natgillin/translations-raw huggingface dataset:
‘Equivalence’ means that the regulatory system under which an authority operates is sufficiently comparable to assure that the process of inspection and the ensuing official GMP documents will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled.
„enakovrednost“ pomeni, da je regulativni sistem, v skladu s katerim organ deluje, dovolj primerljiv za zagotovitev, da bodo proces inšpekcijskih pregledov in na podlagi inšpekcijskih pregledov izdani uradni dokumenti o dobrih proizvodnih praksah zagotavljali zadostne informacije za ugotovitev, ali so izpolnjene ustrezne zakonske in regulativne zahteve organov.
For greater certainty, ‘equivalence’ does not require that the respective regulatory systems have identical procedures.
Pojasniti je treba, da „enakovrednost“ ne pomeni, da morata zadevna regulativna sistema uporabljati enake postopke;
‘Enforcement’ means an action taken by an authority to protect the public from products of suspect quality, safety and efficacy or to assure that products are manufactured in compliance with appropriate laws, regulations, standards and commitments made as part of the approval to market a product.
„izvrševanje“ pomeni ukrepe organa za zaščito javnosti pred proizvodi sumljive kakovosti, varnosti in učinkovitosti ali za zagotavljanje skladnosti proizvodnje z ustreznimi zakoni, predpisi, standardi in zavezami, sprejetimi v okviru odobritve proizvoda za trg;
‘Good Manufacturing Practices’ (GMPs) means systems that assure proper design, monitoring, and control of manufacturing processes and facilities, the adherence to which assures the identity, strength, quality, and purity of pharmaceuticals.
„dobre proizvodne prakse“ pomenijo sisteme za zagotavljanje ustreznega oblikovanja, spremljanja in nadzora proizvodnih postopkov in obratov, katerih uporaba zagotavlja identiteto, učinkovitost, kakovost in čistost farmacevtskih izdelkov.
GMPs include strong quality management systems, obtaining appropriate quality raw materials (including starting materials) and packaging materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
Dobre proizvodne prakse vključujejo zanesljive sisteme vodenja kakovosti, pridobivanje ustreznih kakovostnih surovin (vključno z vhodnimi snovmi) in embalažnih materialov, vzpostavljanje zanesljivih operativnih postopkov, odkrivanje in preiskovanje odstopanj pri kakovosti proizvodov ter vzdrževanje zanesljivih preskusnih laboratorijev;
‘Inspection’ means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practices and/or commitments made as part of the approval to market a product.
„inšpekcijski pregled“ pomeni vrednotenje proizvodnega obrata na kraju samem, s katerim se ugotovi, ali obrat deluje v skladu z dobrimi proizvodnimi praksami in/ali zavezami, sprejetimi v okviru odobritve proizvoda za trg;
‘Inspection Report’ means a report written by an investigator or inspector of an authority listed in Appendix 2 concerning an inspection of a manufacturing facility that the investigator or inspector conducted that describes the purpose and scope of an inspection and includes written observations and findings bearing on the manufacturing facilities conformance to applicable GMP requirements set out in the laws, regulations and administrative procedures listed in Appendix 1 and any commitments made as part of the approval to market a product.
„poročilo o inšpekcijskem pregledu“ pomeni poročilo, ki ga napiše preiskovalec ali inšpektor organa s seznama v Dodatku 2 v zvezi z inšpekcijskim pregledom proizvodnega obrata, ki ga je opravil preiskovalec ali inšpektor, in ki opisuje namen in obseg inšpekcijskega pregleda ter vključuje pisne pripombe in ugotovitve o skladnosti proizvodnih obratov z veljavnimi zahtevami glede dobrih proizvodnih praks iz zakonov in drugih predpisov, navedenih v Dodatku 1, in zavezami, sprejetimi v okviru odobritve proizvoda za trg;
‘Official GMPs document’ means a document issued by an authority listed in Appendix 2 following an inspection of a manufacturing facility.
„uradni dokument o dobrih proizvodnih praksah“ pomeni dokument, ki ga izda organ s seznama v Dodatku 2 po inšpekcijskem pregledu proizvodnega obrata.
Examples of official GMPs documents include inspection reports, certificates issued by an authority attesting the compliance of a manufacturing facility with GMPs, GMPs non-compliance statement issued by authorities of the EU, and notice of observations, untitled letters, warning letters, and import alerts issued by the FDA.
