natgillin/translations-raw huggingface dataset:
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended 1 January 2014 (RO 2013 4137)
Ako se nacionalna mjera smatra:
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)
opravdanom, sve države članice i Švicarska poduzimaju potrebne mjere kako bi osigurale povlačenje nesukladne opreme za osobnu zaštitu sa svojih tržišta i o tome obavješćuju Komisiju,
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235)
neopravdanom, predmetna država članica ili Švicarska povlači tu mjeru.
Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391)
U skladu sa stavkom 8. stranka može proslijediti problem Odboru osnovanom u skladu s člankom 10. ovog Sporazuma.
Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 25 October 2017 (RO 2017 5935)
Sukladna oprema za osobnu zaštitu koja ipak predstavlja rizik
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)
Ako država članica ili Švicarska utvrdi da oprema za osobnu zaštitu koju je gospodarski subjekt stavio na tržište EU-a i švicarsko tržište i koja je u skladu sa zakonodavstvom iz odjeljka I. ovog poglavlja ipak predstavlja rizik za zdravlje ili sigurnost osoba, poduzima sve prikladne mjere i bez odlaganja obavješćuje Komisiju, druge države članice i Švicarsku.
Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)
Te informacije uključuju sve dostupne podatke, a posebno one potrebne za identifikaciju predmetne opreme za osobnu zaštitu, njezina podrijetla i opskrbnog lanca opreme za osobnu zaštitu, vrstu rizika te vrstu i trajanje poduzetih nacionalnih mjera.
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
Komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima te ocjenjuje poduzete nacionalne mjere kako bi utvrdila je li nacionalna mjera opravdana i prema potrebi predložila prikladne mjere.
For the designation of conformity assessment bodies under this Chapter, the designating authorities shall:
Zaštitna klauzula u slučaju ustrajnog neslaganja među strankama
comply with the general principles contained in Annex 2 to this Agreement,
U slučaju neslaganja među strankama u vezi s mjerama iz navedenih stavaka 6. i 7., problem se prosljeđuje Odboru osnovanom u skladu s člankom 10. ovog Sporazuma koji odlučuje o smjeru daljnjeg djelovanja, uključujući mogućnost provođenja stručnog istraživanja.
as laid down in Regulation (EU) No 920/2013, comply with 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, and
Ako Odbor smatra da je mjera:
comply with the assessment criteria set out in Chapter IV and Annex VII of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746.
opravdana, stranke poduzimaju potrebne mjere kako bi osigurale povlačenje opreme za osobnu zaštitu sa svojih tržišta;
The Parties shall make available assessors for the pool established under Regulation (EC) No 920/2013, Article 40 of Regulation (EU) 2017/745 and Article 36 of Regulation (EU) 2017/746.
neopravdana, nacionalno tijelo države članice ili Švicarska povlači mjeru.”
The designating authorities of the Parties shall cooperate for the assessment of notified bodies in line with Article 39 of Regulation (EU) 2017/745 and Article 35 of Regulation (EU) 2017/746.
DODATAK B
They shall participate in peer reviews pursuant to Article 48 of Regulation (EU) 2017/745 and Article 44 of Regulation (EU) 2017/746.
U Prilogu 1.
Registration of the person responsible for placing devices on the market
Proizvodni sektori, poglavlje 4.
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.
Medicinski proizvodi trebalo bi izbrisati i zamijeniti sljedećim:
The Parties shall reciprocally recognise that registration.
„POGLAVLJE 4.
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.
MEDICINSKI PROIZVODI
Labelling of medical devices
Direktiva Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstava država članica koja se odnose na aktivne medicinske proizvode za ugradnju, kako je zadnje izmijenjena Uredbom (EZ) br.
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.
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
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.
(SL L 284, 31.10.2003., str. 1.)
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.
Direktiva Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima, kako je zadnje izmijenjena Uredbom (EZ) br. 1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
Information exchange and cooperation
(SL L 284, 31.10.2003., str. 1.)
