natgillin/translations-raw huggingface dataset:
For greater certainty, if the recognized authority indicates that it will not conduct the inspection, the requesting authority has the right to conduct its own inspection of the manufacturing facility and the requested authority has the right to join the inspection.
Podrazumijeva se da ako priznato tijelo navede da neće provesti kontrolu, tijelo koje podnosi zahtjev ima pravo samo provesti kontrolu proizvodnog postrojenja, a tijelo koje je primilo zahtjev ima pravo sudjelovati u toj kontroli.
Each Party shall maintain ongoing activities to monitor that recognized authorities in its territory maintain the criteria for recognition.
Svaka stranka održava aktivnosti kojima prati ispunjavaju li priznata tijela na njezinu području i dalje kriterije za priznavanje.
For the purpose of such monitoring activities, each Party shall rely on established programmes that include regular audits or assessments of authorities based on the criteria specified in Appendix 4.
U svrhu takvih aktivnosti praćenja, svaka se stranka oslanja na utvrđene programe koji obuhvaćaju redovite revizije ili ocjenjivanja tijela na temelju kriterija utvrđenih Dodatkom 4.
The frequency and nature of such activities shall be consistent with international best practices.
Učestalost i priroda takvih aktivnosti moraju biti usklađene s najboljom međunarodnom praksom.
A Party may invite the other Party to participate in these monitoring activities at the other Party's expense.
Stranka može pozvati drugu stranku da sudjeluje u tim aktivnostima praćenja na trošak druge stranke.
Each Party shall notify the other Party of any significant changes to its monitoring programmes.
Svaka stranka obavješćuje drugu stranku o svim bitnim izmjenama njezinih programa praćenja.
Suspension of a recognized authority
Suspenzija priznatog tijela
Each Party has the right to suspend recognition of a recognized authority of the other Party.
Svaka stranka ima pravo suspendirati priznanje priznatog tijela druge stranke.
This right shall be exercised in an objective and reasoned manner and communicated in writing to the other Party and the recognized authority.
To se pravo ostvaruje na objektivan i obrazložen način te se pisanim putem priopćuje drugoj stranci i priznatom tijelu.
A Party suspending recognition of a recognized authority of the other Party shall, upon request of the other Party or the authority whose recognition was suspended, promptly discuss in the Joint Sectoral Committee the suspension, the reason therefore, and corrective actions that would need to be taken for the suspension to be lifted.
Stranka koja suspendira priznanje priznatog tijela druge stranke na zahtjev druge stranke ili tijela čije je priznanje suspendirano odmah u Zajedničkom sektorskom odredu raspravlja o suspenziji, razlozima zbog kojih je do nje došlo i korektivnim mjerama koje bi trebalo poduzeti za prekid suspenzije.
Upon the suspension of an authority previously listed as a recognized authority, a Party is no longer obligated to accept official GMPs documents of the suspended authority.
Nakon suspenzije tijela koje je prethodno navedeno kao priznato tijelo stranka više nije obvezna prihvaćati službene dokumente o GMP-u suspendiranog tijela.
A Party shall continue to accept official GMPs documents of that authority prior to suspension, unless the Party decides otherwise based on health or safety considerations.
Stranka nastavlja prihvaćati službene dokumente o GMP-u tog tijela prije suspenzije, osim ako stranka odluči drukčije na osnovi zdravstvenih ili sigurnosnih razmatranja.
The suspension shall remain in effect until the Parties decide to lift the suspension or until a positive determination of recognition has been made in accordance with Article 7 pursuant to a reassessment.
Suspenzija ostaje na snazi dok stranke ne odluče prekinuti suspenziju ili dok se ne donese pozitivna odluka o priznavanju u skladu s člankom 7. na temelju ponovnog ocjenjivanja.
JOINT SECTORAL COMMITTEE
ZAJEDNIČKI SEKTORSKI ODBOR
Role and composition of the Joint Sectoral Committee
Uloga i sastav Zajedničkog sektorskog odbora
A Joint Sectoral Committee is set up to monitor the activities performed under this Annex.
