natgillin/translations-raw huggingface dataset:
For the purposes of paragraph 1, the Commission shall also take into account:
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 neizpolnitve obveznosti.
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
Za namene odstavka 1 Komisija upošteva tudi:
any sanctions, including penalties, already imposed on the same marketing authorisation holder on the basis of the same legal grounds and the same facts.
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
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.
vse sankcije, vključno s kaznimi, ki so istemu že naložene in temeljijo na isti pravni podlagi in istih dejstvih.
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.
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.
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.
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.
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.
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.
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.
Pri izvajanju preiskave o neizpolnjevanju obveznosti iz odstavka 1, lahko Komisija sodeluje s pristojnimi nacionalnimi organi in uporabi vire, ki jih zagotavlja Agencija.
The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has imposed financial penalties.
Kadar Komisija sprejme odločitev 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 legitimen interes imetnikov dovoljenj za promet glede varovanja njihovih poslovnih skrivnosti.
The Court of Justice of the European Union may cancel, reduce or increase the fine or periodic penalty payment imposed by the Commission.
Sodišče Evropske unije ima neomejeno pristojnost za pregled sklepov, s katerimi je Komisija naložila denarne kazni.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by laying down:
Sodišče Evropske unije lahko naloženo globo ali periodično denarno kazen, ki jo je naložila Komisija, prekliče, zniža ali poviša.
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 the defence, access to file, legal representation and confidentiality;
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 87b za dopolnitev te uredbe z določitvijo:
further detailed rules on the imposition by the Commission of financial penalties on legal entities other than the marketing authorisation holder;
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, dostopa do dokumentacije, pravnega zastopanja in zaupnosti;
rules on duration of procedure and limitation periods;
dodatnih podrobnih pravil o nalaganju denarnih kazni Komisije pravnim subjektom, ki niso imetniki dovoljenja za promet;
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.’;
pravil o trajanju postopka in zastaralnih rokih;
Article 86 is replaced by the following:
elementov, ki jih mora Komisija upoštevati pri določanju višine glob in periodičnih denarnih kazni ter njihovem nalaganju, ter pogojev in načinov izterjave.“;
‘Article 86
člen 86 se nadomesti z naslednjim:
At least every 10 years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation and in Chapter 4 of Title III of Directive 2001/83/EC.’;
„Člen 86
‘Article 86a
Komisija vsaj vsakih deset let objavi splošno poročilo o izkušnjah, pridobljenih pri uporabi postopkov iz te uredbe in iz poglavja 4 naslova III Direktive 2001/83/ES.“;
By 2019, the Commission shall review the regulatory framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products.
„Člen 86a
The Commission shall put forward, as appropriate, legislative proposals with a view to update that framework.
Komisija do leta 2019 pregleda regulativni okvir za pristojbine, ki se Agenciji plačujejo v zvezi z zdravili za humano uporabo in veterinarskimi zdravili.
When reviewing the regulatory framework for fees payable to the Agency, the Commission shall pay attention to potential risks related to the fluctuations in the fee revenue of the Agency.’;
Komisija ustrezno pripravi zakonodajne predloge za posodobitev tega okvira.
Article 87 is replaced by the following:
Pri pregledu regulativnega okvira za pristojbine, ki se plačujejo Agenciji, je Komisija pozorna na morebitna tveganja v zvezi z nihanji v prihodkih, ki jih Agencija prejme od pristojbin.“;
‘Article 87
člen 87 se nadomesti z naslednjim:
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Article 121 of Directive 2001/83/EC.
„Člen 87
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Komisiji pomaga Stalni odbor za zdravila za humano uporabo, ustanovljen s členom 121 Direktive 2001/83/ES.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Ta odbor je odbor v smislu Uredbe (EU) št. 182/2011 Evropskega parlamenta in Sveta.
Article 87b is replaced by the following:
Pri sklicevanju na ta odstavek se uporabi člen 5 Uredbe (EU) št. 182/2011.
