natgillin/translations-raw huggingface dataset:
Without prejudice to the outcome of the free trade negotiations between the European Union and the United States, the discussions on the applicable conditions will include consultations to ensure consistency between the calculation method agreed between the European Union and the United States and the method applicable under this Agreement for products of Chapter 87, if necessary.
Zmluvné strany uzatvoria správne dojednanie o SVP po nadobudnutí platnosti tejto dohody.
Accordingly Table D.1 will cease to apply one year following the entry into application of such cumulation.
Toto dojednanie nepodlieha ustanoveniam kapitoly 29 (Urovnávanie sporov).
The application of cumulation and deletion of Note 1 will be published in the Official Journal of the European Union for information purposes.
Na účely tohto článku poplatok zahŕňa opatrenie na krytie nákladov, ako je používateľský poplatok, regulačný poplatok alebo suma stanovená na základe zmluvy.
Review Provision
Každá zmluvná strana má právo určiť poplatok uplatniteľný na výrobné závody na svojom území vrátane poplatkov za vydávanie osvedčení o zhode s SVP a poplatkov týkajúcich sa inšpekcií alebo hodnotení na mieste.
If seven years after entry into force of this Agreement, cumulation with the United States has not yet entered into force, upon the request of a Party, both Parties shall meet to review these provisions.
Poplatky účtované výrobnému závodu v prípade inšpekcie alebo hodnotenia na mieste, ktoré vykonala zmluvná strana na žiadosť druhej zmluvnej strany, musia byť v súlade s odsekom 2.
Alternative Product-Specific Rules of Origin for Products of heading 87.02
LIEKY ALEBO LIEČIVÁ
For products of heading 87.02 exported from Canada to the European Union, the following rule of origin applies as an alternative to the rule of origin provided in Annex 5:
Rozsah liekov alebo liečiv
A change from any other heading, except from heading 87.06 through 87.08; or
Tento protokol sa vzťahuje na nasledujúce lieky alebo liečivá definované v právnych predpisoch zmluvných strán uvedených v prílohe 3 za predpokladu, že požiadavky na SVP a programy zhody s SVP oboch zmluvných strán týkajúce sa týchto liekov sú rovnocenné:
A change from within this heading or heading 87.06 through 87.08, whether or not there is a change from any other heading, provided that the value of non-originating materials of this heading or heading 87.06 through 87.08 does not exceed 50 per cent of the transaction value or ex-works price of the product.
humánne farmaceutické výrobky vrátane liekov alebo liečiv a medicinálnych plynov na predpis alebo na voľný predaj;
This rule of origin will apply to the enterprises located in Canada and their successors and assigns producing products of heading 87.02 in Canada, as of the conclusion of negotiations on 1 August 2014.
humánne biologické výrobky vrátane imunologických výrobkov, stabilných liekov z ľudskej krvi alebo ľudskej krvnej plazmy, a bioterapeutických výrobkov;
Note 2
humánne rádiofarmaká;
Provided that there is a Free Trade Agreement in force between each Party and the United States consistent with the Parties' WTO obligations and the Parties reach agreement on all the applicable conditions, any material of Chapter 84, 85, 87 or 94 of the Harmonized System originating in the United States used in the production of a product of heading 87.02 of the Harmonized System in Canada or the European Union will be considered as originating.
veterinárne farmaceutické výrobky vrátane liekov alebo liečiv na predpis alebo na voľný predaj, a zmesí na prípravu veterinárneho medikovaného krmiva;
Accordingly, the alternative Product-Specific Rules of Origin for products of heading 87.02 will cease to apply one year following the entry into application of such cumulation.
veterinárne biologické prípravky;
The application of cumulation and deletion of Note 2 will be published in the Official Journal of the European Union for information purposes.
ak je to vhodné, vitamíny, minerály, rastlinné liečivá a homeopatické lieky;
The products, to which Table A.1 applies, must contain 65 per cent or more by net weight of added cane or beet sugar of subheading 1701.91 through 1701.99.
účinné farmaceutické látky;
All the cane or beet sugar must have been refined in Canada
medziprodukty a nebalené farmaceutické výrobky (napríklad nebalené tablety);
With regard to the products to which Table A.1 applies, it is understood that the sufficient production included in this column provides for production beyond the insufficient production provided in Article 7.
výrobky určené na použitie v klinickom skúšaní alebo skúšané lieky; a
With regard to the rule of origin for products of subheading 0304.83, it is understood that the production is beyond the insufficient production provided in Article 7.
lieky na inovatívnu liečbu.