Uradni dokumenti o dobrih proizvodnih praksah so na primer poročila o inšpekcijskem pregledu, potrdila organa o skladnosti proizvodnega obrata z dobrimi proizvodnimi praksami, izjava o neskladju z dobrimi proizvodnimi praksami, ki jo izdajo organi EU, ter obvestilo o ugotovitvah, dopisi brez naslova, opozorilna pisma in opozorila o uvozu, ki jih izda FDA;
‘Pharmaceuticals’ includes drugs and medicinal products as defined in the laws and regulations listed in Appendix 1.
„farmacevtski izdelki“ vključujejo zdravila, kot so opredeljena v zakonih in drugih predpisih, navedenih v Dodatku 1;
‘Post-approval inspections’ means GMP surveillance inspections during the marketing of products.
„inšpekcijski pregledi po odobritvi“ pomenijo nadzorne inšpekcijske preglede dobrih proizvodnih praks med trženjem proizvodov;
‘Pre-approval inspections’ means pharmaceutical inspections of manufacturing facilities carried out in the territory of a Party as part of the review of an application before marketing approval is granted.
„inšpekcijski pregledi pred odobritvijo“ pomenijo farmacevtske inšpekcijske preglede proizvodnih obratov, ki se opravijo na ozemlju pogodbenice kot del pregleda vloge pred odobritvijo dovoljenja za trženje;
‘Regulatory System’ means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.
„regulativni sistem“ pomeni zbirko pravnih zahtev za dobre proizvodne prakse, inšpekcijske preglede in izvršilne ukrepe, ki zagotavljajo varovanje javnega zdravja in so pravna podlaga za zagotavljanje izpolnjevanja teh zahtev.
This Annex facilitates the exchange of official GMPs documents between the Parties and reliance on the factual findings in such documents.
Ta priloga omogoča izmenjavo uradnih dokumentov o dobrih proizvodnih praksah med pogodbenicama in zaupanje v ugotovitve o dejanskem stanju v takih dokumentih.
This Annex seeks to facilitate trade and benefit public health by allowing each Party to leverage and to reallocate its inspection resources, including by avoiding duplication of inspections, so as to improve oversight of manufacturing facilities and better address quality risk and prevent adverse health consequences.
Namen te priloge je olajšati trgovanje in koristiti javnemu zdravju, saj vsaki pogodbenici omogoča, da izboljša in prerazporedi svoja sredstva za inšpekcijske preglede, med drugim s preprečevanjem podvajanja inšpekcijskih pregledov, da se izboljšata nadzor nad proizvodnimi obrati in obvladovanje tveganja na področju kakovosti ter preprečijo škodljive posledice za zdravje.
The provisions of this Annex apply to pharmaceutical inspections of manufacturing facilities carried out in the territory of a Party during the marketing of products (hereafter referred to as ‘post-approval inspections’) and, to the extent provided for in Article 11, before products are marketed (hereafter referred to as ‘pre-approval inspections’), as well as, to the extent provided for in Article 8(3), to pharmaceutical inspections of manufacturing facilities carried out outside the territory of either Party.
Določbe te priloge se uporabljajo za farmacevtske inšpekcijske preglede proizvodnih obratov, ki se izvedejo na ozemlju pogodbenice med trženjem proizvodov (v nadaljnjem besedilu: inšpekcijski pregledi po odobritvi) in, v obsegu, določenem v členu 11, pred trženjem proizvodov (v nadaljnjem besedilu: inšpekcijski pregledi pred odobritvijo), ter, v obsegu, določenem v členu 8(3), za farmacevtske inšpekcijske preglede proizvodnih obratov, izvedene zunaj ozemlja posamezne pogodbenice.
Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMPs requirements.
V Dodatku 1 so navedeni zakoni in drugi predpisi, ki veljajo za te inšpekcijske preglede in zahteve v zvezi z dobrimi proizvodnimi praksami.
Appendix 2 lists all the authorities responsible for the oversight of facilities that manufacture products within the product coverage of this Annex.
V Dodatku 2 so navedeni vsi organi, odgovorni za nadzor nad obrati, ki proizvajajo proizvode s seznama proizvodov, ki jih zajema ta priloga.
Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.
Členi 6, 7, 8, 9, 10 in 11 Sporazuma se ne uporabljajo za to prilogo.
Product coverage
Seznam proizvodov
These provisions apply to marketed finished pharmaceuticals for human or animal use, intermediates (for the EU as defined in EU legislation) and in-process materials (for the United States as defined under U.S. law), certain marketed biological products for human use, and active pharmaceutical ingredients, only to the extent they are regulated by the authorities of both Parties as listed in Appendix 2 and subject to Article 20.
