natgillin/translations-raw huggingface dataset:
Pursuant to a request made under paragraph 2, and subject to paragraph 3, a Party shall recognise a competent accreditation body established in the territory of the other Party under conditions no less favourable than those applied to the recognition of accreditation bodies established in its territory.
Državna služba za hrano in veterino /Valstybinės maisto ir veterinarijo tarnyba
The recognising Party shall respond in writing within 60 days to a request made under paragraph 2, and provide the following information in its response:
Luksemburg
that it recognises the nominating Party's accreditation body as competent to accredit conformity assessment bodies for the scope proposed;
Nacionalni inštitut za farmacijo / Országos Gyógyszerészeti Intézet (OGYI)
that it will recognise the nominating Party's accreditation body as competent to accredit conformity assessment bodies for the scope proposed following necessary legislative or regulatory amendments.
Nacionalni urad za varnost živilske verige, direktorat za zdravila za uporabo v veterinarski medicini / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
Such a response must include an explanation of the amendments required and an estimate of the period of time required for the entry into force of the amendments;
Regulativni organ za zdravila / Medicines Regulatory Authority
that the nominating Party failed to provide the information described in paragraph 2.
Oddelek za zdravila za uporabo v veterinarski medicini in prehrano živali (VMANS), direktorat za veterinarsko ureditev (VRD) v okviru oddelka za veterinarsko in fitosanitarno ureditev / Veterinary Medicines and Animal Nutrition section VMANS) (Veterinary Regulation Directorate (VRD) within The Veterinary and Phytosanitary Regulation Department (VPRD)
Such a response must include a statement of what information is missing; or
Inšpektorat za zdravstveno varstvo / Inspectie voor de Gezondheidszorg (IGZ)
that it does not recognise the nominated accreditation body as competent to accredit conformity assessment bodies for the scope proposed.
Odbor za vrednotenje zdravil /College ter beoordeling van de Geneesmiddelen (CBG)
Such a statement must be justified in an objective and reasoned manner, and state explicitly the conditions under which recognition would be granted.
Avstrijska agencija za zdravje in varnost hrane /Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Each Party shall publish the names of the accreditation bodies of the other Party that it recognises, and for each accreditation body, the scope of the technical regulations for which it recognises that accreditation body.
Poljska
Article 13
Glavni inšpektorat za farmacevtske izdelke /Główny Inspektorat Farmaceutyczny (GIF) /
Cessation of the recognition of accreditation bodies
Nacionalna agencija za zdravila in izdelke za zdravje /INFARMED, I.P
If an accreditation body that is recognised by a Party pursuant to Article 12 ceases to be a signatory of a multilateral or regional arrangement referred to in subparagraph (l) of Article 12.2 or of a cooperation arrangement of the type described in Article 12.3, the recognising Party may cease to recognise that accreditation body as competent, as well as any conformity assessment bodies recognised on the basis that they were accredited solely by that accreditation body.
Generalni direktorat za hrano in veterino / DGAV – Direção Geral de Alimentação e Veterinária (PT)
Challenges to the recognition of accreditation bodies
Slovenija
Without prejudice to Article 13, the recognising Party may challenge the competence of an accreditation body that it has recognised under subparagraphs (a) or (b) of Article 12.5 on the grounds that the accreditation body is no longer competent to accredit conformity assessment bodies as, themselves, competent to assess conformity with the relevant technical regulations of the recognising Party.
Agencija za zdravila in medicinske pripomočke Republike Slovenije / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
The recognising Party shall immediately notify the nominating Party of the challenge and shall justify its reasons in an objective and reasoned manner.
Slovaška (Slovaška)
The Parties shall cooperate and make reasonable efforts to promptly resolve the challenge.
Državni inštitut za nadzor zdravil /Štátny ústav pre kontrolu liečiv (ŠÚKL)
If a cooperation arrangement referred to in Article 12.3 exists, the Parties shall ensure that the European and Canadian accreditation systems or bodies, referred to in Article 12.3, seek to resolve the challenge on behalf of the Parties.
