natgillin/translations-raw huggingface dataset:
Except for customs procedures, a Party shall ensure that activities performed by market surveillance or enforcement authorities for the inspection or verification of conformity with applicable technical regulations for products assessed by a recognised conformity assessment body established in the territory of the other Party or an in-house body which meets the conditions of Article 10, are conducted under conditions no less favourable than those conducted with respect to products assessed by conformity assessment bodies in the territory of the recognising Party.
Selle halduskokkuleppe suhtes ei kohaldata 29. peatükki („Vaidluste lahendamine“).
The Parties shall co-operate as necessary in the conduct of these activities.
Käesoleva artikli kohaldamisel hõlmab tasu selliseid kulude tagasisaamise meetmeid nagu kasutustasu, seadusjärgne kulu ja lepingujärgsed summad.
If a product's placement or use on the market could compromise the fulfilment of a legitimate objective, a Party may adopt or maintain measures with respect to that product provided that they are consistent with this Agreement.
Lepinguosalisel on õigus määrata oma territooriumil tegutsevate tootmisasutuste suhtes kohaldatavaid tasusid, sh headele tootmistavadele vastavuse sertifikaatide välja andmisega seotud tasud ja inspekteerimise või kohapealse hindamisega seotud tasud.
These measures can include withdrawing the product from the market, prohibiting its placement or use on the market or restricting its movement on the market.
Tootmisasutuselt lepinguosalise poolt teise lepinguosalise taotlusel tehtava inspekteerimise või kohapealse hindamise eest nõutavad tasud peavad olema kooskõlas lõikega 2.
A Party that adopts or maintains such measures shall promptly inform the other Party and, at the request of the other Party, provide its reasons for adopting or maintaining these measures.
RAVIMID
A Party shall, upon receipt of a written complaint by the other Party, which must be supported by evidence, that products assessed by a conformity assessment body that the Party designated do not comply with applicable technical regulations:
Kohaldamisalasse kuuluvad ravimid
promptly seek additional information from the designated conformity assessment body, its accreditation body and relevant operators when necessary;
Käesolevat protokolli kohaldatakse lepinguosaliste 3. lisas osutatud õigusaktides määratletud järgmiste ravimite suhtes eeldusel, et mõlema lepinguosalise heade tootmistavade nõuded ja headele tootmistavadele vastavuse programmid on nende ravimite puhul samaväärsed:
investigate the complaint; and
inimestel kasutatavad ravimid, sealhulgas retseptiravimid ja käsimüügiravimid, ja ravigaasid;
provide the other Party with a written reply to the complaint.
inimestel kasutatavad bioloogilised ravimid, sealhulgas immunoloogilised ravimid, inimverest või -plasmast saadud stabiilsed ravimid ja bioloogilise ravi vahendid;
A Party may take the actions in paragraph 3 through an accreditation body.
inimestel kasutatavad radiofarmatseutilised ravimid;
Recognition of accreditation bodies
veterinaarravimid, sealhulgas retseptiravimid ja käsimüügiravimid, ja veterinaarsete ravimsöötade valmistamisel kasutatavad eelsegud;
A Party (‘recognising Party’) may, in accordance with the procedure described under paragraphs 2 and 3, recognise an accreditation body established in the territory of the other Party (‘nominating Party’) as competent to accredit conformity assessment bodies as, themselves, competent to assess conformity with the relevant technical regulations of the recognising Party.
bioloogilised veterinaarravimid;
The nominating Party may request that the other Party recognise an accreditation body established on its territory as competent by providing a notification to the recognising Party that includes the following information regarding that accreditation body (‘nominated accreditation body’):
vajaduse korral vitamiinid, mineraalid, taimsed ravimid ja homöopaatilised preparaadid;
its name, address and contact details;
ravimite toimeained;
evidence that its authority is derived from the government;
vahesaadused ja pakkimata ravimid (näiteks lahtised tabletid);
whether it acts on a non-commercial and non-competitive basis;
kliinilistes uuringutes kasutamiseks ette nähtud tooted või uuritavad ravimid; ning
evidence of its independence from the conformity assessment bodies it assesses and from commercial pressures, in order to ensure that no conflicts of interest with conformity assessment bodies occur;
uudsed ravimid.
