natgillin/translations-raw huggingface dataset:
the entry ‘Moussa Ben Omar Ben Ali Essaadi (alias (a) Dah Dah, (b) Abdelrahmman, (c) Bechir). Address: Sudan. Date of birth: 4.12.1964. Place of birth: Tabarka, Tunisia. Nationality: Tunisian. Passport No: L335915 (Tunisian passport issued on 8.11.1996, expired on 7.11.2001). Other information: Considered a fugitive from justice by the Italian authorities (as of November 2009). Date of designation referred to in Article 2a (4) (b): 25.6.2003’ under the heading ‘Natural persons’ shall be replaced by the following:
vnos „Moussa Ben Omar Ben Ali Essaadi (tudi (a) Dah Dah, (b) Abdelrahmman, (c) Bechir). Naslov: Sudan. Datum rojstva: 4.12.1964. Kraj rojstva: Tabarka, Tunizija. Državljanstvo: tunizijsko. Potni list št.: L335915 (tunizijski potni list, izdan 8.11.1996, prenehal veljati 7.11.2001). Drugi podatki: domnevno na begu pred italijanskimi pravosodnimi organi (od novembra 2009). Datum uvrstitve iz člena 2a(4)(b): 25.6.2003.“ pod naslovom „Fizične osebe“ se zamenja z:
‘Moussa Ben Omar Ben Ali Essaadi (alias (a) Dah Dah, (b) Abdelrahmman, (c) Bechir). Address: Tunisia. Date of birth: 4.12.1964. Place of birth: Tabarka, Tunisia. Nationality: Tunisian. Passport No: L335915 (Tunisian passport issued in Milan, Italy on 8.11.1996, expired on 7.11.2001). Other information: Left Sudan to Tunisia in 2011. Date of designation referred to in Article 2a (4) (b): 25.6.2003.’;
„Moussa Ben Omar Ben Ali Essaadi (tudi (a) Dah Dah, (b) Abdelrahmman, (c) Bechir). Naslov: Tunizija. Datum rojstva: 4.12.1964. Kraj rojstva: Tabarka, Tunizija. Državljanstvo: tunizijsko. Potni list št.: L335915 (tunizijski potni list, izdan v Milanu, Italija, 8.11.1996, prenehal veljati 7.11.2001). Drugi podatki: zapustil Sudan in vstopil v Tunizijo leta 2011. Datum uvrstitve iz člena 2a(4)(b): 25.6.2003.“;
the entry ‘Ibrahim Awwad Ibrahim Ali Al-Badri Al-Samarrai (alias (a) Dr. Ibrahim ‘Awwad Ibrahim’ Ali al-Badri al-Samarrai’, (b) Ibrahim ‘Awad Ibrahim al-Badri al-Samarrai, (c) Ibrahim ‘Awad Ibrahim al-Samarra’i, (d) Dr. Ibrahim Awwad Ibrahim al-Samarra’i, (e) Abu Du’a, (f) Abu Duaa, (g) Dr. Ibrahim, (h) Abu Bakr al-Baghdadi al-Husayni al-Quraishi, (i) Abu Bakr al-Baghdadi. Title: Dr. Address: Iraq. Date of birth: 1971. Place of birth: Samarra, Iraq. Nationality: Iraqi. Other information: (a) Leader of Al-Qaida in Iraq; (b) Currently based in Iraq; (c) Responsible for managing and directing AQI large scale operations; (d) Prominently known by nom de guerre (Abu Du’a, Abu Duaa’). Date of designation referred to in Article 2a(4)(b): 5.10.2011’ under the heading ‘Natural persons’ shall be replaced by the following:
vnos „Ibrahim Awwad Ibrahim Ali Al-Badri Al-Samarrai (tudi (a) Dr. Ibrahim ‘Awwad Ibrahim ’Ali al-Badri al-Samarrai’, (b) Ibrahim ‘Awad Ibrahim al-Badri al-Samarrai, (c) Ibrahim ‘Awad Ibrahim al-Samarra’i, (d) Dr. Ibrahim Awwad Ibrahim al-Samarra’i, (e) Abu Du’a, (f) Abu Duaa’, (g) Dr. Ibrahim, (h) Abu Bakr al-Baghdadi al-Husayni al-Quraishi, (i) Abu Bakr al-Baghdadi. Naziv: Dr. Naslov: Irak. Datum rojstva: 1971. Kraj rojstva: Samara, Irak. Državljanstvo: Iraško. Druge informacije: (a) vodja Al-Kaide v Iraku; (b) trenutno se nahaja v Iraku; (c) pristojen za upravljanje in vodenje obsežnih dejavnosti Al-Kaide; (d) zelo znan po privzetem imenu (Abu Du’a, Abu Duaa’). Datum uvrstitve na seznam iz člena 2a(4)(b): 5.10.2011.“ pod naslovom „Fizične osebe“ se zamenja z:
