natgillin/translations-raw huggingface dataset:
Det nationale kontor for fødevarekædesikkerhed, direktoratet for veterinærlægemidler / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
These origin quotas are expressed in terms of volumes classified by product category, and includes considering dyeing as equivalent to printing, for a limited and clearly identified range of product categories.
Reguleringsmyndighed for lægemidler
The Parties affirm that these origin quotas, which are exceptional, will be applied in strict adherence to the Protocol on rules of origin and origin procedures.
Afdelingen for veterinærlægemidler og dyrefoder (VMANS) (direktoratet for veterinærbestemmelser (VRD)) under Departementet for veterinær- og plantesundhedsbestemmelser (VPRD)
ANNEX 7
Sundhedsinspektoratet / Inspectie voor de Gezondheidszorg (IGZ)
JOINT DECLARATIONS CONCERNING THE PRINCIPALITY OF ANDORRA AND THE REPUBLIC OF SAN MARINO
Nævnet for lægemiddelvurdering / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
JOINT DECLARATION CONCERNING THE PRINCIPALITY OF ANDORRA
Den østrigske styrelse for sundhed og fødevaresikkerhed / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Products originating in the Principality of Andorra falling within Chapter 25 to 97 of the Harmonized System shall be accepted by Canada as originating in the European Union within the meaning of this Agreement, provided that the customs union established by Council Decision 90/680/EEC of 26 November 1990 on the conclusion of an agreement in the form of an exchange of letters between the European Economic Community and the Principality of Andorra remains in force.
Polen
The Protocol on rules of origin and origin procedures shall apply mutatis mutandis for the purpose of defining the originating status of products referred to in paragraph 1 of this Joint Declaration.
Det overordnede inspektorat for lægemidler / Główny Inspektorat Farmaceutyczny (GIF) /
JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO
Den nationale myndighed for lægemidler og sundhedsprodukter / INFARMED, I.P
Products originating in the Republic of San Marino shall be accepted by Canada as originating in the European Union within the meaning of this Agreement, provided that these products are covered by the Agreement on Cooperation and Customs Union between the European Economic Community and the Republic of San Marino, done at Brussels on 16 December 1991, and that the latter remains in force.
Generaldirektoratet for fødevarer og veterinære anliggender / DGAV — Direção Geral de Alimentação e Veterinária (PT)
The Protocol on rules of origin and origin procedures shall apply mutatis mutandis for the purpose of defining the originating status of the products referred to in paragraph 1 of this Joint Declaration.
Slovenien
Protocol on the mutual acceptance of the results of conformity assessment
Styrelsen for lægemidler og medicinsk udstyr i Republikken Slovenien / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
Except as otherwise provided, the definitions contained in Annex 1 to the TBT Agreement apply to this Protocol.
Den Slovakiske Republik (Slovakiet)
However, the definitions contained in the sixth edition of the ISO/IEC Guide 2: 1991 General Terms and Their Definitions Concerning Standardization and Related Activities do not apply to this Protocol.
Statens institut for kontrol med lægemidler / Štátny ústav pre kontrolu liečiv (ŠÚKL)
The following additional definitions also apply:
Instituttet for statens kontrol med biologiske veterinærlægemidler og andre veterinærlægemidler / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
accreditation means third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks;
Den finske lægemiddelstyrelse / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
accreditation body means an authoritative body that performs accreditation [1];
Styrelsen for lægemidler / Läkemedelsverket
attestation means the issuing of a statement based on a decision following review, that fulfilment of specified technical requirements has been demonstrated;
Det Forenede Kongerige
Canadian technical regulation means a technical regulation of Canada's national government or of one or more of its provinces and territories;
Bulgarien
conformity assessment means a process to determine whether relevant requirements in technical regulations have been fulfilled.
