natgillin/translations-raw huggingface dataset:
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p.
Uredba Komisije (EU) št. 722/2012 z dne 8. avgusta 2012 o posebnih zahtevah v zvezi z zahtevami iz direktiv Sveta 90/385/EGS in 93/42/EGS glede aktivnih medicinskih pripomočkov za vsaditev in medicinskih pripomočkov, izdelanih z uporabo tkiv živalskega izvora (UL L 212, 9.8.2012, str.
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p.
Direktiva Komisije 2005/50/ES z dne 11. avgusta 2005 o ponovni razvrstitvi protez kolčnih, kolenskih in ramenskih sklepov v okviru Direktive Sveta 93/42/EGS o medicinskih pripomočkih (UL L 210, 12.8.2005, str.
41)
41)
Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p.
Uredba Komisije (ES) št. 2007/2006 z dne 22. decembra 2006 o izvajanju Uredbe (ES) št. 1774/2002 Evropskega parlamenta in Sveta v zvezi z uvozom in tranzitom nekaterih vmesnih proizvodov, pridobljenih iz snovi kategorije 3 in namenjenih za tehnično uporabo v medicinskih pripomočkih, in vitro diagnostičnih medicinskih pripomočkih in laboratorijskih reagentih, ter o spremembi te uredbe (UL L 379, 28.12.2006, str. 98)
98)
Direktiva 2007/47/ES Evropskega parlamenta in Sveta z dne 5. septembra 2007 o spremembah Direktive Sveta 90/385/EGS o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev, Direktive Sveta 93/42/EGS o medicinskih pripomočkih in Direktive 98/8/ES o dajanju biocidnih pripravkov v promet (UL L 247, 21.9.2007, str.
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p.
21)
21)
Sklep Komisije 2011/869/EU z dne 20. decembra 2011 o spremembi Odločbe 2002/364/ES o skupnih tehničnih specifikacijah za in vitro diagnostične medicinske pripomočke (UL L 341, 22.12.2011, str.
Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
63)
63)
Direktiva Komisije 2011/100/EU z dne 20. decembra 2011 o spremembi Direktive 98/79/ES Evropskega parlamenta in Sveta o in vitro diagnostičnih medicinskih pripomočkih (UL L 341, 22.12.2011, str.
Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and the Council on in-vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
50)
50)
Direktiva 2011/65/EU Evropskega parlamenta in Sveta z dne 8. junija 2011 o omejevanju uporabe nekaterih nevarnih snovi v električni in elektronski opremi (UL L 174, 1.7.2011, str.
Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p.
88)
88)
Sklep Komisije 2010/227/EU z dne 19. aprila 2010 o evropski banki podatkov za medicinske pripomočke (Eudamed) (UL L 102, 23.4.2010, str.
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p.
45)
45)
Uredba Komisije (EU) št. 207/2012 z dne 9. marca 2012 o elektronskih navodilih za uporabo medicinskih pripomočkov (UL L 72, 10.3.2012, str.
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p.
28)
28)
Izvedbena uredba Komisije (EU) št. 920/2013 z dne 24. septembra 2013 o imenovanju in nadzoru priglašenih organov iz Direktive Sveta 90/385/EGS o aktivnih medicinskih pripomočkih za vsaditev in Direktive Sveta 93/42/EGS o medicinskih pripomočkih (UL L 253, 25.9.2013, str.
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p.
8)
8)
Švica
Switzerland
Zvezni zakon z dne 15. decembra 2000 o zdravilih in medicinskih pripomočkih (RO 2001 2790), kakor je bil nazadnje spremenjen 1. januarja 2014 (RO 2013 4137)
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended 1 January 2014 (RO 2013 4137)
Zvezni zakon z dne 24. junija 1902 o električnih napeljavah šibkega in jakega toka (RO 19 252 in RS 4 798), kakor je bil nazadnje spremenjen 20. marca 2008 (RO 2008 3437)
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 20 March 2008 (RO 2008 3437)
Zvezni zakon z dne 9. junija 1977 o meroslovju (RO 1977 2394), kakor je bil nazadnje spremenjen 17. junija 2011 (RO 2012 6235)
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235)
Zvezni zakon z dne 22. marca 1991 o zaščiti pred sevanjem (RO 1994 1933), kakor je bil nazadnje spremenjen 10. decembra 2004 (RO 2004 5391)
Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391)
Odlok z dne 17. oktobra 2001 o medicinskih pripomočkih (RO 2001 3487), kakor je bil nazadnje spremenjen 15. aprila 2015 (RO 2015 999)
Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 15 April 2015 (RO 2015 999)
Odlok z dne 18. aprila 2007 o uvozu, tranzitu in izvozu živali in živalskih proizvodov (RO 2007 1847), kakor je bil nazadnje spremenjen 4. septembra 2013 (RO 2013 3041)
Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847), as last amended on 4 September 2013 (RO 2013 3041)
Odlok z dne 17. junija 1996 o akreditaciji in imenovanju organov za ugotavljanje skladnosti (RO 1996 1904), kakor je bil nazadnje spremenjen 15. junija 2012 (RO 2012 3631)
Ordinance of 17 June 1996 on Accreditation and Designation of Conformity Assessment Bodies (RO 1996 1904), as last amended on 15 June 2012 (RO 2012 3631)
Zvezni zakon o varstvu podatkov z dne 19. junija 1992 (RO 1992 1945), kakor je bil nazadnje spremenjen 30. septembra 2011 (RO 2013 3215)
Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)
ODDELEK II
SECTION II
Organi za ugotavljanje skladnosti
Conformity assessment bodies
Odbor, ustanovljen v skladu s členom 10 tega sporazuma, sestavi in redno posodablja seznam organov za ugotavljanje skladnosti v skladu s postopkom iz člena 11 Sporazuma.