In accordance with Article 9 of the Agreement,
Direktiva 98/79/EZ Europskog parlamenta i Vijeća od 27. listopada 1998. o in vitro dijagnostičkim medicinskim proizvodima (SL L 331, 7.12.1998., str. 1.), kako je zadnje izmijenjena Uredbom (EZ) br. 1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
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 Regulation (EU) No 920/2013,
(SL L 284, 31.10.2003., str. 1.) i ispravljena ispravcima (SL L 22, 29.1.1999., str. 75. i SL L 6, 10.1.2002., str. 70.)
the Parties shall in particular cooperate according to Articles 102 and 103 of Regulation (EC) No 2017/745 and Articles 97 and 98 of Regulation (EU) 2017/746.
Odluka Komisije 2002/364/EZ od 7. svibnja 2002. o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 131, 16.5.2002., str. 17.)
Switzerland may submit the application of expert laboratories for designation by the Commission in accordance with Article 106 of Regulation (EU) 2017/745 or the application of reference laboratories for designation by the Commission in accordance with Article 100 of Regulation (EU) 2017/746.
Direktiva Komisije 2003/12/EZ od 3. veljače 2003. o ponovnoj klasifikaciji implantata za dojke u okviru Direktive 93/42/EEZ u pogledu medicinskih proizvoda (SL L 28, 4.2.2003., str. 43.)
European databases
Uredba Komisije (EU) br.
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, Article 3 of Regulation (EU) No 920/2013, Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746.
722/2012 od 8. kolovoza 2012. o posebnim zahtjevima u vezi sa zahtjevima utvrđenim u direktivama Vijeća 90/385/EEZ i 93/42/EEZ s obzirom na aktivne medicinske proizvode za ugradnju i medicinske proizvode proizvedene korištenjem tkiva životinjskog podrijetla (SL L 22, 9.8.2012., str. 3.)
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.
Direktiva Komisije 2005/50/EZ od 11. kolovoza 2005. o ponovnoj kategorizaciji zglobnih proteza kuka, koljena i ramena u okviru Direktive Vijeća 93/42/EEZ o medicinskim proizvodima (SL L 210, 12.8.2005., str. 41.)
Transitional provisions
Uredba Komisije (EZ) br.
By way of derogation to the legislation in Section I, devices which comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may be placed on the market of both Parties respectively.
2007/2006 od 22. prosinca 2006. o provedbi Uredbe (EZ) br. 1774/2002 Europskog parlamenta i Vijeća s obzirom na uvoz i provoz određenih međuproizvoda dobivenih od materijala kategorije 3. namijenjenih za tehničku upotrebu u medicinskim proizvodima, in vitro dijagnostici i laboratorijskim reagensima te o izmjeni te Uredbe (SL L 379, 28.12.2006., str. 98.)
By way of derogation to the legislation in Section I, notified bodies which are designated and notified in accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may carry out assessment procedures laid down in these regulations and issue certificates in accordance with these Regulations.
Direktiva 2007/47/EZ Europskog parlamenta i Vijeća od 5. rujna 2007. o izmjeni Direktive Vijeća 90/385/EEZ o usklađivanju zakonodavstava država članica u odnosu na aktivne medicinske proizvode za ugradnju, Direktive Vijeća 93/42/EEZ o medicinskim proizvodima i Direktive 98/8/EZ o stavljanju biocidnih pripravaka na tržište (SL L 247, 21.9.2007., str. 21.)
Such certificates shall be recognized by the Parties.’
Odluka Komisije 2011/869/EU od 20. prosinca 2011. o izmjeni Odluke 2002/364/EZ o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 341, 22.12.2011., str. 63.)
ATTACHMENT C
Direktiva Komisije 2011/100/EU od 20. prosinca 2011. o izmjeni Direktive 98/79/EZ Europskog parlamenta i Vijeća o in vitro dijagnostičkim medicinskim proizvodima (SL L 341, 22.12.2011., str. 50.)
