natgillin/translations-raw huggingface dataset:
Member States shall, by 28 January 2022, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendments affecting them.
Komisija lahko naloži denarne kazni v obliki glob ali periodičnih denarnih kazni imetnikom centralno izdanih dovoljenj za promet za zdravila za uporabo v veterinarski medicini, ki so izdana po tej uredbi, če ne izpolnjujejo katere od obveznosti, določenih v Prilogi III v zvezi z dovoljenji za promet.
The competent authorities shall ensure the publication of information on the type and number of cases where financial penalties were imposed, having regard to the legitimate interest of the concerned parties for the protection of their business secrets.
Komisija lahko, če je to posebej določeno v delegiranih aktih iz odstavka 7(b), naloži denarne kazni iz odstavka 1 tudi pravnemu subjektu ali pravnim subjektom, ki niso imetniki dovoljenja za promet, če so ti del istega gospodarskega subjekta kot imetnik dovoljenja za promet in če so ti drugi pravni subjekti:
Member States shall inform the Commission immediately of any litigation against the holders of marketing authorisations for centrally authorised veterinary medicinal products brought for infringement of this Regulation.
odločilno vplivali na imetnika dovoljenja za promet ali
Article 136
sodelovali pri neizpolnjevanju obveznosti, ki jo je zakrivil imetnik dovoljenja za promet, oziroma bi to lahko preprečili.
Financial penalties imposed by the Commission on holders of marketing authorisation for centrally authorised veterinary medicinal products
Kadar Agencija ali pristojni organ države članice meni, da imetnik dovoljenja za promet ni izpolnil katere od obveznosti iz odstavka 1, lahko zaprosi Komisijo, da preuči, ali je treba v skladu z navedenim odstavkom naložiti denarne kazni.
The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisation for centrally authorised veterinary medicinal products granted under this Regulation if they fail to comply with any of their obligations laid down in Annex III in connection with the marketing authorisations.
Komisija pri odločanju, ali se naloži denarna kazen, in pri določanju ustrezne vsote upošteva načela učinkovitosti, sorazmernosti in odvračanja, po potrebi pa tudi resnost in posledice neizpolnjevanja obveznosti.
The Commission may, insofar as specifically provided for in the delegated acts referred to in point (b) of paragraph 7, impose the financial penalties referred to in paragraph 1 also on a legal entity or legal entities other than the marketing authorisation holder provided that such entities form part of the same economic entity as the marketing authorisation holder and that such other legal entities:
Za namene odstavka 1 Komisija upošteva tudi:
exerted a decisive influence over the marketing authorisation holder; or
vsak postopek za ugotavljanje kršitev, ki ga država članica sproži proti istemu imetniku dovoljenja za promet, ki temelji na isti pravni podlagi in istih dejstvih, in
were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder.
vse sankcije, vključno s kaznimi, ki so istemu imetniku dovoljenja za promet že naložene in temeljijo na isti pravni podlagi in istih dejstvih.
Where the Agency or a competent authority of a Member State is of the opinion that a marketing authorisation holder has failed to comply with any of the obligations, as referred to in paragraph 1, it may request the Commission to investigate whether to impose financial penalties pursuant to that paragraph.
Kadar Komisija ugotovi, da imetnik dovoljenja za promet namerno ali iz malomarnosti ni izpolnil obveznosti iz odstavka 1, lahko sprejme odločitev o naložitvi globe, ki ne presega 5 % prometa imetnika dovoljenja za promet v Uniji v poslovnem letu pred datumom te odločitve.
In determining whether to impose a financial penalty and in determining its appropriate amount, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness and take into consideration, where relevant, the seriousness and the effects of the failure to comply with the obligations.
Kadar imetnik dovoljenja za promet še naprej ne izpolnjuje svojih obveznosti iz odstavka 1, lahko Komisija sprejme odločitev, s katero naloži periodične denarne kazni na dan, ki ne presegajo 2,5 % povprečnega dnevnega prometa imetnika dovoljenja za promet v Uniji v poslovnem letu pred datumom te odločitve.