Te določbe se uporabljajo za tržene končne farmacevtske izdelke za humano ali veterinarsko rabo, vmesne izdelke (za EU, kot so opredeljeni v zakonodaji EU) in vmesne snovi (za Združene države Amerike, kot so opredeljene v zakonodaji ZDA), nekatere tržene biološke izdelke za humano rabo ter aktivne farmacevtske učinkovine samo, kolikor jih regulirajo organi obeh pogodbenic, kot so navedeni v Dodatku 2, in ob upoštevanju člena 20.
Human blood, human plasma, human tissues and organs, and veterinary immunologicals are excluded from the scope of this Annex.
Človeška kri, človeška plazma, človeška tkiva in organi ter veterinarske imunološke snovi so izvzeti iz področja uporabe te priloge.
Appendix 3 contains the list of products covered by this Annex.
Dodatek 3 vsebuje seznam proizvodov, ki jih zajema ta priloga.
DETERMINATION OF RECOGNITION
ODLOČITEV O PRIZNAVANJU
Assessments
Ocenjevanje
Each Party shall conduct assessments of authorities listed in Appendix 2 pursuant to this Annex on the request of the other Party as expeditiously as possible, including for authorities added to Appendix 2 after the effective date of this Annex and as regards products listed in Appendix 3 (including those that are included in the scope of this Annex pursuant to Article 20 after the effective date of this Annex).
Vsaka pogodbenica na zahtevo druge pogodbenice izvede ocenjevanje organov s seznama iz Dodatka 2 v skladu s to prilogo, kakor hitro je to mogoče, vključno z organi, dodanimi na seznam iz Dodatka 2 po datumu začetka veljavnosti te priloge, in za proizvode s seznama iz Dodatka 3 (vključno s tistimi, ki so v področje uporabe te priloge vključeni v skladu s členom 20 po datumu začetka veljavnosti te priloge).
Each Party shall use the criteria and procedure specified in Appendix 4 to conduct assessments pursuant to this Annex.
Za izvajanje ocenjevanja v skladu s to prilogo vsaka pogodbenica uporabi merila in postopek, določene v Dodatku 4.
Participation in and completion of assessments
Sodelovanje in zaključek ocenjevanja
Each Party with respect to the authorities listed in Appendix 2 shall participate in the procedure as described in Appendix 4.
Kar zadeva organe, navedene v Dodatku 2, vsaka pogodbenica sodeluje v postopku, ki je opisan v Dodatku 4.
Each Party shall exercise good faith efforts to complete assessments pursuant to this Annex as expeditiously as possible.
Vsaka pogodbenica si v dobri veri prizadeva čim hitreje zaključiti ocenjevanje v skladu s to prilogo.
To this end:
Zato bo:
The EU shall complete an assessment of the FDA for human pharmaceuticals under this Annex no later than by 1 July 2017.
EU ocenjevanje FDA za farmacevtske izdelke za humano rabo na podlagi te priloge zaključila najpozneje do 1. julija 2017;
The FDA shall complete an assessment under this Annex of each EU Member State authority for human pharmaceuticals listed in Appendix 2 as set out in Appendix 5.
uprava FDA zaključila ocenjevanje na podlagi te priloge za vsak organ držav članic EU za farmacevtske izdelke za humano rabo iz Dodatka 2, kot je določeno v Dodatku 5.
Recognition of authorities
Priznavanje organov
Each Party shall determine whether to recognize an authority according to the criteria specified in Appendix 4.
Vsaka pogodbenica odloči, ali bo priznala organ v skladu z merili iz Dodatka 4.
Each Party shall promptly notify the Joint Sectoral Committee of any determination to recognize an authority of the other Party.
Vsaka pogodbenica nemudoma obvesti Skupni področni odbor o odločitvi, da prizna organ druge pogodbenice.
The Joint Sectoral Committee shall maintain a list of recognized authorities and shall keep the list up-to-date.
Skupni področni odbor vodi seznam priznanih organov in ga sproti posodablja.
The list shall be made publicly available by each Party.
Vsaka pogodbenica zagotovi, da je seznam javno dostopen.
The assessing Party shall promptly notify the other Party and the relevant authority of any deficiencies identified in the course of the assessment.
Pogodbenica, ki izvaja ocenjevanje, nemudoma obvesti drugo pogodbenico in zadevni organ o kakršnih koli pomanjkljivostih, ugotovljenih pri ocenjevanju.
In the event of a negative determination, the assessing Party shall notify the other Party and the relevant authority of the reasons for the negative determination and provide sufficient detail to allow the authority to understand corrective measures that must be taken to attain a positive determination.
