natgillin/translations-raw huggingface dataset:
the following shall be inserted after point 54zzzy (Commission Directive 2008/60/EC):
Za točko 54zzzy (Direktiva Komisije 2008/60/ES) se vstavi naslednje besedilo:
Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5), as amended by:
32006 R 1881: Uredba Komisije (ES) št. 1881/2006 z dne 19. decembra 2006 (UL L 364, 20.12.2006, str. 5), kakor jo spreminjata:
Commission Regulation (EC) No 1126/2007 of 28 September 2007 (OJ L 255, 29.9.2007, p. 14),
32007 R 1126: Uredba Komisije (ES) št. 1126/2007 z dne 28. septembra 2007 (UL L 255, 29.9.2007, str. 14),
Commission Regulation (EC) No 629/2008 of 2 July 2008 (OJ L 173, 3.7.2008, p. 6).
32008 R 0629: Uredba Komisije (ES) št. 629/2008 z dne 2. julija 2008 (UL L 173, 3.7.2008, str. 6).
The following shall be inserted in Article 1:
V člen 1 se vstavi naslednje besedilo:
“With regard to the maximum level for dioxins and dioxin-like PCBs in marine oil, Iceland and Norway may maintain a maximum level for the sum of dioxins, furans and dioxin-like PCBs (WHO-PCDD/F-PCB-TEQ) of 5 pg/g fat.”’
‚Glede mejnih vrednosti dioksinov in dioksinom podobnih polikloriranih bifenilov (PCB) v olju morskih organizmov lahko Islandija in Norveška ohranita mejno vrednost za vsoto dioksinov, furanov in dioksinom podobnih polikloriranih bifenilov (PCB) (WHO-PCDD/F-PCB-TEQ) v vrednosti 5 pg/g maščobe.‘“
The texts of Regulations (EC) No 1881/2006, (EC) No 1126/2007 and (EC) No 629/2008 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedila uredb (ES) št. 1881/2006, 1126/2007 in 629/2008 v islandskem in norveškem jeziku, ki se objavijo v Dopolnilu EGP k Uradnemu listu Evropske unije, so verodostojna.
This Decision shall enter into force on 30 May 2009, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee [6].
Ta sklep začne veljati dne 30. maja 2009 pod pogojem, da so bila Skupnemu odboru EGP predložena vsa uradna obvestila v skladu s členom 103(1) Sporazuma [6].
OJ L 364, 20.12.2006, p. 5.
UL L 364, 20.12.2006, str. 5.
OJ L 255, 29.9.2007, p. 14.
UL L 255, 29.9.2007, str. 14.
OJ L 173, 3.7.2008, p. 6.
UL L 173, 3.7.2008, str. 6.
OJ L 77, 16.3.2001, p. 1.
UL L 77, 16.3.2001, str. 1.
amending Annex II (Technical regulations, standards, testing and certification) and Protocol 37 to the EEA Agreement
o spremembah Priloge II (Tehnični predpisi, standardi, preskušanje in certificiranje) ter Protokola 37 k Sporazumu EGP
Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular Article 98 and 101 thereof,
ob upoštevanju Sporazuma o Evropskem gospodarskem prostoru, kakor je bil spremenjen s Protokolom o prilagoditvi Sporazuma o Evropskem gospodarskem prostoru (v nadaljnjem besedilu: Sporazum), zlasti členov 98 in 101 Sporazuma,
Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 6/2009 of 5 February 2009 [1].
Priloga II k Sporazumu je bila spremenjena s Sklepom Skupnega odbora EGP št. 6/2009 z dne 5. februarja 2009 [1].
Protocol 37 to the Agreement was amended by Decision of the EEA Joint Committee No 81/2008 of 4 July 2008 [2].
Protokol 37 k Sporazumu je bil spremenjen s Sklepom Skupnega odbora EGP št. 81/2008 z dne 4. julija 2008 [2].
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 [3] is to be incorporated into the Agreement.
Uredbo (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 [3] se vključi v Sporazum.
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use [4] is to be incorporated into the Agreement.
Direktivo 2004/27/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [4] se vključi v Sporazum.
Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products [5] is to be incorporated into the Agreement.
Direktivo 2004/28/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembi Direktive 2001/82/ES o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [5] se vključi v Sporazum.
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use [6] is to be incorporated into the Agreement.
Direktivo 2004/24/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembi Direktive 2001/83/ES o Kodeksu Skupnosti o zdravilih za uporabo v humani medicini glede tradicionalnih zdravil rastlinskega izvora [6] se vključi v Sporazum.
Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises [7] is to be incorporated into the Agreement.
Uredbo Komisije (ES) št. 2049/2005 z dne 15. decembra 2005 o določitvi pravil v zvezi s plačevanjem pristojbin Evropski agenciji za zdravila s strani mikro, malih in srednje velikih podjetij in o nudenju upravne pomoči mikro, malim in srednje velikim podjetjem s strani Evropske agencije za zdravila v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta [7] se vključi v Sporazum.
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council [8] is to be incorporated into the Agreement.
Uredbo Komisije (ES) št. 507/2006 z dne 29. marca 2006 o pogojnem dovoljenju za promet zdravil za humano uporabo, ki sodijo na področje uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [8], se vključi v Sporazum.
Protocol 37 to the Agreement is to be extended to include the Coordination groups for Mutual Recognition and Decentralised procedures (human) and (veterinary) in accordance with Article 101 of the Agreement,
Protokol 37 k Sporazumu EGP se razširi, da v skladu s členom 101 Sporazuma vključuje skupini za usklajevanje postopka medsebojnega priznavanja in decentraliziranega postopka (v humani in v veterinarski medicini) –
Annex II and Protocol 37 to the Agreement shall be amended as specified in the Annex to this Decision.
Priloga II in Protokol 37 k Sporazumu se spremenita, kakor je določeno v Prilogi k temu sklepu.
The texts of Regulations (EC) No 726/2004, (EC) No 2049/2005 and (EC) No 507/2006 and Directives 2004/27/EC, 2004/28/EC and 2004/24/EC in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Besedila uredb (ES) št. 726/2004, 2049/2005 in 507/2006 ter direktiv 2004/27/ES, 2004/28/ES in 2004/24/ES v islandskem in norveškem jeziku, ki se objavijo v Dopolnilu EGP k Uradnemu listu Evropske unije, so verodostojna.
This Decision shall enter into force on 30 May 2009 or on the day following the last notification to the EEA Joint Committee under Article 103(1) of the Agreement, whichever is the later [9].
Ta sklep začne veljati 30. maja 2009 ali dan po predložitvi zadnjega uradnega obvestila Skupnemu odboru EGP v skladu s členom 103(1) Sporazuma, če slednje nastopi pozneje [9].
For Liechtenstein, this Decision shall enter into force on the same day or on the day of entry into force of the Agreement between Liechtenstein and Austria laying down the technical details for Liechtenstein’s recognition of Austrian marketing authorisations within the decentralised procedure (DCP) and the mutual recognition procedure (MRP), whichever is the later.
Za Lihtenštajn začne ta sklep veljati isti dan ali na dan začetka veljavnosti sporazuma med Lihtenštajnom in Avstrijo o tehničnih podrobnostih za lihtenštajnsko priznavanje avstrijskih dovoljenj za promet v okviru decentraliziranega postopka in postopka medsebojnega priznavanja, če slednje nastopi pozneje.
OJ L 73, 19.3.2009, p. 39.
UL L 73, 19.3.2009, str. 39.
OJ L 136, 30.4.2004, p. 1.
UL L 136, 30.4.2004, str. 1.
OJ L 136, 30.4.2004, p. 34.
UL L 136, 30.4.2004, str. 34.
OJ L 136, 30.4.2004, p. 58.
UL L 136, 30.4.2004, str. 58.
OJ L 136, 30.4.2004, p. 85.
UL L 136, 30.4.2004, str. 85.
OJ L 329, 16.12.2005, p. 4.
UL L 329, 16.12.2005, str. 4.
OJ L 92, 30.3.2006, p. 6.
UL L 92, 30.3.2006, str. 6.
