natgillin/translations-raw huggingface dataset:
Canada Post Corporation Act,R.S.C.
This Arrangement is not subject to the provisions of Chapter Twenty-Nine (Dispute Settlement).
Letter Definition Regulations,S.O.R./83-481
For the purposes of this Article, a fee includes a cost-recovery measure such as a user fee, a regulatory charge or an amount set under a contract.
Ene- og eksklusivretten til at indsamle, videresende og levere »breve« i Canada, som defineret i Letter Definition Regulations er forbeholdt postmonopolet.
A Party shall have the right to determine a fee applicable to manufacturing facilities in its territory, including fees related to issuing certificates of GMP compliance and fees related to inspections or on-site evaluations.
Til præcisering: Aktiviteter med relation til ene- og eksklusivretten kan også begrænses, herunder udstedelse af frimærker samt installation, opførelse eller flytning på et offentligt sted af en postkasse eller anordning, der skal anvendes til indsamling, levering eller opbevaring af post.
The fees charged to a manufacturing facility in case of an inspection or on-site evaluation conducted by a Party at the request of the other Party must be consistent with paragraph 2.
Canadas liste — provins- og territorieniveau
MEDICINAL PRODUCTS OR DRUGS
Regnskabsføring
human pharmaceuticals including prescription and non-prescription medicinal products or drugs and medicinal gases;
Revision og bogføring
human biologicals including immunologicals, stable medicinal products derived from human blood or human plasma, and biotherapeutics;
Certified General Accountants Regulation, Alta.
veterinary pharmaceuticals, including prescription and non-prescription medicinal products or drugs, and pre-mixes for the preparation of veterinary medicated feeds;
Reg.
veterinary biologicals;
176/2001
if appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products;
Certified Management Accountants Regulation, Alta.
active pharmaceutical ingredients;
Reg.
intermediate products and bulk pharmaceuticals (for example, bulk tablets);
177/2001
products intended for use in clinical trials or investigational medicinal products; and
Chartered Accountants Regulation,Alta.
advanced therapy medicinal products.
Reg.
Operational scope of medicinal products or drugs
178/2001
Further to paragraph 1, the GMP requirements and compliance programmes of both Parties are equivalent for the following medicinal products or drugs:
En ansøger, der ønsker at blive registreret som et reguleret medlem, skal fremlægge dokumentation for canadisk statsborgerskab eller for, at vedkommende er rejst ind i Canada på lovlig vis og har ret til at arbejde i Canada.
human biologicals including immunologicals and biotherapeutics;
Hvert kontor i Alberta, som tilhører en registreret ansøger, der udøver offentlig regnskabspraksis, skal være under et medlems personlige ansvar og ledelse, og vedkommende skal normalt være til rådighed med henblik på at opfylde klienters behov inden for de tidsperioder, hvor kontoret er åbent for offentligheden.
intermediate products and bulk pharmaceuticals;
Forbehold I-PT-2
products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence; and
General Regulation, Alta.
vitamins, minerals and herbal remedies, homeopathic medicinal products (known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence, in the case of Canada.
Reg.
REGULATORY AUTHORITIES
Kun canadiske statsborgere eller personer, der på lovlig vis har fået adgang og berettigelse til at arbejde i Canada, kan blive godkendt til registrering af registreringsudvalget efter fremlæggelse af tilfredsstillende dokumentation med henblik på dette.
For the European Union:
Forbehold I-PT-3
Country
Fast ejendom
For medicinal products for human use
Tjenesteydere er tilladt gennem mæglervirksomhed, som skal have et registreret forretningssted i provinsen.
Belgium
Det registrerede forretningssted skal være: det sted, hvorfra den pågældende person udøver virksomhed, under tjenesteudbyderens tilsyn og det sted, hvor de påkrævede regnskaber skal opbevares i henhold til loven.
Federal agency for medicines and health products/Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/Agence fédérale des médicaments et produits de santé
Forbehold I-PT-4
See responsible authority for human medicinal products
Landmåling
State Institute for Drug Control/Státní ústav pro kontrolu léčiv (SÚKL)
For tjenesteydelser, der ydes af et selskab, skal den handelmæssige tilstedeværelse være i form af en landmålervirksomhed.
