natgillin/translations-raw huggingface dataset:
That period shall be extended by two months at the initiative of the European Parliament or of the Council.
u članku 1. umeće se sljedeća točka:
Article 3
Izmjena ili izmjena uvjeta odobrenja za stavljanje u promet:
Amendment to Regulation (EC) No 1901/2006
Izmjena sadržaja podataka i dokumenata iz:
In Article 49 of Regulation (EC) No 1901/2006, paragraph 3 is replaced by the following:
članka 8. stavka 3. i članaka od 9. do 11. ove Direktive i njezina Priloga I., članka 6. stavka 2.
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 (EZ) br. 726/2004 i članka 7.
Article 4
Uredbe (EZ) br. 1394/2007; i
Transitional provisions
uvjeta odluke o izdavanju odobrenja za stavljanje u promet lijeka za humanu uporabu, uključujući sažetak opisa svojstava lijeka i sve uvjete, obveze ili ograničenja koja se odnose na odobrenje za stavljanje u promet, ili promjene u označivanju ili uputi o lijeku povezane s promjenama sažetka opisa svojstava lijeka.”;
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(EC) No 2049/2005, (EC) No 507/2006 and (EC) No 658/2007 shall remain in force and continue to apply unless and until repealed.
2. članak 23.b mijenja se kako slijedi:
Regulation (EC) No 1234/2008 shall continue to apply unless and until repealed as regards medicinal products for human use that are covered by Regulation (EC) No 726/2004 and Directive 2001/83/EC and that are not excluded from the scope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.
stavci od 1. do 4. zamjenjuju se sljedećim:
Article 5
Raspon tih kategorija je od promjena uvjeta odobrenja za stavljanje u promet koje imaju najveći mogući utjecaj na kakvoću, neškodljivost ili djelotvornost lijeka, do promjena koje imaju minimalni utjecaj na navedeno ili ga nemaju.
Entry into force and application
Ti postupci variraju od postupaka kojima se provedba dopušta tek nakon odobrenja temeljenog na potpunom znanstvenom ocjenjivanju do postupaka kojima se dopušta da se izmjene trenutačno provedu i da nositelj odobrenja za stavljanje u promet podatke naknadno dostavi nadležnom tijelu.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 121.a radi dopune ove Direktive:
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.
Pri donošenju delegiranih akata iz ovog članka Komisija nastoji omogućiti podnošenje jedinstvenog zahtjeva za jednu ili više identičnih promjena uvjeta različitih odobrenja za stavljanje u promet.
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.
Država članica može nastaviti primjenjivati nacionalne odredbe o izmjenama, primjenjive u trenutku stupanja na snagu Uredbe Komisije (EZ) br. 1234/2008, na odobrenja za stavljanje u promet izdana prije 1. siječnja 1998. za lijekove odobrene samo u toj državi članici.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Ako se lijeku podložnom nacionalnim odredbama u skladu s ovim člankom naknadno dodijeli odobrenje za stavljanje u promet u drugoj državi članici, Uredba (EZ) br. 1234/2008 primjenjuje se od tog datuma na taj lijek.
Done at Strasbourg, 11 December 2018.
u stavku 5. riječi „provedbeni propis” zamjenjuju se riječima „Uredba (EZ) br. 1234/2008”;
For the European Parliament
članci 121.a, 121.b i 121.c zamjenjuju se sljedećim:
The President
„Članak 121.a
For the Council
Europski parlament ili Vijeće u svakom trenutku mogu opozvati delegiranje ovlasti iz članka 22.b, članka 23.b stavka 2.a te članaka 47., 52.b i 54.a.
OJ C 242, 23.7.2015, p. 39.
Delegirani akt donesen na temelju članka 22.b, članka 23.b stavka 2.a te članaka 47., 52.b i 54.a stupa na snagu samo ako ni Europski parlament ni Vijeće u roku od dva mjeseca od priopćenja tog akta Europskom parlamentu i Vijeću na njega ne podnesu nikakav prigovor ili ako su prije isteka tog roka i Europski parlament i Vijeće obavijestili Komisiju da neće podnijeti prigovore.
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.
Taj se rok produljuje za dva mjeseca na inicijativu Europskog parlamenta ili Vijeća.
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).
Članak 3.
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).
Izmjena Uredbe (EZ) br. 1901/2006
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).
U članku 49.
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).
Uredbe (EZ) br. 1901/2006 stavak 3. zamjenjuje se sljedećim:
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).
Komisija može u pogledu lijekova odobrenih u skladu s Uredbom (EZ) br. 726/2004 izreći, u skladu s postupkom utvrđenim u članku 84.a te uredbe, financijske sankcije u obliku novčanih kazni ili periodičnih penala za nepoštovanje obveza iz ove Uredbe koje su navedene u Prilogu II.
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).
Uredbi (EZ) br. 726/2004.”.
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).
Članak 4.
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).
Prijelazne odredbe
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).
Uredbe (EZ) br. 2141/96, (EZ) br. 2049/2005, (EZ) br. 507/2006 i (EZ) br. 658/2007 ostaju na snazi i nastavljaju se primjenjivati ako se i dok se ne stave izvan snage.
