natgillin/translations-raw huggingface dataset:
For the purpose of the obligation in Article 9(2) of Directive 2014/33/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 9(1) of Directive 2014/33/EU or the corresponding Swiss provisions.
Oznaka koja se mora staviti jest oznaka EZ-a i dodatna oznaka o mjeriteljstvu ili nacionalni znak dotične države članice EZ-a kako je utvrđeno u točki 3.1. prvoj alineji Priloga I. i točki 3.1.1.1.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Directive 2014/33/EU.
Priloga II.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Directive 2014/33/EU, directly or by means of designated representatives.
Direktivi 2009/34/EZ od 23. travnja 2009.
Procedure for dealing with lifts or safety components for lifts presenting a risk not restricted to the national territory
Neautomatske vage obuhvaćene Direktivom 2014/31/EU i mjerni instrumenti obuhvaćeni Direktivom 2014/32/EU
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 lift or a safety component for lifts covered by this chapter presents a risk to the health or safety of persons or, where appropriate, to the safety of 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:
Posebne obveze gospodarskih subjekata u skladu sa zakonodavstvom iz odjeljka I.
where the installer does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the placing on their national market or the use of the lift concerned, or to recall it,
za potrebe obveza iz članka 6. stavka 6. i članka 8. stavka 3.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the safety component for lifts being made available on their national market, to withdraw the safety component for lifts from that market or to recall it.
Direktive 2014/31/EU i članka 8. stavka 6. i članka 10. stavka 3.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant lift or safety component for lifts, 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.
Direktive 2014/32/EU i odgovarajućih švicarskih odredaba, dostatno je navesti ime, registrirano trgovačko ime ili registrirani žig i poštansku adresu na kojoj je dostupan proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske.
failure of the lift or the safety component for lifts to meet requirements relating to the health and safety requirements referred to in the legislation in Section I, or
za potrebe obveza iz članka 6. stavka 3. i članka 8. stavka 8.
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 lift or the safety component for lifts concerned.
Direktive 2014/31/EU, članka 8. stavka 3. i članka 10. stavka 8.
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the lift or the safety component for lifts concerned, such as withdrawal of the lift or safety component for lifts from their market, without delay.
Direktive 2014/32/EU i odgovarajućih švicarskih odredaba, dostatno je da proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske čuva tehničku dokumentaciju i EU izjavu o sukladnosti ili, prema potrebi, potvrdu o sukladnosti 10 godina nakon što je instrument stavljen na tržište u Europskoj uniji ili Švicarskoj.
Should Switzerland or a Member State disagree with the notified national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.
Ako proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, dostatno je da uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske čuva primjerak EU izjave o sukladnosti ili, prema potrebi, potvrde o sukladnosti kako bi bile na raspolaganju tijelima za nadzor tržišta i da osigura da tim tijelima može na zahtjev dostaviti tehničku dokumentaciju 10 godina nakon što je instrument stavljen na tržište u Europskoj uniji ili Švicarskoj;
If the national measure relating to a lift is considered justified, all Member States and Switzerland shall take the measures necessary to ensure that the placing on the market or use of the non-compliant lift concerned is restricted or prohibited, or that the lift is recalled, and shall inform the Commission accordingly.
za potrebe obveza iz članka 6. stavka 4., drugog podstavka i članka 8. stavka 6.
If the national measure relating to a safety component for lift is considered justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant safety component for lifts is withdrawn from their markets, and shall inform the Commission accordingly.
Direktive 2014/31/EU i članka 8. stavka 4. drugog podstavka i članka 10. stavka 6.
If the national measure is considered unjustified, the Member State concerned or Switzerland shall withdraw that measure.
Direktive 2014/32/EU i odgovarajućih švicarskih odredaba, dostatno je da te obveze ispuni proizvođač s poslovnim nastanom na državnom području Europske unije ili Švicarske ili, ako taj proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske.
Where a Member State or Switzerland finds that, although a lift or a safety component for lifts 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 to the health or safety of persons and, where appropriate, the safety of property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Za potrebe obveze iz članka 7. stavka 2.
That information shall include all available details, in particular the data necessary for the identification of the lift or safety component for lifts 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.
Direktive 2014/31/EU i članka 9. stavka 2.
In case of a disagreement between the Parties on measures pursuant to 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.
