natgillin/translations-raw huggingface dataset:
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.
opravdanom, sve države članice i Švicarska poduzimaju potrebne mjere kako bi osigurale povlačenje ili opoziv nesukladne opreme sa svojih tržišta i o tome obavješćuju Komisiju,
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.
U skladu sa stavkom 14. stranka može proslijediti problem Odboru osnovanom u skladu s člankom 10. ovog Sporazuma.
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.
Sukladna radijska oprema koja ipak predstavlja rizik
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.
Ako država članica ili Švicarska utvrdi da radijska oprema koju je gospodarski subjekt stavio na tržište EU-a i na švicarsko tržište i koja je u skladu sa zakonodavstvom iz odjeljka I. ovog poglavlja ipak predstavlja rizik za zdravlje ili sigurnost osoba ili za ostale aspekte zaštite javnog interesa, ona poduzima sve prikladne mjere i bez odlaganja obavješćuje Komisiju, druge države članice i Švicarsku.
If the national measure relating to an instrument is considered:
Komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima te ocjenjuje poduzete nacionalne mjere kako bi utvrdila je li nacionalna mjera opravdana i, prema potrebi, predložila prikladne mjere.
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all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant instrument is withdrawn from their markets, and shall inform the Commission accordingly,
U slučaju neslaganja među strankama u vezi s mjerama iz prethodnih stavaka 10. i 11., problem se prosljeđuje Odboru osnovanom u skladu s člankom 10. ovog Sporazuma koji odlučuje o smjeru daljnjeg djelovanja, uključujući mogućnost provođenja stručnog istraživanja.
A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 3.8.
Ako Odbor smatra da je mjera
Compliant instruments which nevertheless present a risk to health and safety
neopravdana, nacionalno tijelo države članice ili Švicarske povlači mjeru;
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.
opravdana, poduzimaju odgovarajuće mjere kako bi osigurale povlačenje ili opoziv proizvoda sa svojih tržišta.”
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.
Upućivanje na identifikator razreda iz članka 2.
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.
Odluke Komisije 2000/299 ne primjenjuje se.
justified, the Parties shall take the measures necessary to ensure that the instrument is withdrawn from their market;
Ne dovodeći u pitanje Poglavlje 9.
ATTACHMENT G
Uredba (EU) br.
In Annex 1, Product Sectors, Chapter 15, Medicinal products, GMP Inspection and Batch Certification should be deleted and replaced by the following:
1025/2012 Europskog parlamenta i Vijeća od 25. listopada 2012. o europskoj normizaciji, o izmjeni direktiva Vijeća 89/686/EEZ i 93/15/EEZ i direktiva 94/9/EZ, 94/25/EZ, 95/16/EZ, 97/23/EZ, 98/34/EZ, 2004/22/EZ, 2007/23/EZ, 2009/23/EZ i 2009/105/EZ Europskog parlamenta i Vijeća te o stavljanju izvan snage Odluke Vijeća 87/95/EEZ i Odluke br.
‘CHAPTER 15
1673/2006/EZ Europskog parlamenta i Vijeća (SL L 316, 14.11.2012., str.
MEDICINAL PRODUCTS, GMP INSPECTION AND BATCH CERTIFICATION
12.).
Scope and coverage
U Prilogu 1.
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured and to which Good Manufacturing Practice (GMP) requirements apply.
Proizvodni sektori poglavlje 8.
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.
Oprema i zaštitni sustavi za uporabu u eksplozivnoj atmosferi treba izbrisati i zamijeniti sljedećim:
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).
„POGLAVLJE 8.
The Parties shall cooperate in order to achieve the best use of inspection resources by an appropriate burden sharing.
OPREMA I ZAŠTITNI SUSTAVI NAMIJENJENI ZA UPORABU U POTENCIJALNO EKSPLOZIVNIM ATMOSFERAMA
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.
Direktiva 2014/34/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na opremu i zaštitne sustave namijenjene za uporabu u potencijalno eksplozivnim atmosferama (SL L 96, 29.3.2014., str.
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.
309.).
If the above conditions are not met, each Party can require a re-control in its territory.
Savezni zakon od 24. lipnja 1902. o električnim instalacijama sa slabom i jakom strujom (RO 19 252 i RS 4 798), kako je zadnje izmijenjen 20. ožujka 2008.
In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.
(RO 2008.
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Union and Switzerland as listed in Section I of this Chapter.
3437)
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.
