natgillin/translations-raw huggingface dataset:
The Parties shall deem the applicable requirements of Article R17 of Annex I to Decision 768/2008/EC to be met when the conformity assessment body is accredited pursuant to either procedure described in subparagraph 2(b) and if the accreditation body requires, as a condition for granting the accreditation, that the conformity assessment body meet requirements equivalent to the applicable requirements of Article R17 of Annex I to Decision 768/2008/EC or the corresponding requirements in successor instruments.
Skupna področna skupina razvije program ohranjanja enakovrednosti v skladu z upravnim dogovorom o dobrih proizvodnih praksah, navedenim v členu 15.3, da ohrani enakovrednost regulativnih organov.
If the European Union considers revising the requirements set out in Article R17 of Annex I to Decision 768/2008/EC, it shall consult Canada at the earliest stage of, and throughout, the review process with a view to ensuring that conformity assessment bodies in the territory of Canada continue to meet any revised requirements on no less favourable conditions than conformity assessment bodies in the territory of the European Union.
Ko se pogodbenici odločata, ali naj spremenita status enakovrednosti regulativnega organa, ravnata v skladu s tem programom.
A Member State of the European Union shall only designate a conformity assessment body that meets the following conditions and shall take reasonable measures to ensure that the conditions continue to be met:
Če se status enakovrednosti regulativnega organa spremeni, ga lahko pogodbenica znova ovrednoti.
the conformity assessment body is established in the territory of the Member State; and
Vsako ponovno vrednotenje je treba opraviti v skladu s postopkom iz člena 12.
the conformity assessment body is accredited, by an accreditation body recognised by Canada, as competent to assess conformity with the Canadian technical regulations for which the conformity assessment body is being designated; or
Obseg ponovnega vrednotenja je omejen na elemente, zaradi katerih se je status enakovrednosti spremenil.
the conformity assessment body is accredited, by an accreditation body established in the European Union that has been recognised pursuant to Article 12 or 15, as competent to assess conformity with the Canadian technical regulations for which the conformity assessment body is being designated.
Pogodbenici si izmenjata vse potrebne informacije za zagotovitev, da obe ostaneta prepričani, da so enakovredni regulativni organi dejansko enakovredni.
A Party may refuse to recognise a conformity assessment body that does not meet the conditions in paragraph 2 or 5, as the case may be.
Pogodbenica obvesti drugo pogodbenico, preden sprejme spremembe svojih tehničnih smernic ali predpisov, ki se nanašajo na dobre proizvodne prakse.
Objections to the designation of conformity assessment bodies
Pogodbenica obvesti drugo pogodbenico o novih tehničnih smernicah, inšpekcijskih postopkih ali predpisih, ki se nanašajo na dobre proizvodne prakse.
A Party may object to the designation of a conformity assessment body, within 30 days of the notification by the other Party pursuant to Article 5.1, if:
Pogodbenica javno ne razkriva nejavnih in zaupnih tehničnih, poslovnih ali znanstvenih informacij, vključno s poslovnimi skrivnostmi in lastniškimi informacijami, ki jih je prejela od druge pogodbenice.
the Party which designated the conformity assessment body failed to provide the information described in Annex 3; or
Pogodbenica lahko razkrije informacije iz odstavka 1, če meni, da je tako razkritje potrebno za zaščito javnega zdravja in varnosti.
the Party has reasons to believe that the conformity assessment body that is designated does not meet the conditions described in Article 5.2 or 5.5.
Pred razkritjem se posvetuje z drugo pogodbenico.
Following any subsequent transmission of information by the other Party, a Party may object within 30 days of the receipt of that information, if the information remains insufficient to demonstrate that the designated conformity assessment body meets the conditions described in Article 5.2 or 5.5.
Upravljanje Protokola
Challenges to designations of conformity assessment bodies
Skupna področna skupina, ustanovljena v skladu s členom 26.2.1(a) (Specializirani odbori), je sestavljena iz predstavnikov obeh pogodbenic.
A Party which has recognised a conformity assessment body under this Protocol may challenge the competence of that conformity assessment body if:
Skupna področna skupina sama določi svojo sestavo in poslovnik ter postopke dela.
the Party which designated the conformity assessment body failed to take the actions required by Article 11.3, following a notification by the other Party of the non-conformity with applicable technical regulations of a product that had been assessed as being in conformity with these technical regulations by that conformity assessment body; or
Skupna področna skupina sklene upravni dogovor o dobrih proizvodnih praksah, da olajša učinkovito izvajanje tega protokola.
the Party has reasons to believe that the results of conformity assessment activities performed by that conformity assessment body do not provide sufficient assurances that the products assessed by that body as conforming with applicable technical regulations are in fact in conformity with these technical regulations.