For the purposes of paragraph 1, the Commission shall also take into account:
Periodične denarne kazni se lahko naložijo za obdobje, ki traja od datuma obvestila o zadevni odločbi Komisije do takrat, ko preneha neizpolnjevanje obveznosti iz odstavka 1 s strani imetnika dovoljenja za promet.
any infringement procedure initiated by a Member State against the same marketing authorisation holder on the basis of the same legal grounds and the same facts; and
Komisija sprejme delegirane akte v skladu s členom 147 za dopolnitev te uredbe z določitvijo:
any sanctions, including penalties, already imposed on the same marketing authorisation holder on the basis of the same legal grounds and the same facts.
postopkov, ki jih mora Komisija uporabljati pri naložitvi glob ali periodičnih denarnih kazni, vključno s pravili o sprožitvi postopka, ukrepi za preiskavo, pravicami do obrambe, dostopom do dokumentacije, pravnim zastopanjem in zaupnostjo;
Where the Commission finds that the marketing authorisation holder has failed, intentionally or negligently, to comply with its obligations, as referred to in paragraph 1, it may adopt a decision imposing a fine not exceeding 5 % of the marketing authorisation holder’s Union turnover in the business year preceding the date of that decision.
dodatnih podrobnih pravil o nalaganju denarnih kazni Komisije pravnim subjektom, ki niso imetniki dovoljenja za promet;
Where the marketing authorisation holder continues to fail to comply with its obligations referred to in paragraph 1, the Commission may adopt a decision imposing periodic penalty payments per day not exceeding 2,5 % of the marketing authorisation holder’s average daily Union turnover in the business year preceding the date of that decision.
pravil o trajanju postopka in zastaralnih rokih;
Periodic penalty payments may be imposed for a period running from the date of notification of the relevant Commission's decision until the failure to comply with the obligation by the marketing authorisation holder, as referred to in paragraph 1, has been brought to an end.
elementov, ki jih mora Komisija upoštevati pri določanju višine in nalaganju glob ter periodičnih denarnih kazni ter njihovem nalaganju, ter pogojev in načinov izterjave.
The Commission shall adopt delegated acts in accordance with Article 147 in order to supplement this Regulation by laying down:
Pri izvajanju preiskave o neizpolnjevanju katerih koli obveznosti iz odstavka 1 lahko Komisija sodeluje s pristojnimi nacionalnimi organi in uporabi vire, ki jih zagotavlja Agencija.
procedures to be applied by the Commission when imposing fines or periodic penalty payments, including rules on the initiation of the procedure, measures of inquiry, rights of defence, access to file, legal representation and confidentiality;
Kadar Komisija sprejme sklep o naložitvi denarne kazni, objavi kratek povzetek primera z imeni vpletenih imetnikov dovoljenj za promet in zneski naloženih denarnih kazni ter razlogi zanje, pri čemer upošteva pravni interes imetnikov dovoljenj za promet glede varstva njihovih poslovnih skrivnosti.
further detailed rules on the imposition by the Commission of financial penalties on legal entities other than the marketing authorisation holder;
Sodišče Evropske unije ima neomejeno pristojnost za pregled sklepov, s katerimi je Komisija naložila denarne kazni.
rules on duration of procedure and limitation periods;
Sodišče Evropske unije lahko naloženo globo ali periodično denarno kazen, ki jo je naložila Komisija, prekliče, zniža ali poviša.
elements to be taken into account by the Commission when setting the level of, and imposing, fines and periodic penalty payments, as well as the conditions and methods for their collection.
POGLAVJE X
When conducting the investigation on a failure to comply with any of the obligations referred to in paragraph 1, the Commission may cooperate with national competent authorities and rely on resources provided by the Agency.
REGULATIVNO OMREŽJE
Where the Commission adopts a decision imposing a financial penalty, it shall publish a concise summary of the case, including the names of the marketing authorisation holders involved and the amounts of, and reasons for, the financial penalties imposed, having regard to the legitimate interest of the marketing authorisation holders for the protection of their business secrets.
Člen 137
The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has imposed financial penalties.
Pristojni organi
The Court of Justice of the European Union may cancel, reduce or increase the fine or periodic penalty payment imposed by the Commission.
Države članice imenujejo pristojne organe za izvajanje nalog v skladu s to uredbo.
CHAPTER X
Države članice zagotovijo, da so na voljo ustrezna finančna sredstva za osebje in druga sredstva, ki jih pristojni organi potrebujejo za izvajanje dejavnosti iz te uredbe.
REGULATORY NETWORK
Pristojni organi medsebojno sodelujejo pri opravljanju svojih nalog v skladu s to uredbo ter pristojnim organom drugih držav članic v ta namen zagotavljajo potrebno podporo, ki bi jim lahko koristila.