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).
Uredba (EZ) br. 1234/2008 nastavlja se primjenjivati ako se i dok se ne stavi izvan snage u pogledu lijekova za humanu uporabu koji su obuhvaćeni Uredbom (EZ) br. 726/2004 i Direktivom 2001/83/EZ i koji nisu isključeni iz područja primjene Uredbe (EZ) br. 1234/2008 na temelju članka 23.b stavaka 4. i 5.
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).
Direktive 2001/83/EZ.
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).
Članak 5.
OJ L 123, 12.5.2016, p. 1.
Stupanje na snagu i primjena
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).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
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).
Članak 1. točke od 2. do 5., 10., od 12. do 16., 18., 26., 28., 29., 31., 37., 38., 40., od 42. do 44. i 46. te članci 2., 3. i 4. primjenjuju se od 28. siječnja 2019.
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.
Članak 1. točke 1., od 6. do 9., 11., 17., od 19. do 25., 27., 30., od 32. do 36., 39., 41. i 45. primjenjuju se od 28. siječnja 2022.
43).’;
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
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).’;
Sastavljeno u Strasbourgu 11. prosinca 2018.
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).
Za Europski parlament
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).’;
Predsjednica
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).’;
Za Vijeće
OJ L 123, 12.5.2016, p. 1.’;
SL C 242, 23.7.2015., str. 39.
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).’;
Stajalište Europskog parlamenta od 25. listopada 2018. (još nije objavljeno u Službenom listu) i odluka Vijeća od 26. studenoga 2018.
OJ L 123, 12.5.2016, p. 1.’.
Direktiva 2001/82/EZ Europskog parlamenta i Vijeća od 6. studenoga 2001. o zakoniku Zajednice o veterinarsko-medicinskim proizvodima (SL L 311, 28.11.2001., str. 1.).
ANNEX
Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća od 31. ožujka 2004. o utvrđivanju postupaka odobravanja primjene i postupaka nadzora nad primjenom lijekova koji se rabe u humanoj i veterinarskoj medicini, te uspostavi Europske agencije za lijekove (SL L 136, 30.4.2004., str. 1.).
‘ANNEX II
Uredba (EU) 2019/6 Europskog parlamenta i Vijeća od 11. prosinca 2018. o veterinarsko-medicinskim proizvodima i stavljanju izvan snage Direktive 2001/82/EZ (vidjeti str.
LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 84A
43 ovoga Službenog lista).
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;
Uredba Vijeća (EZ) br. 297/95 od 10. veljače 1995. o naknadama koje se plaćaju Europskoj agenciji za ocjenu lijekova (SL L 35, 15.2.1995., str. 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);
Uredba (EU) br. 658/2014 Europskog parlamenta i Vijeća od 15. svibnja 2014. o naknadama koje se plaćaju Europskoj agenciji za lijekove za provedbu aktivnosti farmakovigilancije u pogledu lijekova za primjenu kod ljudi (SL L 189, 27.6.2014., str. 112.).
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);
Uredba Komisije (EZ) br. 2049/2005 od 15. prosinca 2005. o utvrđivanju, u skladu s Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća, pravila za naknade koje mikro, mala i srednja poduzeća plaćaju Europskoj agenciji za lijekove, te pravila za primanje administrativne pomoći koju Europska agencija za lijekove pruža mikro, malim i srednjim poduzećima (SL L 329, 16.12.2005., str. 4.).
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);
Uredba Komisije (EZ) br. 507/2006 od 29. ožujka 2006. o uvjetnom odobrenju za stavljanje u promet lijekova za humanu primjenu koji su obuhvaćeni Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća (SL L 92, 30.3.2006., str. 6.).
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);
Direktiva 2001/83/EZ Europskog parlamenta i Vijeća od 6. studenoga 2001. o zakoniku Zajednice o lijekovima za humanu primjenu (SL L 311, 28.11.2001., str. 67.).
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);
Direktiva 2009/53/EZ Europskog parlamenta i Vijeća od 18. lipnja 2009. o izmjeni Direktive 2001/82/EZ i Direktive 2001/83/EZ u pogledu izmjena uvjeta pod kojima se izdaju odobrenja za stavljanje gotovog lijeka, medicinskih i veterinarsko-medicinskih proizvoda u promet (SL L 168, 30.6.2009., str. 33.).
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);
Uredba Komisije (EZ) br.
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;
1234/2008 od 24. studenoga 2008. o razmatranju izmjena uvjeta odobrenja za stavljanje u promet lijekova za humanu primjenu i veterinarsko-medicinskih proizvoda (SL L 334, 12.12.2008., str. 7.).
the obligation to comply with the conditions referred to in Article 14(8)and Article 14-a;
Uredba (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006. o lijekovima za pedijatrijsku upotrebu i o izmjeni Uredbe (EEZ) br. 1768/92, Direktive 2001/20/EZ, Direktive 2001/83/EZ i Uredbe (EZ) br. 726/2004 (SL L 378, 27.12.2006., str. 1.).