‘Article 87b
člen 87b se nadomesti z naslednjim:
The power to adopt delegated acts referred to in Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) shall be conferred on the Commission for a period of five years from 28 January 2019.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Pooblastilo iz členov 10b(1), 4-a(9), 16a(3), drugega odstavka člena 16b in člena 84a(10) lahko kadar koli prekliče Evropski parlament ali Svet.
The delegation of power referred to in Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) may be revoked at any time by the European Parliament or by the Council.
S sklepom o preklicu preneha veljati prenos pooblastila iz navedenega sklepa.
A decision to revoke shall put an end to the delegation of the power specified in that decision.
Preklic začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Delegirani akt, sprejet na podlagi členov 10b(1), 14-a(9), 16a(3), drugega odstavka člena 16b in člena 84a(10), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku treh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu ali če pred iztekom roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
A delegated act adopted pursuant to Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za tri mesece.
That period shall be extended by three months at the initiative of the European Parliament or of the Council.
člena 87c in 87d se črtata;
Articles 87c and 87d are deleted;
Priloga postane Priloga I;
the Annex becomes Annex I;
točka 2 Priloge I se črta;
point 2 of Annex I is deleted;
besedilo iz Priloge k tej uredbi se doda kot Priloga II.
the text set out in the Annex to this Regulation is added as Annex II.
Člen 2
Article 2
Spremembe Direktive 2001/83/ES
Amendments to Directive 2001/83/EC
Direktiva 2001/83/ES se spremeni:
Directive 2001/83/EC is amended as follows:
v členu 1 se vstavi naslednja točka:
in Article 1, the following point is inserted:
Sprememba ali sprememba pogojev za dovoljenje za promet z zdravilom:
Variation or variation to the terms of a marketing authorisation:
Sprememba vsebine podatkov in dokumentov iz:
An amendment to the contents of the particulars and documents referred to in:
člena 8(3) in členov 9 do 11 te direktive in Priloge I k tej direktivi, člena 6(2) Uredbe (ES) št. 726/2004 in člena 7 Uredbe (ES) št. 1394/2007 ter
Article 8(3) and Articles 9 to 11 of this Directive and Annex I thereto, Article 6(2) of Regulation (EC) No 726/2004 and in Article 7 of Regulation (EC) No 1394/2007; and
pogojev sklepa o izdaji dovoljenja za promet z zdravilom za uporabo v humani medicini, vključno s povzetkom glavnih značilnosti zdravila, in katerih koli pogojev, obveznosti ali omejitev, ki vplivajo na dovoljenje za promet, ali sprememb označevanja ali navodila za uporabo, povezanih s spremembami povzetka glavnih značilnosti zdravila.“;
the terms of the decision granting the marketing authorisation for a medicinal product for human use, including the summary of the product characteristics and any conditions, obligations, or restrictions affecting the marketing authorisation, or changes to the labelling or the package leaflet related to changes to the summary of the product characteristics.’;
člen 23b se spremeni:
Article 23b is amended as follows:
odstavki 1 do 4 se nadomestijo z naslednjim:
paragraphs 1 to 4 are replaced by the following:
Te skupine zajemajo vse od sprememb pogojev za dovoljenje za promet z zdravilom, pri katerih je možnost vpliva na kakovost, varnost ali učinkovitost zdravila največja, do sprememb, ki na zdravilo nimajo nobenega vpliva ali pa je ta minimalen.
Those categories shall range from changes to terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon.
Ti postopki vključujejo tako postopke, ki omogočajo izvajanje šele po odobritvi na podlagi popolne znanstvene ocene, kot tudi postopke, ki omogočajo takojšnje izvajanje in naknadno obvestilo imetnika dovoljenja za promet pristojnemu organu.
Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 121a za dopolnitev te direktive v zvezi z:
The Commission is empowered to adopt delegated acts in accordance with Article 121a in order to supplement this Directive by:
Pri sprejemanju delegiranih aktov iz tega člena si Komisija prizadeva za možnost predložitve enotne vloge za eno ali več enakih sprememb pogojev različnih dovoljenj za promet z zdravilom.
