natgillin/translations-raw huggingface dataset:
Each Party shall maintain ongoing activities to monitor that recognized authorities in its territory maintain the criteria for recognition.
Vsaka pogodbenica stalno izvaja tekoče dejavnosti za spremljanje, da priznani organi na njenem ozemlju stalno izpolnjujejo merila za priznanje.
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.
Za namene takih dejavnosti spremljanja vsaka pogodbenica zaupa vzpostavljenim programom, ki vključujejo redne revizije ali ocenjevanje organov na podlagi meril iz Dodatka 4.
The frequency and nature of such activities shall be consistent with international best practices.
Pogostost in narava takih dejavnosti morata biti skladni z mednarodnimi dobrimi praksami.
A Party may invite the other Party to participate in these monitoring activities at the other Party's expense.
Pogodbenica lahko povabi drugo pogodbenico k sodelovanju pri teh dejavnostih spremljanja na stroške druge pogodbenice.
Each Party shall notify the other Party of any significant changes to its monitoring programmes.
Vsaka pogodbenica obvesti drugo pogodbenico o morebitnih pomembnih spremembah svojih programov spremljanja.
Suspension of a recognized authority
Začasni preklic priznavanja priznanega organa
Each Party has the right to suspend recognition of a recognized authority of the other Party.
Vsaka pogodbenica ima pravico, da začasno prekliče priznavanje priznanega organa druge pogodbenice.
This right shall be exercised in an objective and reasoned manner and communicated in writing to the other Party and the recognized authority.
Ta pravica se uveljavlja objektivno in utemeljeno, njeno uveljavljanje pa se pisno sporoči drugi pogodbenici in priznanemu organu.
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.
Pogodbenica, ki začasno prekliče priznavanje priznanega organa druge pogodbenice, na zahtevo druge pogodbenice ali organa, katerega priznavanje je začasno preklicano, v okviru Skupnega področnega odbora nemudoma začne razpravo o začasnem preklicu, razlogih zanj in popravnih ukrepih, ki bi jih bilo treba sprejeti za odpravo začasnega preklica.
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.
Ob začasnem preklicu priznavanja organa, ki je bil prej naveden kot priznani organ, pogodbenica ni več zavezana sprejemanju uradnih dokumentov o dobrih proizvodnih praksah, ki jih je izdal organ, katerega priznavanje je začasno preklicano.
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.
Pogodbenica še naprej sprejema uradne dokumente o dobrih proizvodnih praksah, ki jih je zadevni organ izdal pred začasnim preklicem, razen če se pogodbenica iz zdravstvenih ali varnostnih razlogov odloči drugače.
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.
Začasni preklic velja, dokler se pogodbenici ne odločita za odpravo začasnega preklica ali do pozitivne odločitve o priznavanju v skladu s členom 7 na podlagi ponovne ocene.
JOINT SECTORAL COMMITTEE
SKUPNI PODROČNI ODBOR
Role and composition of the Joint Sectoral Committee
Vloga in sestava Skupnega področnega odbora
A Joint Sectoral Committee is set up to monitor the activities performed under this Annex.
Ustanovi se Skupni področni odbor za spremljanje dejavnosti, ki se izvajajo na podlagi te priloge.
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.
Odboru skupaj predsedujeta predstavnik FDA za Združene države Amerike in predstavnik EU, ki imata vsak po en glas v Skupnem področnem odboru.
The Joint Sectoral Committee shall make its decision by unanimous consent.
Skupni področni odbor sprejema odločitve soglasno.
The Joint Sectoral Committee shall determine its own rules and procedures.
Skupni področni odbor določi svoja pravila in postopke.
