natgillin/translations-raw huggingface dataset:
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.
enakovredni organ pomeni regulativni organ pogodbenice, ki ga druga pogodbenica priznava kot enakovreden organ;
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.
proizvodnja vključuje izdelavo, pakiranje, prepakiranje, označevanje, preskušanje in skladiščenje;
JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO
zdravilo pomeni vsak izdelek, ki se uvršča med zdravila v skladu z zakonom o hrani in zdravilih (Food and Drugs Act), R.S.C., 1985, 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.
F-27, ali veljavno zakonodajo Evropske unije, in sicer kot končni izdelek, vmesni izdelek ali izdelek v preskušanju ali kot zdravilna učinkovina;
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.
vrednotenje na kraju samem pomeni posebno vrednotenje za izdelek, opravljeno v okviru vloge za pridobitev dovoljenja za promet z zdravilom na kraju proizvodnje, da se oceni skladnost prostorov, v katerih se zdravilo proizvaja, skladnost postopka, pogojev in nadzora nad proizvodnjo s predloženimi informacijami ter obravnavajo morebitna odprta vprašanja iz vrednotenja vloge za pridobitev dovoljenja za promet z zdravilom; ter
Protocol on the mutual acceptance of the results of conformity assessment
regulativni organ pomeni subjekt pogodbenice, ki ima v skladu z njenim pravom zakonito pravico, da v njej nadzira in kontrolira zdravila.
Except as otherwise provided, the definitions contained in Annex 1 to the TBT Agreement apply to this Protocol.
Kadar se ta protokol sklicuje na inšpekcijske preglede, ti sklici ne vključujejo vrednotenja na kraju samem, če ni določeno drugače.
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.
Cilj tega protokola je okrepiti sodelovanje med organi pogodbenic pri zagotavljanju, da zdravila dosegajo ustrezne standarde kakovosti, z vzajemnim priznavanjem potrdil o skladnosti z dobrimi proizvodnimi praksami.
The following additional definitions also apply:
Zajeti proizvodi
accreditation means third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks;
Ta protokol se uporablja za vsa zdravila, za katera v obeh pogodbenicah veljajo zahteve glede dobre proizvodne prakse, kakor so navedene v Prilogi 1.
accreditation body means an authoritative body that performs accreditation [1];
Priznavanje regulativnih organov
attestation means the issuing of a statement based on a decision following review, that fulfilment of specified technical requirements has been demonstrated;
Postopek vrednotenja enakovrednosti novega regulativnega organa, navedenega v Prilogi 2, se opravi v skladu s členom 12.
For the purpose of this Protocol, conformity assessment does not include accreditation;
Pogodbenica sprejme potrdilo o skladnosti z dobrimi proizvodnimi praksami, ki ga je izdal enakovredni regulativni organ druge pogodbenice, skladno z odstavkom 3, kot dokaz, da je proizvodni obrat, na katerega se potrdilo nanaša in ki se nahaja na ozemlju ene od pogodbenic, skladen z dobrimi proizvodnimi praksami, opredeljenimi v potrdilu.
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
Pogodbenica lahko sprejme potrdilo o skladnosti z dobrimi proizvodnimi praksami, ki ga je izdal enakovredni regulativni organ druge pogodbenice v zvezi s proizvodnim obratom zunaj ozemlja pogodbenic, skladno z odstavkom 3.
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;
Pogodbenica lahko določi pogoje, pod katerimi sprejme potrdilo.
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;
Potrdilo o skladnosti z dobrimi proizvodnimi praksami mora vsebovati:
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;
ime in naslov proizvodnega obrata;
legitimate objective has the same meaning as under Article 2.2 of the TBT Agreement;
datum, na katerega je enakovredni regulativni organ, ki je izdal potrdilo, proizvodni obrat nazadnje pregledal;
Mutual Recognition Agreement means the Agreement on Mutual Recognition between the European Community and Canada, done at London on 14 May 1998;
proizvodne procese, in če je primerno, zdravila in farmacevtske oblike, v zvezi s katerimi je obrat skladen z dobrimi proizvodnimi praksami, in
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;
obdobje veljavnosti potrdila o skladnosti z dobrimi proizvodnimi praksami.
third-party conformity assessment body means a conformity assessment body that performs third-party conformity assessments.
Če uvoznik, izvoznik ali regulativni organ pogodbenice zahteva potrdilo o skladnosti z dobrimi proizvodnimi praksami za proizvodni obrat, ki ga je potrdil enakovredni organ druge pogodbenice, druga pogodbenica zagotovi, da enakovredni regulativni organ izda potrdilo o skladnosti z dobrimi proizvodnimi praksami:
Scope and exceptions
v 30 koledarskih dneh od datuma, ko je certifikacijski organ prejel zahtevek za potrdilo, če ni potreben nov inšpekcijski pregled, in
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.
v 90 koledarskih dneh od datuma, ko je certifikacijski organ prejel zahtevek za potrdilo, če je potreben nov inšpekcijski pregled in ga proizvodni obrat uspešno opravi.
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.
