natgillin/translations-raw huggingface dataset:
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.
Părțile recunosc următoarele entități, sau succesoarele lor notificate de către o parte grupului sectorial mixt, în calitate de autorități de reglementare respective ale acestora:
Alternative Product-Specific Rules of Origin for Products of heading 87.02
Pentru Uniunea Europeană:
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:
Țară
A change from any other heading, except from heading 87.06 through 87.08; or
Pentru produsele medicamentoase de uz uman
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.
Pentru produsele medicamentoase de uz veterinar
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.
Belgia
Note 2
Agenția Federală pentru Medicamente și Produse de Îngrijire a Sănătății / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé
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.
A se vedea autoritatea responsabilă pentru produsele medicamentoase de uz uman
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.
Institutul de Stat pentru Controlul Medicamentelor/ Státní ústav pro kontrolu léčiv (SÚKL)
The application of cumulation and deletion of Note 2 will be published in the Official Journal of the European Union for information purposes.
Institutul pentru Controlul de Stat al Produselor Biologice și al Medicamentelor de Uz Veterinar / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)
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.
Croația
All the cane or beet sugar must have been refined in Canada
Agenția pentru Produse Medicamentoase și Dispozitive Medicale / Agencija za lijekove i medicinske proizvode (HALMED)
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.
Ministerul Agriculturii, Direcția veterinară și pentru siguranța alimentelor / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane
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.
Autoritatea Daneză pentru Sănătate și Medicamente / Laegemiddelstyrelsen
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.
Institutul Federal pentru Medicamente și Dispozitive Medicale / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
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.
Paul-Ehrlich-Institute (PEI), Institutul Federal pentru Vaccinuri și Medicamente Biologice / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
ANNEX 6
Ministerul Federal al Sănătății / Bundesministerium für Gesundheit (BMG)
JOINT DECLARATION CONCERNING RULES OF ORIGIN FOR TEXTILES AND APPAREL
Biroul Federal pentru Protecția Consumatorilor și Siguranța Alimentară / Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Under this Agreement, trade in textiles and apparel between the Parties is based on the principle that double transformation confers origin, as reflected in Annex 5 (Product-specific rules of origin) of the Protocol on rules of origin and origin procedures.
Ministerul Federal al Alimentației și Agriculturii, Bundesministerium für Ernährung und Landwirtschaft
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.
Agenția de Stat pentru Medicamente / Ravimiamet
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.
Organizația Națională pentru Medicamente / Ethnikos Organismos Farmakon (EOF) – (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ))
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.
Agenția Spaniolă pentru Medicamente și Dispozitive Medicale / Agencia Española de Medicamentos y Productos Sanitários
ANNEX 7
Agenția Națională pentru securitatea medicamentelor și a produselor de îngrijire a sănătății Agence nationale de sécurité du médicament et des produits de santé (ANSM)
JOINT DECLARATIONS CONCERNING THE PRINCIPALITY OF ANDORRA AND THE REPUBLIC OF SAN MARINO
Agenția Națională pentru securitatea sanitară a produselor alimentare, a mediului și a muncii – Agenția Națională pentru medicamente de uz veterinar/ Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
JOINT DECLARATION CONCERNING THE PRINCIPALITY OF ANDORRA
Irlanda
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.
Autoritatea de reglementare a produselor pentru îngrijirea sănătății (HPRA)
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.
Agenția Italiană a Medicamentelor / Agenzia Italiana del Farmaco
JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO
Ministerul Sănătății, Direcția generală pentru sănătatea animalelor și produse medicamentoase de uz veterinar
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.
Ministerul Sănătății – Servicii farmaceutice / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
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.
Ministerul Agriculturii, Dezvoltării Rurale și Mediului- Servicii veterinare / Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
Protocol on the mutual acceptance of the results of conformity assessment
Letonia
Except as otherwise provided, the definitions contained in Annex 1 to the TBT Agreement apply to this Protocol.
Agenția de Stat pentru Medicamente / Zāļu valsts aģentūra
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.