Institute for State Control of Veterinary Biologicals and Medicaments/Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)
Provisionsagenturvirksomhed
Ministry of Agriculture, Veterinary and Food Safety Directorate/Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane
Engroshandel
Danish Health and Medicines Authority/Laegemiddelstyrelsen
Detailhandel (spiritus, vin og øl, spiritus-, vin- og ølforretninger)
Federal Institute for Drugs and Medical Devices/Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Fremstilling af alkoholiske drikkevarer
Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines/Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
CPC 24 (bortset fra 244), 62112, 62226, 63107, 643 og 88411
Federal Ministry of Health/Bundesministerium für Gesundheit (BMG)
Gaming and Liquor Act,R.S.A.
Federal Office for Consumer Protection and Food Safety/Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Gaming and Liquor Regulation, Alta.
Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft
Reg.
Estonia
143/96
State Agency of Medicines/Ravimiamet
De ovenfor anførte foranstaltninger giver Alberta tilladelse til at kontrollere fremstilling, import, salg, køb, besiddelse, opbevaring, transport, anvendelse og indtagelse af spiritus, herunder gennem tilladelser og bevillinger, som kan omfatte statsborgerskab, bopæl og andre begrænsninger for etablering, drift og tilvejebringelse af disse aktiviteter.
Spanish Agency of Medicines and Medical Devices/Agencia Española de Medicamentos y Productos Sanitários
Forbehold I-PT-6
French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Landbrug
French agency for food, environmental and occupational health safety-National Agency for Veterinary Medicinal Products/Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
Jord
Ireland
Tjenesteydelser i tilknytning til landbrug
Health Products Regulatory Authority (HPRA)
CPC 8811 (bortset fra leje af landbrugsudstyr med betjeningspersonale), 531
Italian Medicines Agency/Agenzia Italiana del Farmaco
Provincial Parks (Dispositions) Regulations, Alta.
Direction General for Animal Health and Veterinary Medicinal Products
Reg.
Ministry of Health — Pharmaceutical Services/Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
241/77
Ministry of Agriculture, Rural Development and Environment-Veterinary Services/Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
Provincial Parks (General) Regulation,Alta.
Latvia
Reg.
State Agency of Medicines/Zāļu valsts aģentūra
102/85
Assessment and Registration Department of the Food and Veterinary Service/Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
Dispositions and Fees Regulation, Alta.
Lithuania
Reg.
State Medicines Control Agency/Valstybinė maisto ir veterinarijos tarnyba
54/2000
State Food and Veterinary Service/Valstybinės maisto ir veterinarijo tarnyba
Special Areas Disposition Regulation, Alta.
Luxembourg
Reg.
Minìstere de la Santé, Division de la Pharmacie et des Médicaments
137/2001
National Institute of Pharmacy/Országos Gyógyszerészeti Intézet (OGYI)
Declaration Regulation,Alta.
National Food Chain Safety Office, Directorate of Veterinary Medicinal Products/Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
195/2001
Medicines Regulatory Authority
Forest Reserves Regulation, Alta.
Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD)
Reg.
Healthcare Inspectorate/Inspectie voor de Gezondheidszorg (IGZ)
42/2005
Medicines Evaluation Board/Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
Overdragelse i forbindelse med statsjord (»Crown land«), også i parker på provinsniveau, er begrænset til personer, der er bosiddende i Alberta, som er canadiske statsborgere, eller personer med fast bopæl i henhold til Immigration and Refugee Protection Act, S.C.
Austrian Agency for Health and Food Safety/Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Forbehold I-PT-7
Poland
Tjenesteydelser i tilknytning til jagt
National Authority of Medicines and Health Products/INFARMED, I.P
Selvstændige jagtguider
General Directorate of Food and Veterinary/DGAV — Direção Geral de Alimentação e Veterinária (PT)
Andre kulturelle aktiviteter
Slovenia
Wildlife Regulation, Alta.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia/Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
Reg.
Slovak Republic (Slovakia)
143/97
State Institute for Drug Control/Štátny ústav pre kontrolu liečiv (ŠÚKL)
Krav om statsborgerskab eller om fast bopæl kan pålægges som en betingelse for udnævnelser, tilladelser eller bevillinger i forbindelse med guidning og outfitting til vildtjagt.
