natgillin/translations-raw huggingface dataset:
Article 4
Vjerodostojni su tekstovi Uredbe (EU) 2016/114 na islandskom i norveškom jeziku koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije.
OJ L 23, 29.1.2016, p. 40.
Ova se Odluka objavljuje u odjeljku o EGP-u Službenog lista Europske unije i u Dodatku o EGP-u Službenom listu Europske unije.
amending Annex XXII (Company law) to the EEA Agreement [2017/2053]
o izmjeni Priloga XXII.
THE EEA JOINT COMMITTEE,
(Pravo trgovačkih društava) Sporazumu o EGP-u [2017/2053]
Commission Regulation (EU) 2015/2113 of 23 November 2015 amending Regulation (EC) No 1126/2008 adopting certain international accounting standards in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council as regards International Accounting Standards 16 and 41 [1] is to be incorporated into the EEA Agreement.
budući da:
Annex XXII to the EEA Agreement should therefore be amended accordingly,
Uredba Komisije (EU) 2015/2113 оd 23. studenoga 2015. o izmjeni Uredbe (EZ) br. 1126/2008 o usvajanju određenih međunarodnih računovodstvenih standarda u skladu s Uredbom (EZ) br. 1606/2002 Europskog parlamenta i Vijeća u vezi s međunarodnim računovodstvenim standardima 16 i 41 [1] treba se uključiti u Sporazum o EGP-u.
32015 R 2113: Commission Regulation (EU) 2015/2113 of 23 November 2015 (OJ L 306, 24.11.2015, p. 7).’
Članak 1.
The text of Regulation (EU) 2015/2113 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Sporazumu o EGP-u dodaje se sljedeća alineja:
Article 3
32015 R 2113: Uredbom Komisije (EU) 2015/2113 od 23. studenoga 2015.
This Decision shall enter into force on 30 April 2016, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [2].
(SL L 306, 24.11.2015., str. 7.).”
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
Vjerodostojni su tekstovi Uredbe (EU) 2015/2113 na islandskom i norveškom jeziku koji se objavljuju u Dodatku o EGP-u Službenom listu Europske unije.
OJ L 306, 24.11.2015, p. 7.
Članak 4.
The European Union has adopted a new Directive on simple pressure vessels and a new Directive on pressure equipment and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Stranke sporazuma suglasile su se prilagoditi poglavlje 4. o medicinskim proizvodima iz Priloga I. u cilju poticanja suradnje među regulatorima u području medicinskih proizvoda.
Chapter 6, Pressure vessels, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o jednostavnim tlačnim posudama i novu direktivu o tlačnoj opremi, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The European Union has adopted a new Directive on radio equipment and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
The European Union has adopted a new Directive on equipment and protective systems intended for use in potentially explosive atmosphere and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Tlačne posude Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Chapter 8, Equipment and protective systems intended for use in potentially explosive atmosphere, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o radijskoj opremi, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The European Union has adopted a new Directive on electrical equipment and a new Directive on electromagnetic compatibility and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Sporazuma smatraju jednakovrijednima prethodno navedenom zakonodavstvu Europske unije.
The European Union has adopted a new Directive on non-automatic weighing instruments and a new Directive on measuring instruments Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Radijska oprema i oprema telekomunikacijskih terminala Priloga 1. trebalo bi izmijeniti tako da odražava te promjene.
Chapter 11, Measuring instruments and prepackages, of Annex 1 should be amended to reflect these developments;
Europska unija donijela je novu direktivu o opremi i zaštitnim sustavima namijenjenima za uporabu u potencijalno eksplozivnim atmosferama,a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
The European Union has adopted a new Directive on lifts and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Poglavlje 8.