Departamentul de evaluare și înregistrare din cadrul serviciului responsabil de sectoarele alimentar și veterinar/Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
The following additional definitions also apply:
Lituania
accreditation means third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks;
Agenția pentru Controlul de Stat al Medicamentelor / Valstybinė maisto ir veterinarijos tarnyba
accreditation body means an authoritative body that performs accreditation [1];
Serviciul de stat responsabil de sectoarele alimentar și veterinar / Valstybinės maisto ir veterinarijo tarnyba
attestation means the issuing of a statement based on a decision following review, that fulfilment of specified technical requirements has been demonstrated;
Luxemburg
Canadian technical regulation means a technical regulation of Canada's national government or of one or more of its provinces and territories;
Institutul Național de Farmacie/ Országos Gyógyszerészeti Intézet (OGYI)
conformity assessment means a process to determine whether relevant requirements in technical regulations have been fulfilled.
Oficiul național pentru siguranța lanțului alimentar, Direcția pentru produse medicamentoase de uz veterinar / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
For the purpose of this Protocol, conformity assessment does not include accreditation;
Autoritatea de Reglementare a Medicamentelor
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
Secțiunea pentru medicamentele de uz veterinar și hrana animalelor (VMANS) [Direcția pentru reglementare în domeniul veterinar (VRD) din Departamentul pentru reglementare în domeniul veterinar și fitosanitar (VPRD)]
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;
Inspectoratul pentru Asistență Medicală / Inspectie voor de Gezondheidszorg (IGZ)
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;
Consiliul de Evaluare a Medicamentelor / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
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;
Agenția Austriacă pentru Sănătate și Siguranță Alimentară / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
legitimate objective has the same meaning as under Article 2.2 of the TBT Agreement;
Polonia
Mutual Recognition Agreement means the Agreement on Mutual Recognition between the European Community and Canada, done at London on 14 May 1998;
Inspectoratul Principal pentru Produse Farmaceutice / Główny Inspektorat Farmaceutyczny (GIF) /
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;
Autoritatea Națională pentru Medicamente și Produse de Îngrijire a Sănătății / INFARMED, I.P
third-party conformity assessment body means a conformity assessment body that performs third-party conformity assessments.
Direcția Generală pentru Produse Alimentare și Veterinare / DGAV – Direção Geral de Alimentação e Veterinária (PT)
Scope and exceptions
Agenția pentru Produse Medicamentoase și Dispozitive Medicale din Republica Slovenia / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
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.
Republica Slovacă (Slovacia)
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.
Institutul de Stat pentru Controlul Medicamentelor / Štátny ústav pre kontrolu liečiv (ŠÚKL)
Priority categories of goods for consideration are set out in Annex 2.
Institutul pentru Controlul de Stat al Produselor Biologice și al Medicamentelor de Uz Veterinar / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
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.
Finlanda
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.
Agenția Finlandeză pentru Medicamente / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
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.
Agenția pentru Produse Medicale / Läkemedelsverket
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.
Regatul Unit
This Protocol does not apply:
Agenția Bulgară pentru Medicamente / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
to sanitary and phytosanitary measures as defined in Annex A to the SPS Agreement;
Agenția Bulgară pentru Siguranța Alimentară/ Българска агенция по безопасност на храните
to purchasing specifications prepared by a governmental body for production or consumption requirements of that body;
National Agency for Medicines and Medical Devices / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
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;
National Sanitary Veterinary and Food Safety Authority / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
if a Party has delegated exclusive authority to a single non-governmental body to assess conformity of goods with that Party's technical regulations;
Pentru Canada:
to agricultural goods;
LEGISLAȚIA APLICABILĂ
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
Directiva 2001/83/CE a Parlamentului European și a Consiliului din 6 noiembrie 2001 de instituire a unui cod comunitar cu privire la medicamentele de uz uman;
to the statutory inspection and certification of vessels other than recreational craft.
Directiva 2001/82/CE a Parlamentului European și a Consiliului din 6 noiembrie 2001 de instituire a unui cod comunitar cu privire la produsele medicamentoase veterinare;
This Protocol does not require the recognition or acceptance by a Party that the other Party's technical regulations are equivalent to its own.
