natgillin/translations-raw huggingface dataset:
the third-party conformity assessment body established in Canada is designated by Canada in accordance with the procedures set out in Article 5;
lääkkeiden vaikuttavat aineet;
the designation made in accordance with the procedures set out Article 5 is not withdrawn by Canada; and
välituotteet ja irtovalmisteena olevat lääkkeet (esimerkiksi irtovalmisteena olevat tabletit);
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
kliinisissä tutkimuksissa käytettäviksi tarkoitetut valmisteet tai tutkimuslääkkeet; ja
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;
pitkälle kehitetyssä terapiassa käytettävät lääkkeet.
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.
Toiminnalliseen soveltamisalaan kuuluvat lääkkeet
Each Party shall maintain and publish a list of recognised conformity assessment bodies which includes the scope for which each body is recognised.
Viitaten 1 kohtaan molempien osapuolten ohjelmat, jotka koskevat hyviin tuotantotapoihin liittyviä vaatimuksia ja hyvien tuotantotapojen noudattamista, ovat vastaavat seuraavien lääkkeiden osalta:
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.
ihmisille tarkoitetut biologiset valmisteet, mukaan lukien immunologiset valmisteet ja bioterapeuttiset valmisteet;
Accreditation of conformity assessment bodies
välituotteet ja irtovalmisteena olevat lääkkeet;
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.
kliinisissä tutkimuksissa käytettäviksi tarkoitetut valmisteet tai tutkimuslääkkeet; valmistajalla on valmistuslupa tai laitokselle myönnetty lupa; ja
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:
vitamiinit, kivennäisaineet, rohdosvalmisteet, homeopaattiset lääkkeet (Kanadassa nimeltään ”natural health products”), joiden valmistajalla on valmistuslupa tai, Kanadassa, laitokselle myönnetty lupa (”establishment licence”).
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;
SÄÄNTELYVIRANOMAISET
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;
Osapuolet tunnustavat seuraavat yksiköt tai niiden seuraajat, jotka osapuoli on ilmoittanut alakohtaiselle sekaryhmälle, vastaaviksi sääntelyviranomaisikseen:
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.
Euroopan unioni:
Designation of conformity assessment bodies
Maa
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.
Ihmisille tarkoitettujen lääkkeiden osalta
The European Union shall allow Canada to use the European Union's electronic notification tool for those purposes.
Eläimille tarkoitettujen lääkkeiden osalta
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:
Belgia
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
Lääkkeistä ja terveystuotteista vastaava liittovaltion virasto / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten / Agence fédérale des médicaments et produits de santé
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
Ks. ihmisille tarkoitetuista lääkkeistä vastaava viranomainen
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.
Valtion lääkevalvontavirasto / Státní ústav pro kontrolu léčiv (SÚKL)
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.
Eläimille tarkoitettujen lääkkeiden ja biologisten valmisteiden valvontainstituutti / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL)
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.
Kroatia
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:
Lääkkeiden ja lääkinnällisten laitteiden virasto / Agencija za lijekove i medicinske proizvode (HALMED)
the conformity assessment body is established in the territory of the Member State; and
Maatalousministeriö, eläinlääkinnän ja elintarviketurvallisuuden osasto / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane
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
Tanskan terveys- ja lääkevirasto / Laegemiddelstyrelsen
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.
Lääkkeistä ja lääkinnällisistä laitteista vastaava Saksan liittotasavallan laitos / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
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.
Paul-Ehrlich-Institute (PEI), Rokotteista ja biolääkkeistä vastaava Saksan liittotasavallan laitos / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Objections to the designation of conformity assessment bodies
Saksan liittovaltion terveysministeriö/ Bundesministerium für Gesundheit (BMG)
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:
Saksan liittotasavallan kuluttajansuoja- ja elintarviketurvallisuusvirasto Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
the Party which designated the conformity assessment body failed to provide the information described in Annex 3; or
Saksan liittovaltion elintarvike- ja maatalousministeriö / Bundesministerium für Ernährung und Landwirtschaft
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.
Viro
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.
Valtion lääkevirasto / Ravimiamet
Challenges to designations of conformity assessment bodies
Kansallinen lääkelaitos / Ethnikos Organismos Farmakon (EOF) – (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ))
A Party which has recognised a conformity assessment body under this Protocol may challenge the competence of that conformity assessment body if:
Lääkkeistä ja lääkinnällisistä laitteista vastaava Espanjan virasto / Agencia Española de Medicamentos y Productos Sanitários
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
Lääkkeiden ja terveystuotteiden turvallisuudesta vastaava Ranskan kansallinen virasto Agence nationale de sécurité du médicament et des produits de santé (ANSM)
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.
Elintarvike-, ympäristö- sekä työterveys- ja työturvallisuusasioista vastaava Ranskan virasto –Eläinlääkkeistä vastaava kansallinen virasto / Agence Nationale de Sécurité Sanitaire de l'alimentation, de l'environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV)
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.
Irlanti
A Party that:
Terveydenhoitotuotteiden sääntelyviranomainen / Health Products Regulatory Authority (HPRA)
has challenged the competence of a recognised conformity assessment body under this Protocol; and
Italian lääkevirasto / Agenzia Italiana del Farmaco
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,
Eläinten terveydestä ja eläinlääkkeistä vastaava pääosasto
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.
Terveysministeriö – Apteekkipalvelut / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
The Parties shall cooperate and make reasonable efforts to resolve the challenge promptly.