evidence that it is organised and operated so as to safeguard the objectivity and impartiality of its activities and the confidentiality of the information it obtains;
Tegevuslikku kohaldamisalasse kuuluvad ravimid
evidence that each decision relating to the attestation of competence of conformity assessment bodies is taken by a competent person different from those who carry out the assessment;
Lõikes 1 sätestatule lisandub, et mõlema lepinguosalise heade tootmistavade nõuded ja headele tootmistavadele vastavuse programmid on samaväärsed järgmiste ravimite puhul:
the scope for which its recognition is requested;
inimestel kasutatavad bioloogilised ravimid, sealhulgas immunoloogilised ravimid ja bioloogilise ravi vahendid;
evidence of its competence to accredit conformity assessment bodies within the scope for which its recognition is requested, referring to applicable international standards, guides and recommendations, and applicable European or Canadian standards, technical regulations and conformity assessment procedures;
vahesaadused ja pakkimata ravimid;
evidence of its internal procedures to ensure efficient management and appropriate internal controls, including the procedures in place for documenting the duties, responsibilities and authorities of personnel who can affect the quality of the assessment as well as the attestation of competence;
kliinilistes uuringutes kasutamiseks ette nähtud tooted või uuritavad ravimid, mille on tootnud tootjad, kellel on tootmisluba või asutamisluba; ning
evidence of the number of competent personnel at its disposal, which should be sufficient for the proper performance of its tasks, and of the procedures in place for monitoring the performance and competence of the personnel involved in the accreditation process;
Kanada puhul vitamiinid, mineraalid ja taimsed ravimid, homöopaatilised preparaadid (Kanadas tuntud looduslike tervisetoodetena), mille on tootnud tootjad, kellel on tootmisluba või asutamisluba.
whether or not it is appointed for the scope for which its recognition is requested in the territory of the nominating Party;
REGULEERIVAD ASUTUSED
evidence of its status as a signatory to the International Laboratory Accreditation Cooperation (‘ILAC’) or International Accreditation Forum (‘IAF’) multilateral recognition arrangements and to any related regional recognition arrangements; and
Lepinguosalised tunnustavad vastavate samaväärsete reguleerivate asutustena järgmisi üksusi või, kui lepinguosaline on valdkondlikku ühiskomiteed järglasest teavitanud, nende järglasi:
any other information that the Parties may decide is necessary.
Euroopa Liidu puhul:
The Parties recognise that differences may exist between their respective standards, technical regulations and conformity assessment procedures.
Riik
When such differences exist, the recognising Party may seek to satisfy itself that the nominated accreditation body is competent to accredit conformity assessment bodies as competent to assess conformity with the relevant technical regulations of the recognising Party.
Inimravimite puhul
The recognising Party may satisfy itself based on the following:
Veterinaarravimite puhul
an arrangement establishing cooperation between the European and Canadian accreditation systems;
Belgia
or, in the absence of such an arrangement,
Ravimite ja tervisetoodete föderaalne asutus / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé
a cooperation arrangement between the nominated accreditation body and an accreditation body recognised as competent by the recognising Party.
Vt vastutavat asutust inimravimite veerust
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.
Ravimikontrolli riiklik instituut / Státní ústav pro kontrolu léčiv (SÚKL)
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:
Veterinaarbiovalmististe ja -ravimite riikliku kontrolli instituut / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)
that it recognises the nominating Party's accreditation body as competent to accredit conformity assessment bodies for the scope proposed;
Horvaatia
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.
Ravimite ja meditsiiniseadmete amet / Agencija za lijekove i medicinske proizvode (HALMED)
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;
Põllumajandusministeerium, veterinaaria ja toiduohutuse direktoraat / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane
that the nominating Party failed to provide the information described in paragraph 2.
Taani ravimiamet / Laegemiddelstyrelsen
Such a response must include a statement of what information is missing; or
Föderaalne ravimi- ja meditsiiniseadmete instituut / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
that it does not recognise the nominated accreditation body as competent to accredit conformity assessment bodies for the scope proposed.
Paul Ehrlichi Instituut (PEI) – vaktsiinide ja bioravimite föderaalne instituut / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Such a statement must be justified in an objective and reasoned manner, and state explicitly the conditions under which recognition would be granted.
Federal Ministry of Health / Bundesministerium für Gesundheit (BMG)
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.
Tarbijakaitse ja toiduohutuse föderaalamet / Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Article 13
Toidu ja põllumajanduse föderaalministeerium / Bundesministerium für Ernährung und Landwirtschaft
Cessation of the recognition of accreditation bodies
Eesti
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.
Ravimiamet
Challenges to the recognition of accreditation bodies
Riiklik Ravimiorgan /Ethnikos Organismos Farmakon (EOF) – (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ))
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.
Hispaania ravimite ja meditsiiniseadmete asutus / Agencia Española de Medicamentos y Productos Sanitários
The recognising Party shall immediately notify the nominating Party of the challenge and shall justify its reasons in an objective and reasoned manner.
