natgillin/translations-raw huggingface dataset:
after the expiry of the 30 day period of time referred to in Article 6.1 or 6.2, the third-party conformity assessment body established in Canada continues to meet all the conditions described in Article 5.2.
partiisse kuuluvad tooted toodeti tootmisasutuses, millele samaväärne reguleeriv asutus on välja andnud vastavuse sertifikaadi;
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
partiisertifikaat on kooskõlas Partii sertifitseerimise rahvusvaheliselt ühtlustatud nõuetes ravimite partiisertifikaadile kehtestatud sisunõuetega; ning
The European Union shall assign an identification number to conformity assessment bodies established in Canada that are recognised under this Protocol, and shall list those conformity assessment bodies in the information system of the European Union, namely the New Approach Notified and Designated Organisations (‘NANDO’) or a successor system.
partiisertifikaadile on alla kirjutanud isik, kes vastutab partii müüki või tarnimiseks lubamise eest.
Accreditation of conformity assessment bodies
Lõige 1 ei mõjuta lepinguosalise õigust korraldada partii ametlikku kasutamiseks vabastamist.
The Parties recognise that a conformity assessment body should seek accreditation from an accreditation body that is in the territory in which the conformity assessment body is established, provided that that accreditation body has been recognised pursuant to Article 12 or 15 as able to grant the specific accreditation sought by the conformity assessment body.
Partii kasutamiseks vabastamise eest vastutav isik peab
If there is no accreditation body in the territory of a Party that is recognised pursuant to Article 12 or 15 as able to grant a specific accreditation sought by a conformity assessment body established in the territory of that Party, then:
Euroopa Liidus valmisravimi partii müümise või tootmisasutustele tarnimise puhul olema direktiivi 2001/83/EÜ artikli 48 ja direktiivi 2001/82/EÜ artikli 52 kohane asjatundja; või
each Party shall take such reasonable measures as may be available to it to ensure that accreditation bodies in its territory accredit conformity assessment bodies established in the territory of the other Party under conditions no less favourable than those applied to conformity assessment bodies established in its territory;
Kanadas ravimipartii müümise või tootmisasutustele tarnimise puhul olema dokumendi Food and Drugs Regulations (C.R.C., ptk 870, C osa, 2. jagu, jaotis C.02.014) kohane kvaliteedikontrolli osakonna eest vastutav isik.
a Party shall not adopt or maintain measures which limit the ability of accreditation bodies in its territory to accredit, or discourage those accreditation bodies from accrediting, on conditions no less favourable than those applied for the accreditation of conformity assessment bodies established in the recognising Party's territory, conformity assessment bodies established in the territory of the other Party;
Kohapealne hindamine
a Party shall not adopt or maintain measures requiring or encouraging accreditation bodies in its territory to apply conditions for the accreditation of conformity assessment bodies in the territory of the other Party that are less favourable than those applied for the accreditation of conformity assessment bodies in its territory.
Lepinguosalisel on õigus teise lepinguosalise samaväärse reguleeriva asutuse välja antud vastavuse sertifikaadi saanud tootmisasutust ise kohapeal hinnata.
Designation of conformity assessment bodies
Lepinguosaline teavitab enne lõike 1 kohast kohapealset hindamist teist lepinguosalist sellest kirjalikult ja annab teisele lepinguosalisele teada kohapealse hindamise ulatusest.
A Party shall designate a conformity assessment body by notifying the contact point of the other Party and sending to that contact point the information described in Annex 3.
Lepinguosaline annab endast parima, et teatada teisele lepinguosalisele kavandatud kohapealsest hindamisest kirjalikult vähemalt 30 päeva ette, kuid kiireloomulisuse korral võib etteteatamisaeg olla lühem.
The European Union shall allow Canada to use the European Union's electronic notification tool for those purposes.
Teisel lepinguosalisel on õigus lepinguosalise korraldatava kohapealse hindamisega ühineda.