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
ODDELEK III
SECTION III
Organi za uradno imenovanje
Designating authorities
Odbor, ustanovljen v skladu s členom 10 tega sporazuma, sestavi in redno posodablja seznam organov za uradno imenovanje, ki jih priglasita pogodbenici.
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
ODDELEK IV
SECTION IV
Posebna pravila v zvezi z imenovanjem organov za ugotavljanje skladnosti
Special rules relating to the designation of conformity assessment bodies
Organi za uradno imenovanje pri imenovanju organov za ugotavljanje skladnosti v skladu s tem poglavjem upoštevajo splošna načela iz Priloge 2 k temu sporazumu in, kot je navedeno v Izvedbeni uredbi (EU) št. 920/2013, merila za ocenjevanje iz Priloge XI k Direktivi 93/42/EGS, Priloge 8 k Direktivi 90/385/EGS in Priloge IX k Direktivi 98/79/ES.
For the designation of conformity assessment bodies under this Chapter, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and, as laid down in Implementing Regulation (EU) No 920/2013, the assessment criteria set out in Annex XI to Directive 93/42/EEC, in Annex 8 to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC.
Švica da na voljo ocenjevalce za skupino, ustanovljeno na podlagi Izvedbene uredbe (EU) št. 920/2013.
Switzerland shall make available assessors for the pool established under Implementing Regulation (EU) No 920/2013.
ODDELEK V
SECTION V
Dodatne določbe
Supplementary provisions
Registracija oseb, odgovornih za dajanje pripomočkov na trg
Registration of the person responsible for placing devices on the market
Vsak proizvajalec ali njegov pooblaščeni zastopnik, ki da na trg ene od pogodbenic medicinske pripomočke iz člena 14 Direktive 93/42/EGS ali člena 10 Direktive 98/79/ES, o podrobnostih iz navedenih členov obvesti pristojne organe pogodbenice, v kateri ima sedež.
Any manufacturer or his authorised representative who places on the market of one of the Parties the medical devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles.
Pogodbenici vzajemno priznata takšno registracijo.
The Parties shall reciprocally recognise that registration.
Proizvajalcu ni treba imenovati osebe, odgovorne za dajanje naprav na trg, registrirane na ozemlju druge pogodbenice.
The manufacturer shall not be obliged to designate a person responsible for placing devices on the market established in the territory of the other Party.
Označevanje medicinskih pripomočkov
Labelling of medical devices
Proizvajalci obeh pogodbenic navedejo svoje ime ali trgovsko ime in naslov na oznaki na medicinskih pripomočkih, kakor je določeno v točki 13.3(a) Priloge 1 k Direktivi 93/42/EGS, ter in vitro diagnostičnih medicinskih pripomočkih, kakor je določeno v točki 8.4(a) Priloge 1 k Direktivi 98/79/ES.
Manufacturers of both Parties shall indicate their name or trade name and address on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 93/42/EEC and in vitro diagnostic medical devices specified in Annex 1, point 8.4(a), to Directive 98/79/EC.
Na oznaki, zunanji embalaži ali v navodilih za uporabo jim ni treba navesti imena in naslova osebe, odgovorne za dajanje naprave na trg, zastopnika ali uvoznika, registriranega na ozemlju druge pogodbenice.
They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the representative or of the importer established within the territory of the other Party on the label, outer packaging or instructions for use.
Za pripomočke, uvožene iz tretjih držav, morajo za njihovo distribucijo v Uniji ali Švici oznaka, zunanja embalaža ali navodila za uporabo vsebovati ime in naslov edinega pooblaščenega zastopnika proizvajalca s sedežem v Uniji ali Švici, kakor je ustrezno.
