natgillin/translations-raw huggingface dataset:
Forbehold I-C-17
The objective of this Protocol is to strengthen the cooperation between the authorities of the Parties in ensuring that medicinal products and drugs meet appropriate quality standards through the mutual recognition of certificates of GMP compliance.
Disse aftaler kan kræve, at projektejerne skal forestå og udføre bestemt arbejde i Canada og Newfoundland samt gøre deres yderste for at opnå specifikke canadiske og newfoundlandske målsætningsniveauer i forbindelse med bestemmelserne i en »nytteplan«, som kræves i henhold til Canada-Newfoundland Atlantic Accord Implementation Act. »Nytteplaner« beskrives yderligere i Canadas forbehold I-C-16.
Product scope
Endvidere kan Canada i forbindelse med Hibernia-projektet pålægge et krav eller håndhæve en forpligtelse eller et tilsagn med hensyn til overdragelse af teknologi, en produktionsproces eller anden ejendomsretligt beskyttet viden til en statsborger eller et foretagende i Canada.
This Protocol applies to all medicinal products or drugs to which GMP requirements apply in both Parties, as set out in Annex 1.
Forbehold I-C-18
Recognition of regulatory authorities
Uranminer
The procedure for evaluating the equivalency of a new regulatory authority listed in Annex 2 shall be conducted in accordance with Article 12.
Undtagelser fra Non-Resident Ownership Policy in the Uranium Mining Sector tillades efter godkendelse fra guvernøren i rådet og kun i tilfælde, hvor canadiske deltagere i ejerskabet af ejendommen ikke er til stede.
Each Party shall ensure that a list of regulatory authorities that it recognises as equivalent, including any modifications, is publicly available.
Investeringer i ejendomme, der er foretaget af ikke-canadiere før 23. december 1987, og som ligger over det tilladte ejeskabsniveau, kan fortsat være gyldige.
Mutual recognition of certificates of GMP compliance
En forøgelse af ikke-canadisk ejerskab er ikke tilladt.
A Party shall accept a certificate of GMP compliance issued by an equivalent regulatory authority of the other Party, in conformity with paragraph 3, as demonstrating that the manufacturing facility, that is covered by the certificate and located in the territory of either Party, complies with the good manufacturing practices identified in the certificate.
Når en anmodning fra en investor i Den Europæiske Union om en undtagelse fra politikken tages i betragtning, vil Canada ikke kræve godtgørelse af, at der ikke kan findes en canadisk partner.
A Party may accept a certificate of GMP compliance issued by an equivalent regulatory authority of the other Party with respect to a manufacturing facility outside the territory of the Parties, in conformity with paragraph 3.
Forbehold I-C-19
A Party may determine the terms and conditions upon which it chooses to accept the certificate.
Revision
A certificate of GMP compliance must identify:
Banker skal have et revisionsfirma til at være revisorer for banken.
the name and address of the manufacturing facility;
Et revisionsfirma skal være kvalificeret som anført i Bank Act.
the date on which the equivalent regulatory authority that issued the certificate last inspected the manufacturing facility;
Blandt de krævede kvalifikationer er, at to eller flere medlemmer af firmaet skal have sædvanligt opholdssted i Canada, og at det medlem af firmaet, der af firmaet og banken i fællesskab er udpeget til at udføre revisionen, skal have sædvanligt opholdssted i Canada.
the manufacturing processes and if relevant, medicinal products or drugs and dosage forms for which the facility is in compliance with good manufacturing practices; and
Et forsikringsselskab, et andelskreditinstitut og et investerings- eller låneselskab kræver en revisor, som enten kan være en fysisk person eller et revisionsfirma.
the validity period of the certificate of GMP compliance.
En revisor for en sådan institution skal være kvalificeret som anført i Insurance Companies Act, Cooperative Credit Associations Act eller Trust and Loan Companies Act.
If an importer, an exporter or a regulatory authority of a Party requests a certificate of GMP compliance for a manufacturing facility that is certified by an equivalent authority of the other Party, the other Party shall ensure that the equivalent regulatory authority issues a certificate of GMP compliance:
Hvis en fysisk person udpeges til at være revisor for en sådan finansiel institution, kræves der blandt kvalifikationerne, at den person skal have sædvanligt opholdssted i Canada.
within 30 calendar days of the date on which the certifying authority received the request for the certificate, if a new inspection is not required; and
Hvis et revisionsfirma udpeges til at være revisor for en sådan finansiel institution, skal det medlem af firmaet, der af firmaet og den finansielle institution i fællesskab er udpeget til at udføre revisionen, have sædvanligt opholdssted i Canada.
within 90 calendar days of the date on which the certifying authority received the request for the certificate, if a new inspection is required, and the manufacturing facility passes the inspection.