Den bulgarske lægemiddelstyrelse / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
For the purpose of this Protocol, conformity assessment does not include accreditation;
Den bulgarske styrelse for fødevaresikkerhed / Българска агенция по безопасност на храните
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
Den nationale styrelse for lægemidler og medicinsk udstyr / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
Decision 768/2008/EC means Decision 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC;
National Sanitary Veterinary and Food Safety Authority / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
European Union technical regulation means a technical regulation of the European Union and any measure adopted by a Member State implementing a Directive of the European Union;
GÆLDENDE LOVGIVNING
in-house body means a conformity assessment body that performs conformity assessment activities for the entity of which it forms a part, such as, in the case of the European Union and its Member States, an accredited in-house body fulfilling the requirements in Article R21 of Annex I to Decision 768/2008/EC or the corresponding requirements in a successor instrument;
Europa-Parlamentets og Rådets direktiv 2001/83/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler
legitimate objective has the same meaning as under Article 2.2 of the TBT Agreement;
Europa-Parlamentets og Rådets direktiv 2001/82/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for veterinærlægemidler
Mutual Recognition Agreement means the Agreement on Mutual Recognition between the European Community and Canada, done at London on 14 May 1998;
Europa-Parlamentets og Rådets direktiv 2001/20/EF af 4. april 2001 om indbyrdes tilnærmelse af medlemsstaternes love og administrative bestemmelser om anvendelse af god klinisk praksis ved gennemførelse af kliniske forsøg med lægemidler til human brug
third-party conformity assessment means conformity assessment that is performed by a person or body that is independent of the person or organization that provides the product, and of user interests in that product;
Forordning (EU) nr. 536/2014 af 16. april 2014 om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF
third-party conformity assessment body means a conformity assessment body that performs third-party conformity assessments.
Kommissionens direktiv 2003/94/EF af 8. oktober 2003 om principper og retningslinjer for god fremstillingspraksis for humanmedicinske lægemidler og testpræparater til human brug
Scope and exceptions
Kommissionens direktiv 91/412/EØF af 23. juli 1991 om principper og retningslinjer for god fremstillingspraksis for veterinærmedicinske præparater
This Protocol applies to those categories of goods listed in Annex 1 for which a Party recognises non-governmental bodies for the purpose of assessing conformity of goods with that Party's technical regulations.
Kommissionens delegerede forordning (EU) nr. 1252/2014 af 28. maj 2014 om supplerende regler til Europa-Parlamentets og Rådets direktiv 2001/83/EF for så vidt angår principper og retningslinjer for god fremstillingspraksis for virksomme stoffer til humanmedicinske lægemidler
Within three years of the entry into force of this Agreement, the Parties shall consult with a view to broadening the scope of application of this Protocol by modifying Annex 1, to include additional categories of goods for which a Party has recognised non-governmental bodies for the purpose of assessing conformity of those goods with that Party's technical regulations on or before the entry into force of this Agreement.
Den aktuelle udgave af vejledningen i god fremstillingspraksis, der er indeholdt i bind IV i Rules governing medicinal products in the European Union (bestemmelserne om lægemidler i Den Europæiske Union) og compilation of the community procedures on inspections end exchange of information (samlingen af EU-procedurer for inspektionsbesøg og informationsudveksling)
Priority categories of goods for consideration are set out in Annex 2.
BILAG I
The Parties shall give positive consideration to making this Protocol applicable to additional categories of goods which may become subject to third-party conformity assessment by recognised non-governmental bodies pursuant to technical regulations adopted by a Party after the date of entry into force of this Agreement.
Indledende note
To that end, the Party shall promptly notify the other Party, in writing, of any such technical regulation that is adopted after the entry into force of this Agreement.
Forbehold for nuværende foranstaltninger og liberaliseringsforpligtelser
If the other Party expresses an interest in including a new category of goods in Annex 1 but the notifying Party does not agree to it, the notifying Party shall provide to the other Party, upon request, the reasons that justify its refusal to expand the scope of the Protocol.
En parts liste til dette bilag indeholder i henhold til artikel 8.15 (forbehold og undtagelser), artikel 9.7 (forbehold), artikel 14.4 (forbehold) og, for Den Europæiske Unions vedkommende, artikel 13.10 (forbehold og undtagelser), de forbehold, som denne part har taget med hensyn til eksisterende foranstaltninger, der ikke er i overensstemmelse med de forpligtelser, som indføres ved:
If the Parties decide in accordance with paragraphs 2 or 3 to include additional categories of goods in Annex 1, they shall request the Committee on Trade in Goods, pursuant to Article 18(c), to make recommendations to the CETA Joint Committee to amend Annex 1.