Pravilnik od 25. studenoga 2015. o sigurnosti opreme i zaštitnih sustava namijenjenih za uporabu u potencijalno eksplozivnim atmosferama (RO 2016.
“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.
143)
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.
Za imenovanje tijela za ocjenjivanje sukladnosti tijela nadležna za imenovanje pridržavaju se općih načela iz Priloga 2. ovom Sporazumu i kriterija ocjenjivanja utvrđenih u poglavlju 4.
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.
Direktive 2014/34/EU.
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.
za potrebe obveza iz članka 6. stavka 7. i članka 8. stavka 3.
Operational arrangements are detailed under Section III, paragraph 3.
Direktive 2014/34/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.
Certification of manufacturers
Ako proizvođač nema poslovni nastan na državnom području Europske unije ili Švicarske, dostatno je navesti ime, registrirano trgovačko ime ili registrirani žig i poštansku adresu na kojoj je dostupan uvoznik s poslovnim nastanom na državnom području Europske unije ili Švicarske;
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:
za potrebe obveza iz članka 6. stavka 3. i članka 8. stavka 8.
is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,
Direktive 2014/34/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 proizvod stavljen na tržište u Europskoj uniji ili Švicarskoj.
is regularly inspected by the authorities,
za potrebe obveza iz članka 6. stavka 4. drugog podstavka i članka 8. stavka 6.
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
Direktive 2014/34/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.
Should different GMP requirements be used as reference, this is to be mentioned in the certificate.
Za potrebe obveze iz članka 7. stavka 2.
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.
Direktive 2014/34/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.
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any) and the date of the inspection.
Direktive 2014/34/EU ili odgovarajućim švicarskim odredbama.
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
Švicarska tijela za imenovanje mogu sudjelovati u razmjeni iskustava među nadležnim tijelima država članica kako je navedeno u članku 32.
In exceptional cases, i.e. when a new inspection has to be carried out, this period may be extended to 90 days.
Direktive 2014/34/EU.
Batch certification
Švicarska imenovana tijela za ocjenjivanje sukladnosti mogu sudjelovati u mehanizmima koordinacije i suradnje predviđenima u članku 33.
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.
Direktive 2014/34/EU, izravno ili preko imenovanih predstavnika.
It will be made available upon request of the competent authority.
Komisija, države članice, Švicarska i druga tijela priznata u okviru ovog poglavlja mogu zatražiti primjerak potvrde o ispitivanju tipa i njezinih dodataka.
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.
Komisija, države članice i Švicarska mogu na zahtjev dobiti presliku tehničke dokumentacije i rezultate pregleda koje je obavilo tijelo priznato u okviru ovog poglavlja.
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
U skladu s člankom 12. stavkom 4. ovog Sporazuma, ako tijela za nadzor tržišta države članice ili Švicarske utvrde da proizvod obuhvaćen ovim poglavljem nije u skladu s propisima iz odjeljka I. ovog poglavlja i ako smatraju da nesukladnost nije ograničena na njihovo državno područje, ona bez odlaganja obavješćuju Europsku komisiju, ostale države članice i Švicarsku o sljedećem:
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.
ako relevantni gospodarski subjekt ne poduzme odgovarajuće korektivne mjere, o svim prikladnim privremenim mjerama poduzetima kako bi se zabranila ili ograničila dostupnost proizvoda na njihovu nacionalnom tržištu te kako bi se proizvod povukao ili opozvao s tržišta.
Official Batch Release
Te informacije uključuju sve dostupne pojedinosti, a posebno podatke potrebne za identifikaciju nesukladnog proizvoda, njegova podrijetla, vrste navodne nesukladnosti i s tim povezanih rizika, vrste i trajanja poduzetih nacionalnih mjera te obrazloženje dotičnoga gospodarskog subjekta.
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.
činjenica da proizvod ne udovoljava propisima u pogledu zdravlja i sigurnosti osoba ili zaštite domaćih životinja ili imovine navedenima u zakonodavstvu iz odjeljka I. ili
The manufacturer shall provide the certificate of the official batch release.
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.
For the European Union, the official batch release procedure is specified in document “Control Authority Batch Release of Vaccination and Blood Products, 2001” or subsequent versions and in different specific batch release procedures.
Države članice i Švicarska bez odlaganja osiguravaju provedbu odgovarajućih mjera ograničavanja u pogledu predmetnog proizvoda, kao što je povlačenje proizvoda sa svojeg tržišta.
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.
