natgillin/translations-raw huggingface dataset:
It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the instrument.
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 instrument dan na trg Evropske unije ali Švice.
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Directive 2014/31/EU and Article 39 of Directive 2014/32/EU.
za namene obveznosti iz drugega pododstavka člena 6(4) in člena 8(6) Direktive 2014/31/EU oziroma drugega pododstavka člena 8(4) in člena 10(6) Direktive 2014/32/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.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Directive 2014/31/EU, respectively Article 40 of Directive 2014/32/EU, directly or by means of designated representatives.
Za namene obveznosti iz člena 7(2) Direktive 2014/31/EU oziroma člena 9(2) Direktive 2014/32/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 7(1) Direktive 2014/31/EU oziroma členom 9(1) Direktive 2014/32/EU ali ustreznimi določbami Švice.
Procedure for dealing with instruments presenting a risk caused by non-compliance not restricted to the national territory
Pristojni nacionalni organ za nadzor trga države članice Evropske unije ali Švice lahko na utemeljeno zahtevo od zadevnih gospodarskih subjektov v Evropski uniji in Švici zahteva predložitev vseh potrebnih informacij in dokumentacije, ki dokazujejo skladnost instrumenta z zakonodajo iz oddelka I.
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 instrument covered by this chapter presents a risk to aspects of public interest protection covered by Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, 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:
Od gospodarskih subjektov lahko zahteva, naj sodelujejo pri kateri koli dejavnosti, katere cilj je preprečiti tveganje, povezano z instrumentom.
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the instrument's being made available on their national market, to withdraw the instrument from that market or to recall it.
Švicarski organi za uradno imenovanje lahko sodelujejo pri izmenjavi izkušenj med nacionalnimi organi držav članic iz člena 34 Direktive 2014/31/EU in člena 39 Direktive 2014/32/EU.
This information shall include all available details, in particular the data necessary for the identification of the non-compliant instrument, the origin of the instrument, 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.
Švicarski organi za ugotavljanje skladnosti lahko neposredno ali prek pooblaščenih zastopnikov sodelujejo v mehanizmih usklajevanja in sodelovanja, določenih v členu 35 Direktive 2014/31/EU oziroma členu 40 Direktive 2014/32/EU.
failure of the instrument to meet requirements relating to aspects of public interest protection laid down in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, or
Postopek za obravnavanje instrumentov, ki pomenijo tveganje, povzročeno zaradi neskladnosti, ki ni omejena na nacionalno ozemlje
shortcomings in the harmonised standards referred to in Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions.
Kadar organi za nadzor trga države članice ali Švice sprejmejo ukrepe ali imajo zadostne razloge za domnevo, da instrument iz tega poglavja pomeni tveganje za vidike zaščite javnega interesa iz Direktive 2014/31/EU ali Direktive 2014/32/EU oziroma ustreznih določb Švice, 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:
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 instrument concerned.
kadar zadevni gospodarski subjekt ne sprejme ustreznih korektivnih ukrepov, o vseh ustreznih začasnih ukrepih za prepoved ali omejitev dostopnosti instrumenta na svojem nacionalnem trgu, za umik instrumenta z navedenega trga ali njegov odpoklic.
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the instrument concerned, such as withdrawal of an instrument from their market, without delay.
Te informacije vsebujejo vse razpoložljive podatke, zlasti podatke, potrebne za določitev neskladnega instrumenta, porekla instrumenta, vrsto domnevne neskladnosti in tveganja ter vrsto in trajanje izvedenih nacionalnih ukrepov in pojasnilo zadevnega gospodarskega subjekta.
Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.
instrument ne izpolnjuje pogojev, ki so povezani z vidiki zaščite javnega interesa, določenimi v Direktivi 2014/31/EU ali Direktivi 2014/32/EU oziroma ustreznih določbah Švice, ali
Where, on completion of the procedure set out in paragraph 3.4, 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 Directive 2014/31/EU or Directive 2014/32/EU, or the corresponding Swiss provisions, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators.
pomanjkljivosti harmoniziranih standardov iz Direktive 2014/31/EU ali Direktive 2014/32/EU oziroma ustreznih določb Švice.