Direktive 2014/32/EU i odgovarajućih švicarskih odredaba, ovlašteni predstavnik jest svaka fizička ili pravna osoba s poslovnim nastanom u Europskoj uniji ili Švicarskoj koju je proizvođač pismeno ovlastio da djeluje u njegovo ime u skladu s člankom 7. stavkom 1.
ATTACHMENT I
Direktive 2014/31/EU, člankom 9. stavkom 1.
In Annex 1, Product Sectors, Chapter 20, Explosives for civil use should be deleted and replaced by the following one:
Direktive 2014/32/EU ili odgovarajućim švicarskim odredbama.
‘CHAPTER 20
Nadležno tijelo za nadzor tržišta države članice Europske unije ili Švicarske može, na temelju obrazloženog zahtjeva, tražiti od relevantnih gospodarskih subjekata u Europskoj uniji i Švicarskoj da dostave sve informacije i dokumentaciju koji su potrebni za dokazivanje sukladnosti instrumenta sa zakonodavstvom iz odjeljka I.
EXPLOSIVES FOR CIVIL USE
Od gospodarskih subjekata može zatražiti da surađuju u mjerama za uklanjanje rizika koje predstavlja taj instrument.
Directive 2014/28/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 and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1)
Švicarska tijela nadležna za imenovanje mogu sudjelovati u razmjeni iskustava među nadležnim tijelima država članica kako je navedeno u članku 34.
Commission Directive 2008/43/EC of 4 April 2008 setting up, pursuant to Council Directive 93/15/EEC, a system for the indication and traceability of explosives for civil uses (OJ L 94, 5.4.2008, p.
Direktive 2014/31/EU i članku 39.
8), as amended by Commission Directive 2012/4/EU (OJ L 50, 23.2.2012, p.
Direktive 2014/32/EU.
18), hereinafter referred to as “Directive 2008/43/EC”
Švicarska imenovana tijela za ocjenjivanje sukladnosti mogu sudjelovati u mehanizmima koordinacije i suradnje predviđenima u članku 35.
Commission Decision 2004/388/EC of 15 April 2004 on an Intra-Community transfer of explosives document (OJ L 120, 24.4.2004, p.
Direktive 2014/31/EU i članku 40.
43), as amended by Commission Decision 2010/347/EU (OJ L 155, 22.6.2010, p.
Direktive 2014/32/EU, izravno ili preko imenovanih predstavnika.
54), hereinafter referred to as “Decision 2004/388/EC”
Postupanje s instrumentima koji predstavljaju rizik zbog nesukladnosti koji nije ograničen na državno područje
Federal Act of 25 March 1977 on explosive substances (Explosives Act) as last amended on 12 June 2009 (RO 2010 2617)
U skladu s člankom 12. stavkom 4. ovog Sporazuma, ako su tijela za nadzor tržišta države članice ili Švicarske poduzela mjere ili ako imaju dostatan razlog vjerovati da instrument obuhvaćen ovim poglavljem predstavlja rizik za aspekte zaštite javnog interesa navedene u direktivama 2014/31/EU ili 2014/32/EU, ili odgovarajućim švicarskim odredbama, i ako smatraju da nesukladnost nije ograničena na njihovo državno područje, ona bez odlaganja obavješćuju Europsku komisiju, ostale države članice i Švicarsku o sljedećem:
Ordinance of 27 November 2000 on explosives (Explosives Ordinance), as last amended on 25 November 2015 (RO 2016 247)
ako relevantni gospodarski subjekt ne poduzme odgovarajuće korektivne mjere, o svim prikladnim privremenim mjerama poduzetima kako bi se zabranila ili ograničila dostupnost instrumenta na njihovu nacionalnom tržištu te kako bi se instrument povukao ili opozvao s tržišta.
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designation of authorities notified by the Parties.
Te informacije uključuju sve dostupne pojedinosti, a posebno podatke potrebne za identifikaciju nesukladnog instrumenta, podrijetla instrumenta, vrste navodne nesukladnosti i povezanih rizika, vrste i trajanja poduzetih nacionalnih mjera te obrazloženje dotičnoga gospodarskog subjekta.
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 5 of Directive 2014/28/EU.
