natgillin/translations-raw huggingface dataset:
Federal Law of 12 June 2009 on product safety (RO 2010 2573)
Odluka Komisije 2010/227/EU od 19. travnja 2010. o Europskoj bazi podataka za medicinske proizvode (Eudamed) (SL L 102, 23.4.2010., str.
Ordinance of 19 May 2010 on product safety (RO 2010 2583), as last amended on 15 June 2012 (RO 2012 3631)
45.)
Ordinance of 25 November 2015 on the safety of simple pressure vessels (RO 2016 227)
Uredba Komisije (EU) br.
Ordinance of 25 November 2015 on the safety of pressure equipment (RO 2016 233)
207/2012 od 9. ožujka 2012. o elektronskim uputama za uporabu medicinskih proizvoda (SL L 72, 10.3.2012., str.
Ordinance of 31 October 2012 relating to the placing on the market of dangerous goods receptacles and the market surveillance (RO 2012 6607)
28).
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)
Provedbena uredba Komisije (EU) br.
Ordinance of 31 October 2012 on the transport of dangerous goods by rail and cableway (RO 2012 6541)
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 Vijeća 93/42/EEZ o medicinskim proizvodima (SL L 253, 25.9.2013., str.
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)
8.)
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.
Švicarska
Economic operators
Savezni zakon od 15. prosinca 2000. o lijekovima i medicinskim proizvodima (RO 2001.
Specific obligations of economic operators pursuant to the legislation under Section I
2790), kako je zadnje izmijenjen 1. siječnja 2014.
Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.
(RO 2013.
In order to avoid unnecessary duplication of obligations:
4137)
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.
Savezni zakon od 24. lipnja 1902. o električnim instalacijama sa slabom i jakom strujom (RO 19252 i RS 4798), kako je zadnje izmijenjen 20. ožujka 2008.
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;
(RO 2008.
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.
3437)
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;
Savezni zakon od 9. lipnja 1977. o mjeriteljstvu (RO 1977.
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.
2394), kako je zadnje izmijenjen 17. lipnja 2011.
Authorised representative
(RO 2012.
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.
6235)
Cooperation with market surveillance authorities
Savezni zakon od 22. ožujka 1991. o zaštiti od zračenja (RO 1994.
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.
1933), kako je zadnje izmijenjen 10. prosinca 2004.
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.
(RO 2004.
It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority.
5391)
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.
Pravilnik od 17. listopada 2001. o medicinskim proizvodima (RO 2001.
Exchange of experience
3487), kako je zadnje izmijenjen 15. travnja 2015.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 28 of Directive 2010/35/EU, Article 32 of Directive 2014/29/EU and Article 37 of Directive 2014/68/EU.
(RO 2015.
Coordination of conformity assessment bodies
999)
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 29 of Directive 2010/35/EU, Article 33 of Directive 2014/29/EU and Article 38 of Directive 2014/68/EU, directly or by means of designated representatives.
Pravilnik od 18. travnja 2007. o uvozu, provozu i izvozu životinja i životinjskih proizvoda (RO 2007.
Mutual assistance of market surveillance authorities
1847), kako je zadnje izmijenjen 4. rujna 2013.
Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities.
(RO 2013.
The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information.
3041)
They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.
Pravilnik od 17. lipnja 1996. o akreditaciji i imenovanju tijela za ocjenjivanje sukladnosti (RO 1996.
Procedure for dealing with products presenting a risk not restricted to the national territory
1904), kako je zadnje izmijenjen 15. lipnja 2012.
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 a product covered by this chapter presents a risk to the health or safety of persons or to other aspects of public interest protection referred to in the relevant 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:
(RO 2012.
the results of the evaluation and of the actions which they have required the economic operator to take,
3631)
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the product being made available on their national market, to withdraw the product from that market or to recall it.
Savezni zakon o zaštiti podataka od 19. lipnja 1992.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
(RO 1992.
In particular, it shall be indicated whether the non-compliance is due to either:
1945), kako je zadnje izmijenjen 30. rujna 2011.
failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection in the legislation in Section I, or
(RO 2013.
shortcomings in the harmonised standards referred to in the legislation in Section I.