The Joint Sectoral Committee's functions include in particular:
Naloge Skupnega področnega odbora so zlasti:
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,
oblikovanje in posodabljanje seznama priznanih organov, vključno z morebitnimi omejitvami glede vrste inšpekcijskih pregledov ali proizvodov, in seznama organov iz Dodatka 2 ter predložitev teh seznamov vsem organom iz Dodatka 2 in Skupnemu 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;
zagotavljanje foruma za razpravo o zadevah v zvezi s to prilogo, vključno v zvezi z nesoglasji glede odločitev o priznavanju ali začasnem preklicu in rokih za zaključek ocenjevanja organov iz Dodatka 2 na podlagi te priloge;
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
obravnava statusa proizvodov iz člena 20 in sprejemanje odločitev o njihovi vključitvi v skladu s členom 20 in Dodatkom 3 ter
adopting, where necessary, appropriate complementary technical and administrative arrangements for the effective implementation of this Annex.
po potrebi sprejemanje ustreznih dopolnilnih tehničnih in upravnih ureditev za učinkovito izvajanje te priloge.
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.
Skupni področni odbor se sestane na zahtevo katere koli pogodbenice zaradi vprašanj v zvezi z nesoglasji glede odločitev o priznavanju ali začasnem preklicu in takrat, ko se pogodbenici o tem dogovorita.
The Joint Sectoral Committee may meet in person or by other means.
Člani Skupnega področnega odbora se lahko sestanejo osebno ali drugače.
REGULATORY COOPERATION AND INFORMATION EXCHANGE
REGULATIVNO SODELOVANJE IN IZMENJAVA INFORMACIJ
Regulatory cooperation
Regulativno sodelovanje
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.
Pogodbenici se med seboj v skladu z zakonom obveščata in posvetujeta o predlogih za uvedbo novih kontrol ali spremembo obstoječih tehničnih predpisov ali uvedbo pomembnih sprememb postopkov farmacevtskih inšpekcijskih pregledov ter omogočata predložitev pripomb na take predloge.
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.
Pogodbenici vzpostavita ustrezne ureditve, vključno z dostopom do ustreznih zbirk podatkov, za izmenjavo uradnih dokumentov o dobrih proizvodnih praksah in drugih ustreznih informacij v zvezi z inšpekcijskim pregledom proizvodnega obrata ter izmenjavo informacij o morebitnih poročilih o potrjenih težavah, popravnih ukrepih, odpoklicih, zavrnjenih uvoznih pošiljkah in drugih zakonodajnih ter izvršilnih težavah v zvezi s proizvodi iz te priloge.
Alert System
Sistem opozarjanja
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.
Vsaka pogodbenica vzdržuje sistem opozarjanja, ki organom druge pogodbenice po potrebi omogoča, da so proaktivno in dovolj hitro obveščeni o napaki v kakovosti, odpoklicu, ponarejenih ali lažnih proizvodih ali morebitnem hudem pomanjkanju in drugih težavah v zvezi s kakovostjo ali neskladnostjo z dobrimi proizvodnimi praksami, zaradi katerih bi lahko bile potrebne dodatne kontrole ali začasna prekinitev distribucije zadevnih proizvodov.
SAFEGUARD CLAUSE
ZAŠČITNA KLAVZULA
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.
Vsaka pogodbenica priznava, da ima država uvoznica pravico izvrševati svoje zakonske obveznosti z ukrepi, potrebnimi za zagotovitev ravni zaščite zdravja ljudi in živali, ki je po njeni presoji ustrezna.
An authority of a Party has the right to conduct its own inspection of a manufacturing facility in the territory of the other Party.
Organ pogodbenice ima pravico sam opraviti inšpekcijski pregled proizvodnega obrata na ozemlju druge pogodbenice.
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.
Primer, ko organ pogodbenice sam opravi inšpekcijski pregled proizvodnega obrata na ozemlju druge pogodbenice, bi moral biti izjema glede na običajno prakso pogodbenice od dne, na katerega se začnejo uporabljati členi, navedeni v členu 19(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.
Preden organ pogodbenice opravi inšpekcijski pregled na podlagi odstavka 1, o tem pisno obvesti drugo pogodbenico, organ druge pogodbenice pa ima pravico, da se pridruži inšpekcijskemu pregledu, ki ga opravi pogodbenica.
Entry Into Force
Začetek veljavnosti
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.
Ta priloga začne veljati na dan, na katerega pogodbenici zaključita izmenjavo dopisov o potrditvi zaključka zadevnih postopkov za začetek veljavnosti te priloge.
