natgillin/translations-raw huggingface dataset:
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 (OJ L 311, 28.11.2001, p. 67).
Uredba (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 (UL L 378, 27.12.2006, str. 1).
Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33).
Uredba Komisije (ES) št. 658/2007 z dne 14. junija 2007 o denarnih kaznih za kršitev nekaterih obveznosti v zvezi z dovoljenji za promet, izdanimi v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 155, 15.6.2007, str. 10).
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).
UL L 123, 12.5.2016, str. 1.
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str. 13).
Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10).
Uredba Komisije (ES) št. 2141/96 z dne 7. novembra 1996 o pregledu vloge za prenos odobritve za trženje zdravil, ki spada na področje Uredbe Sveta (ES) št. 2309/93 (UL L 286, 8.11.1996, str. 6).
OJ L 123, 12.5.2016, p. 1.
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 (UL L 4, 7.1.2019, str.
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
43).“;
Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 (OJ L 286, 8.11.1996, p. 6).
Uredba (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 (UL L 378, 27.12.2006, str. 1).“;
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 (OJ L 4, 7.1.2019, p.
Uredba (EU, Euratom) 2018/1046 Evropskega parlamenta in Sveta z dne 18. julija 2018 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, spremembi Uredb (EU) št. 1296/2013, (EU) št. 1301/2013, (EU) št. 1303/2013, (EU) št. 1304/2013, (EU) št. 1309/2013, (EU) št. 1316/2013, (EU) št. 223/2014, (EU) št. 283/2014 in Sklepa št. 541/2014/EU ter razveljavitvi Uredbe (EU, Euratom) št. 966/2012 (UL L 193, 30.7.2018, str. 1.).
43).’;
Delegirana uredba Komisije (EU) št. 1271/2013 z dne 30. septembra 2013 o okvirni finančni uredbi za organe iz člena 208 Uredbe (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta (UL L 328, 7.12.2013, str. 42).“;
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).’;
Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str. 13).“;
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
UL L 123, 12.5.2016, str. 1.“;
Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42).’;
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).“;
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;
UL L 123, 12.5.2016, str. 1.“
OJ L 123, 12.5.2016, p. 1.’;
PRILOGA
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).’;
„PRILOGA II
OJ L 123, 12.5.2016, p. 1.’.
SEZNAM OBVEZNOSTI IZ ČLENA 84A
ANNEX
Obveznost predložitve popolnih in točnih podatkov in dokumentov v vlogi za pridobitev dovoljenja za promet z zdravilom, predloženi Agenciji, ali kot odziv na obveznosti iz te uredbe in Uredbe (ES) št. 1901/2006, če neizpolnjevanje obveznosti zadeva vsebinsko napako;
‘ANNEX II
obveznost glede skladnosti s pogoji ali omejitvami, ki jih vsebuje dovoljenje za promet in se nanašajo na dobavo ali uporabo zdravila za humano uporabo iz točke (b) člena 9(4) in drugega pododstavka člena 10(1);
LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 84A
obveznost glede skladnosti s pogoji ali omejitvami, ki jih vsebuje dovoljenje za promet v zvezi z varno in učinkovito uporabo zdravila za humano uporabo iz točk (aa), (c), (ca), (cb) in (cc) člena 9(4) in člena 10(1);
the obligation to submit complete and accurate particulars and documents in an application for marketing authorisation submitted to the Agency or in response to obligations laid down in this Regulation and in Regulation (EC) No 1901/2006 to the extent that the failure to comply with the obligation concerns a material particular;
obveznost uvedbe vseh potrebnih sprememb pogojev dovoljenja za promet zaradi upoštevanja tehničnega in znanstvenega napredka in omogočanja, da se zdravila za humano uporabo proizvajajo in preverjajo po splošno sprejetih znanstvenih metodah, kot določa člen 16(1);
the obligation to comply with conditions or restrictions included in the marketing authorisation and concerning the supply or use of the medicinal product for human use, as referred to in point (b) of Article 9(4) and in the second subparagraph of Article 10(1);
obveznost predložitve novih informacij, ki bi lahko privedle do spremembe pogojev dovoljenja za promet, obvestila o prepovedih ali omejitvah, ki so jih uvedli pristojni organi katere koli države, v kateri je zdravilo za humano uporabo v prometu, ali predložitve informacij, ki bi lahko vplivale na oceno tveganj in koristi zdravila, kot določa člen 16(2);
the obligation to comply with conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product for human use as referred to in points (aa), (c), (ca), (cb) and (cc) of Article 9(4) and in Article 10(1);
