natgillin/translations-raw huggingface dataset:
For active substances which do not fall in the prioritised categories in Implementing Decision C/2016/6104, the approval period should be extended by either 2 or 3 years, taking into account the present date of expiry, the fact that according to Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance shall be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs, and the available resources necessary for assessment and decision-making.
Za aktivne tvari koje nisu obuhvaćene prioritetnim kategorijama u Provedbenoj odluci C/2016/6104 rok valjanosti odobrenja trebalo bi produljiti za dvije ili tri godine, uzimajući u obzir sadašnji datum isteka, činjenicu da se u skladu s člankom 6. stavkom 3. Provedbene uredbe (EU) br. 844/2012 dodatna dokumentacija za aktivnu tvar dostavlja najkasnije 30 mjeseci prije isteka odobrenja, potrebu da se osigura ujednačena raspodjela odgovornosti i rada među državama članicama koje djeluju kao izvjestiteljice i suizvjestiteljice te raspoložive resurse potrebne za procjenu i donošenje odluke.
It is therefore appropriate to extend the approval periods for 2-phenylphenol (including its salts such as the sodium salt), chlormequat, dimethachlor, etofenprox, penconazole, propaquizafop, tetraconazole, tri-allate, and zeta-cypermethrin by 2 years, and to extend the approval periods of active substances bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad by 3 years.
Stoga je primjereno produljiti rok valjanosti odobrenja za 2-fenilfenol (uključujući njegove soli kao što je natrijeva sol), klormekvat, dimetaklor, etofenproks, penkonazol, propakizafop, tetrakonazol, tri-alat i zeta-cipermetrin za dvije godine te produljiti rok valjanosti odobrenja za aktivne tvari bensulfuron, natrijev 5-nitrogvaiakolat, natrijev o-nitrofenolat, natrijev p-nitrofenolat i tebufenpirad za tri godine.
The Commission received an application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-ethyl) and a separate application for the renewal of the approval of the active substance quizalofop-P (variant quizalofop-p-tefuryl).
Komisija je primila zahtjev za produljenje odobrenja aktivne tvari kizalofop-P (varijanta kizalofop-P-etil) i zaseban zahtjev za produljenje odobrenja aktivne tvari kizalofop-P (varijanta kizalofop-P-tefuril).
Given this fact and due to the different risk profiles of quizalofop-p-ethyl and quizalofop-p-tefuryl, it is appropriate to consider them as two different active substances for the purpose of the renewal procedure.
S obzirom na tu činjenicu i na različite profile rizika varijanti kizalofop-P-etil i kizalofop-P-tefuril, primjereno je smatrati ih dvjema različitim aktivnim tvarima za potrebe postupka produljenja.
The variant quizalofop-p-ethyl does not fall in the prioritised categories in Implementing Decision C/2016/6104.
Varijanta kizalofop-P-etil nije obuhvaćena prioritetnim kategorijama iz Provedbene odluke C/2016/6104.
Therefore, and taking into account the reasons given in recital 5, it is appropriate to extend its approval period by 2 years.
Zbog toga, i uzimajući u obzir razloge navedene u uvodnoj izjavi 5., primjereno je produljiti rok valjanosti njezina odobrenja za dvije godine.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br. 1107/2009 u slučajevima kada dodatna dokumentacija u skladu s Provedbenom uredbom (EU) br. 844/2012 nije dostavljena najkasnije 30 mjeseci prije datuma isteka utvrđenog u Prilogu toj uredbi, Komisija kao datum isteka određuje isti datum koji je vrijedio prije donošenja ove Uredbe ili najraniji mogući datum nakon tog datuma.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br. 1107/2009 u slučajevima u kojima Komisija donosi uredbu kojom se predviđa da se odobrenje aktivne tvari iz Priloga ovoj Uredbi ne produljuje jer nisu ispunjena mjerila za odobravanje, Komisija kao datum isteka određuje isti datum koji je vrijedio prije donošenja ove Uredbe ili datum stupanja na snagu uredbe kojom se predviđa da se odobrenje aktivne tvari ne produljuje, ovisno o tome koji je datum kasniji.
Taking into account that the approvals of some of the substances expire on 31 October 2019, and that applicants should submit supplementary dossiers 30 months before the expiry of the approval, this Regulation should enter into force as soon as possible.