‘Ibrahim Awwad Ibrahim Ali Al-Badri Al-Samarrai (alias (a) Dr. Ibrahim ‘Awwad Ibrahim’ Ali al-Badri al-Samarrai’, (b) Ibrahim ‘Awad Ibrahim al-Badri al-Samarrai, (c) Ibrahim ‘Awad Ibrahim al-Samarra’i, (d) Dr. Ibrahim Awwad Ibrahim al-Samarra’i, (e) Abu Du’a, (f) Abu Duaa, (g) Dr. Ibrahim, (h) Abu Bakr al-Baghdadi al-Husayni al-Quraishi, (i) Abu Bakr al-Baghdadi. Title: Dr. Address: Iraq. Date of birth: 1971. Place of birth: (a) Samarra, Iraq, (b) Iraq. Nationality: Iraqi. Other information: (a) Leader of Al-Qaida in Iraq; (b) Currently based in Iraq; (c) Prominently known by nom de guerre (Abu Du’a, Abu Duaa’). Date of designation referred to in Article 2a(4)(b): 5.10.2011.’
„Ibrahim Awwad Ibrahim Ali Al-Badri Al-Samarrai (tudi (a) Dr. Ibrahim ‘Awwad Ibrahim ’Ali al-Badri al-Samarrai’, (b) Ibrahim ‘Awad Ibrahim al-Badri al-Samarrai, (c) Ibrahim ‘Awad Ibrahim al-Samarra’i, (d) Dr. Ibrahim Awwad Ibrahim al-Samarra’i, (e) Abu Du’a, (f) Abu Duaa’, (g) Dr. Ibrahim, (h) Abu Bakr al-Baghdadi al-Husayni al-Quraishi, (i) Abu Bakr al-Baghdadi. Naziv: Dr. Naslov: Irak. Datum rojstva: 1971. Kraj rojstva: (a) Samara, Irak, (b) Irak. Državljanstvo: iraško. Drugi podatki: (a) vodja Al-Kaide v Iraku; (b) trenutno se nahaja v Iraku; (c) zelo znan po privzetem imenu (Abu Du’a, Abu Duaa’). Datum uvrstitve iz člena 2a(4)(b): 5.10.2011.“
Commission Implementing Regulation (EU) No 707/2012
Izvedbena uredba Komisije (EU) št. 707/2012
Council Regulation (EU) No 708/2012
Uredba Sveta (EU) št. 708/2012
amending Regulation (EU) No 267/2012 concerning restrictive measures against Iran
o spremembi Uredbe (EU) št. 267/2012 o omejevalnih ukrepih proti Iranu
Having regard to Council Decision 2010/413/CFSP of 26 July 2010 concerning restrictive measures against Iran [1],
ob upoštevanju Sklepa Sveta 2010/413/SZVP z dne 26. julija 2010 o omejevalnih ukrepih proti Iranu [1],
Council Regulation (EU) No 267/2012 [2] gives effect to the measures provided for in Decision 2010/413/CFSP.
Uredba Sveta (EU) št. 267/2012 [2] uveljavlja ukrepe iz Sklepa 2010/413/SZVP.
That Regulation provides for, inter alia, the freezing of all funds and economic resources belonging to, owned, held or controlled by the persons, entities and bodies listed in Annexes VIII and IX thereto.
Ta uredba določa, da se med drugim zamrznejo vsa sredstva in gospodarski viri, ki pripadajo, so v lasti ali s katerimi razpolagajo ali jih nadzirajo osebe, subjekti ali organi, navedeni v prilogah VIII in IX k Uredbi.
In order to clarify the criteria for listing persons, entities and bodies in Annex IX to that Regulation, an amendment to Article 23 is necessary.
Da se razjasnijo merila za vključitev na seznam oseb, subjektov in organov v Prilogo IX k navedeni uredbi, je treba spremeniti člen 23.
This Regulation falls within the scope of the Treaty on the Functioning of the European Union and regulatory action at the level of the Union is therefore necessary in order to implement it, in particular with a view to ensuring its uniform application by economic operators in all Member States.
