natgillin/translations-raw huggingface dataset:
The Agency shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(a) and (b) for failing to comply with the request or for supplying incorrect or misleading information.
Agencija navede pravno podlago in namen zahteve, določi rok za predložitev informacij, ki je najmanj štiri tedne, in pouči imetnika dovoljenja za promet o globah iz člena 19(1)(a) in (b) v primeru neizpolnitve zahteve ali predložitve nepravilnih ali zavajajočih informacij.
The Agency may request national competent authorities to cooperate in the investigation in the following ways:
Agencija lahko zahteva, da nacionalni pristojni organi sodelujejo pri preiskavi na naslednje načine:
by performing any of the tasks entrusted to the supervisory authorities by Articles 19(1) and 44(1) of Regulation (EC) No 726/2004;
z izvajanjem katere koli od nalog, zaupanih nadzornim organom s členoma 19(1) in 44(1) Uredbe (ES) št. 726/2004;
by performing inspections or other supervisory measures in accordance with Articles 111 to 115 of Directive 2001/83/EC and Articles 80, 81 and 82 of Directive 2001/82/EC.
z izvajanjem inšpekcijskih pregledov ali drugih nadzornih ukrepov v skladu s členi 111 do 115 Direktive 2001/83/ES in členi 80, 81 in 82 Direktive 2001/82/ES.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request.
Zahteve se naslovijo pisno, v njih pa se navedeta pravna podlaga in namen zahteve.
The time-limit for the submission of the reply or the conduct of the measure of inquiry shall be determined by agreement between the Agency and the national competent authority to which the request is addressed, having regard to the specific circumstances of the case.
Rok za predložitev odgovora ali izvedbe preiskovalnega ukrepa se določi v sporazumu med Agencijo in nacionalnim pristojnim organom, na katerega je zahteva naslovljena, ob upoštevanju posebnih okoliščin primera.
The Agency may ask any natural or legal persons to provide information relating to the alleged infringement.
Agencija lahko zaprosi katero koli fizično ali pravno osebo, da zagotovi informacije v zvezi z domnevno kršitvijo.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request, and shall fix a time-limit by which the information should be provided, which shall be at least four weeks.
Zahteve se naslovijo pisno, v njih pa se navedeta pravna podlaga in namen zahteve ter določi rok za predložitev informacij, ki je najmanj štiri tedne.
Right to be heard
Pravica do zaslišanja
Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.
Pred sprejetjem poročila iz člena 10 Agencija pozove imetnika dovoljenja za promet, da predloži pisne pripombe.
It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.
Agencija to stori pisno, z navedbo roka za predložitev teh pripomb, ki je najmanj štiri tedne.
Content and time-limits
Vsebina in roki
The Agency shall provide the Commission, the Member States and the marketing authorisation holder with a report summarising its findings in the light of the inquiry carried out in accordance with this Section.
Agencija priskrbi Komisiji, državam članicam in imetniku dovoljenja za promet poročilo s povzetkom svojih ugotovitev z vidika preiskave, izvedene v skladu s tem oddelkom.
Where the Agency considers that the marketing authorisation holder has committed an infringement as referred to in Article 1, the report shall also include an assessment of the circumstances of the specific case in accordance with the criteria set out in Article 18(2) and a request to the Commission for application of financial penalties.
Kadar Agencija meni, da je imetnik dovoljenja za promet zagrešil kršitev iz člena 1, poročilo vključuje tudi oceno okoliščin posebnega primera v skladu z merili iz člena 18(2) in zahtevo, da Komisija uporabi denarne kazni.
The Agency shall adopt its report no later than 18 months after notification of initiation of the procedure in accordance with Article 7 or one year after notification by the Commission of the return of the file in accordance with Article 15.
Agencija sprejme svoje poročilo najpozneje 18 mesecev po obvestilu o začetku postopka v skladu s členom 7 ali eno leto po sporočilu Komisije o vračilu spisa v skladu s členom 15.