Upravni dogovor o dobrih proizvodnih praksah vključuje:
A Party which challenges the competence of a recognised conformity assessment body under this Protocol shall immediately notify the Party which designated the conformity assessment body of the challenge, and provide the reasons for the challenge.
pristojnosti skupne področne skupine;
A Party that:
dvosmerni program opozarjanja;
has challenged the competence of a recognised conformity assessment body under this Protocol; and
seznam kontaktnih točk, odgovornih za zadeve, ki izhajajo iz tega protokola;
has well-founded reasons to believe that the products assessed to be in conformity with applicable technical regulations by that conformity assessment body may fail to conform to its technical regulations,
sestavine postopka za izmenjavo informacij;
may refuse to accept the results of that conformity assessment body's conformity assessment activities until the challenge is resolved or the recognising Party has ceased to recognise the conformity assessment body in accordance with paragraph 5.
sestavine programa skladnosti z dobrimi proizvodnimi praksami;
The Parties shall cooperate and make reasonable efforts to resolve the challenge promptly.
postopek vrednotenja novih regulativnih organov in
Without prejudice to paragraph 3, the recognising Party may cease to recognise the conformity assessment body whose competence is challenged if:
program ohranjanja enakovrednosti.
the Parties resolve the challenge by concluding that the recognising Party has raised valid concerns as to the competence of the conformity assessment body;
Skupna področna skupina lahko spremeni upravni dogovor o dobrih proizvodnih praksah, če se ji to zdi potrebno.
the Party which designated the conformity assessment body failed to complete the actions required by Article 11.3 within 60 days after being notified pursuant to subparagraph 1(a); or
Skupna področna skupina na zahtevo pogodbenic pregleda priloge k temu protokolu in razvije priporočila za spremembe teh prilog, ki se predložijo v preučitev Skupnemu odboru CETA.
the recognising Party objectively demonstrates to the other Party that the results of conformity assessment activities performed by that conformity assessment body do not provide sufficient assurance that the products assessed by it as conforming with the applicable technical regulations are in fact in conformity with these technical regulations; and
Skupna področna skupina v skladu z odstavkom 5 pregleda operativno področje uporabe zdravil iz odstavka 2 Priloge 1, da bi zadevna zdravila vključila v odstavek 1 Priloge 1.
the challenge has not been resolved within 120 days after the Party that had designated the conformity assessment body has been notified of the challenge pursuant to paragraph 1.
Pogodbenici ob začetku veljavnosti sporazuma sprejmeta upravni dogovor o dobrih proizvodnih praksah.
Withdrawals of conformity assessment bodies
Za ta dogovor ne veljajo določbe poglavja devetindvajset (Reševanje sporov).
A Party shall withdraw the designation, or modify the scope of the designation, as appropriate, of a conformity assessment body it has designated if the Party becomes aware that:
Za namene tega člena pristojbina vključuje ukrep za povračilo stroškov, kot so uporabnina, regulativna taksa ali s pogodbo določen znesek.
the conformity assessment body's scope of accreditation has been reduced;
Pogodbenica ima pravico določiti pristojbino, ki velja za proizvodne obrate na njenem ozemlju, vključno s pristojbinami, ki se nanašajo na izdajanje potrdil o skladnosti z dobrimi proizvodnimi praksami, in pristojbinami v zvezi z inšpekcijskimi pregledi ali vrednotenji na kraju samem.
the conformity assessment body's accreditation lapses;
Pristojbine, zaračunane proizvodnemu obratu v primeru inšpekcijskega pregleda ali vrednotenja na kraju samem, ki ga pogodbenica opravi na zahtevo druge pogodbenice, morajo biti skladne z odstavkom 2.
the conformity assessment body no longer meets the other conditions described in Article 5.2 or 5.5; or
ZDRAVILA
the conformity assessment body is no longer willing, or is otherwise no longer competent or able, to assess conformity within the scope for which it was designated.
Zajeta zdravila
A Party shall notify the other Party, in writing, of a withdrawal or modification of the scope of a designation under paragraph 1.