Article 137
Pristojni organi si medsebojno izmenjujejo ustrezne informacije.
Competent authorities
Na utemeljeno zahtevo pristojni organi nemudoma pošljejo pisne evidence iz člena 123 in poročila o nadzoru iz člena 127 pristojnim organom drugih držav članic.
Member States shall designate the competent authorities to carry out tasks under this Regulation.
Člen 138
Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to carry out the activities required by this Regulation.
Znanstveno mnenje mednarodnim organizacijam za zdravje živali
The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end.
Agencija lahko izda znanstvena mnenja v okviru sodelovanja z mednarodnimi organizacijami za zdravje živali za vrednotenje zdravil za uporabo v veterinarski medicini, namenjenih izključno za trge zunaj Unije.
Competent authorities shall communicate the appropriate information to each other.
V ta namen je treba Agenciji predložiti vlogo v skladu s členom 8.
On reasoned request, the competent authorities shall forthwith communicate the written records referred to in Article 123 and control reports referred to in Article 127 to the competent authorities of other Member States.
Agencija lahko po posvetovanju z ustrezno organizacijo pripravi znanstveno mnenje.
Article 138
Agencija oblikuje posebna postopkovna pravila za izvajanje odstavka 1.
Scientific opinion for international organisations for animal health
Člen 139
The Agency may give scientific opinions, in the context of cooperation with international organisations for animal health, for the evaluation of veterinary medicinal products intended exclusively for markets outside the Union.
Odbor za zdravila za uporabo v veterinarski medicini
For that purpose, an application shall be submitted to the Agency in accordance with Article 8.
V okviru Agencije se ustanovi Odbor za zdravila za uporabo v veterinarski medicini (v nadaljnjem besedilu: Odbor).
The Agency may, after consulting the relevant organisation, draw up a scientific opinion.
Izvršni direktor Agencije ali njegov predstavnik in predstavniki Komisije se lahko udeležijo vseh sej odborov ter njihovih delovnih in znanstvenih svetovalnih skupin.
The Agency shall establish specific procedural rules for the implementation of paragraph 1.
Odbor lahko ustanovi stalne in začasne delovne skupine.
Article 139
Odbor lahko ustanovi znanstvene svetovalne skupine v povezavi z vrednotenjem specifičnih vrst zdravil za uporabo v veterinarski medicini, na katere lahko Odbor prenese nekatere naloge, povezane s pripravo znanstvenih mnenj iz točke (b) člena 141(1).
Committee for Veterinary Medicinal Products
Odbor ustanovi stalno delovno skupino, katere edina naloga je zagotavljanje znanstvenega svetovanja podjetjem.
A Committee for Veterinary Medicinal Products (‘the Committee’) is hereby set up within the Agency.
Izvršni direktor v sodelovanju z Odborom vzpostavi upravne strukture in postopke, ki omogočajo razvoj svetovanja podjetjem, kot je določeno v točki (n) člena 57(1) Uredbe (ES) št. 726/2004, zlasti glede razvoja zdravil za uporabo v veterinarski medicini za nove terapije.
The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the Committee, working parties and scientific advisory groups.
Odbor vzpostavi stalno delovno skupino za farmakovigilanco, katere delovno področje zajema tudi oceno morebitnih signalov v farmakovigilanci, ki izhajajo iz sistema farmakovigilance v Uniji, predlaganje možnosti za obvladovanje tveganja iz člena 79 Odboru in koordinacijski skupini ter usklajevanje komunikacije o farmakovigilanci med pristojnimi organi in Agencijo.
The Committee may establish standing and temporary working parties.
Odbor sprejme svoj poslovnik.
The Committee may establish scientific advisory groups in connection with the evaluation of specific types of veterinary medicinal products, to which the Committee may delegate certain tasks associated with drawing up the scientific opinions referred to in point (b) of Article 141(1).