Annex II and Protocol 37 to the Agreement shall be amended as follows:
Priloga II in Protokol 37 k Sporazumu se spremenita:
The text of the introductory part of Chapter XIII of Annex II to the Agreement shall be replaced as of the fourth paragraph by the following:
uvodno besedilo poglavja XIII Priloge II k Sporazumu se nadomesti z:
‘When decisions on approval of medicinal products are taken according to the Community procedures laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council, Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council, the EFTA States shall simultaneously and within 30 days of the Community Decision, take corresponding decisions on the basis of the relevant acts.
„Kadar se sprejmejo odločbe o odobritvi zdravil v skladu s postopki Skupnosti, določenimi v Uredbi (ES) št. 726/2004 Evropskega parlamenta in Sveta, Direktivi 2001/83/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/27/ES Evropskega parlamenta in Sveta, ter Direktivi 2001/82/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/28/ES Evropskega parlamenta in Sveta, države Efte na podlagi ustreznih aktov hkrati oziroma v 30 dneh od sprejetja odločbe Skupnosti sprejmejo enake odločbe.
The EEA Joint Committee shall be informed and shall periodically publish lists of such decisions in the EEA Supplement to the Official Journal.
O tem se obvesti Skupni odbor EGP, ki periodično objavlja seznam takih odločb v Dopolnilu EGP k Uradnemu listu.
The EFTA Surveillance Authority shall monitor the application of the decisions taken by the EFTA States as provided for in Article 109 of the Agreement.
Nadzorni organ Efte spremlja uporabo odločb, ki jih sprejmejo države Efte, kakor je predvideno v členu 109 Sporazuma.
Where any of the relevant acts provide for Community procedures on the granting, suspension and withdrawal of a marketing authorisation as well as supervision, including pharmacovigilance, and inspections and sanctions, these and similar tasks shall be carried out by the competent authorities in the EFTA States, on the basis of the same obligations as those of the competent authorities of EC Member States.
Kadar kateri koli od ustreznih aktov predvideva postopke Skupnosti za izdajo, umik in ukinitev dovoljenj za promet ter nadzor, vključno s farmakovigilanco, inšpekcijske preglede in kazni, te in podobne naloge izvajajo pristojni organi v državah Efte na podlagi enakih obveznosti, kakor jih imajo pristojni organi držav članic ES.
The EFTA States shall participate in the work of the European Medicines Agency, hereinafter referred to as “the Agency”, as set up by Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Države Efte sodelujejo pri delu Evropske agencije za zdravila (v nadaljnjem besedilu: Agencija), ki je bila ustanovljena z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta.
The financial provisions of Title IV, Chapter 2, of Regulation (EC) No 726/2004 of the European Parliament and of the Council shall apply to the participation of the EFTA States in the work of the Agency.
Za sodelovanje držav Efte pri delu Agencije se uporabljajo finančne določbe poglavja 2 naslova IV Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta.
The EFTA States shall therefore participate in the Community contribution referred to in Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Države Efte zato sodelujejo pri prispevku Skupnosti iz člena 67(3) Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta.
For this purpose the procedures laid down in Article 82(1)(a) and Protocol 32 of the Agreement shall apply mutatis mutandis with regard to the financial contribution of the EFTA States to the above mentioned Community contribution.
Za ta namen se za finančni prispevek držav Efte pri navedenem prispevku Skupnosti smiselno uporabljajo postopki iz člena 82(1)(a) Sporazuma in Protokola 32 k Sporazumu.
The EFTA States may send observers to meetings of the Agency's Management Board.
Države Efte lahko pošljejo opazovalce na sestanke uprave Agencije.
The EFTA States shall be fully associated with the work of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee on Orphan Medicinal Products (COMP) and the Committee on Herbal Medicinal Products (HMPC).
Države Efte so v celoti vključene v delo Odbora za zdravila za humano uporabo, Odbora za zdravila za veterinarsko uporabo, Odbora za zdravila sirote in Odbora za zdravila rastlinskega izvora.
The detailed arrangements of participation for the representatives of EFTA States shall be in accordance with the provisions of Title IV, chapter 1, of Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Podrobna ureditev sodelovanja predstavnikov držav Efte je v skladu z določbami poglavja 1 naslova IV Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta.