Canada shall only designate a conformity assessment body that meets the following conditions and shall take reasonable measures to ensure that the conditions continue to be met:
Inspekteerimine ja kohapealne hindamine lepinguosalise taotlusel
the conformity assessment body meets the requirements set out in Article R17 of Annex I to Decision 768/2008/EC, or the corresponding requirements in successor instruments, except that establishment under national law is interpreted as meaning Canadian law for the purposes of this Protocol; and
Lepinguosalise taotlusel inspekteerib teine lepinguosaline taotleva lepinguosalise territooriumile imporditava ravimi tootmise protsessis osalevat asutust, et veenduda asutuse vastavuses headele tootmistavadele.
the conformity assessment body is accredited, by an accreditation body appointed by a Member State of the European Union, as competent to assess conformity with the European Union technical regulations for which the conformity assessment body is being designated; or
Lepinguosalise taotlusel võib teine lepinguosaline korraldada kohapealse hindamise toote kohta esitatud toimiku andmete põhjal.
the conformity assessment body is accredited, by an accreditation body established in Canada that is recognised pursuant to Articles 12 or 15, as competent to assess conformity with the European Union technical regulations for which the conformity assessment body is being designated.
Kohapealse hindamise taotluse korral võivad lepinguosalised vahetada asjakohast tooteteavet, kooskõlas artikliga 14.
The Parties shall deem the applicable requirements of Article R17 of Annex I to Decision 768/2008/EC to be met when the conformity assessment body is accredited pursuant to either procedure described in subparagraph 2(b) and if the accreditation body requires, as a condition for granting the accreditation, that the conformity assessment body meet requirements equivalent to the applicable requirements of Article R17 of Annex I to Decision 768/2008/EC or the corresponding requirements in successor instruments.
Kaitsemeetmed
If the European Union considers revising the requirements set out in Article R17 of Annex I to Decision 768/2008/EC, it shall consult Canada at the earliest stage of, and throughout, the review process with a view to ensuring that conformity assessment bodies in the territory of Canada continue to meet any revised requirements on no less favourable conditions than conformity assessment bodies in the territory of the European Union.
Lepinguosalisel on õigus teise lepinguosalise samaväärse reguleeriva asutuse välja antud vastavuse sertifikaadi saanud tootmisasutust ise inspekteerida.
A Member State of the European Union shall only designate a conformity assessment body that meets the following conditions and shall take reasonable measures to ensure that the conditions continue to be met:
Selle õiguse kasutamine ei tohiks olla lepinguosalise tavapraktika, vaid erand.
the conformity assessment body is established in the territory of the Member State; and
Lepinguosaline teavitab enne lõike 1 kohast inspekteerimist teist lepinguosalist sellest kirjalikult ning teatab teisele lepinguosalisele ka ise inspekteerima asumise põhjused.
the conformity assessment body is accredited, by an accreditation body recognised by Canada, as competent to assess conformity with the Canadian technical regulations for which the conformity assessment body is being designated; or
Lepinguosaline annab endast parima, et teatada teisele lepinguosalisele kavandatud kohapealsest inspekteerimisest kirjalikult vähemalt 30 päeva ette, kuid kiireloomulisuse korral võib etteteatamisaeg olla lühem.
the conformity assessment body is accredited, by an accreditation body established in the European Union that has been recognised pursuant to Article 12 or 15, as competent to assess conformity with the Canadian technical regulations for which the conformity assessment body is being designated.
Teisel lepinguosalisel on õigus lepinguosalise korraldatava inspekteerimisega ühineda.
A Party may refuse to recognise a conformity assessment body that does not meet the conditions in paragraph 2 or 5, as the case may be.
Kahesuunaline hoiatusteadete programm ja teabe jagamine
Objections to the designation of conformity assessment bodies
Lepinguosaline peab heade tootmistavade kohta artikli 15.3 kohaselt sõlmitud halduskokkulepe kohase kahesuunalise hoiatusteadete programmi raames
A Party may object to the designation of a conformity assessment body, within 30 days of the notification by the other Party pursuant to Article 5.1, if:
tagama, et tema territooriumi asjaomane reguleeriv asutus teatab teise lepinguosalise territooriumil asuvale reguleerivale asutusele rahvatervise kaitset mõjutada võivast tootmisloa piiramisest, peatamisest või tagasivõtmisest; ning
the Party which designated the conformity assessment body failed to provide the information described in Annex 3; or
kui see on asjakohane, teatama proaktiivselt teisele lepinguosalisele kirjalikult oma territooriumil asuva tootmisasutusega seotud tõsist probleemi käsitlevast kinnitatud aruandest või teise lepinguosalise territooriumil korraldatud kohapealsel hindamisel või inspekteerimisel tuvastatud tõsisest probleemist, sh probleemist, mis on seotud kvaliteedidefektidega, partiide tagasikutsumisega, järeletehtud või võltsitud ravimitega, või võimalikest tõsistest puudujääkidest.
the Party has reasons to believe that the conformity assessment body that is designated does not meet the conditions described in Article 5.2 or 5.5.