Ta protokol se uporablja za naslednja zdravila, kot so opredeljena v zakonodaji pogodbenic, navedeni v Prilogi 3, če so zahteve glede dobrih proizvodnih praks in programi skladnosti obeh pogodbenic z dobrimi proizvodnimi praksami v zvezi s temi zdravili enakovredni:
When a Party withdraws the designation or modifies the scope of the designation of a conformity assessment body owing to concerns about the competence or the continued fulfilment by that conformity assessment body of the requirements and responsibilities to which it is subject under Article 5, it shall communicate the reasons for its decision in writing to the other Party.
zdravila za uporabo v humani mediciji, vključno z zdravili na recept in brez recepta, in medicinske pline;
When communicating with the other Party, a Party shall indicate the date as of which it considers that any of the conditions or concerns enumerated under paragraphs 1 or 3 may have applied to the conformity assessment body.
zdravila za uporabo v humani medicini, ki je snov biološkega izvora, vključno z imunološkimi snovmi, stabilnimi medicinskimi proizvodi, pridobljenimi iz človeške krvi ali plazme, in bioterapevtike;
Without prejudice to Article 7.5, the recognising Party may immediately cease to recognise a conformity assessment body as competent if:
radiofarmake za humano rabo;
the conformity assessment body voluntarily withdraws its recognition;
zdravila za uporabo v veterinarski medicini, vključno z zdravili na recept in brez recepta, in premikse za pripravo veterinarsko medicirane krme;
the designation of the conformity assessment body is withdrawn pursuant to this Article;
zdravila živalskega izvora za uporabo v veterinarski medicini;
the conformity assessment body ceases to be established in the territory of the other Party; or
kjer je primerno vitamine, minerale, zdravila rastlinskega izvora in homeopatska zdravila;
the recognising Party ceases to recognise the accreditation body that accredited the conformity assessment body pursuant to Article 13 or 14.
zdravilne učinkovine;
Acceptance of the results of conformity assessment by recognised conformity assessment bodies
polizdelke in farmacevtske izdelke v razsutem stanju (na primer tablete v zbirni embalaži);
A Party shall accept the results of conformity assessment activities performed by conformity assessment bodies established in the other Party's territory which the Party recognises in accordance with Article 3 under conditions no less favourable than those applied to the results of conformity assessment activities performed by recognised conformity assessment bodies in its territory.
zdravila za uporabo pri kliničnih preskušanjih ali zdravila, ki so predmet ponovnega preverjanja in
The Party shall accept these results regardless of the nationality and location of the supplier or manufacturer, or of the country of origin of the product for which the conformity assessment activities are performed.
zdravila za napredno zdravljenje.
If a Party has ceased to recognise a conformity assessment body established in the territory of the other Party, it may cease to accept the results of conformity assessment activities performed by that conformity assessment body from the date when it ceased to recognise that conformity assessment body.
Operativno področje uporabe zdravil
Unless the Party has reasons to believe that the conformity assessment body established in the territory of the other Party was not competent to assess conformity of products with the technical regulations of the Party prior to the date when the Party ceased to recognise that conformity assessment body, the Party shall continue to accept the results of conformity assessment activities performed by that conformity assessment body prior to the date when the Party ceased to recognise the conformity assessment body, even though the products may have been placed on the market of the Party after that date.
Poleg odstavka 1 so zahteve glede dobrih proizvodnih praks in programi skladnosti obeh pogodbenic z dobrimi proizvodnimi praksami enakovredni za naslednja zdravila:
Acceptance of results of conformity assessment by in-house bodies established in Canada
zdravila za uporabo v humani medicini, ki je snov biološkega izvora, vključno z imunološkimi snovmi in bioterapevtiki;
The European Union shall accept the results of conformity assessment activities performed by an accredited in-house body established in Canada under conditions no less favourable than those applied to the results of conformity assessment activities performed by an accredited in-house body established in the territory of one of the Member States of the European Union, provided that:
polizdelke in zdravila v razsutem stanju;
the in-house body established in Canada is accredited, by an accreditation body that has been appointed by one of the Member States of the European Union, as competent to assess conformity with those technical regulations; or
izdelke za uporabo pri kliničnih preskušanjih ali zdravila, ki so predmet ponovnega preverjanja, ki so jih proizvedli proizvajalci z dovoljenjem za proizvodnjo ali ustanovitev, ter
the in-house body established in Canada is accredited, by an accreditation body that has been recognised pursuant to Article 12 or 15 as competent to assess conformity with those technical regulations.
vitamine, minerale in zdravila rastlinskega izvora, homeopatska zdravila (ki so v Kanadi znana kot naravni izdelki za zdravje), ki so jih proizvedli proizvajalci z dovoljenjem za proizvodnjo ali ustanovitev, v primeru Kanade.