Forbehold I-C-20
Other recognition of certificates of GMP compliance
Lufttransporttjenester (passagerer og gods)
A Party may accept a certificate of GMP compliance with respect to a medicinal product or drug that is not included in paragraph 2 of Annex 1.
»Specialluftfartstjenester« (som anført under elementet Beskrivelse nedenfor)
A Party that accepts a certificate under paragraph 1 may determine the terms and conditions under which it will accept the certificate.
Kurervirksomhed
Acceptance of batch certificates
CPC 73, 7512, »specialluftfartstjenester« (som beskrevet i elementet Beskrivelse nedenfor)
A Party shall accept a batch certificate issued by a manufacturer without re-control of that batch at import provided that:
Øverste ledelse og bestyrelse
the products in the batch were manufactured in a manufacturing facility that has been certified as compliant by an equivalent regulatory authority;
Part II, Subpart 2 — »Aircraft Markings and Registration«;
the batch certificate is consistent with the Content of the Batch Certificate for Medicinal Products of the Internationally Harmonized Requirements for Batch Certification; and
Part IV »Personnel Licensing and Training«;
the batch certificate is signed by the person responsible for releasing the batch for sale or supply.
Part VII »Commercial Air Services«
Paragraph 1 does not affect a Party's right to conduct official batch release.
1.
The person responsible for releasing the batch:
Afsnit 55 i Canada Transportation Act definerer »canadier/canadisk« på følgende måde:
of the finished medicinal product for sale or supply for manufacturing facilities in the European Union, must be a ‘qualified person’ as defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC; or
»...« canadier/canadisk»: en canadisk statsborger eller en person med permanent ophold i henhold til afsnit 2, stk. 1, i Immigration and Refugee Protection Act, en regering i Canada eller en styrelse under en sådan regering eller et selskab eller en anden enhed, der er stiftet eller oprettet i henhold til lovene i Canada eller en provins, og som reelt er kontrolleret af canadiere, og i hvilke mindst femoghalvfjerds procent eller en mindre procentdel, som guvernøren i rådet kan fastsætte ved forskrifter, af stemmerettighederne ejes og kontrolleres af canadiere...«.
for sale or supply of a drug for manufacturing facilities in Canada, is the person in charge of the quality control department as provided for by the Food and Drugs Regulations, C.R.C., c.
Kun canadiere må levere følgende kommercielle lufttransporttjenester:
870, Part C, Division 2, section C.02.014.
indenlandske tjenester (luftfartstjenester mellem punkter eller fra og til samme punkt på canadisk område eller mellem et punkt på canadisk område og et punkt, der ikke befinder sig på et andet lands territorium)
On-site evaluation
planlagte internationale tjenester (planlagte luftfartstjenester mellem et punkt på canadisk område og et punkt på et andet lands område), hvis disse tjenester er forbeholdt canadiske transportvirksomheder i henhold til nuværende og fremtidige aftaler om luftfartstjenester
A Party has the right to conduct its own on-site evaluation of a manufacturing facility that has been certified as compliant by an equivalent regulatory authority of the other Party.
ikke-planlagte internationale tjenester (ikke-planlagte luftfartstjenester mellem et punkt på Canadas territorium og et punkt på et andet lands territorium), hvis disse tjenester er forbeholdt canadiske transportvirksomheder i henhold til Canada Transportation Act;
A Party, prior to conducting an on-site evaluation under paragraph 1, shall notify the other Party in writing and inform that other Party of the scope of the on-site evaluation.
specialluftfartstjenester, herunder kortlægning fra luften, opmåling fra luften, luftfotografering, skovbrandsforvaltning, brandbekæmpelse, luftreklame, slæbning af svævefly, fladskærmsudspring, byggeri fra luften, skovning med helikopter, inspektion fra luften, overvågning fra luften, flyvetræning, rundtur fra luften og sprøjtning fra luften.
The Party shall endeavour to notify the other Party in writing at least 30 days before a proposed on-site evaluation, but may provide less notice in urgent situations.
Ingen udenlandsk person er kvalificeret til at blive registreret ejer af et canadisk registreret luftfartøj.