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 glede na odstavek 1 se členi 8, 10, 11 in 12 te priloge ne uporabljajo do 1. novembra 2017, razen v primerih iz odstavka 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 glede na odstavek 1 se člen 9 te priloge ne uporablja do dne, na katerega FDA prizna vse organe držav članic EU za farmacevtske izdelke za humano rabo iz Dodatka 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.
Če FDA do 1. novembra 2017 ne zaključi ocenjevanja vsaj osem organov držav članic za farmacevtske izdelke za humano rabo iz Dodatka 2 na podlagi te priloge, čeprav je od teh organov prejela popolno dokumentacijo za oceno sposobnosti, kot je opredeljeno v odstavku II(A)(1) Dodatka 4, v skladu s časovnim razporedom iz Dodatka 5, se uporaba členov iz odstavka 2 preloži na dan, na katerega uprava FDA zaključi ocenjevanje vsaj osmih takih organov.
Transitory Provisions
Prehodne določbe
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.
Skupni področni odbor najpozneje do 15. julija 2019 obravnava vprašanje, ali naj se veterinarski izdelki vključijo v seznam proizvodov, ki jih zajema ta priloga.
The Joint Sectoral Committee shall exchange views on the organisation of the assessment of respective authorities by 15 December 2017.
V Skupnem področnem odboru do 15. decembra 2017 poteka izmenjava stališč o organizaciji ocenjevanja zadevnih organov.
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.
Skupni področni odbor najpozneje 15. julija 2022 obravnava vprašanje, ali naj se cepiva za humano rabo in farmacevtski izdelki, pridobljeni iz plazme, vključijo v seznam proizvodov, ki jih zajema ta priloga.
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.
Brez poseganja v to obravnavo od datuma začetka veljavnosti te priloge pogodbenica vnaprej obvesti zadevni organ druge pogodbenice o izvajanju inšpekcijskega pregleda po odobritvi proizvodnega obrata za take proizvode, ki je na ozemlju pogodbenice, in organu omogoči, da se pridruži inšpekcijskemu pregledu.
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.
V podporo vključitvi cepiv za humano rabo in farmacevtskih izdelkov, pridobljenih iz plazme, v seznam proizvodov, ki jih zajema ta priloga, Skupni področni odbor zlasti upošteva izkušnje, pridobljene s takimi skupnimi inšpekcijskimi pregledi.
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.
Skupni področni odbor najpozneje 15. julija 2019 pregleda pridobljene izkušnje, da se odloči, ali bodo določbe o inšpekcijskih pregledih pred odobritvijo iz člena 11 pregledane.
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 odstavkov 1 in 2 se vključijo v seznam proizvodov, ki jih zajema ta priloga, šele, ko se tako odloči Skupni področni odbor v skladu z odstavkoma 1 in 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.
Kadar FDA ugotovi, da je potreben inšpekcijski pregled po odobritvi proizvodnega obrata na ozemlju organa države članice, ki se ocenjuje na podlagi te priloge ali ki ga uprava FDA sicer ni priznala, FDA pisno obvesti navedeni organ in agencijo EMA.
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.
Organ, na ozemlju katerega je proizvodni obrat, ali agencija EMA v imenu tega organa najpozneje v 30 koledarskih dneh od datuma, na katerega prejme obvestilo v skladu z odstavkom 5, obvesti FDA o tem, ali se je odločil od priznanega organa EU zahtevati izvedbo inšpekcijskega pregleda, in, če se je, ali bo tak priznani organ EU inšpekcijski pregled opravil do datuma, navedenega v obvestilu.
The authority in whose territory the manufacturing facility is located shall be allowed to join the inspection.
Organu, na ozemlju katerega je proizvodni obrat, se omogoči, da se pridruži inšpekcijskemu pregledu.
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.