If the national measure relating to an instrument is considered:
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 instrumenta.
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant instrument is withdrawn from their markets, and shall inform the Commission accordingly,
Države članice in Švica zagotovijo takojšnje sprejetje ustreznih omejevalnih ukrepov v zvezi z zadevnim instrumentom, kot je umik instrumenta s trga.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.
Če se Švica ali država članica ne strinjata s priglašenim nacionalnim ukrepom, o svojih ugovorih obvestita Evropsko komisijo v treh mesecih po prejemu informacij.
Compliant instruments which nevertheless present a risk to health and safety
Če na koncu postopka iz odstavka 3.4 država članica ali Švica vloži ugovor zoper ukrep, ki ga sprejmeta Švica oziroma država članica, ali če Komisija meni, da je nacionalni ukrep v nasprotju z Direktivo 2014/31/EU ali Direktivo 2014/32/EU oziroma ustreznimi določbami Švice, se Evropska komisija nemudoma posvetuje z državami članicami in Švico ter prek švicarskih organov z zadevnimi gospodarskimi subjekti.
Where a Member State or Switzerland finds that, although an instrument that an economic operator has been made available on the EU and on the Swiss market is in compliance with Directive 2014/31/EU or Directive 2014/32/EU, respectively the relevant Swiss legislation, presents a risk to aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Če se nacionalni ukrep v zvezi z instrumentom oceni kot:
That information shall include all available details, in particular the data necessary for the identification of the instrument concerned, the origin and the supply chain of the instrument, the nature of the risk involved and the nature and duration of the national measures taken.
upravičen, vse države članice in Švica sprejmejo potrebne ukrepe za umik neskladnega instrumenta s svojih trgov ter o tem obvestijo Komisijo;
In case of a disagreement between the Parties on measures at stake in subparagraphs 3.6 and 3.7 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.
Pogodbenica lahko na podlagi odstavka 3,8 vprašanje pošlje Odboru, ustanovljenemu v skladu s členom 10 tega sporazuma.
justified, the Parties shall take the measures necessary to ensure that the instrument is withdrawn from their market;
Skladni instrumenti, ki vseeno pomenijo tveganje za zdravje in varnost
ATTACHMENT G
Kadar država članica ali Švica ugotovi, da je instrument, katerega dostopnost je gospodarski subjekt omogočil na trgu EU ali Švice, sicer skladen z Direktivo 2014/31/EU oziroma Direktivo 2014/32/EU ali ustreznimi določbami Švice, vendar pomeni tveganje za vidike zaščite javnega interesa, sprejme vse ustrezne ukrepe ter nemudoma obvesti Evropsko komisijo, druge države članice in Švico.
In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:
Te informacije vključujejo vse podrobnosti, ki so na voljo, zlasti podatke, potrebne za določitev zadevnega instrumenta, poreklo in dobavno verigo instrumenta, vrsto tveganja ter vrsto in trajanje sprejetih nacionalnih ukrepov.
‘CHAPTER 15
Če se pogodbenici ne strinjata glede ukrepov iz pododstavkov 3.6 in 3.7, se zadeva predloži Odboru, ki odloči o ustreznih ukrepih, vključno z možnostjo naročila strokovne študije.
MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION
upravičen, pogodbenici sprejmeta potrebne ukrepe za umik instrumenta s svojih trgov;
Scope and coverage
DODATEK G
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.
Poglavje 15 (Nadzor nad zdravili v skladu z dobro proizvodno prakso in certificiranje serij) Priloge 1 (Proizvodni sektorji) bi bilo treba črtati in nadomestiti z naslednjim:
For medicinal products covered by this Chapter, each party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
„POGLAVJE 15
This includes that each Party recognises conclusions of inspections of manufacturers in third countries carried out by the relevant inspection services of the other Party, inter alia, within the framework of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
NADZOR NAD ZDRAVILI V SKLADU Z DOBRO PROIZVODNO PRAKSO IN CERTIFICIRANJE SERIJ
The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.
Področje uporabe in veljavnost
The manufacturer's certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import.