Such representatives shall, however, not participate in the voting and their positions shall be recorded separately.
Ti predstavniki pa ne sodelujejo pri glasovanju in njihova stališča se zabeležijo posebej.
The position of Chairman shall be reserved for a member nominated by an EC Member State.
Položaj predsednika je rezerviran za člana, ki ga predlaga država članica ES.
The EFTA States shall be fully associated with the work of the Coordination Group as set up by Article 27 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and Article 31 of Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council.
Države Efte so v celoti vključene v delo skupin za usklajevanje, ustanovljenih s členom 27 Direktive 2001/83/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/27/ES Evropskega parlamenta in Sveta, ter členom 31 Direktive 2001/82/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/28/ES Evropskega parlamenta in Sveta.
The representatives of the EFTA States shall, however, not participate in the voting and their positions shall be recorded separately.
Predstavniki države Efte pa ne sodelujejo pri glasovanju in njihova stališča se zabeležijo posebej.
An EFTA State may request the Agency to initiate an arbitration procedure according to Title III, Chapter 4 of Directive 2001/83/EC of the European Parliament and of the Council, as amended by Directive 2004/27/EC of the European Parliament and of the Council, and according to Title III, Chapter 4 of Directive 2001/82/EC of the European Parliament and of the Council, as amended by Directive 2004/28/EC of the European Parliament and of the Council.
Država Efte lahko od Agencije zahteva, da sproži postopek arbitraže v skladu s poglavjem 4 naslova III Direktive 2001/83/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/27/ES Evropskega parlamenta in Sveta, ter poglavjem 4 naslova III Direktive 2001/82/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena z Direktivo 2004/28/ES Evropskega parlamenta in Sveta.
Such a request shall, in the first place, be addressed to the Commission which shall, where it considers that the request is of common interest, forward it to the Agency for further processing.
Taka zahteva se najprej naslovi na Komisijo, ki jo, kadar meni, da je zahteva skupnega interesa, pošlje Agenciji v nadaljnjo obravnavo.
The EFTA States shall fully participate in the Telematic Exchange of Information on Medicinal Products (IMP) programme.
Države Efte v celoti sodelujejo pri programu telematske izmenjave informacij o zdravilih.
Iceland and Norway shall provide their national competent authorities and the marketing authorisation holders with the linguistic version of the marketing authorisations required to access their own market.
Islandija in Norveška zagotovita svojim nacionalnim pristojnim organom in imetnikom dovoljenj za promet tisto jezikovno različico dovoljenj za promet, ki jo ti potrebujejo za dostop do svojega trga.
A marketing authorisation granted for a medicinal product following an opinion adopted by the competent EMEA scientific Committee in accordance with Article 9 or Article 34 of Regulation (EC) No 726/2004 of the European Parliament and of the Council shall not be subject to any fees other than those referred to in Article 67(3) and Article 70 of Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Za dovoljenje za promet, izdano za zdravilo na podlagi mnenja, ki ga je sprejel pristojni znanstveni odbor Agencije v skladu s členom 9 ali 34 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta, se ne plačujejo nobene druge pristojbine razen tistih iz člena 67(3) in člena 70 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta.
The Agency having legal personality shall enjoy in all the States of the Contracting Parties the most extensive legal capacity accorded to legal persons under their laws.
Agencija, ki je pravna oseba, ima v vseh državah pogodbenicah kar najširšo pravno in poslovno sposobnost, ki jo pravnim osebam priznava nacionalna zakonodaja.
The EFTA States shall apply to the Agency the Protocol of Privileges and Immunities of the European Communities.
Države Efte za Agencijo uporabljajo Protokol o privilegijih in imunitetah Evropskih skupnosti.
Regulation (EC) No 1049/2001 of the European Parliament and the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents shall, for the application of Regulation (EC) No 726/2004 of the European Parliament and of the Council, apply to any documents of the Agency regarding the EFTA States as well.