Zajednički sektorski odbor osnovan je za praćenje aktivnosti koje se provode u skladu s ovim Prilogom.
The Committee shall be co-chaired by a representative of the FDA for the United States and a representative of the EU who each shall have one vote in the Joint Sectoral Committee.
Odborom zajednički predsjedavaju predstavnik FDA-e za Sjedinjene Američke Države i predstavnik EU-a, a svaki od njih ima jedan glas u Zajedničkom sektorskom odboru.
The Joint Sectoral Committee shall make its decision by unanimous consent.
Odluke Zajedničkog sektorskog odbora donose se jednoglasno.
The Joint Sectoral Committee shall determine its own rules and procedures.
Zajednički sektorski odbor donosi svoj poslovnik o radu.
The Joint Sectoral Committee's functions include in particular:
Funkcije Zajedničkog sektorskog odbora posebno obuhvaćaju sljedeće:
developing and keeping up to date the list of recognized authorities, including any limitation in terms of inspection type or products, and the list of authorities in Appendix 2 and communicating the lists to all authorities listed in Appendix 2 and the Joint Committee,
izrada i ažuriranje popisa priznatih tijela, uključujući sva ograničenja s obzirom na vrstu kontrole ili proizvode, i popisa tijela iz Dodatka 2., te dostava tih popisa svim tijelima navedenima u Dodatku 2. i Zajedničkom odboru;
providing a forum to discuss issues relating to this Annex, including relating to disagreements as regards determinations of recognition or suspension and timelines for completing assessments under this Annex of authorities listed in Appendix 2;
osiguravanje foruma za raspravu o pitanjima povezanima s ovim Prilogom, uključujući ona koja se odnose na neslaganja oko odluka o priznavanju ili suspenziji i rokova za dovršetak ocjenjivanja tijela navedenih u Dodatku 2. u skladu s ovim Prilogom;
in accordance with Article 20 and Appendix 3, considering the status, and taking decisions on the inclusion, of the products referred to in Article 20; and
u skladu s člankom 20. i Dodatkom 3., razmatranje statusa i donošenje odluka o uključivanju proizvoda iz članka 20. i
adopting, where necessary, appropriate complementary technical and administrative arrangements for the effective implementation of this Annex.
prema potrebi, donošenje prikladnih dodatnih tehničkih i administrativnih dogovora za učinkovitu provedbu ovog Priloga.
The Joint Sectoral Committee shall meet at the request of either Party with respect to issues relating to disagreements as regards to determinations of recognition or suspension and otherwise at such times as the Parties may agree.
Zajednički sektorski odbor sastaje se na zahtjev jedne od stranaka zbog pitanja koja se odnose na neslaganja oko odluka o priznavanju ili suspenziji i u ostalim slučajevima kada se stranke dogovore.
The Joint Sectoral Committee may meet in person or by other means.
Članovi Zajedničkog sektorskog odbora mogu se sastajati osobno ili upotrebom drugih sredstava.
REGULATORY COOPERATION AND INFORMATION EXCHANGE
REGULATORNA SURADNJA I RAZMJENA INFORMACIJA
The Parties shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or significant changes to pharmaceutical inspection procedures and to provide the opportunity to comment on such proposals.
Stranke se u okviru zakonskih mogućnosti međusobno obavješćuju i savjetuju o prijedlozima za uvođenje novih nadzora ili za izmjenu postojećih tehničkih propisa ili o znatnim promjenama u postupcima farmaceutske kontrole te si pružaju mogućnost komentiranja takvih prijedloga.
The Parties shall establish appropriate arrangements, including access to relevant databases, for the exchange of official GMPs documents and other appropriate information related to the inspection of a manufacturing facility and the exchange of information concerning any confirmed problem reports, corrective actions, recalls, rejected import consignments and other regulatory and enforcement problems for products subject to this Annex.