Inštitut za državni nadzor bioloških pripravkov in zdravil za uporabo v veterini /Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
The recognising Party may cease to recognise the nominated accreditation body whose competence is challenged and any conformity assessment bodies recognised on the basis that they were accredited solely by that accreditation body if:
Finska
the Parties, including through the European and Canadian accreditation systems, resolve the challenge by concluding that the recognising Party has raised valid concerns as to the competence of the nominated accreditation body; or
Finska agencija za zdravila /Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
the recognising Party objectively demonstrates to the other Party that the accreditation body is no longer competent to accredit conformity assessment bodies as, themselves, competent to assess conformity with the relevant technical regulations of the recognising Party; and
Agencija za zdravila / Läkemedelsverket
the challenge has not been resolved within 120 days after the nominating Party has been notified of the challenge.
Združeno kraljestvo
Recognition of accreditation bodies in the areas of telecommunications and electromagnetic compatibility
Bolgarija
For technical regulations related to telecommunications terminal equipment, information technology equipment, apparatus used for radio communication, and electromagnetic compatibility, from the date of entry into force of this Protocol, the accreditation bodies recognised by:
Bolgarska agencija za zdravila / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Canada, include:
Bolgarska agencija za varnost hrane / Българска агенция по безопасност на храните
for test laboratories, any national accreditation body of a Member State of the European Union that is a signatory to the ILAC multilateral recognition arrangement; and
Nacionalna agencija za zdravila in medicinske pripomočke / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
for certification bodies, any national accreditation body of a Member State of the European Union that is a signatory to the IAF multilateral recognition arrangement;
Nacionalni sanitarni organ za veterinarstvo in varnost hrane / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
the European Union, include the Standards Council of Canada, or its successor.
Za Kanado:
Transition from the Mutual Recognition Agreement
VELJAVNA ZAKONODAJA
The Parties agree that a conformity assessment body which had been designated under the Mutual Recognition Agreement is automatically a recognised conformity assessment body under this Protocol, on the date of entry into force of this Agreement.
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini;
Communication
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini;
Each Party shall identify contact points responsible for communications with the other Party related to any matter arising under this Protocol.
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi;
The contact points may communicate by electronic mail, video-conferencing or other means on which they decide.
Uredba (EU) št. 536/2014 z dne 16. aprila 2014 o kliničnem preskušanju zdravil za uporabo v humani medicini in razveljavitvi Direktive 2001/20/ES;
Management of this Protocol
Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini, ki so predmet ponovnga preverjanja;
For the purposes of this Protocol, the functions of the Committee on Trade in Goods established under Article 26.2.1 (a) (Specialised Committees) include:
Direktiva Komisije 91/412/EGS z dne 23. julija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini;
managing the implementation of this Protocol;
Delegirana uredba Komisije (EU) št. 1252/2014 z dne 28. maja 2014 o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta v zvezi z načeli in smernicami dobre proizvodne prakse za zdravilne učinkovine zdravil za uporabo v humani medicini;
addressing any matter that a Party may raise related to this Protocol;
Veljavna različica navodil za dobre proizvodne prakse iz zvezka IV pravil, ki urejajo zdravila v Evropski uniji, in zbirka postopkov Skupnosti za inšpekcijske preglede in izmenjavo informacij.
developing recommendations for amendments to this Protocol for consideration by the CETA Joint Committee;
Zakon o hrani in zdravilih, R.S.C., 1985, p.
taking any other step that the Parties consider will assist them in implementing this Protocol; and
F-27.
reporting to the CETA Joint Committee on the implementation of this Protocol, as appropriate.
PRILOGA I
The authority of an accreditation body is generally derived from government.
Uvodna opomba
PRODUCT COVERAGE
Pridržki za obstoječe ukrepe in zaveze glede liberalizacije
Electrical and electronic equipment, including electrical installations and appliances, and related components;
Na seznamu pogodbenice, priloženem tej prilogi, so v skladu s členom 8.15 (Pridržki in izjeme), členom 9.7 (Pridržki), členom 14.4.
Radio and telecommunications terminal equipment;
(Pridržki) in, za Evropsko unijo, členom 13.10 (Pridržki in izjeme) navedeni pridržki, ki jih je ta pogodbenica sprejela glede obstoječih ukrepov, ki niso v skladu z obveznostmi, naloženimi s:
Electromagnetic compatibility (EMC);
členom 8.6 (Nacionalna obravnava), členom 9.3 (Nacionalna obravnava) ali, za Evropsko unijo, členom 13.3.
Toys;
(Nacionalna obravnava);
Construction products;
členom 8.7 (Obravnava po načelu največjih ugodnosti), členom 9.5 (Obravnava po načelu največjih ugodnosti) ali, za Evropsko unijo, členom 13.4.