Uzimajući u obzir da valjanost odobrenja nekih aktivnih tvari istječe 31. listopada 2019. i da bi podnositelji zahtjeva 30 mjeseci prije isteka odobrenja trebali dostaviti dodatnu dokumentaciju, ova bi Uredba trebala što prije stupiti na snagu.
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation
Prilog Provedbenoj uredbi (EU) br. 540/2011 mijenja se u skladu s Prilogom ovoj Uredbi.
in the sixth column, expiration of approval, of row 271, Bensulfuron, the date is replaced by ‘31 October 2022’;
u šestom stupcu, prestanak odobrenja, u retku 271., bensulfuron, datum se zamjenjuje datumom „31. listopada 2022.”;
in the sixth column, expiration of approval, of row 272, Sodium 5-nitroguaiacolate, the date is replaced by ‘31 October 2022’;
u šestom stupcu, prestanak odobrenja, u retku 272., natrijev 5-nitrogvaiakolat, datum se zamjenjuje datumom „31. listopada 2022.”;
in the sixth column, expiration of approval, of row 273, Sodium o-nitrophenolate, the date is replaced by ‘31 October 2022’;
u šestom stupcu, prestanak odobrenja, u retku 273., natrijev o-nitrofenolat, datum se zamjenjuje datumom „31. listopada 2022.”;
in the sixth column, expiration of approval, of row 274, Sodium p-nitrophenolate, the date is replaced by ‘31 October 2022’;
u šestom stupcu, prestanak odobrenja, u retku 274., natrijev p-nitrofenolat, datum se zamjenjuje datumom „31. listopada 2022.”;
in the sixth column, expiration of approval, of row 275, Tebufenpyrad, the date is replaced by ‘31 October 2022’;
u šestom stupcu, prestanak odobrenja, u retku 275., tebufenpirad, datum se zamjenjuje datumom „31. listopada 2022.”;
in the sixth column, expiration of approval, of row 276, Chlormequat, the date is replaced by ‘30 November 2021’;
u šestom stupcu, prestanak odobrenja, u retku 276., klormekvat, datum se zamjenjuje datumom „30. studenoga 2021.”;
in the sixth column, expiration of approval, of row 278, Propaquizafop, the date is replaced by ‘30 November 2021’;
u šestom stupcu, prestanak odobrenja, u retku 278., propakizafop, datum se zamjenjuje datumom „30. studenoga 2021.”;
in the sixth column, expiration of approval, of row 281, zeta-Cypermethrin, the date is replaced by ‘30 November 2021’;
u šestom stupcu, prestanak odobrenja, u retku 281., zeta-cipermetrin, datum se zamjenjuje datumom „30. studenoga 2021.”;
in the sixth column, expiration of approval, of row 284, Dimethachlor, the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 284., dimetaklor, datum se zamjenjuje datumom „31. prosinca 2021.”;
in the sixth column, expiration of approval, of row 285, Etofenprox, the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 285., etofenproks, datum se zamjenjuje datumom „31. prosinca 2021.”;
in the sixth column, expiration of approval, of row 287, Penconazole, the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 287., penkonazol, datum se zamjenjuje datumom „31. prosinca 2021.”;
in the sixth column, expiration of approval, of row 288, Tri-allate, the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 288., tri-alat, datum se zamjenjuje datumom „31. prosinca 2021.”;
in the sixth column, expiration of approval, of row 292, Sulphur, the date is replaced by ‘31 December 2020’;
u šestom stupcu, prestanak odobrenja, u retku 292., sumpor, datum se zamjenjuje datumom „31. prosinca 2020.”;
in the sixth column, expiration of approval, of row 293, Tetraconazole, the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 293., tetrakonazol, datum se zamjenjuje datumom „31. prosinca 2021.”;
in the sixth column, expiration of approval, of row 294, Paraffin oils, the date is replaced by ‘31 December 2020’;
u šestom stupcu, prestanak odobrenja, u retku 294., parafinska ulja, datum se zamjenjuje datumom „31. prosinca 2020.”;
in the sixth column, expiration of approval, of row 295, Paraffin oil, the date is replaced by ‘31 December 2020’;
u šestom stupcu, prestanak odobrenja, u retku 295., parafinsko ulje, datum se zamjenjuje datumom „31. prosinca 2020.”;
in the sixth column, expiration of approval, of row 299, 2-phenylphenol (including its salts such as the sodium salt), the date is replaced by ‘31 December 2021’;
u šestom stupcu, prestanak odobrenja, u retku 299., 2-fenilfenol (uključujući njegove soli kao što je natrijeva sol), datum se zamjenjuje datumom „31. prosinca 2021.”;
entry 279 is replaced by the following:
unos 279. zamjenjuje se sljedećim:
CAS No 119738-06-6
CAS br. 119738-06-6
CIPAC No 641.226
CIPAC br. 641.226
(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate
(RS)-tetrahidrofurfuril-(R)-2-[4-(6-klorkinoksalin-2-iloksi)fenoksi]propionat
30 November 2019
30. studenoga 2019.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.