Stranke utvrđuju odgovarajuće mjere, uključujući pristup odgovarajućim bazama podataka, za razmjenu službenih dokumenata o GMP-u i drugih prikladnih informacija povezanih s kontrolom proizvodnog postrojenja i za razmjenu informacija o svim izvješćima o potvrđenom problemu, korektivnim mjerama, povlačenjima, odbijenim uvoznim pošiljkama i drugim regulatornim problemima i problemima s provedbom za proizvode obuhvaćene ovim Prilogom.
Alert System
Sustav upozorenja
Each Party shall maintain an Alert System that permits authorities of the other Party when relevant to be made aware proactively and with the appropriate speed in case of quality defect, recalls, counterfeit or falsified products, or potential serious shortages and other problems concerning quality or non-compliance with GMP, which could necessitate additional controls or suspension of the distribution of the affected products.
Svaka stranka održava sustav upozorenja koji omogućuje tijelima druge stranke da budu proaktivno i na vrijeme obaviještena u slučaju propusta u kvaliteti, povlačenja, krivotvorenih ili lažiranih proizvoda ili potencijalno ozbiljnih nedostataka i drugih problema povezanih s kvalitetom ili neusklađenosti s GMP-om koji bi mogli zahtijevati dodatne kontrole ili suspenziju distribucije predmetnih proizvoda.
SAFEGUARD CLAUSE
ZAŠTITNA KLAUZULA
Each Party recognizes that the importing country has a right to fulfil its legal responsibilities by taking actions necessary to ensure the protection of human and animal health at the level of protection it deems appropriate.
Svaka stranka priznaje da zemlja uvoznica ima pravo ispuniti svoje zakonske obveze poduzimanjem mjera potrebnih kako bi se osigurala zaštita zdravlja ljudi i životinja na razini zaštite koju smatra prikladnom.
An authority of a Party has the right to conduct its own inspection of a manufacturing facility in the territory of the other Party.
Tijelo stranke ima pravo provesti vlastitu kontrolu proizvodnog postrojenja na području druge stranke.
An authority of a Party conducting its own inspection of a manufacturing facility in the territory of the other Party should be an exception from the normal practice of a Party as of the date on which the Articles referred to in Article 19(2) become applicable.
Postupak u kojem tijelo stranke provodi vlastitu kontrolu proizvodnog postrojenja na području druge stranke trebao bi biti iznimka od uobičajene prakse stranke od dana na koji postanu primjenjivi članci navedeni u članku 19. stavku 2.
An authority of a Party, prior to conducting an inspection under paragraph 1, shall notify the other Party in writing and the authority of the other Party has the right to join the inspection conducted by the Party.
Tijelo stranke pismeno obavješćuje drugu stanku prije provođenja kontrole iz stavka 1., a tijelo druge stranke ima pravo sudjelovati u kontroli koju stranka provodi.
Entry Into Force
Stupanje na snagu
This Annex shall enter into force on the date on which the Parties have completed an Exchange of Letters confirming completion of any respective procedures for the entry into force of this Annex.
Ovaj Prilog stupa na snagu dana na koji stranke dovrše razmjenu dopisa kojima potvrđuju dovršetak svih odgovarajućih postupaka za stupanje ovog Priloga na snagu.
Notwithstanding paragraph 1, Articles 8, 10, 11 and 12 of this Annex shall not apply until 1 November 2017, except as provided in paragraph 4.
Ne dovodeći u pitanje stavak 1., članci 8., 10., 11. i 12. ovog Priloga ne primjenjuju se do 1. studenoga 2017., osim kako je predviđeno stavkom 4.
Notwithstanding paragraph 1, Article 9 of this Annex shall not apply until the date on which all the EU Member State authorities for human pharmaceuticals listed in Appendix 2 have been recognized by the FDA.
Ne dovodeći u pitanje stavak 1., članak 9. ovog Priloga ne primjenjuje se do dana na koji FDA prizna sva tijela država članica EU-a nadležna za farmaceutske proizvode za humanu uporabu navedena u Dodatku 2.