Directiva 2001/20/CE a Parlamentului European și a Consiliului din 4 aprilie 2001 de apropiere a actelor cu putere de lege și a actelor administrative ale statelor membre privind aplicarea bunelor practici clinice în cazul efectuării de studii clinice pentru evaluarea produselor medicamentoase de uz uman;
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.
Regulamentul (UE) nr.
This Protocol does not affect or modify the laws or obligations in the territory of a Party applicable to civil liability.
536/2014 din 16 aprilie 2014 privind studiile clinice intervenționale cu medicamente de uz uman și de abrogare a Directivei 2001/20/CE;
Recognition of conformity assessment bodies
Directiva 2003/94/CE a Comisiei din 8 octombrie 2003 de stabilire a principiilor și orientărilor privind buna practică de fabricație cu privire la produsele medicamentoase de uz uman și medicamentele experimentale de uz uman;
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:
Directiva 91/412/CEE a Comisiei din 23 iulie 1991 de stabilire a principiilor și a orientărilor de bună practică de fabricație pentru medicamentele de uz veterinar;
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
Regulamentul delegat (UE) nr.
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;
1252/2014 al Comisiei din 28 mai 2014 al Parlamentului European și a Consiliului în ceea ce privește principiile și orientările de bune practici de fabricație pentru substanțele active utilizate în medicamentele de uz uman;
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;
Versiunea actuală a Ghidului de bune practici de fabricație inclusă în volumul IV din Normele de reglementare a medicamentelor în Uniunea Europeană și în colecția de proceduri ale Uniunii Europene privind inspecțiile și schimbul de informații;
there are no unresolved objections pursuant to Article 6;
ANEXA I
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
Notă preliminară
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.
Rezerve pentru măsurile și angajamentele de liberalizare existente
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:
Lista unei părți din prezenta anexă stabilește, în conformitate cu articolul 8.15 (Rezerve și excepții), articolul 9.7 (Rezerve) și articolul 14.4 (Rezerve) și, pentru Uniunea Europeană, articolul 13.10 (Rezerve și excepții), rezervele adoptate de partea respectivă cu privire la măsurile existente care nu se conformează obligațiilor impuse prin:
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;
articolul 8.6 (Tratamentul național) și articolul 9.3 (Tratamentul național) sau, pentru Uniunea Europeană, articolul 13.3 (Tratamentul național);
the third-party conformity assessment body established in Canada is designated by Canada in accordance with the procedures set out in Article 5;
articolul 8.7 (Tratamentul pe baza clauzei națiunii celei mai favorizate) și articolul 9.5 (Tratamentul pe baza clauzei națiunii celei mai favorizate) sau, pentru Uniunea Europeană, articolul 13.4 (Tratamentul pe baza clauzei națiunii celei mai favorizate);
the designation made in accordance with the procedures set out Article 5 is not withdrawn by Canada; and
articolul 8.5 (Cerințe de performanță);
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
articolul 8.8 (Membrii echipei de conducere și consiliile de administrație) sau, pentru Uniunea Europeană, articolul 13.8 (Membrii echipei de conducere și consiliile de administrație); (f) pentru Uniunea Europeană, articolul 13.7 (Prestare transfrontalieră de servicii financiare); sau
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;
articolul 14.3 (Obligații);
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.
și, în anumite cazuri, prevede angajamente pentru o liberalizare imediată sau viitoare.
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
Rezervele uneia dintre părți nu aduc atingere drepturilor și obligațiilor părților în conformitate cu GATS.
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.
Fiecare rezervă include următoarele elemente:
Accreditation of conformity assessment bodies
Sectorul se referă la sectorul general în care rezerva este adoptată;
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.
Subsectorul se referă la sectorul specific în care rezerva este adoptată;
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:
Clasificarea sectorului de activitate se referă, după caz, la activitatea acoperită de rezervă conform CPC, ISIC rev 3.1 sau astfel cum se descrie în mod expres în rezerva uneia dintre părți;