Za provedbu jedinstvenih načela iz članka 29. stavka 6. Uredbe (EZ) br. 1107/2009 uzimaju se u obzir zaključci izvješća o pregledu za kizalofop-P, a posebice dodaci I. i II., kako su finalizirani na Stalnom odboru za prehrambeni lanac i zdravlje životinja 23. siječnja 2009. godine.
In this overall assessment Member States must pay particular attention to:
U toj cjelokupnoj ocjeni države članice moraju obratiti posebnu pozornost na sljedeće:
the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data.
specifikaciju tehničkog materijala proizvedenog za tržište, koja mora biti potvrđena i potkrijepljena odgovarajućim analitičkim podacima.
The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,
Pokusni materijal koji je upotrijebljen u toksikološkoj dokumentaciji treba usporediti i provjeriti u odnosu na tu specifikaciju tehničkog materijala,
the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,
sigurnost korisnika sredstva i radnika te osigurati da je uvjetima uporabe propisana primjena odgovarajućih osobnih zaštitnih sredstava,
the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.
zaštitu bilja koje ne pripada ciljanoj skupini te osigurati da uvjeti za odobrenje uključuju, prema potrebi, mjere za smanjenje rizika, kao npr. zaštitne zone.
Conditions of authorisation shall include risk mitigation measures, where appropriate.
Uvjeti za odobrenje prema potrebi uključuju mjere za smanjenje rizika.
The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.
Predmetne države članice osiguravaju da podnositelj prijave Komisiji dostavi dodatne informacije o riziku za člankonošce koji ne pripadaju ciljanoj skupini.
They shall ensure that the notifier provides such information to the Commission by 30 November 2011.’
One osiguravaju da podnositelj prijave takve informacije dostavi Komisiji do 30. studenoga 2011.”
CAS No 100646-51-3
CAS br. 100646-51-3
CIPAC No 641.202
CIPAC br. 641.202
ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate
etil (R)-2-[4-(6-klorkinoksalin-2-iloksi)fenoksi]propionat
30 November 2021
30. studenoga 2021.
≥ 795 g/kg
≥ 795 g/kg
Commission Implementing Regulation (EU) 2017/556
Provedbena uredba Komisije (EU) 2017/556
on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
o detaljnim aranžmanima o postupcima inspekcije dobre kliničke prakse u skladu s Uredbom (EU) br. 536/2014 Europskog parlamenta i Vijeća
Having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [1], and in particular Article 78(7) thereof,
uzimajući u obzir Uredbu (EU) br. 536/2014 Europskog parlamenta i Vijeća od 16. travnja 2014. o kliničkim ispitivanjima lijekova za primjenu kod ljudi te o stavljanju izvan snage Direktive 2001/20/EZ [1], a posebno njezin članak 78. stavak 7.,
Regulation (EU) No 536/2014 lays down the legal framework for the conduct of clinical trials on medicinal products for human use in the Union to ensure that the rights, safety and well-being of the subjects are protected, and the data generated in clinical trials are robust and reliable.
Uredbom (EU) br. 536/2014 utvrđuje se pravni okvir za provođenje u Uniji kliničkih ispitivanja lijekova za primjenu kod ljudi kako bi se osiguralo da su prava, sigurnost i dobrobit ispitanika zaštićeni, a podaci dobiveni kliničkim ispitivanjima pouzdani i konzistentni.
In particular, the sponsor of a clinical trial and the investigator are to ensure that the clinical trial is conducted in accordance with the relevant protocol and the principles of good clinical practice.