Pri uporabi Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta se tudi za katere koli dokumente Agencije v zvezi z državami Efte uporablja Uredba Evropskega parlamenta in Sveta (ES) št. 1049/2001 z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije.
By way of derogation from Article 12(2)(a) of the Conditions of employment of other servants of the European Communities, nationals of the EFTA States enjoying their full rights as citizens may be engaged under contract by the Executive Director of the Agency.’
Z odstopanjem od člena 12(2)(a) Pogojev za zaposlitev drugih uslužbencev Evropskih skupnosti lahko državljani držav Efte, ki uživajo vse državljanske pravice, sklenejo pogodbo o zaposlitvi z izvršnim direktorjem Agencije.“;
The text of point 15g (Council Regulation (EEC) No 2309/93) of Chapter XIII of Annex II to the Agreement shall be deleted.
besedilo točke 15g (Uredba Sveta (EGS) št. 2309/93) poglavja XIII Priloge II k Sporazumu se črta;
The following shall be added in point 15p (Directive 2001/82/EC of the European Parliament and of the Council) of Chapter XIII of Annex II to the Agreement:
v točki 15p (Direktiva 2001/82/ES Evropskega parlamenta in Sveta) poglavja XIII Priloge II k Sporazumu se doda:
Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 (OJ L 136, 30.4.2004, p. 58).’
32004 L 0028: Direktiva 2004/28/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 (UL L 136, 30.4.2004, str. 58).“;
The following indents shall be added in point 15q (Directive 2001/83/EC of the European Parliament and of the Council) of Chapter XIII of Annex II to the Agreement:
v točki 15q (Direktiva 2001/83/ES Evropskega parlamenta in Sveta) poglavja XIII Priloge II k Sporazumu se dodata naslednji alinei:
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ L 136, 30.4.2004, p. 34),
32004 L 0027: Direktiva 2004/27/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 (UL L 136, 30.4.2004, str. 34),
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 (OJ L 136, 30.4.2004, p. 85).’
32004 L 0024: Direktiva 2004/24/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 (UL L 136, 30.4.2004, str. 85).“;
The following shall be added in points 15p (Directive 2001/82/EC of the European Parliament and of the Council) and 15q (Directive 2001/83/EC of the European Parliament and of the Council) of Chapter XIII of Annex II to the Agreement, after the transitional arrangements:
v točkah 15p (Direktiva 2001/82/ES Evropskega parlamenta in Sveta) in 15q (Direktiva 2001/83/ES Evropskega parlamenta in Sveta) poglavja XIII Priloge II k Sporazumu se za prehodno ureditvijo doda:
‘The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptation:
„V tem sporazumu veljajo določbe Direktive z naslednjo prilagoditvijo:
Liechtenstein shall not be obliged to participate in the decentralised procedure (DCP) and in the mutual recognition procedure (MRP) and shall, therefore, not be obliged to issue the corresponding marketing authorisations.
Lihtenštajnu ni treba sodelovati v decentraliziranem postopku in postopku medsebojnega priznavanja ter mu zato ni treba izdajati s tem povezanih dovoljenj za promet.
Instead, Austrian marketing authorisations within the DCP and the MRP shall be valid for Liechtenstein upon request of a marketing authorisation applicant.’
Namesto tega so avstrijska dovoljenja za promet v okviru decentraliziranega postopka in postopka medsebojnega priznavanja na zahtevo prosilca za dovoljenje za promet veljavna za Lihtenštajn.“;
The following points shall be inserted after point 15za (Commission Regulation (EC) No 1950/2006) of Chapter XIII of Annex II to the Agreement:
za točko 15za (Uredba Komisije (ES) št. 1950/2006) poglavja XIII Priloge II k Sporazumu se dodajo naslednje točke:
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. 1).
32004 R 0726: 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. 1).
The right to impose financial penalties on the holders of marketing authorisations in accordance with Article 84(3) shall in the cases where the marketing authorisation holder is established in an EFTA State be carried out by that EFTA State based on a proposal of the European Commission.
Imetnikom dovoljenj za promet, ki imajo sedež v državi Efte, lahko naloži denarne kazni v skladu s členom 84(3) navedena država Efte na predlog Evropske komisije.