With regard to the products to which Table C.2 applies, it is understood that the sufficient production included in this column provides for production beyond the insufficient production provided for in Article 7.
Operatívny rozsah liekov alebo liečiv
With regard to the products to which Table C.4 applies, it is understood that the sufficient production included in this column provides for production beyond the insufficient production provided for in Article 7.
V súvislosti s odsekom 1 sú požiadavky na SVP a programy zhody s SVP oboch zmluvných strán rovnocenné v prípade týchto liekov alebo liečiv:
ANNEX 6
humánne biologické prípravky vrátane imunologických a bioterapeutických prípravkov;
Nevertheless, for a number of reasons, including the absence of a negative cumulative effect on the producers of the EU, the Parties agree to derogate from paragraph 1 by providing for limited, reciprocal origin quotas for textiles and apparel.
vitamíny, minerály a rastlinné liečivá, homeopatické lieky (v Kanade známe ako prírodné zdravotné výrobky) vyrábané výrobcami, ktorí sú držiteľmi povolenia na výrobu alebo zriaďovacej licencie, v prípade Kanady.
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.
REGULAČNÉ ORGÁNY
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.
Zmluvné strany uznávajú ako regulačné orgány nasledujúce subjekty alebo ich nástupnícke subjekty, ktoré zmluvné strany oznámili spoločnej odvetvovej skupine:
ANNEX 7
Za Európsku úniu:
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;
Španielska agentúra pre lieky a zdravotnícke pomôcky / Agencia Española de Medicamentos y Productos Sanitários
legitimate objective has the same meaning as under Article 2.2 of the TBT Agreement;
Francúzska národná agentúra pre bezpečnosť liekov a zdravotníckych výrobkov / Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Mutual Recognition Agreement means the Agreement on Mutual Recognition between the European Community and Canada, done at London on 14 May 1998;
Francúzska agentúra pre bezpečnosť potravín, životného prostredia a práce – Národná agentúra pre veterinárne lieky / Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
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;
Írsko
third-party conformity assessment body means a conformity assessment body that performs third-party conformity assessments.
Regulačný orgán pre zdravotnícke výrobky / Health Products Regulatory Authority (HPRA)
Scope and exceptions
Talianska agentúra pre lieky / Agenzia Italiana del Farmaco
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.
Ministerstvo zdravotníctva, generálne riaditeľstvo pre zdravie zvierat a veterinárne lieky /
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.
Ministerstvo zdravotníctva – farmaceutické služby / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
Priority categories of goods for consideration are set out in Annex 2.
Ministerstvo poľnohospodárstva, rozvoja vidieka a životného prostredia – veterinárne služby / Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
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.
Lotyšsko
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.
Štátna agentúra pre lieky / Zāļu valsts aģentūra
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.
Oddelenie pre hodnotenie a evidenciu potravinárskej a veterinárnej služby / Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
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.
Litva
This Protocol does not apply:
Štátna agentúra pre kontrolu liekov / Valstybinė maisto ir veterinarijos tarnyba
to sanitary and phytosanitary measures as defined in Annex A to the SPS Agreement;
Štátna potravinárska a veterinárna služba / Valstybinės maisto ir veterinarijo tarnyba
to purchasing specifications prepared by a governmental body for production or consumption requirements of that body;
Luxembursko
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;
Ministerstvo zdravotníctva, oddelenie pre farmaceutické prípravky a lieky / Minìstere de la Santé, Division de la Pharmacie et des Médicaments
if a Party has delegated exclusive authority to a single non-governmental body to assess conformity of goods with that Party's technical regulations;
Národný farmaceutický ústav / Országos Gyógyszerészeti Intézet (OGYI)
to agricultural goods;
Národný úrad pre bezpečnosť potravinového reťazca, riaditeľstvo pre veterinárne lieky / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
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
Regulačný orgán pre lieky / Medicines Regulatory Authority
to the statutory inspection and certification of vessels other than recreational craft.
Sekcia pre veterinárne lieky a výživu zvierat riaditeľstva pre reguláciu veterinárstva na odbore veterinárnej a fytosanitárnej regulácie / Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD)
This Protocol does not require the recognition or acceptance by a Party that the other Party's technical regulations are equivalent to its own.
Inšpektorát zdravotnej starostlivosti / Inspectie voor de Gezondheidszorg (IGZ)
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.
Rada pre hodnotenie liekov / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
This Protocol does not affect or modify the laws or obligations in the territory of a Party applicable to civil liability.