Ako se Švicarska ili država članica ne slažu s nacionalnom mjerom iz stavka 5., one u roku od tri mjeseca od primitka informacije o svojim prigovorima obavješćuju Europsku komisiju.
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.
Ako po završetku postupka iz stavka 5. država članica ili Švicarska podnesu prigovor na mjeru koju je poduzela Švicarska ili država članica, ili ako Komisija smatra da je nacionalna mjera protivna relevantnom zakonodavstvu navedenom u odjeljku I., Europska komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom, i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima.
1) as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (OJ L 316, 14.11.2012, p.
Ako se nacionalna mjera koja se odnosi na proizvod smatra:
38)
Ako država članica ili Švicarska utvrde da određeni proizvod koji je gospodarski subjekt stavio na tržište EU-a i švicarsko tržište i koji je u skladu sa zakonodavstvom iz odjeljka I. ovog poglavlja ipak predstavlja rizik za zdravlje ili sigurnost osoba, domaćih životinja ili imovine, ona poduzima sve prikladne mjere i bez odlaganja obavješćuje Komisiju, druge države članice i Švicarsku.
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.
Komisija bez odlaganja započinje savjetovanje s državama članicama, Švicarskom i, posredstvom švicarskih tijela, s relevantnim gospodarskim subjektom ili subjektima te ocjenjuje poduzete nacionalne mjere kako bi utvrdila je li nacionalna mjera opravdana i, prema potrebi, predložila prikladne mjere.
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.
U slučaju neslaganja među strankama u vezi s mjerama iz prethodnih stavaka 6. i 7., problem se prosljeđuje Odboru osnovanom u skladu s člankom 10. ovog Sporazuma koji odlučuje o smjeru daljnjeg djelovanja, uključujući mogućnost provođenja stručnog istraživanja.
1)
U Prilogu 1.
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p.
Proizvodni sektori poglavlje 9.
30)
Električna oprema i elektromagnetska kompatibilnost treba izbrisati i zamijeniti sljedećim:
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p.
„POGLAVLJE 9.
1) as last amended by Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p.
ELEKTRIČNA OPREMA I ELEKTROMAGNETSKA KOMPATIBILNOST
33)
Direktiva 2014/35/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje na tržištu električne opreme namijenjene za uporabu unutar određenih naponskih granica (SL L 96, 29.3.2014., str.
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p.
357.)
22)
Direktiva 2014/30/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na elektromagnetsku kompatibilnost (SL L 96, 29.3.2014., str.
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p.
79.)
42)
1185), kako je zadnje izmijenjen 25. studenoga 2015.
Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p.
(RO 2016.
1)
625)
EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (published on website of the European Commission)
Pravilnik od 30. ožujka 1994. o električnim instalacijama s jakom strujom (RO 1994.
Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p.
1199), kako je zadnje izmijenjen 25. studenoga 2015.
34) and Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p.
(RO 2016.
1)
119)
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p.
Pravilnik od 25. studenoga 2015. o niskonaponskoj električnoj opremi (RO 2016.
13)
105)
Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p.
Pravilnik od 25. studenoga 2015. o elektromagnetskoj kompatibilnosti (RO 2016.
Federal Act of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 1 January 2014 (RO 2013 4137)
Pravilnik od 25. studenoga 2015. o telekomunikacijskoj opremi (OIT); (RO2016.
Ordinance of 17 October 2001 on the establishment of licences (RO 2001 3399), as last amended on 1 May 2016 (RO 2016 1171)
179)
Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437), as last amended on 1 May 2016 (RO 2016 1171)
Pravilnik od 17. lipnja 1996. o švicarskom sustavu akreditacije i imenovanju ispitnih laboratorija i tijela za ocjenjivanje sukladnosti (RO 1996.
The list of the official GMP Inspection Services of the Member States of the European Union and of Switzerland can be found below.
261).
For conformity assessment bodies of the European Union:
Za imenovanje tijela za ocjenjivanje sukladnosti tijela nadležna za imenovanje pridržavaju se općih načela iz Priloga 2 ovom Sporazumu i kriterija ocjenjivanja utvrđenih u poglavlju 4.
Competent Authorities of the European Union are the following authorities of the Member States of the European Union or authorities succeeding them:
Direktive 2014/30/EU.
Country
za potrebe obveza iz članka 7. stavka 6. i članka 9. stavka 3.
For medicinal products for human use
Direktive 2014/30/EU i članka 6. stavka 6. i članka 8. stavka 3.