In Annex 1, Product Sectors, Chapter 5, Gas appliances and boilers, should be deleted and replaced by the following one, which shall be effective from 21 April 2018, when Regulation (EU) 2016/426 and the corresponding Swiss legislation become applicable, except for Section IV which becomes effective on the same day as this Decision:
Direktiva 2011/65/EU Europskog parlamenta i Vijeća od 8. lipnja 2011. o ograničenju uporabe određenih opasnih tvari u električnoj i elektroničkoj opremi (SL L 174, 1.7.2011., str. 88.)
‘CHAPTER 5
Odluka Komisije 2010/227/EU od 19. travnja 2010. o Europskoj bazi podataka za medicinske proizvode (Eudamed) (SL L 102, 23.4.2010., str. 45.)
GAS APPLIANCES AND BOILERS
Uredba Komisije (EU) br.
Provisions covered by Article 1(1)
207/2012 od 9. ožujka 2012. o elektronskim uputama za uporabu medicinskih proizvoda (SL L 72, 10.3.2012., str. 28.)
Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17), as subsequently amended
Provedbena uredba Komisije (EU) br. 920/2013 оd 24. rujna 2013. o imenovanju i nadziranju prijavljenih tijela na temelju Direktive Vijeća 90/385/EEZ o aktivnim medicinskim proizvodima za ugradnju i Direktive 93/42/EEZ o medicinskim proizvodima (SL L 253, 25.9.2013., str. 8.)
Ordinance of 16 December 1985 on Air Pollution Control (OAPC) (Annex 3 and 4) (RS 814.318.142.1, as subsequently amended
Poglavlje IV. i Prilog VII.
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99).
Uredbi (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ (SL L 117, 5.5.2017., str. 1.)
Ordinance of 19 May 2010 on product safety (RO 2010 2583), as last amended on 25 October 2017 (RO 2017 5865)
Poglavlje IV. i Prilog VII.
Ordinance of 25 October 2017 on gas appliances (RO 2017 5865)
Uredbi (EU) 2017/746 Europskog parlamenta i Vijeća od 5. travnja 2017. o in vitro dijagnostičkim medicinskim proizvodima te o stavljanju izvan snage Direktive 98/79/EZ i Odluke Komisije 2010/227/EU (SL L 117, 5.5.2017., str. 176.)
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 IV of Regulation (EU) 2016/426.
Savezni zakon od 15. prosinca 2000. o lijekovima i medicinskim proizvodima (RO 2001.
for the purpose of the obligations in Articles 7(6) and 9(3) of Regulation (EU) 2016/426 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.
2790), kako je zadnje izmijenjen 1. siječnja 2014.
for the purpose of the obligations in Article 7(3) and 9(8) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 10 years after the appliance or the fitting has been placed on the market in either the European Union or Switzerland.
(RO 2013.
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 keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 10 years after the appliance or the fitting has been placed on the market in either the European Union or Switzerland;
4137)
for the purpose of the obligations in Article 7(4), second subparagraph, and 9(6) of Regulation (EU) 2016/426 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.
Savezni zakon od 24. lipnja 1902. u pogledu električnih instalacija sa slabom i jakom strujom (RO 19 252 i RS 4 798), kako je zadnje izmijenjen 20. ožujka 2008.
For the purpose of the obligation in Article 8(2) of Regulation (EU) 2016/426 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 8(1) of Regulation (EU) 2016/426 or the corresponding Swiss provisions.
(RO 2008.
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 an appliance or fitting with the legislation in section I.
3437)
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the appliance or the fitting.
Savezni zakon od 9. lipnja 1977. o mjeriteljstvu (RO 1977.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Regulation (EU) 2016/426.
2394), kako je zadnje izmijenjen 17. lipnja 2011.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Regulation (EU) 2016/426, directly or by means of designated representatives.
(RO 2012.
Procedure for dealing with appliances or fittings presenting a risk not restricted to the national territory
6235)
Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an appliance or fitting covered by this Chapter presents a risk to the health or safety of persons or to domestic animals or property covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:
Savezni zakon od 22. ožujka 1991. o zaštiti od zračenja (RO 1994.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the appliances or fittings being made available on their national market, to withdraw the appliance or fitting from that market or to recall it.