Rakúska agentúra pre zdravie a bezpečnosť potravín / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Recognition of conformity assessment bodies
Poľsko
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:
Hlavný farmaceutický inšpektorát / Główny Inspektorat Farmaceutyczny (GIF)
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
Národný úrad pre lieky a zdravotnícke výrobky / INFARMED, I.P
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;
Generálne riaditeľstvo pre potraviny a veterinárstvo / DGAV – Direção Geral de Alimentação e Veterinária (PT)
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;
Slovinsko
there are no unresolved objections pursuant to Article 6;
Agentúra Slovinskej republiky pre lieky a zdravotnícke pomôcky / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
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
Slovenská republika (Slovensko)
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.
Štátny ústav pre kontrolu liečiv (ŠÚKL)
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:
Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (ÚŠKVBL)
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;
Fínsko
the third-party conformity assessment body established in Canada is designated by Canada in accordance with the procedures set out in Article 5;
Fínska agentúra pre lieky / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
the designation made in accordance with the procedures set out Article 5 is not withdrawn by Canada; and
Agentúra pre lieky / Läkemedelsverket
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
Spojené kráľovstvo
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;
Bulharsko
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.
Bulharská agentúra pre liečivá / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
Bulharský úrad pre bezpečnosť potravín / Българска агенция по безопасност на храните
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.
Národná agentúra pre lieky a zdravotnícke pomôcky / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
Accreditation of conformity assessment bodies
Národný úrad pre veterinárstvo a bezpečnosť potravín / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
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.
Za Kanadu:
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:
UPLATNITEĽNÉ PRÁVNE PREDPISY
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;
smernica Európskeho parlamentu a Rady 2001/83/ES zo 6. novembra 2001, ktorou sa ustanovuje zákonník Spoločenstva o humánnych liekoch;
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;
smernica Európskeho parlamentu a Rady 2001/82/ES zo 6. novembra 2001, ktorou sa ustanovuje zákonník Spoločenstva o veterinárnych liekoch;
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.
smernica Európskeho parlamentu a Rady 2001/20/ES zo 4. apríla 2001 o aproximácii zákonov, iných právnych predpisov a správnych opatrení členských štátov týkajúcich sa uplatňovania dobrej klinickej praxe počas klinických pokusov s humánnymi liekmi;
Designation of conformity assessment bodies
nariadenie (EÚ) č. 536/2014 zo 16. apríla 2014 o klinickom skúšaní liekov na humánne použitie, ktorým sa zrušuje smernica 2001/20/ES;
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.
smernica Komisie 2003/94/ES z 8. októbra 2003, ktorou sa ustanovujú zásady a metodické pokyny správnej výrobnej praxe týkajúcej sa liekov na humánne použitie a skúšaných liekov na humánne použitie;
The European Union shall allow Canada to use the European Union's electronic notification tool for those purposes.
smernica Komisie 91/412/EHS z 23. júla 1991, ktorou sa ustanovujú zásady a pokyny týkajúce sa správnej výrobnej praxe veterinárnych liečiv;
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:
delegované nariadenie Komisie (EÚ) č. 1252/2014 z 28. mája 2014, ktorým sa dopĺňa smernica Európskeho parlamentu a Rady, pokiaľ ide o zásady a usmernenia vzťahujúce sa na správnu výrobnú prax pre účinné látky do liekov na humánne použitie;
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
aktuálna verzia pokynov pre správnu výrobnú prax uvedená vo zväzku IV predpisov týkajúcich sa liekov v Európskej únii a súhrn postupov Spoločenstva v oblasti inšpekcií a výmeny informácií.
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
zákon o potravinách a liečivách (Food and Drugs Act, R.S.C., 1985, c.
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.
F-27).
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.
PRÍLOHA I
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.
Úvodná poznámka
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:
Výhrady k existujúcim opatreniam a liberalizačným záväzkom
the conformity assessment body is established in the territory of the Member State; and
V zozname jednej zo zmluvných strán tejto prílohy sa v článkoch 8.15 (Výhrady a výnimky), 9.7 (Výhrady), 14.4 (Výhrady) a pre Európsku úniu v článku 13.10 (Výhrady a výnimky) stanovujú výhrady danej zmluvnej strany, pokiaľ ide o existujúce opatrenia, ktoré nie sú v súlade s povinnosťami uloženými v týchto článkoch:
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
články 8.6 (Národné zaobchádzanie), 9.3 (Národné zaobchádzanie) alebo pre Európsku úniu článok 13.3 (Národné zaobchádzanie);