Ta uredba spada na področje uporabe Pogodbe o delovanju Evropske unije, zato je za njeno izvajanje potreben regulativni ukrep na ravni Unije predvsem zaradi zagotovitve, da jo bodo gospodarski subjekti v vseh državah članicah enotno uporabljali.
Regulation (EU) No 267/2012 should therefore be amended accordingly.
Uredbo (EU) št. 267/2012 bi bilo treba zato ustrezno spremeniti.
In order to ensure that the measures provided for in this Regulation are effective, it should enter into force on the day of its publication,
Za zagotovitev, da so ukrepi iz te uredbe učinkoviti, bi morali začeti veljati z dnem objave Uredbe –
Article 23, point (e) of paragraph 2 of Regulation (EU) No 267/2012 is replaced by the following:
V členu 23(2) Uredbe (EU) št. 267/2012 se točka (e) nadomesti z naslednjim:
being a legal person, entity or body owned or controlled by the Islamic Republic of Iran Shipping Lines (IRISL), or a natural or legal person, entity or body acting on their behalf.’.
pravne osebe, subjekti ali organi, ki so v lasti ali pod nadzorom podjetja Islamic Republic of Iran Shipping Lines (IRISL), ali fizične ali pravne osebe, subjekti ali organi, ki delujejo v njegovem imenu.“
Council Implementing Regulation (EU) No 709/2012
Izvedbena uredba Sveta (EU) št. 709/2012
Having regard to Regulation (EU) No 267/2012 [1], and in particular Article 46(1) and (2) thereof,
ob upoštevanju Uredbe (EU) št. 267/2012 [1] in zlasti člena 46(1) in (2) Uredbe,
The Council considers that certain persons should be removed from the list of natural and legal persons, entities and bodies subject to restrictive measures set out in Annex IX to Regulation (EU) No 267/2012 and that the entries concerning certain entities should be amended.
Svet meni, da bi bilo treba nekatere osebe črtati s seznama fizičnih in pravnih oseb, subjektov in organov, za katere veljajo omejevalni ukrepi iz Priloge IX k Uredbi (EU) št. 267/2012, in da bi bilo treba spremeniti vnose glede nekaterih subjektov na tem seznamu.
Following the decision by the United Nations Security Council (UNSC) Committee established pursuant to UNSC Resolution 1737 (2006), two persons and one entity should be removed from the list set out in Annex IX to Regulation (EU) No 267/2012 and included in the list of natural and legal persons, entities and bodies subject to restrictive measures set out in Annex VIII to that Regulation.
V skladu s sklepom Odbora Varnostnega sveta Združenih narodov (VSZN), ki je bil ustanovljen v skladu z Resolucijo VSZN 1737 (2006), bi bilo treba dve osebi in en subjekt odstraniti s seznama v Prilogi IX k Uredbi (EU) št. 267/2012 in jih vključiti na seznam fizičnih in pravnih oseb, subjektov in organov, za katere se uporabljajo ukrepi iz Priloge VIII k navedeni uredbi.
The lists set out in Annexes VIII and IX to Regulation (EU) No 267/2012 should therefore be amended accordingly.
Seznama iz prilog VIII in IX k Uredbi (EU) št. 267/2012 bi bilo zato treba ustrezno spremeniti.
In order to ensure that the measures provided for in this Regulation are effective, it should enter into force on the day of its publication,
Da se zagotovi učinkovitost ukrepov iz te uredbe, bi morala ta uredba začeti veljati na dan objave –
The persons listed in Annex I to this Regulation shall be deleted from the list set out in Annex IX to Regulation (EU) No 267/2012.
Osebe, navedene v Prilogi I k tej uredbi, se črtajo s seznama iz Priloge IX k Uredbi (EU) št. 267/2012.
In Annex IX to Regulation (EU) No 267/2012, the entries concerning the entities referred to in Annex II to this Regulation shall be replaced by the entries set out in Annex II to this Regulation.
V Prilogi IX k Uredbi (EU) št. 267/2012 se vnosi za subjekte iz Priloge II k tej uredbi nadomestijo z vnosi iz Priloge II k tej uredbi.
The persons and entity listed in Annex III to this Regulation shall be deleted from the list set out in Annex IX to Regulation (EU) No 267/2012 and added to the list set out in Annex VIII to Regulation (EU) No 267/2012, as amended by the entries set out in Annex III to this Regulation.