Decision-making stage
Faza odločanja
Statement of objections
Ugotovitve o možnih kršitvah
Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections containing the following:
Kadar se po zahtevi Agencije na podlagi člena 10(2) Komisija odloči za nadaljevanje postopka za ugotavljanje kršitev, pisno obvesti imetnika dovoljenja za promet z ugotovitvami o možnih kršitvah, ki vsebujejo naslednje:
the allegations against the marketing authorisation holder, including a precise indication of which provision has allegedly been infringed, and the evidence on which those allegations are founded;
trditve proti imetniku dovoljenja za promet, vključno z natančno navedbo, katere določbe so bile domnevno kršene, in dokazom, na katerem temeljijo te trditve;
notice that fines or periodic penalty payments may be imposed.
opozorilo, da se lahko naložijo globe ali periodične denarne kazni.
Where, within 18 months of receiving the request from the Agency, the Commission has not notified a statement of objections, it shall provide the marketing authorisation holder with an explanatory statement.
Kadar Komisija v 18 mesecih po prejemu zahteve Agencije ne sporoči ugotovitev o možnih kršitvah, pošlje imetniku dovoljenja za promet obrazložitev.
Right to reply
Pravica do odgovora
When notifying the statement of objections, the Commission shall set a time-limit within which the marketing authorisation holder may submit to the Commission his written observations on the statement of objections.
Pri sporočanju ugotovitev o možnih kršitvah Komisija določi rok, v katerem lahko imetnik dovoljenja za promet predloži Komisiji svoje pisne pripombe na ugotovitve o možnih kršitvah.
That time-limit shall be at least four weeks.
Ta rok je najmanj štiri tedne.
The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.
Komisija ni dolžna upoštevati pisnih pripomb, prejetih po preteku tega roka.
The marketing authorisation holder may annex to his written observations, statements from other persons who may corroborate any aspect of those written observations.
Imetnik dovoljenja za promet lahko k svojim pisnim pripombam priloži izjave drugih oseb, ki lahko potrjujejo kateri koli vidik teh pisnih pripomb.
Oral hearing
Ustno zaslišanje
Where the marketing authorisation holder so requests in his written observations, the Commission shall give him an opportunity to develop his arguments at an oral hearing.
Kadar imetnik dovoljenja za promet v pisnih pripombah zahteva predstavitev svojih razlogov na ustnem zaslišanju, mu Komisija to omogoči.
The date for the oral hearing shall be set by the Commission.
Datum ustnega zaslišanja določi Komisija.
Where necessary, the Commission may invite the national competent authorities or any other persons to take part in the oral hearing.
Kadar je potrebno, lahko Komisija povabi nacionalne pristojne organe ali katere koli druge osebe, da se udeležijo ustnega zaslišanja.
The oral hearing shall not be public.
Ustna zaslišanja niso javna.
Each person may be heard separately or in the presence of other persons invited to attend, having regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets and other confidential information.
Vsaka oseba se lahko zasliši ločeno ali v navzočnosti drugih povabljenih oseb, pri čemer se upošteva legitimen interes imetnikov dovoljenj za promet in drugih oseb v zvezi z varovanjem njihovih poslovnih skrivnosti in drugih zaupnih podatkov.
Requests for information
Zahteve za informacije
After receipt of a request from the Agency pursuant to Article 10(2) and before adoption of the decision referred to in Article 16, the Commission may at any time request the marketing authorisation holder to provide written or oral explanations, or particulars or documents, relating to the alleged infringement.
Po prejemu zahteve Agencije na podlagi člena 10(2) in pred sprejetjem odločbe iz člena 16 lahko Komisija kadar koli zahteva od imetnika dovoljenja za promet pisne ali ustne razlage ali podrobnosti ali dokumente, ki se nanašajo na domnevno kršitev.
The Commission shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(c) and (d) for failing to comply with the request or supplying incorrect or misleading information.
Komisija navede pravno podlago in namen zahteve, določi rok za predložitev informacij, ki je najmanj štiri tedne, in pouči imetnika dovoljenja za promet o globah iz člena 19(1)(c) in (d) v primeru neizpolnitve zahteve ali predložitve nepravilnih ali zavajajočih informacij.
The Commission may request the Agency, the national competent authorities or any other natural or legal persons to provide information relating to the alleged infringement.
Komisija lahko zahteva od Agencije, nacionalnih pristojnih organov ali katere koli druge fizične ali pravne osebe, da zagotovi informacije v zvezi z domnevno kršitvijo.