Če bo priznani organ EU opravil inšpekcijski pregled, priznani organ ali agencija EMA v imenu tega organa obvesti FDA o datumih, na katere bo opravil inšpekcijski pregled, ter FDA in organu, na ozemlju katerega je bil inšpekcijski pregled opravljen, predloži uradne dokumente o dobrih proizvodnih praksah v zvezi z inšpekcijskim pregledom do datuma, navedenega v obvestilu, v skladu z veljavnimi zakoni in drugimi predpisi iz Dodatka 1.
The FDA shall have the option to participate in the inspection.
FDA lahko sodeluje pri inšpekcijskem pregledu.
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.
Če priznani organ EU ne bo opravil inšpekcijskega pregleda, FDA pa opravi inšpekcijski pregled, ima organ, na ozemlju katerega je bil inšpekcijski pregled opravljen, pravico sodelovati v inšpekcijskem pregledu, FDA pa temu organu predloži uradne dokumente o dobrih proizvodnih praksah v zvezi z inšpekcijskim pregledom.
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.
Priloga preneha veljati 15. julija 2019, če FDA do navedenega datuma ne zaključi ocenjevanja na podlagi te priloge za vse organe držav članic EU za farmacevtske izdelke za humano rabo iz Dodatka 2, če je uprava FDA prejela popolno dokumentacijo za oceno sposobnosti, kot je opredeljeno v odstavku II(A)(1) Dodatka 4, od vseh organov držav članic v skladu s časovnim razporedom iz Dodatka 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 v odstavku 1, se podaljša za 90 koledarskih dni za vsak organ, ki zagotovi popolno dokumentacijo za oceno sposobnosti, kot je opredeljeno v odstavku II(A)(1) Dodatka 4, po veljavnem roku iz Dodatka 5, vendar pred 15. julijem 2019.
The FDA shall, on request, discuss any disagreement raised by the EU regarding an assessment in the Joint Sectoral Committee.
Uprava FDA na zahtevo razpravlja o morebitnem nesoglasju, na katerega opozori EU glede ocene, v okviru Skupnega področnega odbora.
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.
Če se Skupni področni odbor ne more dogovoriti o rešitvi nesoglasja, lahko EU pisno obvesti FDA o svojem formalnem nesoglasju in Priloga preneha veljati tri mesece po datumu obvestila ali na drug datum, o katerem se dogovori Skupni področni odbor.
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.
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str.
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.
Direktiva 2001/82/ES Evropskega parlamenta in sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str.
FOR THE UNITED STATES
ZA ZDRUŽENE DRŽAVE AMERIKE
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq.
Posebno pomembni so: 21 USC 351(a)(2)(B) (zdravilo s primesmi, če ni proizvedeno v skladu s trenutnimi dobrimi proizvodnimi praksami), 21 U.S.C.
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.
355(j)(4)(A) (odobritev zdravila za humano rabo, ki je odvisna od ustreznosti metod, obratov in nadzora, da se pri proizvodnji, predelavi in pakiranju ohranijo identiteta, učinkovitost, kakovost in čistost zdravila), 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.
360b(c)(2)(A)(i), 360b(d)(1)(C) (odobritev zdravila za veterinarsko rabo, ki je odvisna od ustreznosti metod, obratov in nadzora, da se pri proizvodnji, predelavi in pakiranju ohranijo identiteta, učinkovitost, kakovost in čistost zdravila), 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.
374 (inšpekcijski organ), 21 U.S.C.
374 (inspection authority); 21 U.S.C.
384(e) (priznavanje inšpekcijskih pregledov tujih vlad);
384(e) (recognition of foreign government inspections)
Zakon o javni zdravstveni službi (Public Health Service Act), oddelek 351, 42 U.S.C.
Public Health Service Act Section 351, 42 U.S.C.
Posebno pomembni so: 42 U.S.C.
Of particular relevance: 42 U.S.C.
262(a)(2)(C)(i)(II) (izdaja dovoljenja za biološki izdelek, ki je odvisna od dokaza, da je obrat, v katerem je proizveden, predelan, pakiran ali shranjen, skladen s standardi, oblikovanimi za zagotovitev, da ostane izdelek varen in čist ter ohrani učinkovitost), 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(j) (zvezni zakon o živilih, zdravilih in kozmetiki se uporablja za biološke izdelke);