Machinery, including parts, components, including safety components, interchangeable equipment, and assemblies of machines;
(Obravnava po načelu največjih ugodnosti);
Measuring instruments;
členom 8.4 (Dostop do trga), členom 9.6 (Dostop do trga) ali, za Evropsko unijo, členom 13.6.
Hot-water boilers, including related appliances;
(Dostop do trga);
Equipment, machines, apparatus, devices, control components, protection systems, safety devices, controlling devices and regulating devices, and related instrumentation and prevention and detection systems for use in potentially explosive atmospheres (ATEX equipment);
členom 8.5 (Operativne zahteve);
Equipment for use outdoors as it relates to noise emission in the environment; and
členom 8.8.
Recreational craft, including their components.
(Višji vodstveni položaji in upravni odbori) ali, za Evropsko unijo, členom 13.8 (Višji vodstveni položaji in upravni odbori);
PRIORITY CATEGORIES OF GOODS FOR CONSIDERATION FOR INCLUSION IN ANNEX 1 PURSUANT TO ARTICLE 2.2
za Evropsko unijo, členom 13.7 (Čezmejno zagotavljanje finančnih storitev); ali
Medical devices including accessories;
členom 14.3 (Obveznosti);
Pressure equipment, including vessels, piping, accessories and assemblies;
v nekaterih primerih pa so navedene zaveze za takojšnjo ali prihodnjo liberalizacijo.
Appliances burning gaseous fuels, including related fittings;
Pridržki pogodbenice ne posegajo v pravice in obveznosti pogodbenic na podlagi Splošnega sporazuma o trgovini s storitvami (v nadaljnjem besedilu: GATS).
Personal protective equipment;
Vsak pridržek vsebuje naslednje elemente:
Rail systems, subsystems and interoperability constituents; and
sektor se nanaša na splošni sektor, znotraj katerega je sprejet pridržek;
Equipment placed on board a ship
podsektor se nanaša na posebni sektor, znotraj katerega je sprejet pridržek;
INFORMATION TO BE INCLUDED AS PART OF A DESIGNATION
klasifikacija dejavnosti se nanaša, kjer je to primerno, na dejavnost, zajeto v pridržku v skladu s CPC, ISIC rev.
The information that a Party must provide when designating a conformity assessment body is as follows:
3.1 ali kakor je izrecno drugače opisano v pridržku pogodbenice;
in all cases:
vrsta pridržka podrobneje določa obveznost iz odstavka 1, za katero je sprejet pridržek;
the scope of designation (not to exceed that body's scope of accreditation);
raven upravljanja navaja raven upravljanja, ki ohranja ukrep, za katerega je sprejet pridržek;
the accreditation certificate and the related scope of accreditation;
ukrepi opredeljujejo zakone ali druge ukrepe, kakor so opredeljeni, če je to navedeno, z elementom opis, za katere je sprejet pridržek.
the body's address and contact information; and
Ukrep, naveden v elementu ukrepi:
when a Member State of the European Union designates a certification body, except for in regards to the technical regulations described in Article 15:
pomeni ukrep, kakor je bil spremenjen, podaljšan ali obnovljen z datumom začetka veljavnosti tega sporazuma;
the certification body's registered certification mark, including the qualifying statement [1]; and
vključuje kateri koli podrejen ukrep, sprejet ali ohranjen v okviru zadevnega ukrepa in skladen z njim; ter
when a Member State of the European Union designates a conformity assessment body in regards to technical regulations described in Article 15:
vključuje:
in the case of a certification body:
za direktivo Evropske unije, katere koli zakone ali druge ukrepe, s katerimi se direktiva izvaja na ravni države članice; in
its unique identifier [2];
za Kanado, katere koli zakone ali druge ukrepe na nacionalni ali podnacionalni ravni, s katerimi se izvajajo sporazumi med zvezno vlado ter provincami in ozemlji; ter
an application for recognition signed by the body in accordance with CB-01 (Requirements for Certification Bodies), or its successor; and
opis določa neskladne vidike obstoječega ukrepa, za katere je sprejet pridržek.
a cross reference checklist completed by the body with evidence that it meets the applicable recognition criteria in accordance with CB-02 (Recognition Criteria, and Administrative and Operational Requirements Applicable to Certification Bodies (CB) for the Certification of Radio Apparatus to Industry Canada's Standards and Specifications), or its successor; and
Določa lahko tudi zaveze za liberalizacijo.