V tem poslovniku so določeni zlasti:
The Committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings.
postopki za imenovanje in zamenjavo predsednika;
The Executive Director, in consultation with the Committee shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in point (n) of Article 57(1) of Regulation (EC) No 726/2004, particularly regarding the development of novel therapy veterinary medicinal products.
imenovanje članov vseh delovnih skupin ali znanstvenih svetovalnih skupin na podlagi seznamov akreditiranih strokovnjakov iz drugega pododstavka člena 62(2) Uredbe (ES) št. 726/2004 in postopki posvetovanja z delovnimi skupinami in znanstvenimi svetovalnimi skupinami;
The Committee shall establish a standing working party for pharmacovigilance with a remit including evaluating potential signals in pharmacovigilance arising from the Union pharmacovigilance system, proposing the options for risk management referred to in Article 79 to the Committee and to the coordination group, and coordinating the communication about pharmacovigilance between the competent authorities and the Agency.
postopek za nujno sprejetje mnenj, zlasti v zvezi z določbami te uredbe glede nadzora po dajanju v promet in farmakovigilance.
The Committee shall establish its own rules of procedure.
Poslovnik začne veljati po prejemu pozitivnega mnenja Komisije in upravnega odbora Agencije.
Those rules shall, in particular, lay down:
Sekretariat Agencije zagotavlja tehnično, znanstveno in upravno podporo Odboru, skladnost in kakovost mnenj Odbora ter ustrezno usklajevanje med Odborom in drugimi odbori Agencije iz člena 56 Uredbe (ES) št. 726/2004 ter usklajevalno skupino.
procedures for appointing and replacing the Chair;
Mnenja Odbora so javno dostopna.
the appointment of members of any working parties or scientific advisory groups on the basis of the lists of accredited experts referred to in the second subparagraph of Article 62(2) of Regulation (EC) No 726/2004 and procedures for consultation of working parties and scientific advisory groups;
Člen 140
a procedure for urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance.
Člani Odbora
The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.
Vsaka država članica po posvetovanju z upravnim odborom Agencije v Odbor za obdobje treh let z možnostjo podaljšanja imenuje enega člana in enega nadomestnega člana.
The Secretariat of the Agency shall provide technical, scientific and administrative support for the Committee, and shall ensure consistency and quality of opinions of the Committee and appropriate coordination between the Committee and other committees of the Agency referred to in Article 56 of Regulation (EC) No 726/2004 and the coordination group.
Nadomestni člani zastopajo člane in glasujejo namesto njih ob njihovi odsotnosti ter so lahko tudi imenovani za poročevalce.
The opinions of the Committee shall be publicly accessible.
Člani in nadomestni člani Odbora so imenovani na podlagi njihovega ustreznega strokovnega znanja in izkušenj na področju znanstvenih ocen zdravil za uporabo v veterinarski medicini, da se zagotovi najvišja raven usposobljenosti in širok spekter ustreznega strokovnega znanja.
Article 140
Država članica lahko svoje naloge v Odboru prenese na drugo državo članico.
Members of the Committee
Vsaka država članica lahko zastopa največ eno dodatno državo članico.
Each Member State shall, after consultation of the Management Board of the Agency, appoint for a three-year term which may be renewed, one member and an alternate member of the Committee.
Odbor lahko kooptira največ pet dodatnih članov, izbranih na podlagi njihovih specifičnih znanstvenih kompetenc.
The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs.
Ti člani so imenovani za triletni mandat, ki se lahko podaljša, in nimajo nadomestnih članov.
Members and alternates of the Committee shall be appointed on the basis of their relevant expertise and experience in the scientific assessment of veterinary medicinal products, in order to guarantee the highest level of qualifications and a broad spectrum of relevant expertise.
Za kooptiranje teh članov Odbor opredeli dopolnilne specifične znanstvene kompetence dodatnih članov.
A Member State may delegate its tasks within the Committee to another Member State.
Kooptirani člani se izberejo med strokovnjaki, ki jih imenujejo države članice ali Agencija.
Each Member State may represent no more than one other Member State.
Odbor lahko za namene opravljanja svojih nalog iz člena 141 enega od svojih članov imenuje za poročevalca.
The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence.
Odbor lahko določi še drugega člana kot soporočevalca.
Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
Člane Odbora lahko spremljajo strokovnjaki s specifičnih znanstvenih ali tehničnih področij.
With a view to the co-opting of such members, the Committee shall identify the specific complementary scientific competence of the additional members.
Člani Odbora in strokovnjaki, ki so odgovorni za ocenjevanje zdravil za uporabo v veterinarski medicini, se opirajo na znanstveno vrednotenje in vire, ki so na voljo pristojnim organom.
Co-opted members shall be chosen among experts nominated by Member States or the Agency.