Institute for State Control of Veterinary Biologicals and Medicaments/Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
Krav om statsborgerskab eller om fast bopæl kan også pålægges som en betingelse for tilladelser eller bevillinger til at holde dyr i fangenskab, taksidermi, garvning, pelshandel eller pelshåndtering.
Finland
Forbehold I-PT-8
Finnish Medicines Agency/Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
Vejtransport
Medical Products Agency/Läkemedelsverket
Passagerbefordring
United Kingdom
Motor Transport Act,R.S.A.
Medicines and Healthcare products Regulatory Agency Veterinary Medicines Directorate
Motor Vehicle Administration Act,R.S.A.
Bulgaria
Der kan pålægges en analyse af offentlige hensyn og behov forud for godkendelsen af en licens med henblik på at levere bustransport i byer og ikke-regelmæssige/regelmæssige tjenester, herunder også under anvendelsen af nogle eller alle af følgende kriterier: de nuværende serviceniveauers tilstrækkelighed markedsbetingelser, der skaber grundlag for kravet om udvidet service virkningen af nye aktører for offentlige hensyn, herunder hensynet til kontinuitet og servicekvalitet, og ansøgerens egnethed, vilje og evne til at levere en korrekt service.
Bulgarian Drug Agency /ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Forbehold I-PT-9
Bulgarian Food Safety Agency/Българска агенция по безопасност на храните
Politik for industrielle fordele
National Agency for Medicines and Medical Devices/Agenția Națională a Medicamentului și a Dispozitivelor Medicale
Ansøgere kan pålægges præstationskrav (f.eks. et krav om, at tjenesteydere fra Alberta eller Canada skal komme først i betragtning, hvis de er konkurrencedygtige med hensyn til pris og kvalitet) for så vidt angår alle store projekter, der kræver tilladelser i forbindelse med industriel udvikling, skovforvaltning, tjæresand, kraft- eller gasværker samt kuludnyttelse.
National Sanitary Veterinary and Food Safety Authority/Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
Forbehold I-PT-10
For Canada:
Business Corporations Regulation, Alta.
Health Canada
Reg.
APPLICABLE LEGISLATION
118/2000
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;
Mindst 25 procent af bestyrelsesmedlemmerne i et selskab fra Alberta skal være hjemmehørende canadiere.
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;
For så vidt angår disse foranstaltninger, betyder »hjemmehørende canadier« en person, der er:
Directive 2001/20/EC of European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;
canadisk statsborger, der har fast bopæl i Canada
Regulation (EU) 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC;
canadisk statsborger, der ikke har fast bopæl i Canada, og som er medlem af en forud fastlagt persongruppe, eller
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;
en person med fast bopæl i henhold til Immigration and Refugee Protection Act, S.C.
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;
2001, c. 27, og med fast bopæl i Canada.
Commission delegated Regulation (EU) 1252/2014 of 28 May 2014 of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use;
Forbehold I-PT-11
Current version of the Guide to good manufacturing practices contained in volume IV of Rules governing medicinal products in the European Union and compilation of the community procedures on inspections and exchange of information;
Regulations Respecting the Ownership of Agricultural and Recreational Land in Alberta, Alta.
Food and Drugs Act, R.S.C., 1985, c.
Reg.
F-27.
160/79
ANNEX I
Arealer, der ejes af det offentlige, kan ikke sælges til:
Headnote
et selskab, der ikke er et canadisk selskab, eller
Reservations for existing measures and liberalisation commitments
en person eller et selskab, der fungerer som trustforvalter for en person, der ikke er canadisk statsborger eller har fast bopæl som defineret i Immigration and Refugee Protection Act, eller for et selskab, der ikke er et canadisk selskab.