Drugo priznavanje potrdil o skladnosti z dobrimi proizvodnimi praksami
Priority categories of goods for consideration are set out in Annex 2.
Pogodbenica lahko sprejme potrdilo o skladnosti z dobrimi proizvodnimi praksami za zdravilo, ki ni vključeno v odstavek 2 Priloge 1.
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.
Pogodbenica, ki sprejme potrdilo iz odstavka 1, lahko določi pogoje, pod katerimi bo potrdilo sprejela.
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.
Sprejemanje certifikata serije
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.
Pogodbenica sprejme certifikat serije, ki ga je izdal proizvajalec, brez ponovnega nadzora zadevne serije ob uvozu, če:
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.
so bili izdelki v seriji proizvedeni v proizvodnem obratu, ki ga je enakovredni regulativni organ potrdil kot skladen;
This Protocol does not apply:
je certifikat serije skladen z vsebino certifikata serije za zdravila iz mednarodno usklajenih zahtev za potrjevanje serij in
to sanitary and phytosanitary measures as defined in Annex A to the SPS Agreement;
ga je podpisala oseba, pristojna za sprostitev serije v prodajo ali dobavo.
to purchasing specifications prepared by a governmental body for production or consumption requirements of that body;
Odstavek 1 ne vpliva na pravico pogodbenice, da izvede uradno sprostitev serije.
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;
Oseba, odgovorna za sprostitev serije:
if a Party has delegated exclusive authority to a single non-governmental body to assess conformity of goods with that Party's technical regulations;
končanega zdravila za prodajo ali dobavo proizvodnim obratom v Evropski uniji, mora biti „usposobljena oseba“, kakor je opredeljena v členu 48 Direktive 2001/83/ES in členu 52 Direktive 2001/82/ES, ali
to agricultural goods;
zdravila v prodajo ali dobavo proizvodnim obratom v Kanadi, je oseba, ki vodi oddelek za nadzor kakovosti, kakor je opredeljeno v predpisih za hrano in zdravila, C.R.C., p. 870, del C, oddelek 2, razdelek C.02.014.
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
Vrednotenje na kraju samem
to the statutory inspection and certification of vessels other than recreational craft.
Pogodbenica ima pravico sama opraviti vrednotenje na kraju samem za proizvodni obrat, ki ga je enakovredni regulativni organ druge pogodbenice potrdil kot skladen.
This Protocol does not require the recognition or acceptance by a Party that the other Party's technical regulations are equivalent to its own.
Preden pogodbenica opravi vrednotenje na kraju samem iz odstavka 1, o tem pisno obvesti drugo pogodbenico in ji sporoči, kakšen je obseg vrednotenja na kraju samem.
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.
Pogodbenica si prizadeva pisno obvestiti drugo pogodbenico vsaj 30 dni pred predlaganim vrednotenjem na kraju samem, v nujnih primerih pa je to obdobje lahko krajše.
This Protocol does not affect or modify the laws or obligations in the territory of a Party applicable to civil liability.
Druga pogodbenica se ima pravico pridružiti vrednotenju na kraju samem, ki ga opravi pogodbenica.
Recognition of conformity assessment bodies
Inšpekcijski pregledi in vrednotenja na kraju samem na zahtevo pogodbenice
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:
Na zahtevo pogodbenice druga pogodbenica pregleda obrat, vključen v proizvodni proces zdravila, ki se uvaža na ozemlje pogodbenice, ki je zahtevo vložila, da preveri, ali je obrat skladen z dobrimi proizvodnimi praksami.
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
Na zahtevo pogodbenice lahko druga pogodbenica opravi vrednotenje na kraju samem na podlagi ocene podatkov iz predložitvene dokumentacije zdravila.
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;
Pogodbenici si lahko izmenjata ustrezne informacije o zdravilu v zvezi z zahtevo po izvedbi vrednotenja na kraju samem v skladu s členom 14.
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;
Zaščitni ukrepi
there are no unresolved objections pursuant to Article 6;
Pogodbenica ima pravico sama opraviti inšpekcijski pregled proizvodnega obrata, ki ga je enakovredni regulativni organ zadevne pogodbenice potrdil kot skladen.
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
Uporaba te pravice bi morala biti le izjema od običajne prakse pogodbenice.
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.
Preden pogodbenica opravi inšpekcijski pregled v skladu z odstavkom 1, o tem pisno obvesti drugo pogodbenico in ji sporoči razloge, zakaj ga želi opraviti sama.
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:
Pogodbenica si prizadeva pisno obvestiti drugo pogodbenico vsaj 30 dni pred predlaganim inšpekcijskim pregledom, v nujnih primerih pa je to obdobje lahko krajše.