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);
Uredba Komisije (EZ) br. 658/2007 od 14. lipnja 2007. o novčanim kaznama u slučaju kršenja određenih obveza vezanih uz odobrenja za stavljanje u promet dana u skladu s Uredbom (EZ) br. 726/2004 Europskog parlamenta i Vijeća (SL L 155, 15.6.2007., str. 10.).
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;
SL L 123, 12.5.2016., str. 1.
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);
Uredba (EU) br. 182/2011 Europskog parlamenta i Vijeća od 16. veljače 2011. o utvrđivanju pravila i općih načela u vezi s mehanizmima nadzora država članica nad izvršavanjem provedbenih ovlasti Komisije (SL L 55, 28.2.2011., str. 13.).
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;
Uredba Komisije (EZ) br. 2141/96 od 7. studenoga 1996. o ispitivanju zahtjeva za prijenos odobrenja za stavljanje u promet lijeka obuhvaćenog Uredbom Vijeća (EZ) br. 2309/93 (SL L 286, 8.11.1996., str. 6.).
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;
Uredba (EU) 2019/6 Europskog parlamenta i Vijeća od 11. prosinca 2018. o veterinarsko-medicinskim proizvodima i stavljanju izvan snage Direktive 2001/82/EZ (SL L 4, 7.1.2019., str.
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;
43).”;
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;
Uredba (EZ) br. 1901/2006 Europskog parlamenta i Vijeća od 12. prosinca 2006. o lijekovima za pedijatrijsku upotrebu i izmjeni Uredbe (EEZ) br. 1768/92, Direktive 2001/20/EZ, Direktive 2001/83/EZ i Uredbe (EZ) br. 726/2004 (SL L 378, 27.12.2006., str. 1.).”;
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;
Uredba (EU, Euratom) 2018/1046 Europskog parlamenta i Vijeća od 18. srpnja 2018. o financijskim pravilima koja se primjenjuju na opći proračun Unije, o izmjeni uredaba (EU) br. 1296/2013, (EU) 1301/2013, (EU) br. 1303/2013, (EU) br. 1304/2013, (EU) br. 1309/2013, (EU) br. 1316/2013, (EU) br. 223/2014, (EU) br. 283/2014 i Odluke br. 541/2014/EU te o stavljanju izvan snage Uredbe (EU, Euratom) br. 966/2012 (SL L 193, 30.7.2018., str. 1.).
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;
Delegirana uredba Komisije (EU) br. 1271/2013 оd 30. rujna 2013. o Okvirnoj financijskoj uredbi za tijela iz članka 208.
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;
Uredba (EU) br. 182/2011 Europskog parlamenta i Vijeća od 16. veljače 2011. o utvrđivanju pravila i općih načela u vezi s mehanizmima nadzora država članica nad izvršavanjem provedbenih ovlasti Komisije (SL L 55, 28.2.2011., str. 13.).”;
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;
SL L 123, 12.5.2016., str. 1.”;
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.’.
Uredba Komisije (EZ) br. 1234/2008 od 24. studenoga 2008. o razmatranju izmjena uvjeta odobrenja za stavljanje u promet lijekova za humanu primjenu i veterinarsko-medicinskih proizvoda (SL L 334, 12.12.2008., str. 7.).”;
Regulation (EU) 2019/6 of the European Parliament and of the Council
Uredba (EU) 2019/6 Europskog parlamenta i Vijeća
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4)(b) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 114. i članak 168. stavak 4. točku (b),
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/EZ Europskog parlamenta i Vijeća i Uredba (EZ) br. 726/2004 Europskog parlamenta i Vijeća činile su regulatorni okvir Unije za stavljanje u promet, proizvodnju, uvoz, izvoz, opskrbu, distribuciju, farmakovigilanciju, kontrolu i primjenu veterinarsko-medicinskih proizvoda.
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’.
Isto bi tako trebao uključivati glavne ciljeve politike utvrđene u Komunikaciji Komisije od 3. ožujka 2010. pod naslovom „Europa 2020. – Strategija za pametan, održiv i uključiv rast”.
This Regulation applies to veterinary medicinal products, including those products which Directive 2001/82/EC referred to as ‘pre-mixes’ and which in this Regulation are considered to be a pharmaceutical form of a veterinary medicinal product, until such time as those products are included in medicated feed or intermediate products, after which Regulation (EU) 2019/4 of the European Parliament and of the Council applies to the exclusion of this Regulation.
Ova se Uredba primjenjuje na veterinarsko-medicinske proizvode, uključujući one proizvode koji su u Direktivi 2001/82/EZ navedeni kao „premiksi” i koje se u ovoj Uredbi smatra farmaceutskim oblikom veterinarsko-medicinskog proizvoda, sve dok ti proizvodi ne budu uključeni u ljekovitu hranu za životinje ili međuproizvode, nakon čega se umjesto ove Uredbe primjenjuje Uredba (EU) 2019/4 Europskog parlamenta i Vijeća.