If, at the date of entry into force of this Agreement, Canada has no conformity assessment procedure providing for conformity assessment activities to be performed by in-house bodies and after the date of entry into force of this Agreement, Canada considers developing conformity assessment procedures providing for conformity assessment activities to be performed by in-house bodies, it shall consult the European Union at the earliest stage of, and throughout the rule-making process with a view to ensuring that in-house bodies established in the European Union can meet any requirements laid down in those provisions on no less favourable conditions than in-house bodies established in Canada.
REGULATIVNI ORGANI
Results pursuant to paragraphs 1 and 2 shall be accepted regardless of the country of origin of the product for which the conformity assessment activities were performed.
Pogodbenici priznavata naslednje subjekte ali njihove naslednike, ki jih je pogodbenica priglasila Skupni področni skupini, kot svoje zadevne regulativne organe:
Market surveillance, enforcement and safeguards
Za Evropsko unijo:
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.
Država
The Parties shall co-operate as necessary in the conduct of these activities.
Za zdravila za uporabo v humani medicini
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.
Zdravila za uporabo v veterinarski medicini
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.
Belgija
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.
Zvezna agencija za zdravila in izdelke za zdravje / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé
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:
Glej odgovorni organ za zdravila za humano rabo
promptly seek additional information from the designated conformity assessment body, its accreditation body and relevant operators when necessary;
Državni inštitut za nadzor zdravil / Státní ústav pro kontrolu léčiv (SÚKL)
investigate the complaint; and
Inštitut za državni nadzor veterinarskih bioloških pripravkov in zdravil / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)
provide the other Party with a written reply to the complaint.
Hrvaška
A Party may take the actions in paragraph 3 through an accreditation body.
Agencija za zdravila in medicinske izdelke / Agencija za lijekove i medicinske proizvode (HALMED)
Recognition of accreditation bodies
Ministrstvo za kmetijstvo, uprava za veterino in varnost hrane / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane
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.
Danska uprava za zdravje in zdravila / Laegemiddelstyrelsen
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’):
Zvezni inštitut za zdravila in medicinske izdelke / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
its name, address and contact details;
Zvezni urad za varstvo potrošnikov in varnost hrane /Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
evidence that its authority is derived from the government;
Zvezno ministrstvo za hrano in kmetijstvo / Bundesministerium für Ernährung und Landwirtschaft
whether it acts on a non-commercial and non-competitive basis;
Estonija
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;
Državna agencija za zdravila / Ravimiamet
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;
Nacionalna organizacija za zdravila /Ethnikos Organismos Farmakon (EOF) – (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ))
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;
Španska agencija za zdravila in medicinske izdelke /Agencia Española de Medicamentos y Productos Sanitários
the scope for which its recognition is requested;
Francoska nacionalna agencija za zdravila in varnost izdelkov za zdravje Agence nationale de sécurité du médicament et des produits de santé (ANSM)
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;
Francoska agencija za varnost hrane in okolja ter varnost pri delu – nacionalna agencija za zdravila za uporabo v veterinarski medicini /Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
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;
Irska
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;
Regulativni organ za izdelke za zdravje / Health Products Regulatory Authority (HPRA)
whether or not it is appointed for the scope for which its recognition is requested in the territory of the nominating Party;
Italijanska agencija za zdravila/ Agenzia Italiana del Farmaco
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
Generalna direkcija za zdravje živali in zdravila za uporabo v veterinarski medicini
any other information that the Parties may decide is necessary.
Ministrstvo za zdravje – farmacevtske službe /Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
The Parties recognise that differences may exist between their respective standards, technical regulations and conformity assessment procedures.
Ministrstvo za kmetijstvo, razvoj podeželja in okolje – Veterinarske službe /Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
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.
Latvija
The recognising Party may satisfy itself based on the following:
Državna agencija za zdravila / Zāļu valsts aģentūra
an arrangement establishing cooperation between the European and Canadian accreditation systems;
Oddelek za oceno in registracijo pri službi za hrano in veterino / Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
or, in the absence of such an arrangement,
Litva
a cooperation arrangement between the nominated accreditation body and an accreditation body recognised as competent by the recognising Party.
Državna agencija za nadzor zdravil /Valstybinė maisto ir veterinarijos tarnyba