natgillin/translations-raw huggingface dataset:
The Parties to the Agreement shall keep each other informed on these sessions.
Ti inšpekcijski pregledi so namenjeni razvijanju skupnega razumevanja ter razlagi prakse in zahtev.
Joint inspections
Priprava in oblika teh pregledov se določita s postopki, ki jih odobri Odbor, ustanovljen v skladu s členom 10 tega sporazuma.
In accordance with Article 12 of this Agreement, and by mutual agreement between the Parties, joint inspections may be organised.
Sistem opozarjanja
These inspections are intended to develop common understanding and interpretation of practice and requirements.
Pogodbenici se dogovorita o kontaktnih točkah in tako omogočita organom in proizvajalcem ustrezno hitro obveščanje organov druge pogodbenice v primeru pomanjkljive kakovosti, razveljavitve serij, ponarejanja in drugih težav v zvezi s kakovostjo, zaradi katerih je lahko potreben dodaten nadzor ali začasni preklic distribucije serije.
The setting up of these inspections and their form shall be agreed through procedures approved by the Committee established under Article 10 of this Agreement.
Sporazumno se pripravi podroben postopek opozarjanja.
Alert system
Pogodbenici zagotovita, da druga drugo z ustrezno stopnjo nujnosti obvestita o vsakem začasnem preklicu ali umiku (celotnega ali dela) proizvodnega dovoljenja, ki temelji na neskladju z dobro proizvodno prakso in ki bi lahko imel posledice za javno zdravje.
Contact points shall be agreed between both Parties to permit authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defect, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch.
Kontaktne točke
A detailed alert procedure shall be agreed.
Za namene tega sporazuma so kontaktne točke za vsa strokovna vprašanja, kakor so izmenjava inšpekcijskih poročil, usposabljanje inšpektorjev, tehnične zahteve, naslednje:
The Parties shall ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could have public health implications, are communicated to each other with the appropriate degree of urgency.
Za Evropsko unijo:
Contact points
Direktor Evropske agencije za zdravila.
For the purpose of this Agreement, the contact points for any technical question, such as exchanges of inspection reports, inspectors training sessions, technical requirements, are:
Za Švico:
For the European Union
Uradne inšpekcijske službe za dobro proizvodno prakso, naštete v oddelku II.
The Director of the European Medicines Agency.
Razlike v mnenjih
For Switzerland
Pogodbenici po svojih najboljših močeh rešujeta vse razlike v mnenjih, ki med drugim zadevajo skladnost proizvajalcev in ugotovitve inšpekcijskih poročil.
The official GMP inspection services listed in Section II above.
Nerešene razlike v mnenjih naslovita na Odbor, ustanovljen v skladu s členom 10 tega sporazuma.“
Divergence of views
Za namene te priloge in brez poseganja v notranjo delitev pristojnosti v Nemčiji glede zadev, ki spadajo na področje uporabe te priloge, se za ZLG šteje, da zajema vse pristojne organe nemških zveznih dežel, ki izdajajo dokumente o dobrih proizvodnih praksah in izvajajo farmacevtske inšpekcijske preglede.
Both Parties shall use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports.
Za namene te priloge in brez poseganja v notranjo delitev pristojnosti v Španiji glede zadev, ki spadajo na področje uporabe te priloge, se za agencijo Agencia Española de Medicamentos y Productos Sanitarios šteje, da zajema vse pristojne regionalne organe, ki izdajajo dokumente o dobrih proizvodnih praksah in izvajajo farmacevtske inšpekcijske preglede.
Unresolved divergences of view will be referred to the Committee as established under Article 10 of this Agreement.’
DODATEK H
For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as covering all the competent Länder authorities issuing GMP documents and conducting pharmaceutical inspections.
Poglavje 17 (Dvigala) Priloge 1 (Proizvodni sektorji) bi bilo treba črtati in nadomestiti z naslednjim:
For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing GMP documents and conducting pharmaceutical inspections.
„POGLAVJE 17
ATTACHMENT H
DVIGALA
In Annex 1, Product Sectors, Chapter 17, Lifts should be deleted and replaced by the following one:
Direktiva 2014/33/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaje držav članic v zvezi z dvigali in varnostnimi komponentami za dvigala (UL L 96, 29.3.2014, str.
‘CHAPTER 17
251)
LIFTS
Odlok z dne 25. novembra 2015 o varnosti dvigal (RO 2016 219)
Directive 2014/33/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 lifts and safety components for lifts (OJ L 96, 29.3.2014, p.
Organi za uradno imenovanje pri imenovanju organov za ugotavljanje skladnosti upoštevajo splošna načela iz tega sporazuma in merila za ocenjevanje iz poglavja 4 Direktive 2014/33/EU.
251)
za namene obveznosti iz členov 8(6) in 10(3) Direktive 2014/33/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.