The European Union has adopted a new Directive on explosives for civil use and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the abovementioned European Union legislation;
Europska unija donijela je novu direktivu o električnoj opremi i novu direktivu o elektromagnetskoj kompatibilnosti, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
HAS DECIDED AS FOLLOWS:
Europska unija donijela je novu direktivu o neautomatskim vagama i novu direktivu o mjernim instrumentima, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
Chapter 11, Measuring instruments and prepackages, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment F to this Decision.
Europska unija donijela je novu direktivu o dizalima, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment J annexed to this Decision.
Europska unija donijela je novu direktivu o eksplozivima za civilnu upotrebu, a Švicarska je izmijenila svoje zakone i druge propise koji se prema članku 1. stavku 2.
This Decision shall be effective from the date of the later of these signatures.
Poglavlje 20.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
ODLUČIO JE:
Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
Poglavlje 6.
Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149).
Tlačne posude Priloga 1.
Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
Sporazumu mijenja se u skladu s odredbama iz Dodatka B priloženog ovoj Odluci.
Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on 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).
Poglavlje 7.
ATTACHMENT A
Radijska oprema i oprema telekomunikacijskih terminala Priloga 1.
In Annex 1, Product Sectors, Chapter 4, Medical devices should be deleted and replaced by the following one:
Sporazumu mijenja se u skladu s odredbama iz Dodatka C priloženog ovoj Odluci.
‘CHAPTER 4
Poglavlje 8.
MEDICAL DEVICES
Oprema i zaštitni sustavi za upotrebu u eksplozivnoj atmosferi Priloga 1.
SECTION I
Sporazumu mijenja se u skladu s odredbama iz Dodatka D priloženog ovoj Odluci.
Legislative, regulatory and administrative provisions
Poglavlje 9.
Provisions covered by Article 1(2)
Električna oprema i elektromagnetska kompatibilnost Priloga 1.
European Union
Sporazumu mijenja se u skladu s odredbama iz Dodatka E priloženog ovoj Odluci.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
Poglavlje 11.
1)
Mjerni instrumenti i pretpakiranja Priloga 1.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka F priloženog ovoj Odluci.
1)
Poglavlje 15.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p.
Nadzor dobre proizvodne prakse (DPP) lijekova i certificiranje serije Priloga 1.
1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka G priloženog ovoj Odluci.
1) and corrected by Corrigenda (OJ L 22, 29.1.1999, p.
Poglavlje 17.
75 and OJ L 6, 10.1.2002, p.
Dizala Priloga 1.
70)
Sporazumu mijenja se u skladu s odredbama iz Dodatka H priloženog ovoj Odluci.
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p.
Poglavlje 20.
17)
Eksplozivi za civilnu upotrebu Priloga 1.
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p.
Sporazumu mijenja se u skladu s odredbama iz Dodatka I priloženog ovoj Odluci.
43)
10.
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p.
Prilog 1.
3)
Sporazumu mijenja se u skladu s odredbama iz Dodatka J priloženog ovoj Odluci.
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p.
Ovu Odluku, sastavljenu u dva primjerka, potpisuju predstavnici Odbora koji su ovlašteni djelovati u ime stranaka.
41)
Ova Odluka stupa na snagu od datuma zadnjeg potpisa.
Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p.
U ime Švicarske Konfederacije
98)
Potpisano u Bernu 28. srpnja 2017.
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p.
U ime Europske unije
21)
Potpisano u Bruxellesu 27. srpnja 2017.
Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
Direktiva 2014/29/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje na tržištu jednostavnih tlačnih posuda (SL L 96, 29.3.2014., str. 45.).
63)
Direktiva 2014/68/EU Europskog parlamenta i Vijeća od 15. svibnja 2014. o usklađivanju zakonodavstava država članica o stavljanju na raspolaganje na tržištu tlačne opreme (SL L 189, 27.6.2014., str. 164.).
Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and the Council on in-vitro diagnostic medical devices (OJ L 341, 22.12.2011, p.