The other Party has the right to join the on-site evaluation conducted by the Party.
Ud over Canadian Aviation Regulations må et selskab, der er stiftet i Canada, men som ikke opfylder kravene for canadisk ejerskab og kontrol, kun registrere et luftfartøj til privat anvendelse, når en væsentlig hoveddel af luftfartøjets anvendelse (mindst 60 procent) finder sted i Canada.
Inspections and on-site evaluations at the request of a Party
Canadian Aviation Regulations har også den virkning at begrænse udenlandsk registrerede private luftfartøjer, der er registreret til ikke-canadiske selskaber, til højst at måtte befinde sig i Canada i 90 dage for hver periode på tolv måneder.
At the request of a Party, the other Party shall inspect a facility involved in the manufacturing process of a medicinal product or drug that is being imported into the territory of the requesting Party in order to verify that the facility is in compliance with good manufacturing practices.
Et udenlandsk registreret privat luftfartøj skal begrænses til privat anvendelse, ligesom det ville være tilfældet for canadisk registrerede luftfartøjer, der kræver et privat luftfartscertifikat.
At the request of a Party, the other Party may conduct an on-site evaluation based on the assessment of data contained in a product submission dossier.
Forbehold I-C-21
The Parties may exchange relevant product information with respect to a request to conduct an on-site evaluation in accordance with Article 14.
Reparation og vedligeholdelse af luftfartøjer
Safeguards
Groundhandling (kun linjevedligeholdelse) som defineret i kapitlerne om grænseoverskridende handel med tjenesteydelser og investering
A Party has the right to conduct its own inspection of a manufacturing facility that has been certified as compliant by an equivalent regulatory authority of the other Party.
»Reparation og vedligeholdelse af luftfartøjer« og »groundhandling« (kun linjevedligeholdelse) som defineret i artikel 8.1 (definitioner) og artikel 9.1 (definitioner)
Recourse to this right should be an exception from the normal practice of the Party.
Part IV »Personnel Licensing and Training«;
A Party, prior to conducting an inspection under paragraph 1, shall notify the other Party in writing and shall inform the other Party of the reasons for conducting its own inspection.
Part V »Airworthiness«;
The Party shall endeavour to notify the other Party in writing at least 30 days before a proposed inspection, but may provide less notice in urgent situations.
Part VI »General Operating and Flight Rules«;
The other Party has the right to join the inspection conducted by the Party.
Reparation af luftfartøjer og andre luftfartsprodukter, eftersyn eller vedligeholdelsesaktiviteter (herunder linjevedligeholdelse), som er nødvendig med henblik på at opretholde luftdygtigheden for canadisk registrerede luftfartøjer og andre luftfartsprodukter, skal udføres af personer, der opfylder canadiske myndighedskrav for luftfart (dvs. godkendte vedligeholdelsesorganisationer og vedligeholdelsesteknikere inden for luftfartøjer).
Two-way alert programme and information sharing
Der gives ikke certificeringer til personer, der har hjemsted uden for Canada, undtagen i forbindelse med underorganisationer af godkendte vedligeholdelsesorganisationer, som har hjemsted i Canada.
A Party shall, pursuant to the two-way alert programme under the GMP Administrative Arrangement referred to in Article 15.3:
Forbehold I-C-22
ensure that a restriction, suspension or withdrawal of a manufacturing authorisation that could affect the protection of public health is communicated from the relevant regulatory authority in its territory to the relevant regulatory authority in the territory of the other Party; and
Planlagt og ikke-planlagt passagerbefordring og godstransport ad vej, herunder kurertjenester.
if relevant, proactively notify the other Party in writing of a confirmed report of a serious problem relating to a manufacturing facility in its territory, or as identified through an on-site evaluation or inspection in the territory of the other Party, including a problem related to quality defects, batch recalls, counterfeited or falsified medicinal products or drugs, or potential serious shortages.
1985, kap. 29 (3rd Supp.), som ændret ved S.C.
A Party shall, as part of the components of the information sharing process under the GMP Administrative Arrangement referred to in Article 15.3:
2001, kap. 13.
respond to a special request for information, including a reasonable request for an inspection report or an on-site evaluation report; and
Kun personer fra Canada, der anvender canadisk registrerede og enten canadisk byggede eller afgiftsbetalte lastbiler eller busser, må levere lastbil- eller bustjenester mellem punkter på canadisk område.
ensure that, at the request of the other Party or of an equivalent authority of the other Party, an equivalent authority within its territory provides relevant information.