artikel 8.6 (national behandling), artikel 9.3 (national behandling) eller for Den Europæiske Unions vedkommende artikel 13.3 (national behandling)
This Protocol does not apply:
artikel 8.7 (mestbegunstigelsesbehandling), artikel 9.5 (mestbegunstigelsesbehandling) eller, for Den Europæiske Unions vedkommende, artikel 13.4 (mestbegunstigelsesbehandling);
to sanitary and phytosanitary measures as defined in Annex A to the SPS Agreement;
artikel 8.4 (markedsadgang), artikel 9.6 (markedsadgang) eller, for Den Europæiske Unions vedkommende, artikel 13.6 (markedsadgang);
to purchasing specifications prepared by a governmental body for production or consumption requirements of that body;
artikel 8.5 (præstationskrav)
to activities performed by a non-governmental body on behalf of a market surveillance or enforcement authority for post-market surveillance and enforcement, except as provided for in Article 11;
artikel 8.8 (øverste ledelse og bestyrelse) eller for Den Europæiske Unions vedkommende artikel 13.8 (øverste ledelse og bestyrelse)
if a Party has delegated exclusive authority to a single non-governmental body to assess conformity of goods with that Party's technical regulations;
for Den Europæiske Union, artikel 13.7 (grænseoverskridende levering af finansielle tjenesteydelser); eller
to agricultural goods;
artikel 14.3 (forpligtelser);
to the assessment of aviation safety, whether or not it is covered under the Agreement on Civil Aviation Safety between Canada and the European Community, done at Prague on 6 May 2009; and
og anfører i visse tilfælde forpligtelser til øjeblikkelig eller fremtidig liberalisering.
to the statutory inspection and certification of vessels other than recreational craft.
En parts forbehold berører ikke parternes rettigheder og forpligtelser i medfør af GATS.
This Protocol does not require the recognition or acceptance by a Party that the other Party's technical regulations are equivalent to its own.
Hvert forbehold omfatter følgende elementer:
This Protocol does not limit the ability of a Party to prepare, adopt, apply or amend conformity assessment procedures in accordance with Article 5 of the TBT Agreement.
Sektor den overordnede sektor, hvori forbeholdet er taget
This Protocol does not affect or modify the laws or obligations in the territory of a Party applicable to civil liability.
Delsektor den specifikke sektor, hvori forbeholdet er taget
Recognition of conformity assessment bodies
brancheklassifikation henviser i givet fald til den aktivitet, der er omfattet af forbeholdet i henhold til CPC, ISIC rev 3.1, eller som på anden vis udtrykkeligt er beskrevet i en parts forbehold
Canada shall recognise a conformity assessment body established in the European Union as competent to assess conformity with specific Canadian technical regulations, under conditions no less favourable than those applied for the recognition of conformity assessment bodies established in Canada, provided that the following conditions are met:
forbeholdstype præciserer den forpligtelse, der er omhandlet i stk. 1, og for hvilken der er taget et forbehold
the conformity assessment body is accredited, by an accreditation body recognised by Canada, as competent to assess conformity with those specific Canadian technical regulations; or
Forvaltningsniveau det forvaltningsniveau, hvorpå den foranstaltning, som der er taget forbehold for, opretholdes;
the conformity assessment body established in the European Union is accredited, by an accreditation body that is recognised pursuant to Article 12 or Article 15, as competent to assess conformity with those specific Canadian technical regulations;
Foranstaltninger de love eller andre foranstaltninger, som i givet fald præciseres under elementet Beskrivelse, og som der er taget forbehold for.
the conformity assessment body established in the European Union is designated by a Member State of the European Union in accordance with the procedures set out in Article 5;
En foranstaltning, der er anført under elementet Foranstaltninger:
there are no unresolved objections pursuant to Article 6;
betyder foranstaltningen som ændret, opretholdt eller fornyet fra datoen for denne aftales ikrafttræden;
the designation made in accordance with the procedures set out in Article 5 is not withdrawn by a Member State of the European Union; and
omfatter enhver underordnet foranstaltning, der vedtages eller opretholdes i henhold til beføjelsen i og i overensstemmelse med foranstaltningen;
after the expiry of the 30 day period of time referred to in Article 6.1 or 6.2, the conformity assessment body established in the European Union continues to meet all the conditions described in Article 5.5.