Osebe in subjekti iz Priloge III k tej uredbi se črtajo s seznama iz Priloge IX k Uredbi (EU) št. 267/2012 in vključijo na seznam iz Priloge VIII k Uredbi (EU) št. 267/2012, kakor je spremenjena z vnosi iz Priloge III k tej uredbi.
Entry 3, No 11, 12th Street, Miremad Alley, Abbas Abad, Tehran
Entry 3, No 11, 12th Street, Abbas Abad, Teheran
Number 9/1, Ulitsa Mashkova, Moscow, 130064, Russia
Ulitsa Mashkova št. 9/1, Moskva 130064, Rusija
Alternative addr: Mashkova st. 9/1 Moscow 105062 Russia
; drugi naslov: Mashkova st. 9/1, Moskva 105062, Rusija
It has directly facilitated Iran’s nuclear efforts.
Neposredno podpira iranska jedrska prizadevanja.
For example, in 2011, Bank Tejarat facilitated the movement of tens of millions of dollars in an effort to assist the UN designated Atomic Energy Organisation of Iran’s ongoing effort to acquire yellowcake uranium.
Na primer, leta 2011 je Bank Tejarat omogočila prenos na desetine milijonov dolarjev v podporo Organizaciji za atomsko energijo (AEOI), uvrščeni na seznam OZN, za stalna prizadevanja Irana za pridobitev uranove rumene pogače.
Azim Aghajani (also spelled: Adhajani).
Azim AGHAJANI (tudi: Adhajani).
Function: Member of the IRGC-Qods Force operating under the direction of Qods Force Commander, Major General Qasem Soleimani, who was designated by the UN Security Council in Resolution 1747 (2007).
Položaj: član sil Qods IRGC, ki deluje pod poveljstvom komandanta majorja generala Qasema Soleimanija, ki je bil uvrščen na seznam Varnostnega sveta ZN v Resoluciji 1747 (2007).
Additional information: Nationality: Iran.
Dodatni podatki: državljanstvo: iransko.
Passport Number: 6620505, 9003213
Številka potnega lista: 6620505, 9003213.
Date of UN designation: 18 April 2012
Datum uvrstitve na seznam ZN: 18. april 2012.
Function: Member of the IRGC Qods Force operating under the direction of Qods Force Commander, Major General Qasem Soleimani, who was designated by the UN Security Council in Resolution 1747 (2007).
Položaj: član sil Qods IRGC, ki deluje pod poveljstvom komandanta majorja generala Qasema Soleimanija, ki je bil uvrščen na seznam Varnostnega sveta ZN v Resoluciji 1747 (2007).
Date of birth: 1967
Letnica rojstva: 1967.
Other information: An Iranian company that played a key role in Iran’s illicit transfer of arms to West Africa and acted on behalf of the IRGC Qods Force, commanded by Major General Qasem Soleimani, designated by the UN Security Council in Resolution 1747 (2007), as the shipper of the weapons consignment.
Druge informacije: iransko podjetje, ki je igralo ključno vlogo pri nezakonitem prenosu orožja v Zahodno Afriko in delovalo v imenu sil Qoods IRGC pod poveljstvom general-majorja Qasema Soleimanija, ki je bil uvrščen na seznam Varnostnega sveta ZN v Resoluciji 1747 (2007) kot špediter pošiljke orožja.
Additional information: Location: Tavakoli Building, Opposite of 15th Alley, Emam-Jomeh Street, Tehran, Iran
Dodatni podatki: lokacija: Tavakoli Building, Opposite of 15th Alley, Emam-Jomeh Street, Teheran, Iran
Telephone: +98 9195382305.
Telefon +98 9195382305.