obveznost posodabljanja informacij o zdravilu z novimi znanstvenimi spoznanji, vključno z zaključki ocene, in priporočil, objavljenih na evropskem spletnem portalu o zdravilih, kot določa člen 16(3);
the obligation to introduce any necessary variation to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products for human use to be manufactured and checked by means of generally accepted scientific methods, as provided for in Article 16(1);
na zahtevo Agencije obveznost predložitve podatkov, ki dokazujejo, da ostaja razmerje med tveganjem in koristmi ugodno, kot določa člen 16(3a);
the obligation to supply any new information which may entail a variation to the terms of the marketing authorisation, to notify any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed, or to supply any information that may influence the evaluation of the risks and benefits of the product, as provided for in Article 16(2);
obveznost dajanja zdravila za humano uporabo v promet v skladu z vsebino povzetka glavnih značilnosti zdravila, ovojnino in navodilom za uporabo, kot so navedeni v dovoljenju za promet;
the obligation to keep product information up to date with current scientific knowledge, including the conclusions of the assessment and recommendations made public on the European medicines web-portal, as provided for in Article 16(3);
obveznost glede izpolnjevanja pogojev iz člena 14(8) in člena 14-a;
the obligation to provide, at the request of the Agency, any data demonstrating that the risk-benefit balance remains favourable, as provided for in Article 16(3a);
obveznost obveščanja Agencije o datumih dejanskega dajanja v promet in datumu, ko zdravilo za humano uporabo ni več v prometu, ter zagotavljanja podatkov Agenciji o obsegu prodaje in receptov za zdravilo, kot določa člen 13(4);
the obligation to place the medicinal product for human use 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;
obveznost vodenja celovitega sistema farmakovigilance za izvajanje nalog farmakovigilance, vključno z delovanjem sistema kakovosti, vzdrževanjem glavnega dosjeja o sistemu farmakovigilance in rednim izvajanjem revizij v skladu s členom 21 te uredbe, ki se bere skupaj s členom 104 Direktive 2001/83/ES;
the obligation to comply with the conditions referred to in Article 14(8)and Article 14-a;
obveznost predložitve kopije glavnega dosjeja o sistemu farmakovigilance na zahtevo Agencije, kot določa člen 16(3a);
the obligation to notify the Agency of the dates of actual marketing and of the date when the medicinal product for human use ceases to be on the market, and to provide to the Agency data relating to the volume of sales and the volume of prescriptions of the medicinal product for human use, as provided in Article 13(4);
obveznost vodenja sistema obvladovanja tveganja, kot določata člen 14a in člen 21(2) te uredbe, ki se bereta skupaj s členom 104(3) Direktive 2001/83/ES in členom 34(2) Uredbe (ES) št. 1901/2006;
the obligation to operate a comprehensive pharmacovigilance system for the fulfilment of pharmacovigilance tasks, including the operation of a quality system, maintenance of a pharmacovigilance system master file and performance of regular audits, in accordance with Article 21 of this Regulation in conjunction with Article 104 of Directive 2001/83/EC;
obveznost evidentiranja in sporočanja domnevnih neželenih učinkov za zdravila za humano uporabo v skladu s členom 28(1) te uredbe, ki se bere skupaj s členom 107 Direktive 2001/83/ES;
the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 16(3a);
obveznost predložitve posodobljenih rednih poročil o varnosti zdravil v skladu s členom 28(2) te uredbe, ki se bere skupaj s členom 107b Direktive 2001/83/ES;
the obligation to operate a risk management system as provided for in Article 14a and Article 21(2) of this Regulation in conjunction with Article 104(3) of Directive 2001/83/EC and Article 34(2) of Regulation (EC) No 1901/2006;
obveznost izvajanja študij po dajanju v promet, vključno s študijami o varnosti zdravila po pridobitvi dovoljenja za promet in študijami o učinkovitosti zdravila po pridobitvi dovoljenja za promet, ter predložitve v pregled, kot določata člen 10a te uredbe in člen 34(2) Uredbe (ES) št. 1901/2006;
the obligation to record and report suspected adverse reactions for medicinal products for human use, in accordance with Article 28(1) of this Regulation in conjunction with Article 107 of Directive 2001/83/EC;
obveznost zagotavljanja, da so javna obvestila o podatkih glede farmakovigilance nepristransko predstavljena in niso zavajajoča, ter obveznost sporočanja podatkov Agenciji, kot določata člen 22 te uredbe in člen 106a(1) Direktive 2001/83/ES;
the obligation to submit periodic safety update reports, in accordance with Article 28(2) of this Regulation in conjunction with Article 107b of Directive 2001/83/EC;