omfatter:
The European Union shall recognise a third-party conformity assessment body established in Canada as competent to assess conformity with specific European Union technical regulations, under conditions no less favourable than those applied for the recognition of third-party conformity assessment bodies established in the European Union, provided that the following conditions are met:
for et EU-direktiv, alle love og andre foranstaltninger, som gennemfører direktivet på medlemsstatsplan;
the conformity assessment body is accredited, by an accreditation body appointed by one of the Member States of the European Union, as competent to assess conformity with those specific European Union technical regulations;
for Canada, alle love og andre foranstaltninger på nationalt eller subnationalt plan, der gennemfører aftaler mellem forbundsregeringen og provinserne og territorierne;
the third-party conformity assessment body established in Canada is designated by Canada in accordance with the procedures set out in Article 5;
Beskrivelse de uforenelige aspekter i den eksisterende foranstaltning, som der er taget forbehold for.
the designation made in accordance with the procedures set out Article 5 is not withdrawn by Canada; and
Den kan også anføre forpligtelser til liberalisering.
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; or
I forbindelse med fortolkning af et forbehold skal der tages højde for alle elementer i forbeholdet.
the third-party conformity assessment body established in Canada is accredited, by an accreditation body that is recognised pursuant to Article 12 or 15, as competent to assess conformity with those specific European Union technical regulations;
Et forbehold skal fortolkes i lyset af de relevante forpligtelser i de kapitler, over for hvilke forbeholdet tages.
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.
I det omfang:
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
elementet Foranstaltninger præciseres af en liberaliseringsforpligtelse i elementet Beskrivelse, går det således præciserede element Foranstaltninger forud for alle andre elementer;
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.
elementet Foranstaltninger ikke præciseres, går elementet Foranstaltninger forud for alle andre elementer, medmindre der er et misforhold mellem elementet Foranstaltninger og de øvrige elementer samlet betragtet, som er så væsentligt og betydningsfuldt, at det ville være urimeligt at drage den slutning, at elementet Foranstaltninger går forud, og i det tilfælde går de andre elementer forud i det omfang, misforholdet tilsiger.
Accreditation of conformity assessment bodies
Hvis en part opretholder en foranstaltning, der kræver, at en tjenesteyder er en fysisk person, statsborger, fast bosiddende eller bosiddende på dens territorium som en betingelse for leveringen af en tjenesteydelse på dens territorium, fungerer et forbehold for denne foranstaltning, som er truffet med hensyn til grænseoverskridende handel med tjenesteydelser, som et forbehold med hensyn til investeringer, for så vidt angår foranstaltningen.
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.
Et forbehold for en foranstaltning, som kræver, at en tjenesteyder er en fysisk person, statsborger, fast bosiddende eller bosiddende på dens territorium som en betingelse for leveringen af en finansiel tjenesteydelse på dens område, truffet med hensyn til artikel 13.7 (grænseoverskridende levering af finansielle tjenesteydelser) skal fungere som et forbehold med hensyn til artikel 13.3 (national behandling), artikel 13.4 (mestbegunstigelsesbehandling), artikel 13.6 (markedsadgang) og artikel 13.8 (øverste ledelse og bestyrelse), for så vidt angår foranstaltningen.
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:
Med henblik på anvendelsen af dette bilag, herunder hver parts liste til dette bilag:
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;
forstås der ved ISIC rev 3.1 den internationale standardklassifikation af al erhvervsmæssig virksomhed som fastsat i de statistiske publikationer fra De Forenede Nationers statistiske kontor, Statistical Papers, Series M, No 4, ISIC rev 3.1, 2002.
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;
Følgende forkortelser benyttes i Den Europæiske Unions liste til dette bilag:
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.
EU Den Europæiske Union
Designation of conformity assessment bodies
NL Nederlandene
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.
SK Slovakiet
The European Union shall allow Canada to use the European Union's electronic notification tool for those purposes.
Canadas liste — forbundsstatslig
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:
Forbehold, der gælder i Canada
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
(gælder i alle provinser og på alle territorier)
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
Forbehold I-C-1
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.
Sektor:
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.
Delsektor:
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.
Brancheklassifikation:
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:
Forbeholdstype:
the conformity assessment body is established in the territory of the Member State; and