Določbe tega poglavja zajemajo vsa zdravila, ki se proizvajajo industrijsko in za katere veljajo zahteve dobre proizvodne prakse (Good Manufacturing Practice, GMP).
To the products imported from a third country and further exported to the other Party this provision applies only (1) if each batch of the medicinal products has been subject to the re-control in the territory of one of the Parties; and (2) if the manufacturer in the third country has been subject to the inspection by the competent authority of either Party of which the outcome has been that for the products or products category the manufacturer complies with Good Manufacturing Practice.
Za zdravila, zajeta v tem poglavju, vsaka pogodbenica priznava sklepe pregledov proizvajalcev, ki jih izvajajo ustrezne inšpekcijske službe druge pogodbenice, in ustrezna dovoljenja za proizvodnjo, ki jih izdajo pristojni organi druge pogodbenice.
If the above conditions are not met, each Party can require a re-control in its territory.
To pomeni, da vsaka pogodbenica priznava ugotovitve pregledov proizvajalcev v tretjih državah, ki jih izvedejo ustrezne inšpekcijske službe druge pogodbenice, med drugim v okviru Evropskega direktorata za kakovost zdravil in zdravstvenega varstva (EDQM).
In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.
Pogodbenici sodelujeta, da z ustrezno delitvijo bremen dosežeta najboljšo uporabo inšpekcijskih virov.
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter.
Druga pogodbenica brez ponovnega preverjanja ob uvozu prizna potrdilo proizvajalca o skladnosti vsake serije s svojimi specifikacijami.
The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.
Ta določba se za izdelke, uvožene iz tretje države in nadalje izvožene v drugo pogodbenico, uporablja le, (1) če je bila za vsako serijo zdravil opravljena ponovna kontrola na ozemlju ene od pogodbenic in (2) če je pristojni organ ene od pogodbenic opravil inšpekcijski pregled proizvajalca v tretji državi in ugotovil, da je proizvajalec glede izdelka ali kategorije izdelka v skladu z dobro proizvodno prakso.
“GMP” is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications.
Če navedeni pogoji niso izpolnjeni, lahko vsaka pogodbenica zahteva ponovno kontrolo na svojem ozemlju.
For the purpose of this Chapter it includes the system whereby the manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.
Poleg tega druga pogodbenica prizna uradna dovoljenja za serije, ki jih izda organ pogodbenice izvoznice.
With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service.
‚Zdravila‘ pomeni vse izdelke, ki jih ureja farmacevtska zakonodaja v Evropski uniji in Švici, ki je navedena v oddelku I tega poglavja.
This provision shall apply i.a. to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections.
Opredelitev zdravil zajema vse izdelke za humano in veterinarsko uporabo, kot so kemični in biološki farmacevtski izdelki, imunološki izdelki, radiofarmacevtski izdelki, stabilna zdravila iz človeške krvi ali plazme, predmešanice za pripravo mediciranih dodatkov h krmilom in, kjer je ustrezno, vitamine, minerale, zeliščna zdravila in homeopatska zdravila.
Operational arrangements are detailed under Section III, paragraph 3.
‚Dobra proizvodna praksa‘ je tisti del zagotavljanja kakovosti, ki zagotavlja dosledno proizvodnjo in nadzor nad izdelki v skladu z ustreznimi standardi kakovosti za njihovo nameravano uporabo in z dovoljenji za promet ter specifikacijami izdelkov.
Certification of manufacturers
Za namen tega poglavja vključuje sistem, po katerem proizvajalec prejme specifikacijo izdelka in postopka od nosilca dovoljenja za promet ali prosilca in zagotavlja, da so zdravila narejena v skladu s to specifikacijo.
At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:
V zvezi z zdravili, ki jih zajema zakonodaja ene pogodbenice, druge pa ne, lahko proizvodno podjetje za namene tega sporazuma zahteva pregled, ki ga opravi pristojna lokalna inšpekcijska služba.
is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,
Ta določba se med drugim uporablja za proizvodnjo aktivnih farmacevtskih sestavin, polizdelkov in zdravil v preizkušanju ter na preglede pred začetkom trženja.
is regularly inspected by the authorities,
Operativni režimi so opredeljeni v oddelku III, odstavek 3.