Where the request is addressed to the Agency or a national competent authority, the time-limit by which the information is to be provided shall be determined by the Commission after consultation of the Agency or the national competent authority to which the request is addressed, having regard to the specific circumstances of the case.
Kadar je zahteva naslovljena na Agencijo ali nacionalni pristojni organ, določi rok za predložitev informacij Komisija po posvetovanju z Agencijo ali nacionalnim pristojnim organom, na katerega je naslovljena zahteva, ob upoštevanju posebnih okoliščin primera.
Where the request is addressed to other natural or legal persons, it shall fix a time-limit by which the information is to be provided, which shall be at least four weeks.
Kadar je zahteva naslovljena na druge fizične ali pravne osebe, Komisija določi rok za predložitev informacije, ki je najmanj štiri tedne.
New period of inquiry
Novo obdobje preiskave
Where, having regard to the report of the Agency, the observations of the marketing authorisation holder and, as the case may be, other information submitted to it, the Commission considers that additional information is needed in order to continue the procedure, it may return the case-file to the Agency for a new period of inquiry.
Kadar Komisija ob upoštevanju poročila Agencije, pripomb imetnika dovoljenja za promet in, po potrebi, drugih predloženih informacij meni, da so za nadaljevanje postopka potrebne dodatne informacije, lahko spis o zadevi vrne Agenciji za novo obdobje preiskave.
The Commission shall clearly indicate to the Agency the points of fact which it should further examine and, if appropriate, suggest possible measures of inquiry to that effect.
Komisija jasno navede Agenciji dejstva, ki jih mora nadalje proučiti, in, če je primerno, predlaga možne preiskovalne ukrepe v ta namen.
Subsections 2 and 3 of Section 1 shall apply to the conduct of the new period of inquiry.
Za vodenje novega obdobja preiskave se uporabljata pododdelka 2 in 3 oddelka 1.
Decision and financial penalties
Odločba in denarne kazni
Forms of financial penalty and maximum amounts
Oblike denarne kazni in najvišji zneski
Where, following the procedure provided for in Subsection 1, the Commission finds that the marketing authorisation holder has committed, intentionally or negligently, an infringement as referred to in Article 1, it may adopt a decision imposing a fine not exceeding 5 % of the holder’s Community turnover in the preceding business year.
Kadar Komisija po postopku iz pododdelka 1 ugotovi, da je imetnik dovoljenja za promet namerno ali iz malomarnosti povzročil kršitev iz člena 1, lahko sprejme odločbo o naložitvi globe, ki ne presega 5 % imetnikovega prometa v Skupnosti v predhodnem poslovnem letu.
Where the marketing authorisation holder has not terminated the infringement, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 2,5 % of the holder’s average daily Community turnover in the preceding business year.
Kadar imetnik dovoljenja za promet še ni končal kršitve, lahko Komisija v odločbi iz odstavka 1 naloži periodične denarne kazni na dan, ki ne presegajo 2,5 % imetnikovega povprečnega dnevnega prometa v Skupnosti v predhodnem poslovnem letu.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the infringement has been brought to an end.
Periodične denarne kazni se lahko naložijo za obdobje, ki traja od datuma obvestila o tej odločbi do takrat, ko se kršitev neha.
For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.
Za namene odstavkov 1 in 2 se predhodno poslovno leto nanaša na poslovno leto pred datumom odločbe iz odstavka 1.
The decision provided for in Article 16 shall be based exclusively on grounds on which the marketing authorisation holder has been able to comment.
Odločba iz člena 16 temelji izključno na razlogih, na katere je imetnik dovoljenja za promet lahko dal pripombe.
The Commission shall inform the marketing authorisation holder of the judicial remedies available.
Komisija obvesti imetnika dovoljenja za promet o razpoložljivih pravnih sredstvih.
The Commission shall communicate the adoption of the decision to the Agency and to the Member States.
Komisija obvesti o sprejetju odločbe Agencijo in države članice.
When publishing details of its decision in accordance with the second subparagraph of Article 84(3) of Regulation (EC) No 726/2004, the Commission shall have regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets.