When adopting the delegated acts referred to in this Article, the Commission shall endeavour to make possible the submission of a single application for one or more identical changes made to the terms of different marketing authorisations.
Države članice lahko še naprej uporabljajo nacionalne določbe o spremembah, ki veljajo na dan začetka veljavnosti Uredbe Komisije (ES) št. 1234/2008, za dovoljenja za promet, izdana pred 1. januarjem 1998 za zdravila, za katera je bilo izdano dovoljenje le v tej državi članici.
A Member State may continue to apply national provisions on variations applicable at the time of entry into force of Commission Regulation (EC) No 1234/2008 to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State.
Kadar se za zdravilo, za katerega veljajo nacionalne določbe v skladu s tem členom, naknadno izda dovoljenje za promet v drugi državi članici, velja zanj od tega datuma naprej Uredba (ES) št. 1234/2008.
Where a medicinal product subject to national provisions in accordance with this Article is subsequently granted a marketing authorisation in another Member State, Regulation (EC) No 1234/2008 shall apply to that medicinal product from that date.
v odstavku 5 se besedi „izvedbena uredba“ nadomestita z besedami „Uredba (ES) št. 1234/2008“;
in paragraph 5, the words ‘the implementing regulation’ are replaced by the words ‘Regulation (EC) No 1234/2008’;
členi 121a, 121b in 121c se nadomestijo z naslednjim:
‘Article 121a
Pooblastilo iz členov 22b, 23b(2a), 47, 52b in 54a lahko kadar koli prekliče Evropski parlament ali Svet.
The power to adopt delegated acts referred to in Articles 22b, 23b(2a), 47, 52b and 54a shall be conferred on the Commission for a period of five years from 28 January 2019.
Delegirani akt, sprejet na podlagi členov 22b, 23b(2a), 47, 52b in 54a začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu ali če pred iztekom roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
The delegation of power referred to in Articles 22b, 23b(2a), 47, 52b and 54a may be revoked at any time by the European Parliament or by the Council.
Člen 3
A delegated act adopted pursuant to Articles 22b, 23b(2a), 47, 52b and 54a shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Sprememba Uredbe (ES) št. 1901/2006
That period shall be extended by two months at the initiative of the European Parliament or of the Council.
V členu 49 Uredbe (ES) št. 1901/2006 se odstavek 3 nadomesti z naslednjim:
Article 3
V skladu s členom 84a Uredbe (ES) št. 726/2004 lahko Komisija v zvezi z zdravili, odobrenimi v skladu s postopkom iz navedene uredbe, naloži denarne kazni v obliki glob ali periodičnih denarnih kazni zaradi neizpolnitev obveznosti iz te uredbe, ki so navedene v Prilogi II Uredbe (ES) št. 726/2004.“
Amendment to Regulation (EC) No 1901/2006
Člen 4
In Article 49 of Regulation (EC) No 1901/2006, paragraph 3 is replaced by the following:
Prehodne določbe
The Commission may, in relation to medicinal products authorised in accordance with Regulation (EC) No 726/2004, impose, in accordance with the procedure laid down in Article 84a of that Regulation, financial penalties in the form of fines or periodic penalty payments for the failure to comply with the obligations set out in this Regulation that are listed in Annex II to Regulation (EC) No 726/2004.’.
Uredbe (ES) št. 2141/96, (ES) št. 2049/2005, (ES) št. 507/2006 in (ES) št. 658/2007 ostanejo veljavne, razen če in dokler niso razveljavljene.
Article 4
Uredba (ES) št. 1234/2008 se še naprej uporablja, razen če in dokler ni razveljavljena, in sicer za zdravila za uporabo v humani medicini, ki so zajeta v Uredbi (ES) št. 726/2004 in Direktivi 2001/83/ES in ki niso izključena iz področja uporabe Uredbe (ES) št. 1234/2008 na podlagi člena 23b(4) in (5) Direktive 2001/83/ES.