obveznost spoštovanja rokov za začetek uvedbe ali ukinitev izvajanja ukrepov iz sklepa Agencije o odlogu, ki je sledil prvotnemu dovoljenju za promet z zadevnim zdravilom za humano uporabo, in v skladu z dokončnim mnenjem iz člena 25(5) Uredbe (ES) št. 1901/2006;
the obligation to conduct post-marketing studies, including post-authorisation safety studies and post-authorisation efficacy studies, and to submit them for review, as provided for in Article 10a of this Regulation and Article 34(2) of Regulation (EC) No 1901/2006;
obveznost dajanja zdravila za humano uporabo v promet v dveh letih od datuma, ko je odobreno za pediatrično indikacijo, kot določa člen 33 Uredbe (ES) št. 1901/2006;
the obligation to ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency, as provided for in Article 22 of this Regulation and Article 106a(1) of Directive 2001/83/EC;
obveznost prenosa dovoljenja za promet ali omogočanja tretji osebi, da uporabi dokumentacijo iz dosjeja o zdravilu, kot določa prvi odstavek člena 35 Uredbe (ES) št. 1901/2006;
the obligation to comply with the time limits for initiating or completing measures specified in the Agency’s decision on deferral following the initial marketing authorisation of the medicinal product for human use concerned and in accordance with the definitive opinion referred to in Article 25(5) of Regulation (EC) No 1901/2006;
obveznost predložitve pediatričnih študij Agenciji, vključno z obveznim vnosom informacij o kliničnih preskušanjih v tretjih državah v evropsko podatkovno zbirko, kot določajo členi 41(1) in (2), 45(1) in 46(1) Uredbe (ES) št. 1901/2006;
the obligation to transfer the marketing authorisation or to allow a third party to use documentation contained in the file of the medicinal product, as provided for in the first paragraph of Article 35 of Regulation (EC) No 1901/2006;
Pooblastilo za sprejemanje delegiranih aktov iz členov 10b(1), 14-a(9), 16a(3), drugega odstavka člena 16b in člena 84a(10) se prenese na Komisijo za obdobje petih let od 28. januarja 2019.
the obligation to submit paediatric studies to the Agency, including the obligation to enter information on third country clinical trials into the European database, as provided for in Articles 41(1) and (2), 45(1) and 46(1) of Regulation (EC) No 1901/2006;
Komisija pripravi poročilo o prenosu pooblastila najpozneje devet mesecev pred koncem petletnega obdobja.
the obligation to submit an annual report to the Agency as provided for in Article 34(4) of Regulation (EC) No 1901/2006 and to inform the Agency in accordance with the second paragraph of Article 35 of that Regulation.’.
Pooblastilo za sprejemanje delegiranih aktov iz členov 22b, 23b(2a), 47, 52b in 54a se prenese na Komisijo za obdobje petih let od 28. januarja 2019.
Regulation (EU) 2019/6 of the European Parliament and of the Council
Uredba (EU) 2019/6 Evropskega parlamenta in Sveta
on veterinary medicinal products and repealing Directive 2001/82/EC
o zdravilih za uporabo v veterinarski medicini in razveljavitvi Direktive 2001/82/ES
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(b) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in točke (b) člena 168(4) Pogodbe,
Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council constituted the Union regulatory framework for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products.
Direktiva 2001/82/ES Evropskega parlamenta in Sveta ter Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta sta predstavljali regulativni okvir Unije za dajanje v promet, proizvodnjo, uvoz, izvoz, dobavo, distribucijo, farmakovigilanco, nadzor in uporabo zdravil za uporabo v veterinarski medicini.
In the light of experience and following the assessment by the Commission on the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, while continuing to ensure a high level of protection of animal health, animal welfare and environment and safeguarding public health.
Glede na izkušnje in na podlagi ocene Komisije o delovanju notranjega trga za zdravila za uporabo v veterinarski medicini bi bilo treba regulativni okvir za zdravila za uporabo v veterinarski medicini prilagoditi znanstvenemu napredku, trenutnim tržnim razmeram in ekonomski realnosti, pri tem pa še naprej zagotavljati visoko raven varovanja zdravja živali, dobrobiti živali in okolja ter varovati javno zdravje.
The regulatory framework for veterinary medicinal products should take into account the needs of the businesses in the veterinary pharmaceutical sector and trade in veterinary medicinal products within the Union.
Regulativni okvir za zdravila za uporabo v veterinarski medicini bi moral upoštevati potrebe podjetij v veterinarskem farmacevtskem sektorju in trgovino z zdravili za uporabo v veterinarski medicini znotraj Unije.