Maataloudesta, maaseudun kehittämisestä ja ympäristöstä vastaava ministeriö – Eläinlääkintäpalvelut / Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος
Without prejudice to paragraph 3, the recognising Party may cease to recognise the conformity assessment body whose competence is challenged if:
Valtion lääkevirasto / Zāļu valsts aģentūra
the Parties resolve the challenge by concluding that the recognising Party has raised valid concerns as to the competence of the conformity assessment body;
Elintarvike- ja eläinlääkintäviraston arviointi- ja rekisteröintiosasto / Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments
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
Liettua
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
Valtion lääkevalvontavirasto / Valstybinė maisto ir veterinarijos tarnyba
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.
Valtion elintarvike- ja eläinlääkintävirasto / Valstybinės maisto ir veterinarijo tarnyba
Withdrawals of conformity assessment bodies
Luxemburg
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:
Terveysministeriö, Apteekki- ja lääkejaosto / Minìstere de la Santé, Division de la Pharmacie et des Médicaments
the conformity assessment body's scope of accreditation has been reduced;
Kansallinen farmasialaitos / Országos Gyógyszerészeti Intézet (OGYI)
the conformity assessment body's accreditation lapses;
Kansallisen elintarvikeketjun turvallisuuden toimisto, eläinlääkeosasto / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI)
the conformity assessment body no longer meets the other conditions described in Article 5.2 or 5.5; or
Lääkealan sääntelyviranomainen / Medicines Regulatory Authority
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.
Eläinlääkkeistä ja eläinten ravitsemuksesta vastaava jaosto / Veterinary Medicines and Animal Nutrition section VMANS Eläinlääkintälainsäädännöstä vastaava osasto / Veterinary Regulation Directorate (VRD), Eläinlääkintä- ja kasvinsuojelulainsäädännöstä vastaava laitos / The Veterinary and Phytosanitary Regulation Department (VPRD)
A Party shall notify the other Party, in writing, of a withdrawal or modification of the scope of a designation under paragraph 1.
Terveydenhuollon tarkastusvirasto / Inspectie voor de Gezondheidszorg (IGZ)
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.
Lääkkeiden arvioinnista vastaava lautakunta / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG)/
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.
Terveydestä ja elintarviketurvallisuudesta vastaava Itävallan virasto / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Without prejudice to Article 7.5, the recognising Party may immediately cease to recognise a conformity assessment body as competent if:
Puola
the conformity assessment body voluntarily withdraws its recognition;
Valtion lääkevalvontaviranomainen / Główny Inspektorat Farmaceutyczny (GIF) /
the designation of the conformity assessment body is withdrawn pursuant to this Article;
Kansallinen lääke- ja terveystuoteviranomainen / INFARMED, I.P
the conformity assessment body ceases to be established in the territory of the other Party; or
Elintarvikkeista ja eläinlääkinnästä vastaava pääosasto / DGAV – Direção Geral de Alimentação e Veterinária (PT)
the recognising Party ceases to recognise the accreditation body that accredited the conformity assessment body pursuant to Article 13 or 14.
Slovenian tasavallan lääkkeiden ja lääkinnällisten laitteiden virasto / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)
Acceptance of the results of conformity assessment by recognised conformity assessment bodies
Slovakian tasavalta (Slovakia)
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.
Valtion lääkevalvontavirasto / Štátny ústav pre kontrolu liečiv (ŠÚKL)
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.
Eläimille tarkoitettujen lääkkeiden ja biologisten valmisteiden valvontainstituutti Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
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.
Suomi
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.
Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)
Acceptance of results of conformity assessment by in-house bodies established in Canada
Ruotsin lääkevirasto / Läkemedelsverket
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:
Yhdistynyt kuningaskunta
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
Bulgarian lääkevirasto / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
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.
Bulgarian elintarviketurvallisuusvirasto / Българска агенция по безопасност на храните
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.
Lääkkeistä ja lääkinnällisistä laitteista vastaava kansallinen virasto / Agenția Națională a Medicamentului și a Dispozitivelor Medicale
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.
Terveys- ja eläinlääkintäasioista sekä elintarviketurvallisuudesta vastaava kansallinen viranomainen / Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor
Market surveillance, enforcement and safeguards
Kanada:
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.
SOVELLETTAVA LAINSÄÄDÄNTÖ
The Parties shall co-operate as necessary in the conduct of these activities.
Euroopan parlamentin ja neuvoston direktiivi 2001/83/EY, annettu 6 päivänä marraskuuta 2001, ihmisille tarkoitettuja lääkkeitä koskevista yhteisön säännöistä.
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.
Euroopan parlamentin ja neuvoston direktiivi 2001/82/EY, annettu 6 päivänä marraskuuta 2001, eläinlääkkeitä koskevista yhteisön säännöistä.
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.
Euroopan parlamentin ja neuvoston direktiivi 2001/20/EY, annettu 4 päivänä huhtikuuta 2001, hyvän kliinisen tutkimustavan noudattamista ihmisille tarkoitettujen lääkkeiden kliinisissä tutkimuksissa koskevien jäsenvaltioiden lakien, asetusten ja hallinnollisten määräysten lähentämisestä.
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.
Asetus (EU) N:o 536/2014, annettu 16 päivänä huhtikuuta 2014, ihmisille tarkoitettujen lääkkeiden kliinisistä lääketutkimuksista ja direktiivin 2001/20/EY kumoamisesta.
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:
Komission direktiivi 2003/94/EY, annettu 8 päivänä lokakuuta 2003, ihmisille tarkoitettujen lääkkeiden ja ihmisille tarkoitettujen tutkimuslääkkeiden hyvien tuotantotapojen periaatteista ja yleisohjeista.