If, by 1 November 2017, the FDA has not completed assessments under this Annex of at least eight Member State authorities for human pharmaceuticals listed in Appendix 2, despite having received complete capability assessment packages from those authorities as specified in paragraph II.A.1 of Appendix 4 in accordance with the schedule set out in Appendix 5, application of the Articles referred to in paragraph 2 shall be postponed to the date on which the FDA has completed assessments of at least eight such authorities.
Ako FDA do 1. studenoga 2017. ne dovrši ocjenjivanje u skladu s ovim Prilogom za najmanje osam tijela država članica za farmaceutske proizvode za humanu uporabu navedenih u Dodatku 2. iako su joj ta tijela dostavila potpunu dokumentaciju za ocjenjivanje sposobnosti kako je utvrđeno stavkom II.A.1. Dodatka 4. prema rasporedu utvrđenom Dodatkom 5., primjena članaka iz stavka 2. odgađa se do datuma na koji FDA dovrši ocjenjivanje najmanje osam takvih tijela.
Transitory Provisions
Prijelazne odredbe
No later than by 15 July 2019, the Joint Sectoral Committee shall consider whether to include veterinary products within the product coverage of this Annex.
Zajednički sektorski odbor najkasnije do 15. srpnja 2019. razmatra hoće li uključiti veterinarske proizvode u proizvode obuhvaćene ovim Prilogom.
The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017.
Zajednički sektorski odbor razmjenjuje stajališta o organizaciji ocjenjivanja odgovarajućih tijela do 15. prosinca 2017.
No later than 15 July 2022, the Joint Sectoral Committee shall consider whether to include vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex.
Zajednički sektorski odbor najkasnije do 15. srpnja 2022. razmatra hoće li uključiti cjepiva za humanu uporabu i farmaceutske proizvode dobivene iz plazme u proizvode obuhvaćene ovim Prilogom.
Without prejudice to this consideration, as of the effective date of this Annex, a Party shall notify the relevant authority of the other Party in advance of conducting a post-approval inspection of a manufacturing facility of such products located in the territory of the Party and give the authority the option of joining the inspection.
Ne dovodeći u pitanje to razmatranje, od datuma stupanja na snagu ovog Priloga stranka unaprijed obavješćuje mjerodavno tijelo druge stranke o provođenju kontrole nakon odobrenja u proizvodnom postrojenju za takve proizvode koje se nalazi na području stranke i omogućuje tijelu sudjelovanje u kontroli.
In order to support the inclusion of vaccines for human use and plasma derived pharmaceuticals within the product coverage of this Annex, the Joint Sectoral Committee shall take into account, in particular, the experience gained through such joint inspections.
Radi podržavanja uključivanja cjepiva za humanu uporabu i farmaceutskih proizvoda dobivenih iz plazme u proizvode obuhvaćene ovim Prilogom, Zajednički sektorski odbor osobito uzima u obzir iskustvo stečeno u takvim zajedničkim kontrolama.
No later than 15 July 2019, the Joint Sectoral Committee shall review experience gained in order to decide whether the provisions on pre-approval inspections provided in Article 11 shall be reviewed.
Zajednički sektorski odbor najkasnije do 15. srpnja 2019. razmatra stečeno iskustvo kako bi odlučio treba li preispitati odredbe o kontrolama prije odobrenja predviđene člankom 11.
Products referred to in paragraphs 1 and 2 shall be included within the product coverage of this Annex only once the Joint Sectoral Committee so decides pursuant to paragraphs 1 and 2.
Proizvodi iz stavaka 1. i 2. uključuju se u proizvode obuhvaćene ovim Prilogom tek kada Zajednički sektorski odbor tako odluči u skladu sa stavcima 1. i 2.
Where the FDA identifies the need for a post-approval inspection of a manufacturing facility in a territory of a Member State authority of which an assessment under this Annex is pending or that the FDA has otherwise not recognized, the FDA shall notify that authority and the EMA in writing.
Ako FDA utvrdi da je potrebna kontrola nakon odobrenja u proizvodnom postrojenju na području tijela države članice za koje je u tijeku ocjenjivanje u skladu s ovim Prilogom ili koje FDA nije priznala, FDA pisanim putem obavješćuje to tijelo i EMA-u.