Transitional provisions
Člen 5
Regulations (EC) No 2141/96, (EC) No 2049/2005, (EC) No 507/2006 and (EC) No 658/2007 shall remain in force and continue to apply unless and until repealed.
Začetek veljavnosti in uporaba
Regulation (EC) No 1234/2008 shall continue to apply unless and until repealed as regards medicinal products for human use that are covered by Regulation (EC) No 726/2004 and Directive 2001/83/EC and that are not excluded from the scope of Regulation (EC) No 1234/2008 pursuant to Article 23b(4) and (5) of Directive 2001/83/EC.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Article 5
Točke 2 do 5, 10, 12 do 16, 18, 26, 28, 29, 31, 37, 38, 40, 42 do 44 in 46 člena 1 ter členi 2, 3 in 4 se uporabljajo od 28. januarja 2019.
Entry into force and application
Točke 1, 6 do 9, 11, 17, 19 do 25, 27, 30, 32 do 36, 39, 41 in 45 člena 1 se uporabljajo od 28. januarja 2022.
Points (2) to (5), (10), (12) to (16), (18), (26), (28), (29), (31), (37), (38), (40), (42) to (44) and (46) of Article 1, and Articles 2, 3 and 4 shall apply from 28 January 2019.
V Strasbourgu, 11. decembra 2018
Points (1), (6) to (9), (11), (17), (19) to (25), (27), (30), (32) to (36), (39), (41) and (45) of Article 1 shall apply from 28 January 2022.
Za Evropski parlament
Done at Strasbourg, 11 December 2018.
Za Svet
For the European Parliament
UL C 242, 23.7.2015, str. 39.
The President
Stališče Evropskega parlamenta z dne 25. oktobra 2018 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 26. novembra 2018.
For the Council
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1).
OJ C 242, 23.7.2015, p. 39.
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str. 1).
Position of the European Parliament of 25 October 2018 (not yet published in the Official Journal) and decision of the Council of 26 November 2018.
Uredba (EU) 2019/6 Evropskega parlamenta in Sveta z dne 11. decembra 2018 o zdravilih za uporabo v veterinarski medicini in razveljavitvi Direktive 2001/82/ES (glej stran 43 tega Uradnega lista).
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 (OJ L 311, 28.11.2001, p. 1).
Uredba Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil (UL L 35, 15.2.1995, str. 1).
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Uredba (EU) št. 658/2014 Evropskega parlamenta in Sveta z dne 15. maja 2014 o pristojbinah, ki se plačujejo Evropski agenciji za zdravila za izvajanje dejavnosti farmakovigilance v zvezi z zdravili za uporabo v humani medicini (UL L 189, 27.6.2014, str. 112).
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (see page 43 of this Official Journal).
Uredba Komisije (ES) št. 2049/2005 z dne 15. decembra 2005 o določitvi pravil v zvezi s plačevanjem pristojbin Evropski agenciji za zdravila s strani mikro, malih in srednje velikih podjetij in o nudenju upravne pomoči mikro, malim in srednje velikim podjetjem s strani Evropske agencije za zdravila v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 329, 16.12.2005, str. 4).
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1).
Uredba Komisije (ES) št. 507/2006 z dne 29. marca 2006 o pogojnem dovoljenju za promet zdravil za humano uporabo, ki sodijo na področje uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 92, 30.3.2006, str. 6).
Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, p. 112).
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4).
Direktiva 2009/53/ES Evropskega parlamenta in Sveta z dne 18. junija 2009 o spremembi Direktive 2001/82/ES in Direktive 2001/83/ES v zvezi s spremembami pogojev dovoljenj za promet z zdravili (UL L 168, 30.6.2009, str. 33).
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6).
Uredba Komisije (ES) št. 1234/2008 z dne 24. novembra 2008 o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini (UL L 334, 12.12.2008, str. 7).