For devices imported from third countries, in view of their distribution in the Union and Switzerland, the label, or the outer packaging, or instructions for use, shall contain the name and address of the single authorised representative of the manufacturer established within the Union or Switzerland, as appropriate.
Izmenjava podatkov
Information exchange
Pogodbenici v skladu s členom 9 Sporazuma zlasti izmenjujeta informacije iz člena 8 Direktive 90/385/EGS, člena 10 Direktive 93/42/EGS, člena 11 Direktive 98/79/ES in člena 3 Izvedbene uredbe (EU) št. 920/2013.
In accordance with Article 9 of the Agreement, the Parties shall in particular exchange the information referred to in Article 8 of Directive 90/385/EEC, Article 10 of Directive 93/42/EEC, Article 11 of Directive 98/79/EC and Article 3 of Implementing Regulation (EU) No 920/2013.
4.
European databases
Evropske zbirke podatkov
The competent Swiss authorities shall have access to the European databases established under Article 12 of Directive 98/79/EC, Article 14a of Directive 93/42/EEC and Article 3 of Implementing Regulation (EU) No 920/2013.
Pristojni švicarski organi imajo dostop do evropskih zbirk podatkov, vzpostavljenih v skladu s členom 12 Direktive 98/79/ES, členom 14(a) Direktive 93/42/EGS in členom 3 Izvedbene uredbe (EU) št. 920/2013.
They shall transmit to the Commission and/or body responsible for managing the databases the data provided for in those Articles collected in Switzerland for entry into the European databases.’
Komisiji in/ali organu, odgovornemu za upravljanje zbirk podatkov, pošiljajo podatke, ki jih določajo navedeni členi, zbrane v Švici za vnos v evropske zbirke podatkov.“
In Annex 1, Product Sectors, Chapter 6, Pressure vessels should be deleted and replaced by the following one:
Poglavje 6 (Tlačne posode) Priloge 1 (Proizvodni sektorji) bi bilo treba črtati in nadomestiti z naslednjim:
Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p.
Direktiva 2014/29/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaj držav članic v zvezi z omogočanjem dostopnosti enostavnih tlačnih posod na trgu (UL L 96, 29.3.2014, str.
45)
45)
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p.
Direktiva 2014/68/EU Evropskega parlamenta in Sveta z dne 15. maja 2014 o harmonizaciji zakonodaje držav članic v zvezi z omogočanjem dostopnosti tlačne opreme na trgu (UL L 189, 27.6.2014, str.
164)
164)
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p.
Direktiva 2010/35/EU Evropskega parlamenta in Sveta z dne 16. junija 2010 o premični tlačni opremi in o razveljavitvi direktiv Sveta 76/767/EGS, 84/525/EGS, 84/526/EGS, 84/527/EGS in 1999/36/ES (UL L 165, 30.6.2010, str.
1), hereinafter referred to as “Directive 2010/35/EU”
1), v nadaljnjem besedilu: Direktiva 2010/35/EU
Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p.
Direktiva 2008/68/ES Evropskega parlamenta in Sveta z dne 24. septembra 2008 o notranjem prevozu nevarnega blaga (UL L 260, 30.9.2008, str.
Ordinance of 25 November 2015 on the safety of simple pressure vessels (RO 2016 227)
Odlok z dne 25. novembra 2015 o varnosti enostavnih tlačnih posod (RO 2016 227)
Ordinance of 25 November 2015 on the safety of pressure equipment (RO 2016 233)
Odlok z dne 25. novembra 2015 o varnosti tlačne opreme (RO 2016 233)
Ordinance of 29 November 2002 on the transport of dangerous goods by road (RO 2002 4212), as last amended on 31 October 2012 (RO 2012 6535 and 6537)
Odlok z dne 29. novembra 2002 o prevozu nevarnega blaga po cesti (RO 2002 4212), kakor je bil nazadnje spremenjen 31. oktobra 2012 (RO 2012 6535 in 6537)
Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)
Odlok z dne 17. junija 1996 o švicarskem sistemu akreditacije ter o imenovanju preskusnih laboratorijev in organov za ugotavljanje skladnosti (RO 1996 1904), kakor je bil nazadnje spremenjen 25. novembra 2015 (RO 2016 261)
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/29/EU, Chapter 4 of Directive 2014/68/EU or Chapter 4 of Directive 2010/35/EU.
Organi za uradno imenovanje pri imenovanju organov za ugotavljanje skladnosti upoštevajo splošna načela iz Priloge 2 k temu sporazumu in merila za ocenjevanje iz poglavja 4 Direktive 2014/29/EU, poglavja 4 Direktive 2014/68/EU ali poglavja 4 Direktive 2010/35/EU.
Specific obligations of economic operators pursuant to the legislation under Section I
Posebne obveznosti gospodarskih subjektov v skladu z zakonodajo iz oddelka I
Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.