Prantsusmaa riiklik ravimite ja tervishoiutoodete ohutuse amet Agence nationale de sécurité du médicament et des produits de santé (ANSM)
The Parties shall cooperate and make reasonable efforts to promptly resolve the challenge.
Prantsusmaa toidu, keskkonna ja töö sanitaarohutuse riiklik amet Veterinaarravimite riiklik amet / Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
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.
Iirimaa
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:
Tervisetooteid reguleeriv asutus / Health Products Regulatory Authority (HPRA)
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
Itaalia ravimiamet / Agenzia Italiana del Farmaco
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
Loomatervise ja veterinaarmeditsiinitoodete peadirektoraat
the challenge has not been resolved within 120 days after the nominating Party has been notified of the challenge.
Tervishoiuministeerium – ravimiteenused / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
Recognition of accreditation bodies in the areas of telecommunications and electromagnetic compatibility
Põllumajandus-, maaelu arendamise ja keskkonnaministeerium – Veterinaariteenused / Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
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:
Läti
Canada, include:
Ravimiamet / Zāļu valsts aģentūra
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
Toidu- ja veterinaarteenistuse hindamis- ja registreerimisosakond / Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
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;
Leedu
the European Union, include the Standards Council of Canada, or its successor.
Riiklik ravimikontrolliamet / Valstybinė maisto ir veterinarijos tarnyba
Transition from the Mutual Recognition Agreement
Riiklik toidu- ja veterinaarteenistus / Valstybinės maisto ir veterinarijo tarnyba
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.
Luksemburg
Communication
Minìstère de la Santé, Division de la Pharmacie et des Médicaments
Each Party shall identify contact points responsible for communications with the other Party related to any matter arising under this Protocol.
Riiklik farmaatsiainstituut / Országos Gyógyszerészeti Intézet (OGYI)
The contact points may communicate by electronic mail, video-conferencing or other means on which they decide.
Riiklik toiduahela ohutuse büroo, veterinaarmeditsiinitoodete direktoraat / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
Management of this Protocol
Ravimivaldkonna reguleeriv asutus
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:
Veterinaarravimite ja loomasööda sektsioon (veterinaarregulatsiooni direktoraat (VRD), mis kuulub Veterinaar- ja fütosanitaarmeetmete osakonda (VPRD)
managing the implementation of this Protocol;
Tervishoiuinspektsioon / Inspectie voor de Gezondheidszorg (IGZ)
addressing any matter that a Party may raise related to this Protocol;
Ravimite hindamise nõukogu / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
developing recommendations for amendments to this Protocol for consideration by the CETA Joint Committee;
Austria tervise- ja toiduohutuse amet / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
taking any other step that the Parties consider will assist them in implementing this Protocol; and
Poola
reporting to the CETA Joint Committee on the implementation of this Protocol, as appropriate.
Ravimite peainspektsioon / Główny Inspektorat Farmaceutyczny (GIF) /
The authority of an accreditation body is generally derived from government.
Ravimite ja tervishoiutoodete riiklik amet / INFARMED, I.P
PRODUCT COVERAGE
Toidu ja veterinaaria direktoraat / DGAV – Direção Geral de Alimentação e Veterinária (PT)
Electrical and electronic equipment, including electrical installations and appliances, and related components;
Sloveenia
Radio and telecommunications terminal equipment;
Sloveenia Vabariigi ravimite ja meditsiiniseadmete amet Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
Electromagnetic compatibility (EMC);
Slovaki Vabariik (Slovakkia)
Toys;
Ravimikontrolli riiklik instituut / Štátny ústav pre kontrolu liečiv (ŠÚKL)
Construction products;
Bioloogiliste veterinaarravimite ja ravimite riikliku kontrolli instituut / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
Machinery, including parts, components, including safety components, interchangeable equipment, and assemblies of machines;
Soome
Measuring instruments;
Soome ravimiamet / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
Hot-water boilers, including related appliances;
Ravimiamet / Läkemedelsverket
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);
Ühendkuningriik
Equipment for use outdoors as it relates to noise emission in the environment; and
Bulgaaria
Recreational craft, including their components.