Komisija pri objavi podrobnosti o svoji odločbi v skladu z drugim pododstavkom člena 84(3) Uredbe (ES) št. 726/2004 upošteva legitimen interes imetnikov dovoljenj za promet in drugih oseb v zvezi z varovanjem njihovih poslovnih skrivnosti.
Principles governing the application and quantification of financial penalties
Načela, ki urejajo uporabo in določitev višine denarnih kazni
In determining whether to impose a financial penalty and in determining the appropriate financial penalty, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness.
Pri odločanju za naložitev denarne kazni in pri določanju o njeni ustreznosti Komisija upošteva načela učinkovitosti, sorazmernosti in odvračilnosti.
In each case, the Commission shall take into consideration, where relevant, the following circumstances:
Komisija pri vsakem primeru, kjer je to ustrezno, upošteva naslednje okoliščine:
the seriousness and the effects of the infringement, and, in particular, the following:
resnost in učinke kršitve ter zlasti naslednje:
the way in which the infringement adversely affects the rights, safety or well-being of patients;
način, kako kršitev negativno vpliva na pravice, varnost ali dobro počutje bolnikov;
its effects on animal health and welfare and the impact on animal owners;
njene učinke na zdravje in dobro počutje živali ter vpliv na lastnike živali;
whether it poses or could pose a risk to public health, animal health or the environment;
ali pomeni ali bi lahko pomenila tveganje za javno zdravje, zdravje živali ali za okolje;
the gravity of the infringement in relation to public health, animal health and the environment;
resnost kršitve za javno zdravje, zdravje živali in okolje;
on the one hand, the good faith of the marketing authorisation holder in the interpretation and fulfilment of the obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 or, on the other hand, any evidence of wilful deceit on the part of the marketing authorisation holder;
na eni strani dobro vero imetnika dovoljenja za promet pri razlaganju in izpolnjevanju obveznosti v zvezi z dovoljenjem za promet, izdanim v skladu z Uredbo (ES) št. 726/2004, ali na drugi strani vsak dokaz o namerni prevari s strani imetnika dovoljenja za promet;
on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation;
na eni strani stopnjo vestnosti in pripravljenosti za sodelovanje s strani imetnika dovoljenja za promet pri odkrivanju kršitve in uporabi popravnega ukrepa ali v teku postopka ugotavljanja kršitve ali na drugi strani vsako oviranje s strani imetnika dovoljenja za promet pri odkrivanju kršitve in vodenju postopka ugotavljanja kršitve ali vsako nespoštovanje zahtev Agencije, Komisije ali nacionalnega pristojnega organa pri uporabi te uredbe s strani imetnika dovoljenja za promet;
the turnover of the medicinal product concerned;
promet zadevnega zdravila;
the need to adopt provisional measures by the Commission or urgent action by a Member State in accordance with Articles 20 or 45 of Regulation (EC) No 726/2004 as a result of an infringement;
potrebo po sprejetju začasnih ukrepov Komisije ali nujnega ukrepanja države članice v skladu s členoma 20 ali 45 Uredbe (ES) št. 726/2004, kot posledico kršitve;
the repetition, frequency or duration of the infringement by that marketing authorisation holder;
ponavljanje, pogostost ali trajanje kršitve navedenega imetnika dovoljenja za promet;
prior sanctions, including penalties, imposed on the same marketing authorisation holder.
prejšnje sankcije, vključno s kaznimi, ki so bile naložene istemu imetniku dovoljenja za promet.
In determining the amount of the financial penalty, the Commission shall take into account any penalties already imposed on the marketing authorisation holder at national level on the basis of the same legal grounds and the same facts.
Pri določanju zneska denarne kazni Komisija upošteva kazni, ki so že bile naložene imetniku dovoljenja za promet na nacionalni ravni na podlagi istih zakonskih razlogov in istih dejstev.