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
Certificiranje proizvajalcev
Should different GMP requirements be used as reference, this is to be mentioned in the certificate.
Organi, pristojni za izdajanje proizvodnih dovoljenj in nadzor nad proizvodnjo zdravil, na zahtevo izvoznika, uvoznika ali pristojnega organa druge pogodbenice potrdijo, da je proizvajalec:
For inspections in third countries, at the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for the inspection shall certify that the manufacturer complies or does not comply with the GMP requirements recognised as equivalent by the two Parties, and which are listed in Section I of this Chapter.
ustrezno pooblaščen za proizvodnjo določenega zdravila ali izvajanje s specifikacijo določenega proizvodnega postopka,
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.
deležen rednih inšpekcijskih pregledov s strani organov,
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
izpolnjuje državne zahteve v zvezi z dobro proizvodno prakso, ki jih pogodbenici priznavata kot enakovredne in so naštete v oddelku I tega poglavja.
In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.
Če se za referenco uporabijo drugačne zahteve dobre proizvodne prakse, je to treba navesti v potrdilu.
Batch certification
Za preglede v tretjih državah organi, pristojni za preglede, na zahtevo izvoznika, uvoznika ali pristojnega organa druge pogodbenice potrdijo, da proizvajalec izpolnjuje zahteve dobre proizvodne prakse, ki jih pogodbenici priznavata kot enakovredne in so naštete v oddelku I tega poglavja, ali da jih ne izpolnjuje.
Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation.
V potrdilu so opredeljeni tudi lokacije proizvodnje (in pogodbenih laboratorijev za nadzor kakovosti, če obstajajo) in datum pregleda.
It will be made available upon request of the competent authority.
V izjemnih primerih, ko je na primer treba izvesti nov inšpekcijski pregled, se ta rok lahko podaljša na devetdeset dni.
When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
Certificiranje serij
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
Vsako izvoženo serijo mora spremljati potrdilo, ki ga zagotovi proizvajalec (samopotrdilo) po celoviti kvalitativni analizi, kvantitativni analizi vseh aktivnih sestavin in drugih preskušanjih ali preverjanjih, potrebnih za zagotavljanje kakovosti izdelka v skladu z zahtevami dovoljenja za promet.
It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with GM P. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the “qualified person” referred to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, and in Switzerland the “responsible person” referred to in Articles 5 and 10 of the Ordinance on establishment licences.
To potrdilo jamči, da serija ustreza svojim specifikacijam, in ga hrani uvoznik serije.
Official Batch Release
Treba ga je predložiti na zahtevo pristojnih organov.
When an official batch release procedure applies, official batch releases carried out by an authority of the exporting Party (listed in Section II) will be recognised by the other Party.
Proizvajalec pri izdaji potrdila upošteva določbe veljavne sheme certificiranja WHO o kakovosti farmacevtskih izdelkov v mednarodni trgovini.
The manufacturer shall provide the certificate of the official batch release.
Potrdilo natančno navaja dogovorjene specifikacije izdelka, analitične metode ter rezultate analiz.
For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18-21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.
Potrdilo o seriji podpiše oseba, odgovorna za sprostitev serije v prodajo ali dobavo, tj. v Evropski uniji ‚odgovorna oseba‘ iz člena 48 Direktive 2001/83/ES in člena 52 Direktive 2001/82/ES, v Švici pa ‚odgovorna oseba‘ iz členov 5 in 10 Odloka o dovoljenjih.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.
Uradna sprostitev serije
38)
Potrdilo o uradni sprostitvi serije zagotovi proizvajalec.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.
Za Evropsko unijo je postopek za uradno sprostitev serij opisan v dokumentu ‚Kontrolna/uradna sprostitev serij cepiv in krvnih izdelkov, 2001‘ ter naslednjih različic in v različnih specifičnih postopkih za sprostitev serij.
67) as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p.
Za Švico je postopek za uradno sprostitev serij določen v členu 17 Zveznega zakona o zdravilih in medicinskih pripomočkih ter v členih 18 do 21 Odloka Švicarskega urada za terapevtske izdelke o zahtevah za dovoljenje za promet z zdravili.
1)
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str.