The Schedule of a Party to this Annex sets out, under Articles 8.15 (Reservations and exceptions), 9.7 (Reservations), 14.4 (Reservations), and, for the European Union, Article 13.10 (Reservations and exceptions), the reservations taken by that Party with respect to existing measures that do not conform with obligations imposed by:
Forbehold I-PT-12
Articles 8.6 (National treatment), 9.3 (National treatment) or, for the European Union, Article 13.3 (National treatment);
Fritids- og sportsaktiviteter samt kulturelle aktiviteter
Articles 8.7 (Most-favoured-nation treatment), 9.5 (Most-favoured-nation treatment) or, for the European Union, Article 13.4 (Most-favoured-nation treatment);
Spil og væddemål
Articles 8.4 (Market access), 9.6 (Market access) or, for the European Union, Article 13.6 (Market access);
143/1996
Article 8.5 (Performance requirements);
De ovenfor anførte foranstaltninger giver Alberta tilladelse til at regulere og autorisere tjenesteydelser, leverandører af tjenesteydelser, fremstilling, leverandører af materialer, drift og reparationer i forbindelse med lotterisystemer, spillemaskiner, hasardspil, væddeløb, bingospil og kasinoer samt lignende aktiviteter, herunder gennem tilladelser og bevillinger, som kan omfatte statsborgerskab, bopæl og andre begrænsninger for etablering, drift og tilvejebringelse af disse aktiviteter.
Article 8.8 (Senior management and boards of directors) or, for the European Union, Article 13.8 (Senior management and boards of directors);
Forbehold I-PT-13
For the European Union, Article 13.7 (Cross-border supply of financial services); or
Tjenester i tilknytning til husdyravl
Article 14.3 (Obligations);
Horse Capture Regulation, Alta.
and, in certain cases, sets out commitments for immediate or future liberalisation.
Reg.
The reservations of a Party are without prejudice to the rights and obligations of the Parties under the GATS.
59/94
Each reservation sets out the following elements:
Kun en canadisk statsborger eller en person, der på lovligvis har fået adgang til Canada med henblik på fast bopæl, kan ansøge om, opnå eller være indehaver af en tilladelse til at indfange, fodre, jage, forfølge, følge efter, opspore eller snige sig ind på heste på et offentligt areal i Alberta, der er udpeget til indfangning af heste efter tilladelse.
Sector refers to the general sector in which the reservation is taken;
Forbehold, der gælder i British Columbia
Sub-Sector refers to the specific sector in which the reservation is taken;
Forbehold I-PT-14
Industry Classification refers, where applicable, to the activity covered by the reservation according to the CPC, ISIC rev 3.1, or as expressly otherwise described in a Party's reservation;
Skovbrug
Type of Reservation specifies the obligation referred to in paragraph 1 for which a reservation is taken;
Produkter fra skovbrug og skovning
Level of Government indicates the level of government maintaining the measure for which a reservation is taken;
Provinsen British Columbia
Measures identifies the laws or other measures, as qualified, where indicated, by the Description element, for which the reservation is taken.
Alt tømmer, der fældes fra provinsarealer, skal enten anvendes i provinsen eller forarbejdes til andre varer i provinsen.
A measure cited in the Measures element:
Provinsen kan dog bevilge en undtagelse fra dette krav, hvis tømmeret er i overskud i forhold til behovene på forarbejdningsanlæg i provinsen, hvis det ikke kan forarbejdes på økonomisk vis i nærheden af hugstområdet og ikke kan transporteres på økonomisk vis til et andet anlæg i provinsen, eller hvis en undtagelse ville forhindre spild eller forbedre udnyttelsen af træet.
means the measure as amended, continued or renewed as of the date of entry into force of this Agreement;
Forbehold I-PT-15
includes any subordinate measure adopted or maintained under the authority of and consistent with the measure; and
Juridiske tjenesteydelser
includes:
En person skal være canadisk statsborger eller have fast bopæl for kunne blive udpeget som kommissær, der kan modtage erklæringer på tro og love.
for a European Union Directive, any laws or other measures which implement the Directive at Member State level; and
Forbehold I-PT-16
for Canada, any laws or other measures at the national or sub-national level that implement agreements between the federal government and the provinces and territories; and
Regnskabsføring, revision og bogføring
Description sets out the non-conforming aspects of the existing measure for which the reservation is taken.
Accountants (Management) Act,R.S.B.C.
It may also set out commitments for liberalisation.
Regnskabskontorerne skal ledes af en person, der er hjemmehørende i British Columbia.
In the interpretation of a reservation, all elements of the reservation shall be considered.
Forbehold I-PT-17
A reservation shall be interpreted in the light of the relevant obligations of the Chapters, against which the reservation is taken.
Cooperative Association Act,S.B.C.