1933), kako je zadnje izmijenjen 10. prosinca 2004.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant appliance or fitting, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
(RO 2004.
failure of the appliance or fitting to meet requirements relating to the health or safety of persons or to domestic animals or property referred to in the legislation in section I, or
5391)
Switzerland or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the appliance or fitting concerned.
Pravilnik od 17. listopada 2001. o medicinskim proizvodima (RO 2001.
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the appliance or fitting concerned, such as withdrawal of appliance or fitting from their market, without delay.
3487), kako je zadnje izmijenjen 25. listopada 2017.
If the national measure relating to an appliance or fitting is considered:
(RO 2017.
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant appliance or fitting is withdrawn from their markets, and shall inform the Commission accordingly;
5935)
Compliant appliances or fittings which nevertheless present a risk
Pravilnik od 18. travnja 2007. o uvozu, provozu i izvozu životinja i životinjskih proizvoda (RO 2007.
Where a Member State or Switzerland finds that, although an appliance or fitting that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to domestic animals or property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
1847), kako je zadnje izmijenjen 4. rujna 2013.
That information shall include all available details, in particular the data necessary for the identification of the appliance or fitting concerned, the origin and the supply chain of the appliance or fitting, the nature of the risk involved and the nature and duration of the national measures taken.
(RO 2013.
justified, the Parties shall take the measures necessary to ensure that the appliance or fitting is withdrawn from their market;
3041)
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.
Savezni zakon o zaštiti podataka od 19. lipnja 1992.
Information exchange
(RO 1992.
In accordance with Article 12 of this Agreement, the Parties shall exchange information on the types of gas and the corresponding supply pressures of gaseous fuels used on their territory referred to in Annex II of Regulation (EU) 2016/426.
1945), kako je zadnje izmijenjen 30. rujna 2011.
Further Switzerland shall inform about the changes thereof within six months after the announcement of the envisaged changes.
(RO 2013.
The European Union shall inform about the changes thereof within six months after it received the notification by a Member State.’
3215)
ATTACHMENT D
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira popis tijela nadležnih za imenovanje koja stranke prijave.
In Annex 1, Product Sectors, Chapter 19, Cableway installations should be deleted and replaced by the following one, which shall be effective from 21 April 2018, when Regulation (EU) 2016/424 and the corresponding Swiss legislation become applicable, except for Section IV which becomes effective as the same day as this Decision:
Za imenovanje tijela za ocjenjivanje sukladnosti u skladu s ovim poglavljem, tijela nadležna za imenovanje:
‘CHAPTER 19
postupaju u skladu s općim načelima sadržanima u Prilogu 2. ovom Sporazumu,
CABLEWAY INSTALLATIONS
kako je utvrđeno u Uredbi (EU) br. 920/2013, postupaju u skladu s kriterijima ocjenjivanja utvrđenima u Prilogu XI.
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1).
Direktivi 93/42/EEZ, u Prilogu 8.
Federal Law of 23 June 2006 on cableway installations transporting people (RO 2006 5753) as last amended on 20 March 2009 (RO 2009 5597)
Direktivi 90/385/EEZ i Prilogu IX.
Ordinance of 21 December 2006 on cableway installations transporting people (RO 2007 39) as last amended on 11 October 2017 (RO 2017 5831)
Direktivi 98/79/EZ, i
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 IV of Regulation (EU) 2016/424.
postupaju u skladu s kriterijima ocjenjivanja utvrđenima u poglavlju IV. i Prilogu VII.
for the purpose of the obligations in Articles 11(6) and 13(3) of Regulation (EU) 2016/424 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.
Uredbi (EU) 2017/745 i Uredbi (EU) 2017/746.
for the purpose of the obligations in Article 11(3) and 13(8) of Regulation (EU) 2016/424 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 30 years after the subsystem or the safety component has been placed on the market in either the European Union or Switzerland.
Stranke stavljaju na raspolaganje skupinu ocjenjivača uspostavljenu u skladu s Uredbom (EZ) br. 920/2013, člankom 40.
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 keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 30 years after the subsystem or the safety component has been placed on the market in either the European Union or Switzerland;
Uredbe (EU) 2017/745 i člankom 36.