in the case of a testing laboratory:
V razlagi pridržka se preučijo vsi elementi pridržka.
its unique identifier; and
Pridržek se razlaga ob upoštevanju ustreznih obveznosti iz poglavij, za katere je pridržek sprejet.
an application for recognition signed by the body in accordance with REC-LAB (Procedure for the Recognition of Designated Foreign Testing Laboratories by Industry Canada), or its successor; and
V obsegu, v katerem:
any other information as may be jointly decided upon by the Parties.
je element ukrepi opredeljen z zavezo o liberalizaciji iz elementa opis; tako opredeljen element ukrepi prevlada nad vsemi drugimi elementi;
The qualifying statement normally takes the form of a small ‘c’ placed beside the certification body's registered certification mark to indicate that a product conforms with applicable Canadian technical regulations.
če pa element ukrepi ni tako opredeljen, element ukrepi prevlada nad drugimi elementi, razen če se razhajanje med elementom ukrepi in drugimi elementi v celoti šteje za tako bistveno in pomembno, da bi bilo nerazumno skleniti, da element ukrepi prevlada, in sicer v tem primeru drugi elementi prevladajo v obsegu tega razhajanja.
Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
Kadar pogodbenica ohrani ukrep, ki kot pogoj za ponudbo storitev na njenem ozemlju zahteva, da je ponudnik storitev fizična oseba, državljan, stalni rezident ali rezident na njenem ozemlju, pridržek za ta ukrep, sprejet v zvezi sčezmejno trgovino s storitvami, deluje kot pridržek v zvezi z naložbami, v obsegu tega ukrepa.
certificate of GMP compliance means a certificate issued by a regulatory authority attesting to the compliance of a manufacturing facility with Good Manufacturing Practices (GMP);
Pridržek za ukrep, ki kot pogoj za ponudbo finančnih storitev na ozemlju pogodbenice zahteva, da je ponudnik storitev fizična oseba, državljan, stalni rezident ali rezident na njenem ozemlju, sprejet v zvezi s členom 13.7 (Čezmejno zagotavljanje finančnih storitev), deluje kot pridržek v zvezi s členom 13.3 (Nacionalna obravnava), členom 13.4 (Obravnava po načelu največjih ugodnosti), členom 13.6 (Dostop do trga) in členom 13.8 (Višji vodstveni položaji in upravni odbori), v obsegu tega ukrepa.
equivalent authority means a regulatory authority of a Party that is recognised as an equivalent authority by the other Party;
Za namene te priloge, vključno s seznamom vsake pogodbenice, priloženim tej prilogi:
manufacturing includes fabrication, packaging, re-packaging, labelling, testing and storage;
ISIC rev.
medicinal product or drug means any product qualifying as a drug under the Food and Drugs Act, R.S.C., 1985, c.
3.1 pomeni Mednarodno standardno klasifikacijo gospodarskih dejavnosti, kot je določena v Statističnem uradu Združenih narodov, Statistične listine, serije M, št. 4, ISIC rev.
F-27 or qualifying as a medicinal product, whether it is a finished, intermediate or an investigational product or an active substance under the applicable legislation of the European Union;
3.1, 2002.
on-site evaluation means a product-specific evaluation conducted in the context of a marketing application for a medicinal product or drug at the site of manufacture to assess the conformity of the premises where the medicinal product or drug is manufactured, the conformity of the process, conditions and control of manufacture with the information submitted, and to address any outstanding issues from the evaluation of the marketing application; and
Na seznamu Evropske unije, priloženem tej prilogi, se uporabljajo naslednje kratice:
regulatory authority means an entity in a Party that has the legal right, under the law of the Party, to supervise and control medicinal products or drugs within that Party.
EU Evropska unija
Unless specified otherwise, where this Protocol refers to inspections, these references do not include on-site evaluations.
NL Nizozemska
The objective of this Protocol is to strengthen the cooperation between the authorities of the Parties in ensuring that medicinal products and drugs meet appropriate quality standards through the mutual recognition of certificates of GMP compliance.
SK Slovaška
Product scope
Seznam Kanade – zvezni
This Protocol applies to all medicinal products or drugs to which GMP requirements apply in both Parties, as set out in Annex 1.