Ordinance of 25 November 2015 on the safety of lifts (RO 2016 219)
za namene obveznosti iz členov 8(3) in 10(8) Direktive 2014/33/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 bila varnostna komponenta za dvigala dana na trg Evropske unije ali Švice.
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/33/EU.
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 bila varnostna komponenta za dvigala dana na trg Evropske unije ali Švice;
for the purpose of the obligations in Articles 8(6) and 10(3) of Directive 2014/33/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 drugega pododstavka člena 8(4) in člena 10(6) Direktive 2014/33/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.
for the purpose of the obligations in Article 8(3) and 10(8) of Directive 2014/33/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 safety component for lifts has been placed on the market in either the European Union or Switzerland.
Za namene obveznosti iz člena 9(2) Direktive 2014/33/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 9(1) Direktive 2014/33/EU ali ustreznimi določbami 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 safety component for lifts has been placed on the market in either the European Union or Switzerland;
Švicarski organi za uradno imenovanje lahko sodelujejo pri izmenjavi izkušenj med nacionalnimi organi držav članic iz člena 35 Direktive 2014/33/EU.
for the purpose of the obligations in Articles 8(4), second subparagraph, and 10(6) of Directive 2014/33/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.
Švicarski organi za ugotavljanje skladnosti lahko neposredno ali prek pooblaščenih zastopnikov sodelujejo v mehanizmih usklajevanja in sodelovanja, določenih v členu 36 Direktive 2014/33/EU.
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.
Postopek za obravnavanje dvigal ali varnostnih komponent za dvigala, ki pomenijo tveganje, ki ni omejeno na nacionalno ozemlje
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.
Kadar organi za nadzor trga države članice ali Švice sprejmejo ukrepe ali imajo zadostne razloge za domnevo, da dvigalo ali varnostna komponenta za dvigala iz tega poglavja pomeni tveganje za zdravje ali varnost oseb oziroma, kjer je primerno, za varnost premoženja iz zakonodaje v oddelku I tega poglavja, ter če menijo, da neskladnost ni omejena na njihovo nacionalno ozemlje, v skladu s členom 12(4) tega sporazuma Evropsko komisijo, druge države članice in Švico nemudoma obvestijo:
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.
kadar monter ne sprejme ustreznih korektivnih ukrepov, o vseh ustreznih začasnih ukrepih za prepoved ali omejitev dajanja zadevnega dvigala na njihov nacionalni trg ali uporabe zadevnega dvigala ali za njegov odpoklic;
Procedure for dealing with lifts or safety components for lifts presenting a risk not restricted to the national territory
kadar zadevni gospodarski subjekt ne sprejme ustreznih korektivnih ukrepov, o vseh ustreznih začasnih ukrepih za prepoved ali omejitev dostopnosti varnostne komponente za dvigala na nacionalnem trgu, za umik varnostne komponente za dvigala z navedenega trga ali njen odpoklic.
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:
Te informacije vsebujejo vse razpoložljive podatke, zlasti podatke, potrebne za določitev neskladnega dvigala ali varnostne komponente za dvigala, njunega porekla, vrsto domnevne neskladnosti in tveganja ter vrsto in trajanje izvedenih nacionalnih ukrepov in pojasnilo zadevnega gospodarskega subjekta.
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,
dvigalo ali varnostna komponenta za dvigala ne izpolnjuje zahtev glede varnosti in zdravja iz zakonodaje v oddelku I ali
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.
Švica ali države članice Evropsko komisijo in druge nacionalne organe nemudoma obvestijo o vseh sprejetih ukrepih in drugih razpoložljivih informacijah, ki se nanašajo na neskladnost zadevnega dvigala ali varnostne komponente za dvigala.
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.
Države članice in Švica zagotovijo takojšnje sprejetje ustreznih omejevalnih ukrepov v zvezi z zadevnim dvigalom ali varnostno komponento za dvigala, kot je umik dvigala ali varnostne komponente za dvigala s trga.
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
Če se Švica ali država članica ne strinjata s priglašenim nacionalnim ukrepom iz odstavka 5, o svojih ugovorih obvestita Evropsko komisijo v treh mesecih po prejemu informacij.
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.
Če se šteje, da je nacionalni ukrep v zvezi z dvigalom upravičen, vse države članice in Švica sprejmejo potrebne ukrepe, da zagotovijo odpoklic dvigala s trga ali omejitev ali prepoved dajanja neskladnega dvigala na trg ali v uporabo, ter o tem obvestijo Komisijo.
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.
Če se šteje, da je nacionalni ukrep v zvezi z varnostno komponento za dvigala upravičen, vse države članice in Švica sprejmejo potrebne ukrepe, da zagotovijo umik neskladne varnostne komponente za dvigala z nacionalnih trgov, ter o tem obvestijo Komisijo.