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;
Druga pogodbenica se ima pravico pridružiti inšpekcijskemu pregledu, ki ga opravi pogodbenica.
the third-party conformity assessment body established in Canada is designated by Canada in accordance with the procedures set out in Article 5;
Dvosmerni program opozarjanja in izmenjava informacij
the designation made in accordance with the procedures set out Article 5 is not withdrawn by Canada; and
Pogodbenica skladno z dvosmernim programom opozarjanja v skladu z upravnim dogovorom o dobrih proizvodnih praksah, navedenega v členu 15.3:
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
zagotovi, da zadevni regulativni organ na njenem ozemlju obvesti zadevni regulativni organ na ozemlju druge pogodbenice o omejitvi, prekinitvi ali umiku dovoljenja za proizvodnjo, ki bi lahko vplival na varovanje javnega zdravja, in
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;
če je potrebno, drugo pogodbenico proaktivno pisno obvesti o potrjenem poročilu o resni težavi, povezani s proizvodnim obratom na njenem ozemlju, ali kakor je bila ugotovljena z vrednotenjem na kraju samem ali inšpekcijskim pregledom na ozemlju druge pogodbenice, vključno s težavo, povezano s slabo kakovostjo, odpoklici serij, ponarejenimi ali lažnimi zdravili oziroma morebitnimi resnimi pomanjkljivostmi.
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.
Pogodbenica kot del sestavin postopka za izmenjavo informacij iz upravnega dogovora o dobrih proizvodnih praksah, navedenega v členu 15.3:
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
odgovori na poseben zahtevek za informacije, vključno z razumnim zahtevkom za poročilo o inšpekcijskem pregledu ali poročilo o vrednotenju na kraju samem, in
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.
zagotovi, da enakovredni organ na njenem ozemlju zagotovi ustrezne informacije na zahtevo druge pogodbenice ali enakovrednega organa druge pogodbenice.
Accreditation of conformity assessment bodies
Pogodbenica drugo pogodbenico pisno obvesti o kontaktnih točkah za vsak enakovreden organ na svojem ozemlju.
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.
Enakovrednost novih regulativnih organov
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:
Pogodbenica (v nadaljnjem besedilu: pogodbenica, ki vloži zahtevo) lahko zahteva vrednotenje regulativnega organa na svojem ozemlju, ki ni priznan kot enakovreden regulativnim organom druge pogodbenice (v nadaljnjem besedilu: pogodbenice, ki vrednoti), da se ugotovi, ali bi ga bilo treba priznati kot enakovrednega.
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;
Pogodbenica, ki vrednoti, po prejetju zahteve opravi vrednotenje v skladu s postopkom za vrednotenje novih regulativnih organov iz upravnega dogovora o dobrih proizvodnih praksah, navedenega v členu 15.3.
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;
Pogodbenica, ki vrednoti, ovrednoti novi regulativni organ, tako da uporabi sestavine programa skladnosti z dobrimi proizvodnimi praksami v skladu z upravnim dogovorom, navedenim v členu 15.3.
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.
Sestavine programa skladnosti z dobrimi proizvodnimi praksami morajo vključevati elemente, kot so zakonodajne in regulativne zahteve, inšpekcijski standardi, nadzorni sistemi in sistem upravljanja kakovosti.
Designation of conformity assessment bodies
Če pogodbenica, ki vrednoti, po koncu vrednotenja ugotovi, da je novi regulativni organ enakovreden, pogodbenico, ki vloži zahtevo, pisno obvesti, da novi regulativni organ priznava kot enakovreden.
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.
Če pogodbenica, ki vrednoti, po koncu vrednotenja ugotovi, da novi regulativni organ ni enakovreden, pogodbenici, ki vloži zahtevo, predloži pisno obrazložitev, s katero dokaže, da ima utemeljene razloge, zakaj novega regulativnega organa ne priznava kot enakovrednega.
The European Union shall allow Canada to use the European Union's electronic notification tool for those purposes.
Skupna področna skupina za zdravila (v nadaljnjem besedilu: skupna področna skupina) iz člena 15 na zahtevo pogodbenice, ki vloži zahtevo, preuči zavrnitev pogodbenice, ki vrednoti, da bi novi regulativni organ priznala kot enakovreden, in lahko pripravi priporočila v pomoč pogodbenicama pri reševanju zadeve.
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:
Če pogodbenica, ki vrednoti, po koncu vrednotenja ugotovi, da je novi regulativni organ enakovreden samo za bolj omejeno področje uporabe, kot ga je predlagala pogodbenica, ki vloži zahtevo, prvonavedena pogodbenica predloži drugonavedeni pisno obrazložitev, s katero dokaže, da ima utemeljene razloge za ugotovitev, da je novi regulativni organ enakovreden samo za bolj omejeno področje uporabe.
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
Skupna področna skupina na zahtevo pogodbenice, ki vloži zahtevo, preuči zavrnitev pogodbenice, ki vrednoti, da bi novi regulativni organ priznala kot enakovreden, in lahko pripravi priporočila v pomoč pogodbenicama pri reševanju zadeve.
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
Regulativni organ, priznan kot enakovreden v skladu s Sporazumom o vzajemnem priznavanju med Evropsko skupnostjo in Kanado, sklenjenim 14. maja 1998 v Londonu, je priznan kot enakovreden v skladu s tem sporazumom od začetka njegove veljavnosti.
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.
Program ohranjanja enakovrednosti