Pridržki, ki veljajo v Kanadi
Recognition of regulatory authorities
(veljajo v vseh provincah in na vseh ozemljih)
The procedure for evaluating the equivalency of a new regulatory authority listed in Annex 2 shall be conducted in accordance with Article 12.
Pridržek I-C-1
Each Party shall ensure that a list of regulatory authorities that it recognises as equivalent, including any modifications, is publicly available.
Sektor:
Mutual recognition of certificates of GMP compliance
Podsektor:
A Party shall accept a certificate of GMP compliance issued by an equivalent regulatory authority of the other Party, in conformity with paragraph 3, as demonstrating that the manufacturing facility, that is covered by the certificate and located in the territory of either Party, complies with the good manufacturing practices identified in the certificate.
Klasifikacija dejavnosti:
A Party may accept a certificate of GMP compliance issued by an equivalent regulatory authority of the other Party with respect to a manufacturing facility outside the territory of the Parties, in conformity with paragraph 3.
Vrsta pridržka:
A Party may determine the terms and conditions upon which it chooses to accept the certificate.
Raven upravljanja:
A certificate of GMP compliance must identify:
Nacionalna
the name and address of the manufacturing facility;
Ukrepi:
the date on which the equivalent regulatory authority that issued the certificate last inspected the manufacturing facility;
Opis:
the manufacturing processes and if relevant, medicinal products or drugs and dosage forms for which the facility is in compliance with good manufacturing practices; and
Razen v primerih iz odstavkov 3 in 7 bo direktor za naložbe pregledal neposredno „pridobitev nadzora“, kakor je opredeljena v Investment Canada Act, nad kanadsko družbo s strani vlagatelja iz Evropske unije, če vrednost kanadske družbe ni nižja od 1,5 milijarde CAD, vključno s prilagoditvijo v skladu z veljavno metodologijo v januarju vsakega naslednjega leta, kakor je določeno v Investment Canada Act.
the validity period of the certificate of GMP compliance.
Ne glede na opredelitev pojma „vlagatelj“ iz člena 8.1 (Opredelitev pojmov) so lahko samo vlagatelji, ki so državljani Evropske unije, ali entitete, ki so pod nadzorom državljanov Evropske unije, kakor je določeno v Investment Canada Act, upravičeni do višjega praga za pregled.
If an importer, an exporter or a regulatory authority of a Party requests a certificate of GMP compliance for a manufacturing facility that is certified by an equivalent authority of the other Party, the other Party shall ensure that the equivalent regulatory authority issues a certificate of GMP compliance:
Višji prag iz odstavka 1 ne velja za neposredno pridobitev nadzora nad kanadsko družbo s strani družbe v državni lasti.
within 30 calendar days of the date on which the certifying authority received the request for the certificate, if a new inspection is not required; and
Take pridobitve so predmet pregleda direktorja za naložbe, če vrednost kanadske družbe ni nižja od 369 milijonov CAD v letu 2015, vključno s prilagoditvijo v skladu z veljavno metodologijo v januarju vsakega naslednjega leta, kot je določeno v Investment Canada Act.
within 90 calendar days of the date on which the certifying authority received the request for the certificate, if a new inspection is required, and the manufacturing facility passes the inspection.
Naložba, ki je predmet pregleda v okviru Investment Canada Act, se lahko izvede le, če minister, ki je pristojen za Investment Canada Act,vložnika obvesti, da bo naložba Kanadi prinesla neto koristi.
Other recognition of certificates of GMP compliance
Ta ugotovitev temelji na šestih dejavnikih, opisanih v zgoraj navedenem aktu, ki so povzeti na naslednji način:
A Party may accept a certificate of GMP compliance with respect to a medicinal product or drug that is not included in paragraph 2 of Annex 1.
učinek naložbe na raven in naravo gospodarske dejavnosti v Kanadi, vključno z učinkom na zaposlovanje, uporabo delov, sestavnih delov in storitev, zagotovljenih v Kanadi, in na izvoz iz Kanade;
A Party that accepts a certificate under paragraph 1 may determine the terms and conditions under which it will accept the certificate.
stopnja in pomen udeležbe kanadskih subjektov pri naložbi;
Acceptance of batch certificates
učinek naložbe na produktivnost, učinkovitost na ravni industrije, tehnološki razvoj in inovacije izdelkov v Kanadi;
A Party shall accept a batch certificate issued by a manufacturer without re-control of that batch at import provided that:
učinek naložbe na konkurenco znotraj industrije v Kanadi;