, kot je navedeno v členu 23 in členu 48 Uredbe (ES) št. 726/2004;
recording and reporting of suspected serious adverse reactions and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(1) and Article 49(1) of Regulation (EC) No 726/2004;
evidentiranje in sporočanje domnevnih resnih neželenih učinkov in v primeru veterinarskih zdravil neželenih učinkov pri ljudeh, kot je navedeno v členu 24(1) in členu 49(1) Uredbe (ES) št. 726/2004;
reporting of suspected serious unexpected adverse reactions, suspected transmission of infectious agents and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(2) and Article 49(2) of Regulation (EC) No 726/2004;
sporočanje domnevnih resnih neželenih učinkov, domnevnega prenašanja povzročitelja okužbe in v primeru veterinarskih zdravil neželenih učinkov pri ljudeh, kot je navedeno v členu 24(2) in členu 49(2) Uredbe (ES) št. 726/2004;
detailed recording of all suspected adverse reactions and submission of such records in the form of periodic safety update reports, as referred to in Article 24(3) and Article 49(3) of Regulation (EC) No 726/2004;
podrobno evidentiranje vseh domnevnih neželenih učinkov in predložitev teh evidenc v obliki rednih, z zadnjimi podatki dopolnjenih poročil, kot je navedeno v členu 24(3) in členu 49(3) Uredbe (ES) št. 726/2004;
communication of information relating to pharmacovigilance concerns to the general public, as referred to in Article 24(5) and Article 49(5) of Regulation (EC) No 726/2004;
obveščanje javnosti o informacijah, ki se nanašajo na farmakovigilanco, kot je navedeno v členu 24(5) in členu 49(5) Uredbe (ES) št. 726/2004;
collation and assessment of specific pharmacovigilance data, as referred to in the fourth paragraph of Article 26 and the fourth paragraph of Article 51 of Regulation (EC) No 726/2004.
primerjava in ocena posebnih podatkov o farmakovigilanci, kot je navedeno v četrtem odstavku člena 26 in četrtem odstavku člena 51 Uredbe (ES) št. 726/2004.
Complementarity of procedures
Dopolnjevanje postopkov
For the purposes of the initiation and conduct of the infringement procedure provided for in Chapter II, the Agency and the Commission shall take into account any infringement procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts.
Zaradi začetka in vodenja postopka za ugotavljanje kršitev iz poglavja II Agencija in Komisija upoštevata kateri koli postopek za ugotavljanje kršitev, ki ga vodi država članica proti istemu imetniku dovoljenja za promet ter na podlagi istih zakonskih razlogov in istih dejstev.
Cooperation by the competent authorities of the Member States
Sodelovanje pristojnih organov držav članic
The competent authorities of the Member States shall cooperate with the Agency and the Commission to enable them to carry out their duties under this Regulation.
Pristojni organi držav članic sodelujejo z Agencijo in Komisijo, da jima omogočijo izvajanje dolžnosti po tej uredbi.
Information provided by the national competent authorities in response to a request from the Agency or the Commission under this Regulation shall be used by the Agency and the Commission only for the following purposes:
Informacije, ki jih nacionalni pristojni organi predložijo kot odgovor na zahtevo Agencije ali Komisije po tej uredbi, Agencija in Komisija uporabita le za naslednje namene:
as evidence for the purposes of applying this Regulation;
kot dokaz pri uporabi te uredbe;
for carrying out the tasks entrusted to them for the authorisation and supervision of medicinal products under Regulation (EC) No 726/2004.
za izvajanje nalog, ki so jima zaupane, pri pridobitvi dovoljenja za promet in nadzoru zdravil na podlagi Uredbe (ES) št. 726/2004.
In any infringement procedure under this Regulation, the burden of proving an infringement shall rest on the Commission.
Pri vsakem postopku za ugotavljanje kršitev v okviru te uredbe breme dokazovanja kršitve nosi Komisija.
INFRINGEMENT PROCEDURE
POSTOPEK ZA UGOTAVLJANJE KRŠITEV
Inquiry
Preiskava
Initiation of procedure
Začetek postopka
Initiation of the infringement procedure
Začetek postopka za ugotavljanje kršitev
The Agency may initiate the infringement procedure on its own initiative or following a request from the Commission or a Member State.
Agencija lahko začne postopek za ugotavljanje kršitev na lastno pobudo ali na zahtevo Komisije ali države članice.
The Agency shall inform the Commission that it intends to initiate the infringement procedure.
Agencija obvesti Komisijo, da namerava začeti postopek za ugotavljanje kršitev.
The Agency shall initiate the infringement procedure only after informing the Member States.
Agencija začne postopek za ugotavljanje kršitev šele potem, ko obvesti države članice.
Request for information
Zahteva za informacije
Prior to initiating an infringement procedure, the Agency may request from the marketing authorisation holder concerned any information relating to the alleged infringement.
Pred začetkom postopka za ugotavljanje kršitev lahko Agencija od zadevnega imetnika dovoljenja za promet zahteva katere koli informacije v zvezi z domnevno kršitvijo.
The Agency shall state the purpose of the request and the fact that it is made under this Regulation, and indicate a time-limit for the submission of the reply by the marketing authorisation holder, which shall be at least four weeks.
Agencija pojasni namen zahteve in dejstvo, da je le-ta v skladu s to uredbo, ter navede imetniku dovoljenja za promet rok za predložitev odgovora, ki mora biti najmanj štiri tedne.
Where the request is in response to a request from a Member State under Article 5(1), that Member State shall be informed by the Agency.
Kadar je zahteva odziv na zahtevo države članice iz člena 5(1), Agencija obvesti to državo članico.
The Agency shall send written notification of the initiation of an infringement procedure to the marketing authorisation holder concerned, to the Member States and to the Commission.
Agencija pošlje pisno obvestilo o začetku postopka za ugotavljanje kršitev zadevnemu imetniku dovoljenja za promet, državam članicam in Komisiji.
The notification shall set out the allegations against the marketing authorisation holder, specifying the provision allegedly infringed, and the evidence on which those allegations are founded.
Obvestilo vsebuje trditve proti imetniku dovoljenja za promet ter navaja domnevne kršene določbe in dokaze, na katerih temeljijo te trditve.
It shall give notice to the marketing authorisation holder that fines or periodic penalty payments may be imposed.
Imetnik dovoljenja za promet je obveščen, da se lahko naložijo globe ali periodične denarne kazni.
Measures of inquiry
Preiskovalni ukrepi
Requests by the Agency
Zahteve Agencije
The Agency may request the marketing authorisation holder to provide written or oral explanations, or particulars or documents.
Agencija lahko zahteva od imetnika dovoljenja za promet pisne ali ustne razlage ali podrobnosti ali dokumente.
Requests shall be addressed in writing to the marketing authorisation holder.
Zahteve se na imetnika dovoljenja za promet naslovijo pisno.