činjenica da instrument ne udovoljava zahtjevima u pogledu aspekata zaštite javnog interesa propisanih Direktivom 2014/31/EU ili Direktivom 2014/32/EU ili odgovarajućim švicarskim odredbama ili
for the purpose of the obligations in Articles 5(5)(b) and 7(3) of Directive 2014/28/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.
nedostaci u usklađenim normama navedenima u Direktivi 2014/31/EU ili Direktivi 2014/32/EU ili odgovarajućim švicarskim odredbama.
for the purpose of the obligations in Articles 5(3) and 7(7) of Directive 2014/28/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 explosive has been placed on the market in either the European Union or Switzerland.
Švicarska ili države članice bez odlaganja obavješćuju Europsku komisiju i ostala nacionalna tijela o svim donesenim mjerama te o svim dodatnim informacijama koje su im na raspolaganju u vezi s nesukladnošću predmetnog proizvoda.
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 explosive has been placed on the market in either the European Union or Switzerland.
Države članice i Švicarska bez odlaganja osiguravaju provedbu odgovarajućih mjera ograničavanja u pogledu predmetnog instrumenta, kao što je povlačenje instrumenta sa svojeg tržišta.
For the purpose of the obligation in Article 6(2) of Directive 2014/28/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 6(1) of Directive 2014/28/EU or the corresponding Swiss provisions.
Ako se Švicarska ili država članica ne slažu s prijavljenom nacionalnom mjerom, one u roku od tri mjeseca od primitka informacije o svojim prigovorima obavješćuju Europsku komisiju.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 39 of Directive 2014/28/EU.
Ako po završetku postupka iz stavka 3.4. država članica ili Švicarska podnesu prigovor na mjeru koju je poduzela Švicarska odnosno država članica ili ako Komisija smatra da je nacionalna mjera protivna Direktivi 2014/31/EU ili Direktivi 2014/32/EU ili odgovarajućim švicarskim odredbama, Europska komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom, i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 40 of Directive 2014/28/EU, directly or by means of designated representatives.
Ako se nacionalna mjera koja se odnosi na instrument smatra:
Procedure for dealing with explosives presenting a risk not restricted to the national territory
opravdanom, sve države članice i Švicarska poduzimaju potrebne mjere kako bi osigurale povlačenje nesukladnog instrumenta sa svojih tržišta i o tome obavješćuju Komisiju;
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 explosive covered by this chapter presents a risk to the health or safety of persons or to the property or the environment covered by Directive 2014/28/EU respectively the relevant Swiss legislation, 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:
U skladu sa stavkom 3.8. stranka može proslijediti problem Odboru osnovanom u skladu s člankom 10. ovog Sporazuma.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the explosives' being made available on their national market, to withdraw the explosive from that market or to recall it.
Sukladni instrumenti koji ipak predstavljaju rizik za zdravlje i sigurnost
This information shall include all available details, in particular the data necessary for the identification of the non-compliant explosive, the origin of the explosive, 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.
Ako država članica ili Švicarska utvrdi da instrument koji je gospodarski subjekt stavio na tržište EU-a i na švicarsko tržište i koji je skladu s Direktivom 2014/31/EU ili s Direktivom 2014/32/EU, odnosno s relevantnim švicarskim zakonodavstvom, ipak predstavlja rizik za aspekte zaštite javnog interesa, ona poduzima sve prikladne mjere i bez odlaganja obavješćuje Komisiju, druge države članice i Švicarsku.
failure of the explosive to meet requirements relating to the health or safety of persons, or to the protection of property or the environment and safety requirements referred to in the relevant legislation in Section I, or
Navedene informacije uključuju sve dostupne pojedinosti, a posebno podatke potrebne za identifikaciju određenog instrumenta, podrijetlo i opskrbni lanac instrumenta, vrstu rizika te vrstu i trajanje poduzetih nacionalnih mjera.
shortcomings in the harmonised standards referred to in the relevant legislation in Section I.
U slučaju neslaganja među strankama u vezi s mjerama iz prethodnih podstavaka 3.6. i 3.7., problem se prosljeđuje Odboru koji odlučuje o smjeru daljnjeg djelovanja, uključujući mogućnost provođenja stručnog istraživanja.
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 explosive concerned.
opravdana, stranke poduzimaju potrebne mjere kako bi osigurale povlačenje instrumenta sa svojih tržišta;
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the explosive concerned, such as withdrawal of an explosive from their market, without delay.