V primeru negativne odločitve pogodbenica, ki izvaja ocenjevanje, obvesti drugo pogodbenico in zadevni organ o razlogih za negativno odločitev ter zagotovi zadostne podrobnosti, da lahko organ razume popravne ukrepe, ki jih mora sprejeti, da bo sprejeta pozitivna odločitev.
A Party may request the other Party to conduct a reassessment of any authority for which the other Party has made a negative determination once the authority has taken necessary corrective measures in accordance with Article 5.
Ko organ sprejme potrebne popravne ukrepe v skladu s členom 5, lahko pogodbenica zahteva, da druga pogodbenica znova oceni kateri koli organ, za katerega je druga pogodbenica sprejela negativno odločitev.
An assessing Party shall, upon request of the other Party, promptly discuss with the other Party in the Joint Sectoral Committee the reasons for a negative determination.
Pogodbenica, ki izvaja ocenjevanje, na zahtevo druge pogodbenice nemudoma začne razpravo z drugo pogodbenico v okviru Skupnega področnega odbora o razlogih za negativno odločitev.
In case of a negative determination, efforts shall be made by the Joint Sectoral Committee to discuss within 3 months the appropriate timeframe and exact steps to be taken to reassess the relevant authority.
V primeru negativne odločitve si Skupni področni odbor prizadeva, da v roku 3 mesecev opravi razpravo o ustreznem časovnem okviru in konkretnih ukrepih, ki jih je treba sprejeti za ponovno oceno zadevnega organa.
OPERATIONAL ASPECTS
OPERATIVNI VIDIKI
Recognition of inspections
Priznavanje inšpekcijskih pregledov
A Party shall recognize pharmaceutical inspections and accept official GMPs documents issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority, except as provided in paragraph 2.
Pogodbenica prizna farmacevtske inšpekcijske preglede in sprejme uradne dokumente o dobrih proizvodnih praksah, ki jih izda priznani organ druge pogodbenice za proizvodne obrate, ki so na ozemlju organa izdajatelja, razen v primerih iz odstavka 2.
A Party may in specific circumstances opt not to accept an official GMPs document issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority.
Pogodbenica se lahko v posebnih okoliščinah odloči, da ne bo sprejela uradnega dokumenta o dobrih proizvodnih praksah, ki ga je izdal priznani organ druge pogodbenice za proizvodne obrate, ki so na ozemlju organa izdajatelja.
Examples of such circumstances include the indication of material inconsistencies or inadequacies in an inspection report, quality defects identified in the post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety.
Take okoliščine vključujejo na primer navedbo bistvenih neskladij ali pomanjkljivosti v poročilu o inšpekcijskem pregledu, napake v kakovosti, ugotovljene s poprodajnim nadzorom, ali druge konkretne dokaze o resnih pomislekih glede kakovosti proizvoda ali varnosti potrošnikov.
A Party opting not to accept an official GMPs document issued by a recognized authority of the other Party shall notify the other Party and the relevant authority of the reasons for not accepting the document and may request clarification from that authority.
Pogodbenica, ki se odloči, da ne bo sprejela uradnega dokumenta o dobrih proizvodnih praksah, ki ga je izdal priznani organ druge pogodbenice, drugo pogodbenico in zadevni organ obvesti o razlogih za nesprejetje dokumenta in lahko od zadevnega organa zahteva pojasnilo.
The authority shall endeavour to respond to the request for clarification in a timely manner and shall normally provide the clarification based on input from one or more members of the inspection team.
Zadevni organ si prizadeva pravočasno odgovoriti na zahtevo po pojasnilu in običajno zagotovi pojasnilo na podlagi informacij enega ali več članov inšpekcijske skupine.
A Party may accept official GMPs documents issued by a recognized authority of the other Party for manufacturing facilities located outside the territory of the issuing authority.
Pogodbenica lahko sprejme uradne dokumente o dobrih proizvodnih praksah, ki jih je izdal priznani organ druge pogodbenice za proizvodne obrate, ki niso na ozemlju organa izdajatelja.
Each Party may determine the terms and conditions under which it accepts official GMPs documents issued under paragraph 3.
Vsaka pogodbenica lahko določi pogoje, pod katerimi sprejme uradne dokumente o dobrih proizvodnih praksah, izdane na podlagi odstavka 3.
For purposes of this Annex, to accept an official GMPs document means to rely on the factual findings in such document.
Za namene te priloge sprejetje uradnega dokumenta o dobrih proizvodnih praksah pomeni zaupanje v ugotovitve o dejanskem stanju v takih dokumentih.