3215)
Switzerland or Member States other than the Member State initiating the procedure 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 product concerned.
ODJELJAK II.
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.
Tijela za ocjenjivanje sukladnosti
Safeguard procedure in case of objections against national measures
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira, u skladu s postupkom iz članka 11.
Should it disagree with the notified national measure in paragraph 5, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.
Sporazuma, popis tijela za ocjenjivanje sukladnosti.
Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States and Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measure, in order to determine whether the national measure is justified or not.
ODJELJAK III.
If the national measure is considered:
Tijela nadležna za imenovanje
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant product is withdrawn from their markets, and shall inform the Commission accordingly,
Odbor osnovan člankom 10. ovog Sporazuma izrađuje i ažurira popis tijela nadležnih za imenovanje koja su stranke prijavile.
unjustified, the Member State concerned or Switzerland shall withdraw that measure.
ODJELJAK IV.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.
Posebna pravila za imenovanje tijela za ocjenjivanje sukladnosti
Compliant products which nevertheless present a risk
Za imenovanje tijela za ocjenjivanje sukladnosti u okviru ovog poglavlja, tijela nadležna za imenovanje pridržavaju se općih načela iz Priloga 2. ovom Sporazumu, kako je propisano u Provedbenoj uredbi (EU) br.
Where a Member State or Switzerland finds that, although a product 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 other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
920/2013, kriterija ocjenjivanja utvrđenih u Prilogu XI.
That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
Direktivi 93/42/EEZ, Prilogu 8.
The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary propose appropriate measures.
Direktivi 90/385/EEZ ili u Prilogu IX.
Safeguard clause in case of remaining disagreement between the Parties
Direktivi 98/79/EZ.
In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
Švicarska stavlja na raspolaganje skupinu ocjenjivača uspostavljenu u skladu s Provedbenom uredbom (EU) br. 920/2013.
Where the Committee considers that the measure is:
ODJELJAK V.
justified, the Parties shall take the measures necessary to ensure that the product is withdrawn from their market;
Dodatne odredbe
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.’
Registracija osobe nadležne za stavljanje medicinskih proizvoda na tržište
ATTACHMENT C
Svaki proizvođač ili njegov ovlašteni predstavnik koji stavlja na tržište jedne od stranaka medicinske proizvode iz članka 14.
In Annex 1, Product Sectors, Chapter 7, Radio equipment and telecommunications terminal equipment should be deleted and replaced by the following one:
Direktive 93/42/EEZ ili članka 10.
‘CHAPTER 7
Direktive 98/79/EZ obavješćuje nadležna tijela stranke u kojoj je registriran o pojedinostima iz tih članaka.
RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT
Stranke uzajamno priznaju tu registraciju.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p.
Proizvođač nije dužan odrediti osobu nadležnu za stavljanje proizvoda na uvedeno tržište na državnom području druge stranke.
62)
Označivanje medicinskih proizvoda
Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p.
Proizvođači obiju stranaka navode svoje ime ili trgovačko ime i adresu na oznaci medicinskih proizvoda kako je određeno u točki 13.3. podtočki (a) Priloga 1.
13)
Direktivi 93/42/EEZ i in vitro dijagnostičkih medicinskih proizvoda kako je određeno u točki 8.4. podtočki (a) Priloga 1.
Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50)
Direktivi 98/79/EZ.
Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons (OJ L 55, 24.2.2001, p. 65)
Oni nisu dužni na oznaci, vanjskom pakiranju ili uputama za upotrebu navesti ime i adresu osobe nadležne za stavljanje proizvoda na tržište, predstavnika ili uvoznika s poslovnim nastanom na državnom području druge stranke.
Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14)
Oznaka ili vanjsko pakiranje ili upute za upotrebu proizvoda uvezenih iz trećih zemalja radi distribucije u Uniji i Švicarskoj sadržavaju, prema potrebi, ime i adresu jednog ovlaštenog predstavnika proizvođača s poslovnim nastanom u Uniji ili Švicarskoj.
Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p.
Razmjena informacija
28)
U skladu s člankom 9.
Commission Decision 2013/638/EU of 12 August 2013 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) (OJ L 296, 7.11.2013, p.