DODATAK G
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant explosive is withdrawn from their markets, and shall inform the Commission accordingly,
U Prilogu 1.
Where a Member State or Switzerland finds that, although an explosive that an economic operator has been 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 the property or the environment, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Proizvodni sektori poglavlje 15.
That information shall include all available details, in particular the data necessary for the identification of the explosive 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.
Nadzor dobre proizvodne prakse (DPP) lijekova i certificiranje serije treba izbrisati i zamijeniti sljedećim:
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.
„POGLAVLJE 15.
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.
NADZOR DOBRE PROIZVODNE PRAKSE (DPP) LIJEKOVA I CERTIFICIRANJE SERIJE
Identification of products
Područje primjene i opseg
Both Parties shall ensure that undertakings in the explosives sector which manufacture or import explosives or assemble detonators shall mark explosives and each smallest packaging unit with a unique identification.
Odredbama ovog sektorskog poglavlja obuhvaćeni su svi lijekovi koji su industrijski proizvedeni i na koje se primjenjuju zahtjevi dobre proizvodne prakse (DPP).
Where an explosive is subject to further manufacturing processes, manufacturers shall not be required to mark the explosive with a new unique identification unless the original unique identification is no longer marked in compliance with Directive 2008/43/EC and/or the Explosives Ordinance.
Za lijekove obuhvaćene ovim poglavljem svaka stranka priznaje zaključke pregleda proizvođača koje obavljaju odgovarajuće inspekcijske službe druge stranke te relevantne proizvodne dozvole koje su izdala nadležna tijela druge stranke.
The unique identification shall comprise the components prescribed in the Annex to Directive 2008/43/EC and Annex 14 to the Explosives Ordinance and shall be mutually recognised by both parties.
Time se podrazumijeva da svaka stranka priznaje zaključke pregleda proizvođača u trećim zemljama koje su obavile odgovarajuće inspekcijske službe druge stranke, među ostalim u okviru Europske uprave za kvalitetu lijekova i zdravstvenu skrb (EDQM).
This three-digit code shall be mutually recognised by both Parties if the manufacturing site or the manufacturer is located in the territory of one of the Parties.
Druga stranka priznaje bez ponovne kontrole pri uvozu potvrdu proizvođača o sukladnosti svake serije proizvoda s njihovim specifikacijama.
Provisions governing the supervision of transfers between the European Union and Switzerland
Ova se odredba primjenjuje na proizvode uvezene iz treće zemlje koji se dalje izvoze u drugu stranku samo (1) ako je svaka serija lijekova podvrgnuta ponovnoj kontroli na državnom području jedne od stranaka i (2) ako je proizvođač iz treće zemlje podvrgnut kontroli nadležnog tijela bilo koje stranke kojom je utvrđeno da se proizvođač u pogledu proizvoda ili kategorije proizvoda pridržava dobre proizvodne prakse.
Explosives covered by this Chapter may be transferred between the European Union and Switzerland only in accordance with the following paragraphs.
Ako prethodno navedeni uvjeti nisu ispunjeni, svaka stranka može tražiti ponovnu kontrolu na svojem državnom području.
Approval to transfer explosives shall be obtained by the consignee from the recipient competent authority.
Osim toga, druga stranka priznaje službeno puštanje serije u promet koje je obavilo nadležno tijelo stranke izvoznice.
The competent authority shall verify that the consignee is legally authorised to acquire explosives and that he is in possession of the necessary licenses or authorisations.
‚Lijekovi’ znači svi proizvodi uređeni farmaceutskim zakonodavstvom Europske unije i Švicarske, navedeni u odjeljku I. ovog poglavlja.
The economic operator responsible for the transfer shall notify the competent authorities of the transit Member State or Member States or Switzerland of any movements of explosives through the Member State concerned or Switzerland and shall obtain prior approval of the transit Member State concerned or Switzerland.
Definicija lijekova obuhvaća sve ljudske i veterinarske proizvode, kao što su kemijski i biološki farmaceutski proizvodi, imunološki proizvodi, radiofarmaceutski proizvodi, stabilni lijekovi dobiveni iz ljudske krvi ili plazme, predsmjese za proizvodnju ljekovite hrane za životinje i prema potrebi vitamine, minerale, biljne lijekove i homeopatske lijekove.