It should also integrate the major policy objectives set out in the Communication from the Commission of 3 March 2010 entitled ‘Europe 2020 A Strategy for smart, sustainable and inclusive growth’.
Vključevati bi moral tudi glavne cilje politike iz Sporočila Komisije z dne 3. marca 2010 z naslovom „Evropa 2020 – Strategija za pametno, trajnostno in vključujočo rast“.
Experience has shown that the needs of the veterinary sector differ substantially from those of the human sector in relation to medicinal products.
Izkušnje kažejo, da se potrebe glede zdravil v veterinarskem sektorju bistveno razlikujejo od potreb v sektorju humane medicine.
In particular, the drivers for investment in markets for medicinal products for human use and veterinary medicinal products are different.
Razlikuje se zlasti spodbujanje naložb na trgu z zdravili za uporabo v humani medicini in trgu z zdravili za uporabo v veterinarski medicini.
For example, in the veterinary sector there are many different animal species, which creates both a fragmented market and the need for major investments in order to extend the authorisation of veterinary medicinal products existing for one animal species to another.
V veterinarskem sektorju obstaja na primer veliko različnih živalskih vrst, kar je razlog za razdrobljenost trga in zaradi česar so potrebne obsežne naložbe za razširitev obstoječih dovoljenj za promet z zdravili za uporabo v veterinarski medicini z ene živalske vrste na drugo.
Moreover, the price-setting mechanisms in the veterinary sector follow a completely different logic.
Poleg tega mehanizmi za določanje cen v veterinarskem sektorju sledijo povsem drugačni logiki.
Consequently, prices for veterinary medicinal products are typically substantially lower than for medicinal products for human use.
Zaradi tega so cene zdravil za uporabo v veterinarski medicini običajno precej nižje od cen zdravil za uporabo v humani medicini.
The size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for medicinal products for human use.
Obseg farmacevtske industrije za živali je v primerjavi z obsegom farmacevtske industrije za zdravila za uporabo v humani medicini zelo majhen.
It is therefore appropriate to develop a regulatory framework addressing the characteristics and specificities of the veterinary sector, which cannot be considered as a model for the market for medicinal products for human use.
Zato je primerno, da se vzpostavi regulativni okvir, v katerem se bodo obravnavale značilnosti in posebnosti veterinarskega sektorja, ki ga ni mogoče obravnavati kot model za trg z zdravili za uporabo v humani medicini.
This Regulation aims to reduce the administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection.
Cilj te uredbe je zmanjšati upravno breme, okrepiti notranji trg in povečati razpoložljivost zdravil za uporabo v veterinarski medicini ter hkrati zagotoviti najvišjo raven varovanja javnega zdravja in zdravja živali ter varstva okolja.
The identification of packs of veterinary medicinal products via identification codes is common practice in several Member States.
Prepoznavanje ovojnin zdravil za uporabo v veterinarski medicini z identifikacijskimi kodami je v več državah članicah običajna praksa.
Those Member States have developed integrated electronic systems at national level for the proper functioning of such codes, linked to national databases.
Te države članice so na nacionalni ravni razvile integrirane elektronske sisteme za pravilno delovanje takšnih kod, ki so povezani z nacionalnimi zbirkami podatkov.
The introduction of a harmonised Union-wide system has not been the subject of any assessment as to costs and administrative consequences.
Stroški in upravne posledice uvedbe harmoniziranega sistema na ravni Unije doslej niso bili predmet nobene presoje.
Instead, there should be a possibility for Member States to decide at national level on whether or not to adopt a system for identification codes to be added to the information on the outer packaging of the veterinary medicinal products.
Namesto tega bi državam članicam bilo treba omogočiti, da na državni ravni odločijo o tem, ali bodo sprejele sistem identifikacijskih kod, ki bodo dodane informacijam na zunanji ovojnini zdravil za uporabo v veterinarski medicini.
However, the existing systems for identification codes currently used at national level vary and there is no standard format.
Obstoječi sistemi identifikacijskih kod, ki se trenutno uporabljajo na državni ravni, so raznoliki in ni standardnega formata.
The possibility should be provided for the development of a harmonised identification code for which the Commission should adopt uniform rules.
Predvideti bi bilo treba možnost razvoja harmonizirane identifikacijske kode, za kar bi morala Komisija sprejeti enotna pravila.
The adoption by the Commission of rules concerning such an identification code would not prevent Member States from being able to choose whether or not to use such an identification code.
Sprejetje pravil s strani Komisije v zvezi s tako identifikacijsko kodo ne bi preprečilo državam članicam, da lahko izberejo, ali bodo uporabljale tako identifikacijsko kodo ali ne.