Website: http://www.behinehco.ir
Spletna stran: htt://www.behinehco.ir
P.O.Box: 11365 - 5416, Tehran
P.O.Box: 11365 - 5416, Teheran;
Website: http://www.tejaratbank.ir
spletna stran: http://www.tejaratbank.ir
Tel.: 88826690
tel. 88826690,
Corrigendum to Council Implementing Regulation (EU) No 709/2012 of 2 August 2012 implementing Regulation (EU) No 267/2012 concerning restrictive measures against Iran
Popravek Izvedbene uredbe Sveta (EU) št. 709/2012 z dne 2. avgusta 2012 o izvajanju Uredbe (EU) št. 267/2012 o omejevalnih ukrepih proti Iranu
Page 4, Annex II, fifth entry (‘Bank Tejarat’), third column (‘Reasons’):
Stran 4, Priloga II, peti vnos („Bank Tejarat“), tretji stolpec („Razlogi“):
Commission Implementing Regulation (EU) No 710/2012
Izvedbena uredba Komisije (EU) št. 710/2012
Commission Implementing Regulation (EU) No 711/2012
Izvedbena uredba Komisije (EU) št. 711/2012
amending Regulation (EU) No 185/2010 laying down detailed measures for the implementation of the common basic standards on aviation security as regards the methods used for screening persons other than passengers and items carried
o spremembi Uredbe (EU) št. 185/2010 o določitvi podrobnih ukrepov za izvajanje skupnih osnovnih standardov za varnost letalstva glede metod, ki se uporabljajo za varnostni pregled oseb, razen potnikov, in njihovih osebnih predmetov
Commission Regulation (EC) No 272/2009 of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council [2] provides that the implementing rules to be adopted pursuant to Article 4(3) of Regulation (EC) No 300/2008 may allow the use of explosive trace detection (ETD) equipment and explosive detection dogs for screening persons other than passengers and items carried.
Uredba Komisije (ES) št. 272/2009 z dne 2. aprila 2009 o dopolnitvi skupnih osnovnih standardov na področju varovanja v civilnem letalstvu iz Priloge k Uredbi (ES) št. 300/2008 Evropskega parlamenta in Sveta [2] določa, da izvedbeni ukrepi, sprejeti v skladu s členom 4(3) Uredbe (ES) št. 300/2008, lahko dovoljujejo uporabo naprav za zaznavanje sledi eksplozivov (ETD) in psov za odkrivanje eksplozivov pri varnostnem pregledu oseb, razen potnikov, in njihovih osebnih predmetov.
It is necessary to adopt detailed provisions on the deployment of explosive trace detection (ETD) equipment and explosive detection dogs for screening persons other than passengers and items carried.
Sprejeti je treba podrobne določbe o uporabi naprav za zaznavanje sledi eksplozivov (ETD) in psov za odkrivanje eksplozivov pri varnostnem pregledu oseb, razen potnikov, in njihovih osebnih predmetov.
The use of explosive trace detection (ETD) equipment and explosive detection dogs for screening persons other than passengers and items carried should take into account the specific context of staff screening and can facilitate and improve the effectiveness of the screening process.
Pri uporabi naprav za zaznavanje sledi eksplozivov (ETD) in psov za odkrivanje eksplozivov pri varnostnem pregledu oseb, razen potnikov, in njihovih osebnih predmetov bi bilo treba upoštevati posebne okoliščine varnostnega pregleda osebja, poleg tega lahko takšna uporaba olajša in izboljša učinkovitost varnostnega pregleda.
The provisions relating to walk-through metal detection (WTMD) are laid down in Commission Regulation (EU) No 185/2010 of 4 March 2010 laying down detailed measures for the implementation of the common basic standards on aviation security [3] should be revised in line with the evolution of the threat to civil aviation and the risk posed by different categories of persons.
Določbe o prehodnem detektorju kovin (WTMD) iz Uredbe Komisije (EU) št. 185/2010 z dne 4. marca 2010 o določitvi podrobnih ukrepov za izvajanje skupnih osnovnih standardov za varnost letalstva [3] bi bilo treba revidirati v skladu z razvojem groženj za civilno letalstvo in tveganj, ki ga pomenijo različne kategorije ljudi.
Regulation (EU) No 185/2010 should therefore be amended accordingly.
Uredbo (EU) št. 185/2010 bi bilo zato treba ustrezno spremeniti.
Point 1.3.1 is replaced by the following:
točka 1.3.1 se nadomesti z naslednjim:
Persons other than passengers shall be screened by one of the following means:
Osebe razen potnikov se varnostno pregledajo z eno od naslednjih metod:
hand search;
ročno preiskavo;
walk-through metal detection equipment (WTMD);
prehodnim detektorjem kovin (WTMD);
explosive trace detection (ETD) equipment;
napravami za zaznavanje sledi eksplozivov (ETD);
security scanners which do not use ionising radiation.
varnostnimi skenerji, ki ne uporabljajo ionizirajočega sevanja.
Points 4.1.1.3 — 4.1.1.6 and 4.1.1.10 shall apply to the screening of persons other than passengers.
Za varnostni pregled oseb razen potnikov se uporabljajo točke 4.1.1.3–4.1.1.6 in 4.1.1.10.
Explosive detection dogs and ETD equipment may only be used as a supplementary means of screening or in unpredictable alternation with hand searches, WTMD or security scanners.