To the extent that:
I henhold til Cooperative Association Act skal flertallet af bestyrelsesmedlemmer i en sammenslutning, der er stiftet i henhold til den lov, være hjemmehørende canadiere, og mindst et bestyrelsesmedlem skal være hjemmehørende i provinsen.
the Measures element is qualified by a liberalisation commitment from the Description element, the Measures element as so qualified shall prevail over all other elements; and
I henhold til Society Act skal mindst et bestyrelsesmedlem i en forening, der er stiftet i henhold til den lov, være hjemmehørende i provinsen.
the Measures element is not so qualified, the Measures element shall prevail over other elements, unless a discrepancy between the Measures element and the other elements considered in their totality is so substantial and material that it would be unreasonable to conclude that the Measures element prevails, in which case the other elements shall prevail to the extent of that discrepancy.
Forbehold I-PT-18
Where a Party maintains a measure that requires that a service supplier be a natural person, citizen, permanent resident or resident of its territory as a condition to the supply of a service in its territory, a reservation for that measure taken with respect to cross-border trade in services shall operate as a reservation with respect to investment, to the extent of that measure.
Advokater og notarer
A reservation for a measure that requires a service supplier be a natural person, citizen, permanent resident, or resident of its territory as a condition to the supply of a financial service in its territory taken with respect to Article 13.7 (Cross-border supply of financial services) shall operate as a reservation with respect to Articles 13.3 (National treatment), 13.4 (Most-favoured-nation treatment), 13.6 (Market access), and 13.8 (Senior management and boards of directors), to the extent of that measure.
Kun canadiske statsborgere eller personer med fast bopæl i Canada kan certificeres som notarius publicus i British Columbia.
For the purposes of this Annex, including each Party's Schedule to this Annex:
Notaries Act pålægger begrænsninger med hensyn til notarers mulighed for at levere tjenesteydelser gennem et notarselskab.
ISIC rev 3.1 means the International Standard Industrial Classification of all Economic Activities as set out in Statistical Office of the United Nations, Statistical Papers, Series M, No 4, ISIC rev 3.1, 2002.
Trustfonde skal være anbragt i regulerede finansieringsinstitutter på provins- eller føderalt niveau.
The following abbreviations are used in the European Union's Schedule to this Annex:
Forbehold I-PT-19
EU European Union
Turisme
NL Netherlands
Tjenesteydelser i forbindelse med jagt (jagtguider, outfittere, og vejledninger i lystfiskeri)
SK Slovakia
Tjenesteydelser i tilknytning til fiskeri
Schedule of Canada — Federal
Rejsebureau-, turoperatør- og turistguider
Reservations applicable in Canada
Kun canadiske statsborgere eller personer med fast bopæl i Canada kan få udstedt tilladelse til at udgive vejledninger inden for outfitting og lystfiskeri.
(applicable in all Provinces and Territories)
Forbehold I-PT-20
Reservation I-C-1
Andre liberale tjenesteydelser
Sector:
Tjenesteydelser i tilknytning til skovbrug og skovning
Sub-Sector:
For at kunne blive registreret som professionel forstmand skal der først opnås mindst 24 måneders relevant erhvervserfaring i British Columbia.
Industry Classification:
I nogle tilfælde er professionelle forstmænd, der allerede er registreret i andre Canadiske jurisdiktioner, fritaget fra dette krav.
Type of Reservation:
Forbehold I-PT-21
Level of Government:
Tjenesteydelser i tilknytning til fremstillingsvirksomhed
National
Tilladelse til fældning af juletræer
Measures:
Tilladelser til bjærgning af træ
Description:
Småskovslicenser (Woodlot licences)
Except as set out in paragraphs 3 and 7, the Director of Investments will review a direct ‘acquisition of control’, as defined in the Investment Canada Act, of a Canadian business by an investor of the European Union if the value of the Canadian business is not less than CAD $1.5 billion, adjusted in accordance with the applicable methodology in January of each subsequent year as set out in the Investment Canada Act.
Kun canadiske statsborgere, personer med fast bopæl eller et selskab, der ledes af personer, som er canadiske statsborgere eller har fast bopæl i Canada, kan få tilladelse til at fælde juletræer.
Notwithstanding the definition of ‘investor’ in Article 8.1 (Definitions), only investors who are nationals of the European Union or entities controlled by nationals of the European Union as provided for in the Investment Canada Act may benefit from the higher review threshold.