No later than 30 calendar days of the date it receives a notification pursuant to paragraph 5, the authority in whose territory the manufacturing facility is located or EMA on behalf of this authority shall inform the FDA whether it has opted to request a recognized authority of the EU to conduct the inspection and, if so, whether such recognized authority of the EU will conduct the inspection by the date specified in the notification.
Najkasnije 30 kalendarskih dana od datuma na koji primi obavijest u skladu sa stavkom 5. tijelo na čijem se području nalazi proizvodno postrojenje ili EMA u ime tog tijela obavješćuje FDA-u je li odlučilo zatražiti da priznato tijelo EU-a provede kontrolu i, ako jest, hoće li takvo priznato tijelo EU-a provesti kontrolu do datuma navedenoga u obavijesti.
The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection.
Tijelu na čijem se području nalazi proizvodno postrojenje dopušteno je sudjelovanje u kontroli.
In the case that a recognized authority of the EU will conduct the inspection, the recognized authority or EMA on behalf of this authority shall inform the FDA of the date(s) on which it will conduct the inspection and submit the official GMPs documents relevant to the inspection to the FDA and the authority of the territory in which the inspection has been conducted by the date specified in the notification in accordance with the applicable laws, regulations and administrative provisions listed in Appendix 1.
Ako priznato tijelo EU-a provodi kontrolu, priznato tijelo ili EMA u ime tog tijela obavješćuje FDA-u o datumu ili datumima na koje će provesti kontrolu i podnosi službene dokumente o GMP-u koji se odnose na kontrolu FDA-i i tijelu na čijem je području provedena kontrola do datuma navedenoga u obavijesti u skladu s primjenjivim zakonima i drugim propisima navedenima u Dodatku 1.
The FDA shall have the option to participate in the inspection.
FDA ima mogućnost sudjelovati u kontroli.
In the case that a recognized authority of the EU will not conduct the inspection and the FDA conducts the inspection, the authority of the territory in which the inspection has been conducted has the right to participate in the inspection and the FDA shall submit the official GMPs documents relevant to the inspection to this authority.
Ako priznato tijelo EU-a ne provodi kontrolu, već kontrolu provede FDA, tijelo na čijem je području provedena kontrola ima pravo sudjelovati u kontroli, a FDA podnosi tom tijelu službene dokumente o GMP-u koji se odnose na kontrolu.
The Annex shall terminate on 15 July 2019 in the event that the FDA, by that date, has not completed an assessment under this Annex of each EU Member State authority for human pharmaceuticals listed in Appendix 2, provided that the FDA has received complete capability assessment packages as specified in paragraph II.A.1 of Appendix 4 from each Member State authority in accordance with the schedule set out in Appendix 5.
1. Prilog prestaje važiti 15. srpnja 2019. ako FDA do toga datuma ne dovrši ocjenjivanje u skladu s ovim Prilogom svih tijela država članica EU-a nadležnih za farmaceutske proizvode za humanu uporabu navedenih u Dodatku 2., pod uvjetom da su joj sva tijela država članica dostavila potpunu dokumentaciju za ocjenjivanje sposobnosti, kako je utvrđeno stavkom II.A.1. Dodatka 4., prema rasporedu utvrđenom Dodatkom 5.
The date specified in paragraph 1 shall be extended by 90 calendar days for each authority that provides a complete capability assessment package as specified in paragraph II.A.1 of Appendix 4 after the applicable deadline set out in Appendix 5 but before 15 July 2019.
Datum naveden u stavku 1. produžuje se za 90 kalendarskih dana za svako tijelo koje dostavi potpunu dokumentaciju za ocjenjivanje sposobnosti, kako je utvrđeno stavkom II.A.1. Dodatka 4., nakon primjenjivog roka utvrđenog Dodatkom 5., ali prije 15. srpnja 2019.
The FDA shall, on request, discuss any disagreement raised by the EU regarding an assessment in the Joint Sectoral Committee.