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.
Če se nacionalni ukrep šteje za neupravičenega, ga zadevna država članica ali Švica umakne.
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.
Kadar država članica ali Švica ugotovi, da je dvigalo ali varnostna komponenta za dvigala, katere dostopnost je gospodarski subjekt omogočil na trgu EU ali Švice, sicer skladna z zakonodajo iz oddelka I tega poglavja, vendar pomeni tveganje za zdravje ali varnost oseb oziroma, kjer je ustrezno, za varnost premoženja, sprejme vse ustrezne ukrepe ter nemudoma obvesti Evropsko komisijo, druge države članice in Švico.
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.
Navedene informacije vključujejo vse razpoložljive podrobnosti, zlasti podatke, potrebne za določitev zadevnega dvigala ali varnostne komponente za dvigala, porekla in dobavne verige izdelka, vrste tveganja, ter vrsto in trajanje sprejetih nacionalnih ukrepov.
If the national measure is considered unjustified, the Member State concerned or Switzerland shall withdraw that measure.
Če se pogodbenici ne strinjata glede ukrepov v skladu z odstavkoma 6 in 7, se zadeva predloži Odboru, ki odloči o ustreznih ukrepih, vključno z možnostjo naročila strokovne študije.
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.
DODATEK I
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.
Poglavje 20 (Eksplozivi za civilno uporabo) Priloge 1 (Proizvodni sektorji) bi bilo treba črtati in nadomestiti z naslednjim:
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.
„POGLAVJE 20
ATTACHMENT I
EKSPLOZIVI ZA CIVILNO UPORABO
In Annex 1, Product Sectors, Chapter 20, Explosives for civil use should be deleted and replaced by the following one:
Direktiva 2014/28/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaj držav članic v zvezi z omogočanjem dostopnosti eksplozivov za civilno uporabo na trgu in njihovim nadzorom (UL L 96, 29.3.2014, str.
‘CHAPTER 20
1) [1]
EXPLOSIVES FOR CIVIL USE
Direktiva Komisije 2008/43/ES z dne 4. aprila 2008 o vzpostavitvi sistema za identifikacijo in sledljivost eksplozivov za civilno uporabo v skladu z Direktivo Sveta 93/15/EGS (UL L 94, 5.4.2008, str.
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) [1]
8), kakor je bila spremenjena z Direktivo Komisije 2012/4/EU (UL L 50, 23.2.2012, str.
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.
18) (v nadaljnjem besedilu: Direktiva 2008/43/ES)
8), as amended by Commission Directive 2012/4/EU (OJ L 50, 23.2.2012, p.
Odločba Komisije 2004/388/ES z dne 15. aprila 2004 o dokumentu za transfer eksplozivov znotraj Skupnosti (UL L 120, 24.4.2004, str.
18), hereinafter referred to as “Directive 2008/43/EC”
43), kakor je bila spremenjena s Sklepom Komisije 2010/347/EU (UL L 155, 22.6.2010, str.
Commission Decision 2004/388/EC of 15 April 2004 on an Intra-Community transfer of explosives document (OJ L 120, 24.4.2004, p.
54) (v nadaljnjem besedilu: Odločba 2004/388/ES)
43), as amended by Commission Decision 2010/347/EU (OJ L 155, 22.6.2010, p.
Zvezni zakon z dne 25. marca 1977 o eksplozivnih snoveh (Zakon o eksplozivnih snoveh), kakor je bil nazadnje spremenjen 12. junija 2009 (RO 2010 2617)
54), hereinafter referred to as “Decision 2004/388/EC”
Odlok z dne 27. novembra 2000 o eksplozivih (Odlok o eksplozivih), kakor je bil nazadnje spremenjen 25. novembra 2015 (RO 2016 247)
Federal Act of 25 March 1977 on explosive substances (Explosives Act) as last amended on 12 June 2009 (RO 2010 2617)
Odbor, ustanovljen v skladu s členom 10 tega sporazuma, sestavi in redno posodablja seznam organov za uradno imenovanje, ki jih priglasita pogodbenici.
Ordinance of 27 November 2000 on explosives (Explosives Ordinance), as last amended on 25 November 2015 (RO 2016 247)
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 5 Direktive 2014/28/EU.
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.
za namene obveznosti iz člena 5(5)(b) in člena 7(3) Direktive 2014/28/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.
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.
za namene obveznosti iz členov 5(3) in 7(7) Direktive 2014/28/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 eksploziv dan na trg Evropske unije ali Švice.
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.
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 eksploziv dan na trg Evropske unije ali Švice.
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.
Za namene obveznosti iz člena 6(2) Direktive 2014/28/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 6(1) Direktive 2014/28/EU ali ustreznimi določbami Švice.