Lepinguosaline peab heade tootmistavade kohta artikli 15.3 kohaselt sõlmitud halduskokkulepe kohase teabejagamisprotsessi komponentide osana
Following any subsequent transmission of information by the other Party, a Party may object within 30 days of the receipt of that information, if the information remains insufficient to demonstrate that the designated conformity assessment body meets the conditions described in Article 5.2 or 5.5.
vastama erakorralisele teabepäringule, sh põhjendatud taotlusele inspekteerimisaruande või kohapealse hindamise aruande saamiseks; ning
Challenges to designations of conformity assessment bodies
tagama, et tema territooriumil asuv samaväärne asutus esitab teise lepinguosalise taotluse või teise lepinguosalise samaväärse asutuse taotluse peale asjakohase teabe.
A Party which has recognised a conformity assessment body under this Protocol may challenge the competence of that conformity assessment body if:
Lepinguosaline teatab teisele lepinguosalisele kirja teel kõikide tema territooriumil asuvate samaväärsete asutuste kontaktpunktid.
the Party which designated the conformity assessment body failed to take the actions required by Article 11.3, following a notification by the other Party of the non-conformity with applicable technical regulations of a product that had been assessed as being in conformity with these technical regulations by that conformity assessment body; or
Uute reguleerivate asutuse samaväärsus
the Party has reasons to believe that the results of conformity assessment activities performed by that conformity assessment body do not provide sufficient assurances that the products assessed by that body as conforming with applicable technical regulations are in fact in conformity with these technical regulations.
Lepinguosaline („taotlev lepinguosaline“) võib taotleda hindamist, millega teha kindlaks, kas tema territooriumil asuvat ja seni teise lepinguosalise („hindav lepinguosaline“) reguleerivate asutustega samaväärsena tunnustamata reguleerivat asutust tuleks tunnustada samaväärsena.
A Party which challenges the competence of a recognised conformity assessment body under this Protocol shall immediately notify the Party which designated the conformity assessment body of the challenge, and provide the reasons for the challenge.
Pärast taotluse saamist korraldab hindav lepinguosaline hindamise kooskõlas uute reguleerivate asutuste hindamise korraga, mis on ette nähtud heade tootmistavade kohta artikli 15.3 kohaselt sõlmitud halduskokkulepe raames.
A Party that:
Hindav lepinguosaline hindab uut reguleerivat asutust, kohaldades selleks artikli 15.3 kohase halduskokkulepe raames sätestatud headele tootmistavadele vastavuse programmi komponente.
has challenged the competence of a recognised conformity assessment body under this Protocol; and
Headele tootmistavadele vastavuse programmi komponentide hulka peavad kuuluma sellised elemendid nagu õiguslikud ja regulatiivsed nõuded, inspekteerimisstandardid, järelevalvesüsteemid ja kvaliteedijuhtimissüsteem.
has well-founded reasons to believe that the products assessed to be in conformity with applicable technical regulations by that conformity assessment body may fail to conform to its technical regulations,
Kui hindav lepinguosaline leiab pärast hindamise lõpuleviimist, et uus reguleeriv asutus on samaväärne, siis annab ta taotlevale lepinguosalisele kirjalikult teada, et tunnustab uut reguleerivat asutust samaväärsena.
may refuse to accept the results of that conformity assessment body's conformity assessment activities until the challenge is resolved or the recognising Party has ceased to recognise the conformity assessment body in accordance with paragraph 5.
Kui hindav lepinguosaline leiab pärast hindamise lõpuleviimist, et uus reguleeriv asutus ei ole samaväärne, siis esitab hindav lepinguosaline taotlevale lepinguosalisele kirjaliku põhjenduse, millest nähtub, et uue regulatiivse asutuse samaväärsena tunnustamata jätmine on põhjendatud.
The Parties shall cooperate and make reasonable efforts to resolve the challenge promptly.
Taotleva lepinguosalise taotlusel kaalub artiklis 15 osutatud ravimite valdkondlik ühiskomitee (edaspidi „valdkondlik ühiskomitee“) hindava lepinguosalise keeldumist uut reguleerivat asutust samaväärsena tunnustada ning võib esitada soovitusi, et aidata mõlemat lepinguosalist lahenduse leidmisel.