Naime, naručitelj kliničkog ispitivanja i ispitivač osiguravaju da se kliničko ispitivanje provodi u skladu s odgovarajućim protokolom i načelima dobre kliničke prakse.
Compliance with the applicable legal requirements, the protocol and the principles of good clinical practice, including with standards relating to data integrity and ethical conduct of the clinical trial, is to be verified by means of inspections conducted under the responsibility of the Member State where the inspection takes place.
U cilju provjere usklađenosti s primjenjivim pravnim zahtjevima, protokolom i načelima dobre kliničke prakse, uključujući norme koje se odnose na integritet podataka i etički aspekt kliničkih ispitivanja, potrebno je provoditi inspekcije u okviru nadležnosti države članice u kojoj se provodi inspekcija.
The inspection in the context of clinical trials may concern good manufacturing practices as regards the manufacturing of the investigational medicinal products or good clinical practice as regards the conduct of clinical trials.
Inspekcija u okviru kliničkih ispitivanja može se odnositi na dobre proizvođačke prakse u proizvodnji lijekova koji su u fazi ispitivanja ili dobre kliničke prakse u provođenju kliničkih ispitivanja.
Article 63 of Regulation (EU) No 536/2014 empowers the Commission to adopt delegated acts specifying the detailed arrangements for good manufacturing practice inspections as regards investigational medicinal products.
Člankom 63. Uredbe (EU) br. 536/2014 Komisiju se ovlašćuje da donese delegirane akte u kojima se navode detaljni aranžmani o postupcima inspekcije dobre proizvođačke prakse u proizvodnji lijekova koji su u fazi ispitivanja.
Therefore, this Regulation should only lay down detailed arrangements for good clinical practice inspections procedures and requirements regarding training and qualifications of good clinical practice inspectors.
Stoga bi se ovom Uredbom trebali samo utvrditi detaljni aranžmani o postupcima inspekcije dobre kliničke prakse te zahtjevi u pogledu izobrazbe i stručne spreme inspektora dobre kliničke prakse.
Member States may conduct inspections of clinical trials performed in third countries, either because a clinical trial is related to a clinical trial authorised in the Union or because the data of the clinical trial is being referred to in a clinical trial authorisation application in the Union.
Države članice mogu provoditi inspekcije kliničkih ispitivanja provedenih u trećim zemljama zato što je kliničko ispitivanje povezano s kliničkim ispitivanjem odobrenim u Uniji ili zato što se na podatke iz kliničkog ispitivanja upućuje u zahtjevu za odobrenje kliničkog ispitivanja u Uniji.
Those inspections should allow verifying whether such clinical trials were conducted in accordance with standards equivalent to Union standards.
Tim bi se inspekcijama trebalo moći provjeriti jesu li takva klinička ispitivanja provedena u skladu s normama koje su jednakovrijedne normama Unije.
Inspections of clinical trials in third countries may also be conducted in order to verify whether the clinical trials, whose results are referred to in marketing authorisation applications in the Union, meet the ethical requirements set out in Regulation (EU) No 536/2014.
Inspekcije kliničkih ispitivanja u trećim zemljama mogu se provoditi i kako bi se provjerilo jesu li klinička ispitivanja na čije se rezultate upućuje u zahtjevima za odobrenje za stavljanje u promet u Uniji, u skladu s etičkim zahtjevima iz Uredbe (EU) br. 536/2014.
Therefore, provisions on detailed arrangements for the inspection procedures should apply also to inspections conducted outside the Union in accordance with Regulation (EU) No 536/2014.
Stoga bi se odredbe o detaljnim aranžmanima o postupcima inspekcije trebale primjenjivati i na inspekcije koje se provode izvan Unije u skladu s Uredbom (EU) br. 536/2014.
The International Conference on Harmonisation (‘ICH’) reached a consensus in 1995 to provide a harmonised approach for good clinical practice.
Na Međunarodnoj konferenciji o usklađivanju („ICH”) 1995. postignut je konsenzus o usklađenom pristupu dobroj kliničkoj praksi.
Pursuant to Article 47 of Regulation (EU) No 536/2014, the ICH guidelines should be appropriately taken into account by the sponsor when drafting the clinical trial protocol and conducting the clinical trial.