Bulgaaria ravimiamet / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
PRIORITY CATEGORIES OF GOODS FOR CONSIDERATION FOR INCLUSION IN ANNEX 1 PURSUANT TO ARTICLE 2.2
Bulgaaria toiduohutusamet / Българска агенция по безопасност на храните
Medical devices including accessories;
Ravimite ja meditsiiniseadmete asutus / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
Pressure equipment, including vessels, piping, accessories and assemblies;
Riiklik veterinaaria ja toiduohutusamet / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
Appliances burning gaseous fuels, including related fittings;
Kanada puhul:
Personal protective equipment;
KOHALDATAVAD ÕIGUSAKTID
Rail systems, subsystems and interoperability constituents; and
Euroopa Parlamendi ja nõukogu 6. novembri 2001. aasta direktiiv 2001/83/EÜ inimtervishoius kasutatavaid ravimeid käsitlevate ühenduse eeskirjade kohta;
Equipment placed on board a ship
Euroopa Parlamendi ja nõukogu 6. novembri 2001. aasta direktiiv 2001/82/EÜ veterinaarravimeid käsitlevate ühenduse eeskirjade kohta;
INFORMATION TO BE INCLUDED AS PART OF A DESIGNATION
Euroopa Parlamendi ja nõukogu 4. aprilli 2001. aasta direktiiv 2001/20/EÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta, mis käsitlevad hea kliinilise tava rakendamist inimtervishoius kasutatavate ravimite kliinilistes uuringutes;
The information that a Party must provide when designating a conformity assessment body is as follows:
Euroopa Parlamendi ja nõukogu 16. aprilli 2014. aasta määrus (EL) nr 536/2014, milles käsitletakse inimtervishoius kasutatavate ravimite kliinilisi uuringuid ja millega tunnistatakse kehtetuks direktiiv 2001/20/EÜ;
in all cases:
komisjoni 8. oktoobri 2003. aasta direktiiv 2003/94/EÜ, millega kehtestatakse inimestele mõeldud ravimite ning inimestele mõeldud uuritavate ravimite hea tootmistava põhimõtted ja suunised;
the scope of designation (not to exceed that body's scope of accreditation);
komisjoni 23. juuli 1991. aasta direktiiv 91/412/EMÜ, millega kehtestatakse veterinaarravimite hea tootmistava põhimõtted ja suunised;
the accreditation certificate and the related scope of accreditation;
komisjoni 28. mai 2014. aasta delegeeritud määrus (EL) nr 1252/2014, millega täiendatakse Euroopa Parlamendi ja nõukogu direktiivi 2001/83/EÜ seoses inimtervishoius kasutatavate ravimite toimeainete head tootmistava käsitlevate põhimõtete ja suunistega;
the body's address and contact information; and
Euroopa Liidu ravimieeskirjade IV osas esitatud heade tootmistavade juhiste kehtiv versioon ning ühenduse inspekteerimis- ja teabevahetusmenetluste kogumik.
when a Member State of the European Union designates a certification body, except for in regards to the technical regulations described in Article 15:
Food and Drugs Act, R.S.C., 1985, ptk F-27.
the certification body's registered certification mark, including the qualifying statement [1]; and
I LISA
when a Member State of the European Union designates a conformity assessment body in regards to technical regulations described in Article 15:
Märkus
in the case of a certification body:
Kehtivate meetmetega seotud reservatsioonid ja liberaliseerimiskohustused
its unique identifier [2];
Käesolevas lisas sisalduvas lepinguosalise loetelus esitatakse artiklites 8.15 ( Reservatsioonid ja erandid), 9.7 (Reservatsioonid), 14.4 (Reservatsioonid) ja Euroopa Liidu puhul artiklis 13.10 (Reservatsioonid ja erandid) kõnealuse osapoole poolt kehtivate meetmete suhtes võetud reservatsioonid, mis ei ole kooskõlas järgmiste artiklitega kehtestatud kohustustega:
an application for recognition signed by the body in accordance with CB-01 (Requirements for Certification Bodies), or its successor; and
artikkel 8.6 (Võrdne kohtlemine), artikkel 9.3 (Võrdne kohtlemine) või Euroopa Liidu puhul artikkel 13.3 (Võrdne kohtlemine);
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
artikkel 8.7 (Enamsoodustusrežiim), artikkel 9.5 (Enamsoodustusrežiim) või Euroopa Liidu puhul artikkel 13.4 (Enamsoodustusrežiim);
in the case of a testing laboratory:
artikkel 8.4 (Turulepääs), artikkel 9.6 (Turulepääs) või Euroopa Liidu puhul artikkel 13.6 (Turulepääs);
its unique identifier; and
artikkel 8.5 (Tulemuslikkusnõuded);
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
artikkel 8.8 (Kõrgem juhtkond ja juhatus) või Euroopa Liidu puhul artikkel 13.8 (Kõrgem juhtkond ja juhatus);
any other information as may be jointly decided upon by the Parties.
Euroopa Liidu puhul artikkel 13.7 (Finantsteenuste piiriülene osutamine); või
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.
artikkel 14.3 (Kohustused);