Forbehold I-C-23
A Party shall provide the other Party, through written notification, contact points for each equivalent authority in its territory.
Transporttjenester ad vandveje (passagerer og gods) med søgående og ikke-søgående fartøjer
Equivalence of new regulatory authorities
Støttetjenesteydelser og andre tjenesteydelser i forbindelse med søtransport
A Party (‘requesting Party’) may request that a regulatory authority in its territory that is not recognised as equivalent to regulatory authorities in the other Party (‘evaluating Party’), be evaluated to determine whether it should be recognised as equivalent.
Anlæg af sejlløb, havne, dæmninger og andre vandbygningsværker
Upon receiving the request, the evaluating Party shall conduct an evaluation pursuant to the procedure for evaluating new regulatory authorities under the GMP Administrative Arrangement referred to in Article 15.3.
Enhver anden kommerciel havaktivitet, der udføres fra et fartøj
The evaluating Party shall evaluate the new regulatory authority by applying the components of a GMP compliance programme under the Administrative Arrangement referred to in Article 15.3.
CPC 721, 722, 745, 5133, 5223 og enhver anden kommerciel havaktivitet, der udføres fra et fartøj
The components of a GMP compliance programme must include such elements as legislative and regulatory requirements, inspections standards, surveillance systems and a quality management system.
Investeringer, grænseoverskridende handel med tjenesteydelser og internationale søtransporttjenesteydelser
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is equivalent, it shall notify the requesting Party in writing that it recognises the new regulatory authority as equivalent.
For at registrere et fartøj i Canada skal ejeren af det fartøj eller den person, der har enerådighed over det fartøj, være:
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is not equivalent, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons for not recognising that the new regulatory authority is equivalent.
canadisk statsborger eller en person med permanent ophold i den i afsnit 2, stk. 1, i Immigration and Refugee Protection Act fastlagte betydning
At the request of the requesting Party, the Joint Sectoral Group on Pharmaceuticals (‘Joint Sectoral Group’) referred to in Article 15 shall consider the evaluating Party's refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter.
et selskab, der er stiftet i henhold til Canadisk ret eller en provins eller et territorium, eller
If, upon completion of its evaluation, the evaluating Party determines that the new regulatory authority is only equivalent for a more limited scope than that proposed by the requesting Party, the evaluating Party shall provide to the requesting Party a written justification demonstrating that it has well-founded reasons to determine that the new regulatory authority is only equivalent for the more limited scope.
såfremt fartøjet ikke allerede er registreret i et andet land, et selskab, der er stiftet i henhold til lovene i et andet land end Canada, hvis en af følgende aktører handler med hensyn til alle anliggender i forbindelse med fartøjet, dvs.:
At the request of the requesting Party, the Joint Sectoral Group shall consider the evaluating Party's refusal to recognise the new regulatory authority as equivalent, and may provide recommendations to assist both Parties to resolve the matter.
et datterselskab af det selskab, som er stiftet i henhold til loven i Canada eller en provins eller et territorium
A regulatory authority recognised as equivalent under the Agreement on Mutual Recognition Between the European Community and Canada, done at London on 14 May 1998, is recognised as equivalent under this Agreement from its entry into force.
en ansat eller et bestyrelsesmedlem i Canada i enhver filial af det selskab, der driver virksomhed i Canada, eller
Equivalence maintenance programme
et skibsadministrationsselskab, der er stiftet i henhold til loven i Canada eller en provins eller et territorium.
The Joint Sectoral Group shall develop an equivalence maintenance programme under the GMP Administrative Arrangement referred to in Article 15.3 to maintain the equivalence of the regulatory authorities.
Et fartøj, der er registreret i et fremmed land, og som er blevet totalbefragtet, kan indskrives i Canada under befragtningens varighed, mens fartøjets registrering suspenderes i dets registreringsland, hvis befragteren er:
The Parties shall act in accordance with this programme when deciding whether to change the equivalence status of a regulatory authority.
canadisk statsborger eller en person med permanent ophold, som defineret i afsnit 2, stk. 1, i Immigration and Refugee Protection Act, eller
If the equivalence status of a regulatory authority changes, a Party may re-evaluate that regulatory authority.
et selskab, der er stiftet i henhold til loven i Canada eller en provins eller et territorium.