Batch testing
Preskušanje serije
In the EU, as provided in Article 51 paragraph 2 of Directive 2001/83/EC of the European Parliament and of the Council [1] and in Article 55 paragraph 2 of Directive 2001/82/EC of the European Parliament and of the Council [2], the qualified person will be relieved of responsibility for carrying out the controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC and in Article 55 paragraph 1 of Directive 2001/82/EC provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot.Article 10
Kot je določeno v členu 51(2) Direktive 2001/83/ES Evropskega parlamenta in Sveta [1] in členu 55(2) Direktive 2001/82/ES Evropskega parlamenta in Sveta [2], je v EU usposobljena oseba razbremenjena odgovornosti za izvedbo kontrol iz člena 51(1) Direktive 2001/83/ES in člena 55(1) Direktive 2001/82/ES, če so bile te kontrole izvedene v Združenih državah Amerike, če je bil proizvod proizveden v Združenih državah Amerike in če je vsaki seriji priloženo potrdilo o seriji (v skladu s sistemom Svetovne zdravstvene organizacije za potrjevanje kakovosti zdravil), ki ga je izdal proizvajalec, ki potrjuje, da proizvod izpolnjuje zahteve za dovoljenje za promet, in ki ga je podpisala oseba, odgovorna za sprostitev serije.Člen 10
Transmission of official GMPs documents
Pošiljanje uradnih dokumentov o dobrih proizvodnih praksah
If an importing Party requests a recognized authority of the other Party for a post-approval official GMPs document, the recognized authority shall transmit the document to the Party within 30 calendar days of the date of the request.
Če pogodbenica uvoznica od priznanega organa druge pogodbenice zahteva uradni dokument o dobrih proizvodnih praksah po odobritvi, ga priznani organ pogodbenici pošlje v 30. koledarskih dneh od dneva zahteve.
If, based on that document, the importing Party determines that a new inspection of the manufacturing facility is needed, the importing Party shall notify the relevant recognized authority of the other Party and request, in accordance with Article 11, the recognized authority of the other Party to conduct a new inspection.
Če pogodbenica uvoznica na podlagi navedenega dokumenta odloči, da je potreben nov inšpekcijski pregled proizvodnega obrata, pogodbenica uvoznica obvesti zadevni priznani organ druge pogodbenice in v skladu s členom 11 od priznanega organa druge pogodbenice zahteva izvedbo novega inšpekcijskega pregleda.
Requests for pre-approval and post-approval inspections
Zahteve za inšpekcijske preglede pred odobritvijo in po odobritvi
A Party or a recognized authority of a Party may request in writing that a recognized authority of the other Party conduct a pre-approval or post-approval inspection of a manufacturing facility.
Pogodbenica ali priznani organ pogodbenice lahko pisno zahteva, da priznani organ druge pogodbenice izvede inšpekcijski pregled proizvodnega obrata pred odobritvijo ali po odobritvi.
The request shall include the reason for the request and identify the precise issues to be addressed in the inspection and the requested timeline for completing the inspection and transmitting the official GMPs documents.
V zahtevi morajo biti navedeni razlogi za zahtevo in natančno opredeljena vprašanja, ki jih je treba obravnavati pri inšpekcijskem pregledu, ter določen zahtevani rok za dokončanje inšpekcijskega pregleda in pošiljanje uradnih dokumentov o dobrih proizvodnih praksah.
In the EU, requests shall be sent directly to the relevant recognized authority, with a copy to the European Medicines Agency (EMA).
V EU se zahteve pošljejo neposredno zadevnemu priznanemu organu, kopija pa Evropski agenciji za zdravila (EMA).
Within 15 calendar days of receipt of the request, the recognized authority shall acknowledge receipt and confirm whether it will conduct the inspection in accordance with the requested timelines.
Priznani organ v 15 koledarskih dneh od prejema zahteve potrdi prejem in navede, ali bo izvedel inšpekcijski pregled v skladu z zahtevanimi roki.
Where the authority receiving the request is of the opinion that official GMPs documents relevant to the request are already available or are pending, it should inform the requesting authority accordingly and share these documents upon request.
Kadar organ, ki prejme zahtevek, meni, da so uradni dokumenti o dobrih proizvodnih praksah iz zahteve že na voljo ali so v pripravi, bi moral o tem obvestiti organ, ki je poslal zahtevo, in mu te dokumente na zahtevo predložiti.
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.
Pojasniti je treba, da, če priznani organ navede, da ne bo izvedel inšpekcijskega pregleda, ima organ, ki je poslal zahtevo, pravico izvesti lasten inšpekcijski pregled proizvodnega obrata, organ, na katerega je bila zahteva naslovljena, pa ima pravico, da se inšpekcijskemu pregledu pridruži.
Maintenance
Vzdrževanje