The Commission may by decision impose on marketing authorisation holders fines not exceeding 0,5 % of their Community turnover in the preceding business year where, intentionally or negligently:
Komisija lahko imetnikom dovoljenja za promet z odločbo naloži globo, ki ne presega 0,5 % njihovega prometa v Skupnosti v predhodnem poslovnem letu, če namerno ali iz malomarnosti:
they do not comply with a measure of inquiry adopted pursuant to Article 8(1);
ne ravnajo v skladu s preiskovalnim ukrepom, sprejetim na podlagi člena 8(1);
they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);
predložijo nepravilne ali zavajajoče informacije kot odziv na preiskovalni ukrep, sprejet na podlagi člena 8(1);
they do not comply with a request for information pursuant to Article 14;
ne izpolnijo zahteve po informacijah na podlagi člena 14;
they supply incorrect or misleading information in response to a request for information pursuant to Article 14.
predložijo nepravilne ali zavajajoče informacije v odgovor na zahtevo po informacijah na podlagi člena 14.
Where the non-cooperation of the marketing authorisation holder continues, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 0,5 % of the holder’s average daily Community turnover in the preceding business year.
Kadar se nesodelovanje imetnika dovoljenja za promet nadaljuje, lahko Komisija v odločbi iz odstavka 1 naloži periodične denarne kazni na dan, ki ne presegajo 0,5 % imetnikovega povprečnega dnevnega prometa v Skupnosti v predhodnem poslovnem letu.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the non-cooperation has ceased.
Periodične denarne kazni se lahko naložijo za obdobje, ki traja od datuma obvestila o navedeni odločbi do takrat, ko nesodelovanje preneha.
When the Commission intends to adopt a decision as referred to in Article 19(1), it shall first notify in writing the marketing authorisation holder, setting a time-limit within which the marketing authorisation holder may submit to the Commission his written observations.
Ko namerava Komisija sprejeti odločbo iz člena 19(1), najprej pisno obvesti imetnika dovoljenja za promet in določi rok, v katerem lahko imetnik dovoljenja za promet Komisiji predloži svoje pisne pripombe.
ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS
DOSTOP DO SPISA, ZASTOPANJE, ZAUPNOST IN ZAČASNE DOLOČBE
Access to the file
Dostop do spisa
Following notification under Article 7, the marketing authorisation holder shall have the right, on request, to access the documents and other materials compiled by the Agency and the Commission which serve as evidence of an alleged infringement.
Po obvestilu v skladu s členom 7 ima imetnik dovoljenja za promet pravico zahtevati dostop do dokumentov in drugega gradiva, ki sta ga zbrali Agencija in Komisija in ki služi kot dokaz za domnevno kršitev.
Documents obtained through access to the file shall be used only for the purposes of judicial or administrative proceedings for the application of this Regulation.
Dokumenti, pridobljeni z dostopom do spisa, se uporabijo le za sodne ali upravne postopke pri uporabi te uredbe.
Legal representation
Pravno zastopanje
The marketing authorisation holder shall have the right to legal representation during the infringement procedure.
Imetnik dovoljenja za promet ima med postopkom za ugotavljanje kršitev pravico do pravnega zastopanja.
Confidentiality and professional secrecy
Zaupnost in poklicna skrivnost
Without prejudice to the exchange and to the use of information foreseen in Article 3, an infringement procedure shall be carried out subject to the principles of confidentiality and of professional secrecy.
Brez poseganja v izmenjavo in uporabo informacij iz člena 3 se postopek za ugotavljanje kršitev izvaja ob upoštevanju načel zaupnosti in poklicne skrivnosti.
The Agency and the Commission, their officials, servants and other persons working under their supervision shall not disclose information acquired or exchanged by them pursuant to this Regulation and of the kind covered by the obligation of professional secrecy and confidentiality.
Agencija in Komisija, njuni uradniki, uslužbenci in druge osebe, ki delajo pod njihovim nadzorom, ne razkrijejo informacij, ki so jih pridobili ali izmenjali na podlagi te uredbe, in informacij tiste vrste, ki so predmet poklicne skrivnosti in zaupnosti.
Without prejudice to the right to access the case-file, the marketing authorisation holder shall not have access to business secrets, confidential information or internal documents held by the Agency, the Commission or a Member State.
Brez poseganja v pravico dostopa do spisa o zadevi imetnik dovoljenja za promet nima dostopa do poslovnih skrivnosti, zaupnih informacij ali internih dokumentov Agencije, Komisije ali države članice.