FDA na zahtjev u Zajedničkom sektorskom odboru raspravlja o svim neslaganjima oko ocjenjivanja koje iznese EU.
If the Joint Sectoral Committee cannot agree on resolution of the disagreement, the EU may notify in writing to the FDA its formal disagreement and the Annex shall terminate three months from the date of such notification or on such other date as the Joint Sectoral Committee may agree.
Ako se Zajednički sektorski odbor ne može usuglasiti u vezi s rješenjem tog neslaganja, EU može pismeno obavijestiti FDA-u o svojem službenom neslaganju i Prilog prestaje važiti tri mjeseca od datuma takve obavijesti ili nekog drugog datuma koji odredi Zajednički sektorski odbor.
List of Applicable Laws, Regulations and Administrative Provisions
Popis važećih zakona i drugih propisa
FOR THE UNITED STATES
ZA SJEDINJENE AMERIČKE DRŽAVE
Of particular relevance: 21 USC 351(a)(2)(B) (drug adulterated if not manufactured in conformance with current good manufacturing practice); 21 U.S.C.
Osobito su važne sljedeće odredbe: 21. U.S.C. 351(a)(2)(B) (izmijenjeni lijek ako se ne proizvodi u skladu s trenutačnom dobrom proizvođačkom praksom); 21. U.S.C.
355(j)(4)(A) (approval of human drug contingent on adequacy of methods, facilities, and controls for manufacturing, processing, and packing to preserve the identity, strength, quality, and purity of drug); 21 U.S.C.
355(j)(4)(A) (odobrenje lijeka za humanu uporabu ovisno o prikladnosti metoda, postrojenja i kontrola za proizvodnju, preradu i pakiranje radi očuvanja identiteta, jačine, kvalitete i čistoće lijeka); 21. U.S.C.
360b(c)(2)(A)(i); 360b(d)(1)(C) (approval of animal drug contingent on contingent on adequacy of methods, facilities, and controls for manufacturing, processing, and packing to preserve the identity, strength, quality, and purity of drug); 21 U.S.C.
360b(c)(2)(A)(i); 360b(d)(1)(C) (odobrenje lijeka za životinjsku uporabu ovisno o prikladnosti metoda, postrojenja i kontrola za proizvodnju, preradu i pakiranje radi očuvanja identiteta, jačine, kvalitete i čistoće lijeka); 21. U.S.C.
374 (inspection authority); 21 U.S.C.
374 (tijelo za kontrolu); 21. U.S.C.
384(e) (recognition of foreign government inspections)
384(e) (priznavanje kontrola stranih vlada)
Public Health Service Act Section 351, 42 U.S.C.
Public Health Service Act (Zakon o uslugama javnog zdravstva), odjeljak 351., 42. U.S.C.
Of particular relevance: 42 U.S.C.
Osobito su važne sljedeće odredbe: 42. U.S.C.
262(a)(2)(C)(i)(II) (licensing of biologic contingent on demonstration that the facility in which it is manufactured, processed, packed, or held meets standards designed to assure that the product continues to be safe, pure, and potent); 42 U.S.C.
262(a)(2)(C)(i)(II) (licenciranje bioloških proizvoda ovisno o dokazivanju da postrojenje u kojemu se proizvode, prerađuju, pakiraju ili drže zadovoljava norme utvrđene radi osiguranja sigurnosti, čistoće i snage proizvoda); 42. U.S.C.
262(j) (Federal Food, Drug, and Cosmetic Act applies to biologic products)
262(j) (Federal Food, Drug, and Cosmetic Act primjenjuje se na biološke proizvode)
21 CFR Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Drugs; General)
CFR odjeljak 210. (Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding Drugs; General (Trenutačna dobra proizvođačka praksa u području proizvodnje, prerade, pakiranje ili držanja lijekova; Općenito))
21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
CFR odjeljak 211. (Current Good Manufacturing Practice for Finished Pharmaceuticals (Trenutačna dobra proizvođačka praksa za gotove farmaceutske proizvode))