V skladu z zakonodajo iz oddelka I za gospodarske subjekte s sedežem v EU ali Švici veljajo enakovredne obveznosti.
In order to avoid unnecessary duplication of obligations:
Da se prepreči nepotrebno podvajanje obveznosti:
for the purpose of the obligations in Article 6(3) of Directive 2010/35/EU, respectively Articles 6(6) and 8(3) of Directive 2014/29/EU, or Articles 6(6) and 8(3) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted.
za namene obveznosti iz člena 6(3) Direktive 2010/35/EU, členov 6(6) in 8(3) Direktive 2014/29/EU oziroma členov 6(6) in 8(3) Direktive 2014/68/EU ter ustreznih določb Švice zadostuje navedba imena, registriranega trgovskega imena ali registrirane blagovne znamke in poštnega naslova, na katerem je proizvajalec s sedežem na ozemlju Evropske unije ali Švice dosegljiv.
In cases where the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;
Če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, zadostuje navedba imena, registriranega trgovskega imena ali registrirane blagovne znamke in poštnega naslova, na katerem je dosegljiv uvoznik s sedežem na ozemlju Evropske unije ali Švice;
for the purpose of the obligations in Articles 4(3) and 6(6) of Directive 2010/35/EU, respectively Articles 6(3) and 8(8) of Directive 2014/29/EU or Articles 6(3) and 8(8) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market in either the European Union or Switzerland.
za namene obveznosti iz členov 4(3) in 6(6) Direktive 2010/35/EU, členov 6(3) in 8(8) Direktive 2014/29/EU oziroma členov 6(3) in 8(8) Direktive 2014/68/EU ter ustreznih določb Švice zadostuje, da proizvajalec s sedežem na ozemlju Evropske unije ali Švice hrani tehnično dokumentacijo in izjavo EU o skladnosti ali, kadar je primerno, potrdilo o skladnosti deset let po tem, ko je bil izdelek dan na trg Evropske unije ali Švice.
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the product has been placed on the market in either the European Union or Switzerland;
Če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, zadostuje, da uvoznik s sedežem na ozemlju Evropske unije ali Švice omogoča organom za nadzor trga dostop do izvoda izjave EU o skladnosti ali, kadar je primerno, potrdila o skladnosti in zagotovi, da je tehnična dokumentacija tem organom na zahtevo na voljo deset let po tem, ko je bil izdelek dan na trg Evropske unije ali Švice;
for the purpose of the obligations in Articles 6(4), second subparagraph, and 8(6) of Directive 2014/29/EU or Articles 6(4), second subparagraph, and 8(6) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.
za namene obveznosti iz drugega pododstavka člena 6(4) in člena 8(6) Direktive 2014/29/EU ali drugega pododstavka člena 6(4) in člena 8(6) Direktive 2014/68/EU ter ustreznih določb Švice zadostuje, da take obveznosti izpolnjuje proizvajalec s sedežem na ozemlju Evropske unije ali Švice oziroma, če proizvajalec nima sedeža na ozemlju Evropske unije ali Švice, uvoznik s sedežem na ozemlju Evropske unije ali Švice.
Authorised representative
Pooblaščeni zastopnik
For the purpose of the obligation in Article 5(2) of Directive 2010/35/EU, respectively Article 7(2) of Directive 2014/29/EU, or Article 7(2) of Directive 2014/68/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 5(1) of Directive 2010/35/EU, respectively Article 7(1) of Directive 2014/29/EU, or Article 7(1) of Directive 2014/68/EU or the corresponding Swiss provisions.
Za namene obveznosti iz člena 5(2) Direktive 2010/35/EU, člena 7(2) Direktive 2014/29/EU oziroma člena 7(2) Direktive 2014/68/EU in ustreznih določb Švice pooblaščeni zastopnik pomeni vsako fizično ali pravno osebo s sedežem na ozemlju Evropske unije ali Švice, ki jo je proizvajalec pisno pooblastil, da deluje v njegovem imenu v skladu s členom 5(1) Direktive 2010/35/EU, členom 7(1) Direktive 2014/29/EU oziroma členom 7(1) Direktive 2014/68/EU ali ustreznimi določbami Švice.
Cooperation with market surveillance authorities
Sodelovanje z organi za nadzor trga
The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.
Pristojni nacionalni organ za nadzor trga države članice Evropske unije ali Švice lahko na utemeljeno zahtevo od zadevnih gospodarskih subjektov v Evropski uniji in Švici zahteva predložitev vseh potrebnih informacij in dokumentacije, ki dokazujejo skladnost izdelka z zakonodajo iz oddelka I.
That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party.
Navedeni organ se lahko obrne na gospodarski subjekt s sedežem na ozemlju druge pogodbenice neposredno ali s pomočjo pristojnega nacionalnega organa za nadzor trga druge pogodbenice.