Psi za odkrivanje eksplozivov in naprave za zaznavanje sledi eksplozivov se lahko uporabljajo le kot dopolnilno sredstvo varnostnega pregleda ali pri nepredvidljivem izmenjevanju z ročnimi preiskavami, prehodnim detektorjem kovin ali varnostnimi skenerji.
Items carried by persons other than passengers shall be screened by one of the following means:
Osebni predmeti, ki jih nosijo osebe razen potnikov, se varnostno pregledajo z eno od naslednjih metod:
x-ray equipment;
rentgenskim aparatom;
explosive trace detection (ETD) equipment.
napravami za zaznavanje sledi eksplozivov (ETD).
Points 4.1.2.4 — 4.1.2.7 shall apply to the screening of items carried by persons other than passengers.
Točke 4.1.2.4–4.1.2.7 se uporabljajo za varnostni pregled osebnih predmetov, ki jih nosijo osebe razen potnikov.
Explosive detection dogs and ETD equipment may only be used as a supplementary means of screening or in unpredictable alternation with hand searches, x-ray equipment or EDS equipment.
Psi za odkrivanje eksplozivov in naprave za zaznavanje sledi eksplozivov se lahko uporabljajo le kot dopolnilno sredstvo varnostnega pregleda ali pri nepredvidljivem izmenjevanju z ročnimi preiskavami, rentgenskim aparatom ali sistemi za odkrivanje eksplozivov.
Articles listed in Attachment 4-C may be carried only if the person is authorised to do so in order to undertake tasks that are essential for the operation of airport facilities or of aircraft, or for performing in-flight duties.
Osebni predmeti iz Dodatka 4-C se lahko nosijo le, če je oseba za to pooblaščena, da tako izvaja opravila, ki so bistvenega pomena za delovanje letaliških objektov ali zrakoplovov ali opravljanje nalog med letom.
Where persons other than passengers and items carried have to be screened on a continuous random basis, the frequency shall be established by the appropriate authority on the basis of a risk assessment.
Kadar je treba osebe, razen potnikov, in njihove osebne predmete stalno naključno varnostno pregledovati, pogostost določi pristojni organ na podlagi ocene tveganja.
The screening of persons other than passengers and items carried shall also be subject to the additional provisions laid down in a separate Commission Decision.’
Varnostni pregled oseb, razen potnikov, in njihovih osebnih predmetov je prav tako predmet dodatnih določb iz ločenega sklepa Komisije.“;
Point 12.1.2 is replaced by the following:
točka 12.1.2 se nadomesti z naslednjim:
All WTMD exclusively used for screening persons other than passengers shall meet standard 1.
Vsi prehodni detektorji kovin, ki se uporabljajo izključno za varnostni pregled oseb razen potnikov, izpolnjujejo standard 1.
All WTMD used for screening of passengers shall meet standard 2.’
Vsi prehodni detektorji kovin, ki se uporabljajo za varnostni pregled potnikov, izpolnjujejo standard 2.“
Commission Regulation (EU) No 712/2012
Uredba Komisije (EU) št. 712/2012
amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
o spremembi Uredbe (ES) št. 1234/2008 o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini
Having regard to 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 [1], and in particular Article 27b thereof,
ob upoštevanju Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [1] in zlasti člena 27b Direktive,
Having regard to 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 [2], and in particular Article 23b(1) thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [2] in zlasti člena 23b(1) Direktive,
Having regard to 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], and in particular Article 16(4) and Article 41(6) thereof,
ob upoštevanju Uredbe (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] in zlasti členov 16(4) in 41(6) Uredbe,
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 [4], requires the Commission to adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with Directives 2001/82/EC and 2001/83/EC not yet covered by Commission Regulation (EC) No 1234/2008 [5].
Direktiva 2009/53/ES Evropskega parlamenta in Sveta z dne 18. junija 2009 o spremembi Direktive 2001/82/ES in Direktive 2001/83/ES v zvezi s spremembami pogojev dovoljenj za promet z zdravili [4] zahteva, da Komisija sprejme ustrezne dogovore za pregled sprememb pogojev dovoljenj za promet, izdanih v skladu z direktivama 2001/82/ES in 2001/83/ES, ki niso zajeti v Uredbi Komisije (ES) št. 1234/2008 [5].
It is therefore appropriate to extend the scope of Regulation (EC) No 1234/2008.
Zato je primerno razširiti področje uporabe Uredbe (ES) št. 1234/2008.