Direktiva 2014/53/EU Europskog parlamenta i Vijeća od 16. travnja 2014. o usklađivanju zakonodavstava država članica o stavljanju na raspolaganje radijske opreme na tržištu i stavljanju izvan snage Direktive 1999/5/EZ (SL L 153, 22.5.2014., str. 62.).
50)
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. 309.).
Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p.
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. 357.).
88)
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. 79.).
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p.
Direktiva 2014/31/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje neautomatskih vaga na tržište (SL L 96, 29.3.2014., str. 107.).
45)
Direktiva 2014/32/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje mjernih instrumenata na tržištu (SL L 96, 29.3.2014., str. 149.).
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p.
Direktiva 2014/33/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na dizala i sigurnosne komponente za dizala (SL L 96, 29.3.2014., str. 251.).
28)
Direktiva 2014/28/EU Europskog parlamenta i Vijeća od 26. veljače 2014. o usklađivanju zakonodavstava država članica u odnosu na stavljanje na raspolaganje eksploziva za civilnu upotrebu na tržištu i nadzoru nad njima (SL L 96, 29.3.2014., str. 1.).
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p.
DODATAK A
8)
U Prilogu 1.
Switzerland
Proizvodni sektori poglavlje 4.
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended 1 January 2014 (RO 2013 4137)
Medicinski proizvodi treba izbrisati i zamijeniti sljedećim:
Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 20 March 2008 (RO 2008 3437)
„POGLAVLJE 4.
Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235)
MEDICINSKI PROIZVODI
Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391)
ODJELJAK I.
Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 15 April 2015 (RO 2015 999)
Zakoni i drugi propisi
Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847), as last amended on 4 September 2013 (RO 2013 3041)
Odredbe obuhvaćene člankom 1. stavkom 2.
Ordinance of 17 June 1996 on Accreditation and Designation of Conformity Assessment Bodies (RO 1996 1904), as last amended on 15 June 2012 (RO 2012 3631)
Europska unija
Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)
Direktiva Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstva država članica koji se odnose na aktivne medicinske proizvode za ugradnju, kako je zadnje izmijenjena Uredbom (EZ) br.
SECTION II
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
Conformity assessment bodies
(SL L 284, 31.10.2003., str.
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
1.)
SECTION III
Direktiva Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima, kako je zadnje izmijenjena Uredbom (EZ) br.
Designating authorities
1882/2003 Europskog parlamenta i Vijeća od 29. rujna 2003.
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
(SL L 284, 31.10.2003., str.
SECTION IV
1.)
Special rules relating to the designation of conformity assessment bodies
Direktiva 98/79/EZ Europskog parlamenta i Vijeća od 27. listopada 1998. o in vitro dijagnostičkim medicinskim proizvodima (SL L 331, 7.12.1998., str.
For the designation of conformity assessment bodies under this Chapter, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and, as laid down in Implementing Regulation (EU) No 920/2013, the assessment criteria set out in Annex XI to Directive 93/42/EEC, in Annex 8 to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC.
1.), kako je zadnje izmijenjena Uredbom (EZ) br.
Supplementary provisions
1.) i ispravljena ispravcima (SL L 22, 29.1.1999., str.
Registration of the person responsible for placing devices on the market
75. i SL L 6, 10.1.2002., str.
Any manufacturer or his authorised representative who places on the market of one of the Parties the medical devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles.
70.)
The Parties shall reciprocally recognise that registration.
4.
The manufacturer shall not be obliged to designate a person responsible for placing devices on the market established in the territory of the other Party.
Odluka Komisije 2002/364/EZ od 7. svibnja 2002. o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 131, 16.5.2002., str.
Labelling of medical devices
17.).
Manufacturers of both Parties shall indicate their name or trade name and address on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 93/42/EEC and in vitro diagnostic medical devices specified in Annex 1, point 8.4(a), to Directive 98/79/EC.
Direktiva Komisije 2003/12/EZ od 3. veljače 2003. o ponovnoj klasifikaciji implantata za dojke u okviru Direktive 93/42/EEZ u pogledu medicinskih proizvoda (SL L 28, 4.2.2003., str.