Sporazuma stranke prije svega razmjenjuju informacije iz članka 8.
22)
Direktive 90/385/EEZ, članka 10.
Directive 2014/35/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 electrical equipment designed for use within certain voltage limits (recast) (OJ L 96, 29.3.2014, p.
Direktive 93/42/EEZ, članka 11.
357)
Direktive 98/79/EZ i članka 3.
Directive 2014/30/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 electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p.
Provedbene uredbe (EU) br.
79)
920/2013.
Federal Law of 30 April 1997 on Telecommunications (LTC);
4.
(RO 1997 2187), as last amended on 12 June 2009 (RO 2010 2617)
Europske baze podataka
Ordinance of 25 November 2015 on Telecommunications Equipment (OIT) (RO 2016 179)
Švicarska nadležna tijela imaju pristup europskim bazama podataka uspostavljenima na temelju članka 12.
Ordinance of 26 May 2016 of the Federal Office of Communications (OFCOM) on Telecommunications Equipment;
Direktive 98/79/EZ, članka 14.a Direktive 93/42/EEZ i članka 3.
(RO 2016 1673), as last amended on 15 June 2017(RO 2017 3201)
Provedbene uredbe (EU) br.
Ordinance of 9 March 2007 on Telecommunication Services (RO 2007 945), as last amended on 5 November 2014 (RO 2014 4035)
920/2013.
For the designation of conformity assessment bodies, 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 Directive 2014/53/EU.
Ona Komisiji i/ili tijelu nadležnom za upravljanje bazama podataka dostavljaju podatke predviđene u tim člancima koji su prikupljeni u Švicarskoj radi unosa u europske baze podataka.”
Amendments to legislative, regulatory and administrative provisions of Section I
DODATAK B
Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Directive 2014/53/EU adopted after 13 June 2016 without delay after their publication in the Official Journal of the European Union.
U Prilogu 1.
Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation.
Proizvodni sektori poglavlje 6.
for the purpose of the obligations in Articles 10(7) and 12(3) of Directive 2014/53/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.
Tlačne posude treba izbrisati i zamijeniti sljedećim:
for the purpose of the obligations in Articles 10(4) and 12(8) of Directive 2014/53/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 radio equipment has been placed on the market in either the European Union or Switzerland.
„POGLAVLJE 6.
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 radio equipment has been placed on the market in either the European Union or Switzerland;
TLAČNE POSUDE
for the purpose of the obligations in Article 10(5), second subparagraph, and 12(6) of Directive 2014/53/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.
Direktiva 2014/29/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje na tržištu jednostavnih tlačnih posuda (SL L 96, 29.3.2014., str.
Provision of information on radio equipment and software by manufacturer
45.)
Manufacturers shall ensure that radio equipment shall be so constructed that it can be operated in at least one Member State or Switzerland without infringing applicable requirements on the use of the radio spectrum.
Direktiva 2014/68/EU Europskog parlamenta i Vijeća od 15. svibnja 2014. o usklađivanju zakonodavstava država članica o stavljanju na raspolaganje na tržištu tlačne opreme (SL L 189, 27.6.2014., str.
In cases of restrictions on putting into service or of requirements for authorisation of use of radio equipment, information on the packaging shall identify restrictions existing in Switzerland, Member States or geographical areas within their territory.
164.)
For radio equipment within the scope of Article 4 of Directive 2014/53/EU and the corresponding Swiss legislation, manufacturers of radio equipment and of software allowing radio equipment to be used as intended shall, where required in the legislation under Section I, provide and continuously update the Member States, Switzerland and the Commission, with information on the compliance of intended combinations of radio equipment and software with the essential requirements set out in Directive 2014/53/EU and the corresponding Swiss legislation, in the form of a statement of compliance which includes the elements of the declaration of conformity.
Direktiva 2010/35/EU Europskog parlamenta i Vijeća od 16. lipnja 2010. o pokretnoj tlačnoj opremi i stavljanju izvan snage direktiva Vijeća 76/767/EEZ, 84/525/EEZ, 84/526/EEZ, 84/527/EEZ i 1999/36/EZ (SL L 165, 30.6.2010., str.