U skladu s člankom 47. Uredbe (EU) br. 536/2014, naručitelj ispitivanja trebao bi pri izradi protokola kliničkog ispitivanja i provođenju kliničkog ispitivanja na odgovarajući način uzeti u obzir smjernice ICH-a.
To the extent that those guidelines are compatible with the relevant Union law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each trial.
Pod uvjetom da su te smjernice u skladu s relevantnim pravom Unije i smjernicama EU-a, inspektori bi se trebali pozivati na njih, no uzimati u obzir specifičnosti svakog ispitivanja.
Member States should be required to set up quality systems to ensure that the inspection procedures are observed and consistently monitored.
Od država članica trebalo bi se zahtijevati da uspostave sustav osiguranja kvalitete kako bi se nadziralo i dosljedno pratilo provođenje inspekcija.
A well-functioning quality system should comprise an organisational structure, clear processes and procedures, including the standard operating procedures to be followed by inspectors when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.
Sustav osiguranja kvalitete koji dobro funkcionira trebao bi imati organizacijsku strukturu, jasno definirane procese i postupke, među ostalim standardne operativne postupke koje inspektori moraju poštovati pri izvršavanju svojih zadaća, jasno i detaljno definirane dužnosti i odgovornosti inspektora, uvjete stalne izobrazbe te odgovarajuće resurse i mehanizme za uklanjanje neusklađenosti.
It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good clinical practice.
Potrebno je omogućiti inspektorima praktičnu djelotvornost odredbi o dobroj kliničkoj praksi.
That objective should be reflected in the minimum requirements for the qualification of inspectors, in particular as regards their education and training.
Taj bi se cilj trebao odražavati u minimalnim zahtjevima koji se odnose na stručnu spremu inspektora, posebno u pogledu obrazovanja i izobrazbe.
For the same reasons, detailed rules on inspection procedures should be laid down.
Iz istih bi razloga trebalo utvrditi detaljna pravila o postupcima inspekcije.
In order to safeguard the effectiveness of inspection, the inspectors should be granted the necessary powers of access to the premises and data.
Kako bi se osigurala djelotvornost inspekcije, inspektorima bi se trebale dodijeliti potrebne ovlasti za pristup prostorima i podacima.
This includes in particular any laboratory used for analysis in the clinical trial, any contract research organisation's facilities or the sponsor's premises.
To se posebno odnosi na sve laboratorije koji se upotrebljavaju za analizu u kliničkom ispitivanju, sve prostore ugovornih istraživačkih organizacija i prostore naručitelja ispitivanja.
They should also be empowered to contact the trial subjects in justified cases.
Trebali bi biti ovlašteni i za kontaktiranje s ispitanicima u opravdanim slučajevima.
In order to ensure the compliance with arrangements for good clinical practice inspections and in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective measures if necessary.
Kako bi se osigurala usklađenost s aranžmanima o postupcima inspekcije dobre kliničke prakse i u skladu s člankom 77. Uredbe (EU) br. 536/2014 države članice trebale bi, ako je to potrebno, poduzeti korektivne mjere.
When during an inspection a major non-compliance or breach is identified, or the inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.
Ako se tijekom inspekcije ustanovi znatno nepoštovanje ili kršenje pravila te ako naručitelji ispitivanja ne priznaju ovlasti inspektora, države članice trebale bi primijeniti sankcije.
In order to ensure the protection of confidential information, in particular personal data of clinical trial subjects related to their health as well as commercially confidential information, the inspectors and experts involved in inspections should be bound by the highest standards of confidentiality and the applicable requirements of the Union law, national laws and international agreements.
Kako bi se osigurala zaštita povjerljivih podataka, posebno osobnih zdravstvenih podataka ispitanika koji sudjeluju u kliničkom ispitivanju te poslovno povjerljivih informacija, inspektori i stručnjaci koji sudjeluju u inspekcijama trebali bi poštovati najviše standarde povjerljivosti i primjenjive zahtjeve iz prava Unije, nacionalnih zakona i međunarodnih sporazuma.
The inspectors and experts involved in inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of the Council [2] when processing personal data.
Inspektori i stručnjaci koji sudjeluju u inspekcijama trebali bi tijekom obrade osobnih podataka ispunjavati uvjete iz Direktive br. 95/46/EZ Europskog parlamenta i Vijeća [2].