They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the representative or of the importer established within the territory of the other Party on the label, outer packaging or instructions for use.
43).
For devices imported from third countries, in view of their distribution in the Union and Switzerland, the label, or the outer packaging, or instructions for use, shall contain the name and address of the single authorised representative of the manufacturer established within the Union or Switzerland, as appropriate.
Uredba Komisije (EU) br.
Information exchange
722/2012 od 8. kolovoza 2012. o posebnim zahtjevima u vezi sa zahtjevima utvrđenim u direktivama Vijeća 90/385/EEZ i 93/42/EEZ s obzirom na aktivne medicinske proizvode za ugradnju i medicinske proizvode proizvedene korištenjem tkiva životinjskog podrijetla (SL L 212, 9.8.2012., str.
In accordance with Article 9 of the Agreement, the Parties shall in particular exchange the information referred to in Article 8 of Directive 90/385/EEC, Article 10 of Directive 93/42/EEC, Article 11 of Directive 98/79/EC and Article 3 of Implementing Regulation (EU) No 920/2013.
3.)
European databases
Direktiva Komisije 2005/50/EZ od 11. kolovoza 2005. o ponovnoj kategorizaciji zglobnih proteza kuka, koljena i ramena u okviru Direktive 93/42/EEZ o medicinskim proizvodima (SL L 210, 12.8.2005., str.
The competent Swiss authorities shall have access to the European databases established under Article 12 of Directive 98/79/EC, Article 14a of Directive 93/42/EEC and Article 3 of Implementing Regulation (EU) No 920/2013.
41.)
They shall transmit to the Commission and/or body responsible for managing the databases the data provided for in those Articles collected in Switzerland for entry into the European databases.’
Uredba Komisije (EZ) br.
ATTACHMENT B
2007/2006 od 22. prosinca 2006. o provedbi Uredbe (EZ) br. 1774/2002 Europskog parlamenta i Vijeća s obzirom na uvoz i provoz određenih međuproizvoda dobivenih od materijala kategorije 3. namijenjenih za tehničku upotrebu u medicinskim proizvodima, in vitro dijagnostici i laboratorijskim reagensima te o izmjeni te Uredbe (SL L 379, 28.12.2006., str.
In Annex 1, Product Sectors, Chapter 6, Pressure vessels should be deleted and replaced by the following one:
98.)
‘CHAPTER 6
Direktiva 2007/47/EZ Europskog parlamenta i Vijeća od 5. rujna 2007. o izmjeni Direktive Vijeća 90/385/EEZ o usklađivanju zakonodavstava država članica u odnosu na aktivne medicinske proizvode za ugradnju, Direktive Vijeća 93/42/EEZ o medicinskim proizvodima i Direktive 98/8/EZ o stavljanju biocidnih pripravaka na tržište (SL L 247, 21.9.2007., str.
PRESSURE VESSELS
21.)
Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p.
10.
45)
Odluka Komisije 2011/869/EU od 20. prosinca 2011. o izmjeni Odluke 2002/364/EZ o zajedničkim tehničkim specifikacijama za in vitro dijagnostičke medicinske proizvode (SL L 341, 22.12.2011., str.
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p.
63.)
164)
Direktiva Komisije 2011/100/EU od 20. prosinca 2011. o izmjeni Direktive 98/79/EZ Europskog parlamenta i Vijeća o in vitro dijagnostičkim medicinskim proizvodima (SL L 341, 22.12.2011., str.
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p.
50.)
1), hereinafter referred to as “Directive 2010/35/EU”
Direktiva 2011/65/EU Europskog parlamenta i Vijeća od 8. lipnja 2011. o ograničenju uporabe određenih opasnih tvari u električnoj i elektroničkoj opremi (SL L 174, 1.7.2011., str.
Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p.
88.)