Any re-evaluation must be undertaken pursuant to the procedure set out in Article 12.
Forbehold I-C-24
The scope of re-evaluation shall be limited to the elements that caused the change of the equivalence status.
Grænseoverskridende handel med tjenesteydelser og internationale søtransportydelser
The Parties shall exchange all the necessary information to ensure that both Parties remain confident that equivalent regulatory authorities are in fact equivalent.
Fartøjsførere, styrmænd, maskinmestre og visse andre søfarende skal være indehavere af et certifikat, der udstedes af transportministeren, som et krav for tjeneste på canadisk registrerede fartøjer.
A Party shall inform the other Party before adopting changes to its technical guidance or regulations relating to good manufacturing practices.
Disse certifikater kan kun udstedes til canadiske statsborgere eller personer med permanent ophold.
A Party shall inform the other Party of any new technical guidance, inspection procedures or regulations relating to good manufacturing practices.
Forbehold I-C-25
A Party shall not publicly disclose non-public and confidential technical, commercial or scientific information, including trade secrets and proprietary information that it has received from the other Party.
Lodsning og anløbstjenester
A Party may disclose the information referred to in paragraph 1 if it deems such disclosure necessary to protect public health and safety.
I henhold til Canadas forbehold II-C-15 kræves der en bevilling eller et lodscertifikat, der udstedes af den pågældende regionale lodsmyndighed, for at kunne levere lodstjenester i de lodspligtige farvande på canadisk territorium.
The other Party shall be consulted prior to disclosure.
Kun en canadisk statsborger eller en person med permanent ophold kan opnå en bevilling eller et lodscertifikat.
Management of the Protocol
En person med permanent ophold i Canada, som har fået udstedt en lodsbevilling eller et lodscertifikat, skal blive canadisk statsborger inden for fem år efter modtagelse af den bevilling eller det lodscertifikat for at beholde den eller det.
The Joint Sectoral Group, established under Article 26.2.1(a) (Specialised committees), is composed of representatives from both Parties.
Forbehold I-C-26
The Joint Sectoral Group shall establish its composition and determine its rules and procedures.
Transporttjenester med søgående og ikke-søgående fartøjer
The Joint Sectoral Group shall conclude a GMP Administrative Arrangement to facilitate the effective implementation of this Protocol.
Forbuddene i henhold til Coasting Trade Act, som er anført i Canadas forbehold II-C-14, gælder ikke for noget fartøj, der ejes af regeringen i Amerikas Forenede Stater, når det udelukkende anvendes med det formål at transportere varer, som ejes af regeringen i Amerikas Forenede Stater, fra canadisk territorium med henblik på at forsyne lokaliteter i systemet for tidlig fjernvarsling (DEW).
The GMP Administrative Arrangement shall include:
Forbehold I-C-27
the terms of references of the Joint Sectoral Group;
Planlagt eller ikke-planlagt passagerbefordring ad vej
the two-way alert programme;
1985, kap. 29 (3rd Supp.), som ændret ved S.C.
the list of contact points responsible for matters arising under this Protocol;
2001, kap. 13
the components of the information sharing process;
Provinsstyrelser har fået overdraget beføjelse til at give personer tilladelse til at levere ekstraprovinsielle (mellem provinser og grænseoverskridende) bustjenester i deres pågældende provinser og territorier på samme grundlag som lokale bustjenester.
the components of a good manufacturing practices compliance programme;
Forbehold I-C-28
the equivalence maintenance programme.
Alle transportdelsektorer
The Joint Sectoral Group may modify the GMP Administrative Arrangement if it considers it necessary.
I henhold til Canada Transportation Act kræver enhver foreslået udførelse, som indbefatter et transportmæssigt forehavende, der rejser spørgsmål med hensyn til offentlig interesse, eftersom det vedrører national transport som fastslagt af ministeren, godkendelse af guvernøren i rådet.
At the request of the Parties, the Joint Sectoral Group shall review the Annexes to this Protocol, and shall develop recommendations for amendments to these Annexes for consideration by the CETA Joint Committee.
Forbehold I-C-29
Pursuant to paragraph 5, the Joint Sectoral Group shall review the operational scope of medicinal products or drugs under paragraph 2 of Annex 1, with a view to including those medicinal products or drugs listed in paragraph 1 of Annex 1.
Posttjenester, posttransport med enhver transportform.
The Parties shall establish the GMP Administrative Arrangement upon entry into force of the Agreement.