Without prejudice to paragraph 3, the recognising Party may cease to recognise the conformity assessment body whose competence is challenged if:
Kui hindav lepinguosaline leiab pärast hindamise lõpuleviimist, et uus reguleeriv asutus on samaväärne piiratumas ulatuses kui taotleva lepinguosalise poolt kavandatud, siis esitab hindav lepinguosaline taotlevale lepinguosalisele kirjaliku põhjenduse, millest nähtub, et uue reguleeriva asutuse samaväärsus piiratumas ulatuses on põhjendatud.
the Parties resolve the challenge by concluding that the recognising Party has raised valid concerns as to the competence of the conformity assessment body;
Taotleva lepinguosalise taotlusel kaalub valdkondlik ühiskomitee hindava lepinguosalise keeldumist uut reguleerivat asutust samaväärsena tunnustada ning võib esitada soovitusi, et aidata mõlemat lepinguosalist lahenduse leidmisel.
the Party which designated the conformity assessment body failed to complete the actions required by Article 11.3 within 60 days after being notified pursuant to subparagraph 1(a); or
Londonis 14. mail 1998 sõlmitud Euroopa Ühenduse ja Kanada vahelise vastastikuse tunnustamise lepingu kohaselt samaväärsena tunnustatud reguleerivat asutust tunnustatakse käesoleva lepingu kohaselt samaväärsena alates selle jõustumisest.
the recognising Party objectively demonstrates to the other Party that the results of conformity assessment activities performed by that conformity assessment body do not provide sufficient assurance that the products assessed by it as conforming with the applicable technical regulations are in fact in conformity with these technical regulations; and
Samaväärsuse säilitamise programm
the challenge has not been resolved within 120 days after the Party that had designated the conformity assessment body has been notified of the challenge pursuant to paragraph 1.
Valdkondlik ühiskomitee töötab heade tootmistavade kohta artikli 15.3 kohaselt sõlmitud halduskokkulepe raames reguleerivate asutuste samaväärsuse säilitamiseks välja samaväärsuse säilitamise programmi.
Withdrawals of conformity assessment bodies
Lepinguosalised peavad reguleeriva asutuse samaväärsuse staatuse muutmise üle otsustamisel lähtuma sellest programmist.
A Party shall withdraw the designation, or modify the scope of the designation, as appropriate, of a conformity assessment body it has designated if the Party becomes aware that:
Kui reguleeriva asutuse samaväärsuse staatus muutub, võib lepinguosaline seda reguleerivat asutust uuesti hinnata.
the conformity assessment body's scope of accreditation has been reduced;
Uuesti hindamine peab alati toimuma artiklis 12 sätestatud korras.
the conformity assessment body's accreditation lapses;
Uuesti hindamise ulatus piirdub üksnes nende elementide hindamisega, mille tõttu samaväärsuse staatus muutus.
the conformity assessment body no longer meets the other conditions described in Article 5.2 or 5.5; or
Lepinguosalised vahetavad kogu vajalikku teavet, et tagada mõlema lepinguosalise jätkuv kindlus selles suhtes, et samaväärsed reguleerivad asutused on tegelikult samaväärsed.
the conformity assessment body is no longer willing, or is otherwise no longer competent or able, to assess conformity within the scope for which it was designated.
Lepinguosaline teavitab teist lepinguosalist enne oma tehnilistesse suunistesse või eeskirjadesse heade tootmistavadega seotud muudatuste tegemist.
A Party shall notify the other Party, in writing, of a withdrawal or modification of the scope of a designation under paragraph 1.
Lepinguosaline teavitab teist lepinguosalist kõikidest heade tootmistavadega seotud uutest tehnilistest suunistest, inspekteerimismenetlustest ja eeskirjadest.
When a Party withdraws the designation or modifies the scope of the designation of a conformity assessment body owing to concerns about the competence or the continued fulfilment by that conformity assessment body of the requirements and responsibilities to which it is subject under Article 5, it shall communicate the reasons for its decision in writing to the other Party.
Lepinguosaline ei avalikusta teiselt lepinguosaliselt saadud avaldamisele mittekuuluvat ja konfidentsiaalset tehnilist, kaubanduslikku ja teaduslikku teavet, sh ärisaladusi ja ärisaladusena käsitletavat teavet.
When communicating with the other Party, a Party shall indicate the date as of which it considers that any of the conditions or concerns enumerated under paragraphs 1 or 3 may have applied to the conformity assessment body.
Lepinguosaline võib avaldada lõikes 1 nimetatud teavet juhul, kui peab sellist avaldamist vajalikuks rahvatervise ja ohutuse kaitsmiseks.