Vsak pristojni organ spremlja in zagotavlja znanstveno raven in neodvisnost opravljenega vrednotenja ter zagotovi ustrezni prispevek k nalogam Odbora, ter podpira dejavnosti imenovanih članov Odbora in strokovnjakov.
The Committee may appoint, for the purpose of performing its tasks referred to in Article 141, one of its members to act as rapporteur.
V ta namen države članice članom in strokovnjakom, ki so jih imenovale, zagotovijo ustrezne znanstvene in tehnične vire.
The Committee may also appoint a second member to act as a co-rapporteur.
Države članice se vzdržijo, da bi članom Odbora in strokovnjakom dajale kakršna koli navodila, ki niso združljiva z njihovimi individualnimi nalogami ali z nalogami Odbora in odgovornostmi Agencije.
The members of the Committee may be accompanied by experts in specific scientific or technical fields.
Člen 141
Members of the Committee and experts responsible for assessing veterinary medicinal products shall rely on the scientific evaluation and resources available to competent authorities.
Naloge Odbora
Each competent authority shall monitor and ensure the scientific level and independence of the evaluation carried out and provide appropriate contribution to the tasks of the Committee, and facilitate the activities of appointed Committee members and experts.
Odbor ima naslednje naloge:
To that end, Member States shall provide adequate scientific and technical resources to the members and experts they have nominated.
izvajanje nalog, ki so mu dodeljene, v skladu s to uredbo in Uredbo (ES) št. 726/2004;
Member States shall refrain from giving Committee members and experts instructions incompatible with their own individual tasks, or with the tasks of the Committee and responsibilities of the Agency.
priprava znanstvenih mnenj Agencije o vprašanjih, povezanih z vrednotenjem zdravil in uporabo zdravil za uporabo v veterinarski medicini;
Article 141
priprava mnenj o znanstvenih zadevah v zvezi z vrednotenjem in uporabo zdravil za uporabo v veterinarski medicini na zahtevo izvršnega direktorja Agencije ali Komisije;
Tasks of the Committee
priprava mnenj Agencije o vprašanjih v zvezi s sprejemljivostjo vlog, predloženih v skladu s centraliziranim postopkom, in izdajo, spremembo, začasnim odvzemom ali odvzemom dovoljenj za promet z zdravili za uporabo v veterinarski medicini, odobrenih s centraliziranim postopkom;
The Committee shall have the following tasks:
ustrezno upoštevanje vseh zahtev s strani držav članic za znanstvena mnenja;
carry out the tasks conferred on it under this Regulation and Regulation (EC) No 726/2004;
usmerjanje glede pomembnih vprašanj in vprašanj splošne znanstvene narave;
prepare scientific opinions of the Agency on questions relating to the evaluation and use of veterinary medicinal products;
izdajanje znanstvenih mnenj v okviru sodelovanja s Svetovno organizacijo za zdravje živali glede vrednotenja nekaterih zdravil za uporabo v veterinarski medicini, namenjenih izključno za trge zunaj Unije;
prepare opinions on scientific matters concerning the evaluation and use of veterinary medicinal products on the request of the Executive Director of the Agency or the Commission;
svetovanje o najvišjih mejnih vrednostih ostankov zdravil za uporabo v veterinarski medicini in biocidnih proizvodov za uporabo v reji živali, ki so sprejemljive v živilih živalskega izvora v skladu z Uredbo (ES) št. 470/2009;
prepare opinions of the Agency on questions concerning the admissibility of applications submitted in accordance with the centralised procedure, and on granting, varying, suspending or revoking marketing authorisations for centrally authorised veterinary medicinal products;
zagotavljanje strokovnih nasvetov glede uporabe protimikrobnih snovi in antiparazitikov pri živalih, da bi zmanjšali pojav odpornosti v Uniji, ter to svetovanje po potrebi posodabljati;
take due account of any request made by Member States for scientific opinions;
zagotavljanje objektivnih znanstvenih mnenj državam članicam glede nanj naslovljenih vprašanj.
provide guidance on important questions and issues of general scientific nature;
Člani Odbora zagotovijo ustrezno usklajevanje nalog Agencije in dela pristojnih organov.
give a scientific opinion, in the context of cooperation with the World Organisation for Animal Health, concerning the evaluation of certain veterinary medicinal products intended exclusively for markets outside the Union;
Pri pripravi mnenj si Odbor po svojih najboljših močeh prizadeva doseči znanstveno soglasje.