Without prejudice to Article 7.5, the recognising Party may immediately cease to recognise a conformity assessment body as competent if:
Enne avaldamist tuleb teise lepinguosalisega nõu pidada.
the conformity assessment body voluntarily withdraws its recognition;
Protokolli haldamine
the designation of the conformity assessment body is withdrawn pursuant to this Article;
Artikli 26.2 lõike 1 punkti a alusel asutatav valdkondlik ühiskomitee (ühiskomitee) moodustatakse mõlema lepinguosalise esindajatest.
the conformity assessment body ceases to be established in the territory of the other Party; or
Valdkondlik ühiskomitee määrab oma koosseisu ja töökorra.
the recognising Party ceases to recognise the accreditation body that accredited the conformity assessment body pursuant to Article 13 or 14.
Valdkondlik ühiskomitee sõlmib käesoleva protokolli rakendamise hõlbustamiseks heade tootmistavade halduskokkulepe.
Acceptance of the results of conformity assessment by recognised conformity assessment bodies
Heade tootmistavade halduskokkulepe peab sisaldama järgmist:
A Party shall accept the results of conformity assessment activities performed by conformity assessment bodies established in the other Party's territory which the Party recognises in accordance with Article 3 under conditions no less favourable than those applied to the results of conformity assessment activities performed by recognised conformity assessment bodies in its territory.
valdkondliku ühiskomitee pädevus;
The Party shall accept these results regardless of the nationality and location of the supplier or manufacturer, or of the country of origin of the product for which the conformity assessment activities are performed.
kahesuunaline hoiatusteadete programm;
If a Party has ceased to recognise a conformity assessment body established in the territory of the other Party, it may cease to accept the results of conformity assessment activities performed by that conformity assessment body from the date when it ceased to recognise that conformity assessment body.
käesoleva protokolli rakendamisel tekkivate küsimuste eest vastutavate kontaktpunktide nimekiri;
Unless the Party has reasons to believe that the conformity assessment body established in the territory of the other Party was not competent to assess conformity of products with the technical regulations of the Party prior to the date when the Party ceased to recognise that conformity assessment body, the Party shall continue to accept the results of conformity assessment activities performed by that conformity assessment body prior to the date when the Party ceased to recognise the conformity assessment body, even though the products may have been placed on the market of the Party after that date.
teabejagamisprotsessi komponendid;
Acceptance of results of conformity assessment by in-house bodies established in Canada
headele tootmistavadele vastavuse programmi komponendid;
The European Union shall accept the results of conformity assessment activities performed by an accredited in-house body established in Canada under conditions no less favourable than those applied to the results of conformity assessment activities performed by an accredited in-house body established in the territory of one of the Member States of the European Union, provided that:
uute reguleerivate asutuste hindamise kord ning
the in-house body established in Canada is accredited, by an accreditation body that has been appointed by one of the Member States of the European Union, as competent to assess conformity with those technical regulations; or
samaväärsuse säilitamise programm.
the in-house body established in Canada is accredited, by an accreditation body that has been recognised pursuant to Article 12 or 15 as competent to assess conformity with those technical regulations.
Kui valdkondlik ühiskomitee seda vajalikuks peab, võib ta heade tootmistavade halduskokkulepet muuta.
If, at the date of entry into force of this Agreement, Canada has no conformity assessment procedure providing for conformity assessment activities to be performed by in-house bodies and after the date of entry into force of this Agreement, Canada considers developing conformity assessment procedures providing for conformity assessment activities to be performed by in-house bodies, it shall consult the European Union at the earliest stage of, and throughout the rule-making process with a view to ensuring that in-house bodies established in the European Union can meet any requirements laid down in those provisions on no less favourable conditions than in-house bodies established in Canada.
Lepinguosaliste taotlusel vaatab valdkondlik ühiskomitee käesoleva protokolli lisad uuesti läbi ning töötab välja laiaulatusliku majandus- ja kaubanduslepingu (CETA) ühiskomiteele esitatavad soovitused nende lisade muutmiseks.
Results pursuant to paragraphs 1 and 2 shall be accepted regardless of the country of origin of the product for which the conformity assessment activities were performed.
Kooskõlas lõikega 5 vaatab valdkondlik ühiskomitee uuesti läbi 1. lisa punkti 2 alla kuuluvate ravimite tegevusliku kohaldamisala, et kaaluda 1. lisa punktis 1 loetletud ravimite lisamist.
Market surveillance, enforcement and safeguards
Lepinguosalised kehtestavad tootmistavade halduskokkuleppe lepingu jõustumisel.