natgillin/translations-raw huggingface dataset:
- Direktive 2001/46/ES Evropskega parlamenta in Sveta z dne 23. julija 2001 o spremembi Direktive Sveta 95/53/ES o določitvi načel, ki urejajo organizacijo uradnega nadzora na področju prehrane živali, in direktiv 70/524/EGS, 96/25/ES in 1999/29/ES o prehrani živali
- Directive 2001/46/EC of the European Parliament and of the Council of 23 July 2001 amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition
UL L 234, 1.9.2001, str.
OJ L 234, 1.9.2001, p.
– Odločbe št. 676/2002/ES Evropskega parlamenta in Sveta z dne 7. marca 2002 o pravnem okviru za politiko radijskega spektra v Evropski skupnosti (Odločba o radijskem spektru)
– Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision)
- Direktive 2002/33/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2002 o spremembi direktiv Sveta 90/425/EGS in 92/118/EGS v zvezi z zdravstvenimi zahtevami za stranske živalske proizvode
- Directive 2002/33/EC of the European Parliament and of the Council of 21 October 2002 amending Council Directives 90/425/EEC and 92/118/EEC as regards health requirements for animal by-products
UL L 315, 19.11.2002, str.
OJ L 315, 19.11.2002, p.
- Direktive 2004/3/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o spremembah direktiv Sveta 70/156/EGS in 80/1268/EGS glede merjenja emisij ogljikovega dioksida in porabe goriva vozil kategorije N1
- Directive 2004/3/EC of the European Parliament and of the Council of 11 February 2004 amending Council Directives 70/156/EEC and 80/1268/EEC as regards the measurement of carbon dioxide emissions and fuel consumption of N1 vehicles
- Direktive 2004/41/ES Evropskega parlamenta in Sveta z dne 21. aprila 2004 o razveljavitvi nekaterih direktiv o higieni živil in zdravstvenih pogojih za proizvodnjo in dajanje na trg nekaterih proizvodov živalskega izvora, namenjenih za prehrano ljudi, in o spremembi direktiv Sveta 89/662/EGS in 92/118/EGS in Odločbe Sveta 95/408/ES
- Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC
UL L 195, 2.6.2004, str.
OJ L 195, 2.6.2004, p.
- Direktive 2005/33/ES Evropskega parlamenta in Sveta z dne 6. julija 2005 o spremembi Direktive 1999/32/ES glede deleža žvepla v gorivih za plovila
- Directive 2005/33/EC of the European Parliament and of the Council of 6 July 2005 amending Directive 1999/32/EC as regards the sulphur content of marine fuels
- Direktive 2005/64/ES Evropskega parlamenta in Sveta z dne 26. oktobra 2005 o homologaciji motornih vozil glede na njihovo ponovno uporabnost, možnost recikliranja in predelave ter o spremembi Direktive Sveta 70/156/EGS
- Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC
UL L 310, 25.11.2005, str.
OJ L 310, 25.11.2005, p.
- Direktive 2006/40/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o emisijah iz klimatskih naprav v motornih vozilih in spremembi Direktive Sveta 70/156/EGS
- Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air-conditioning systems in motor vehicles and amending Council Directive 70/156/EEC
UL L 161, 14.6.2006, str.
OJ L 161, 14.6.2006, p.
– Uredbe Sveta (ES) št. 1083/2006 z dne 11. julija 2006 o splošnih določbah o Evropskem skladu za regionalni razvoj, Evropskem socialnem skladu in Kohezijskem skladu in razveljavitvi Uredbe (ES) št. 1260/1999
– Council Regulation (EC) No 1083/2006 of 11 July 2006 laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund and repealing Regulation (EC) No 1260/1999
- Uredbe (ES) št. 1905/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o vzpostavitvi instrumenta za financiranje razvojnega sodelovanja
- Regulation (EC) No 1905/2006 of the European Parliament and of the Council of 18 December 2006 establishing a financing instrument for development cooperation
Po prilagoditvi 26 prednostnih aktov ter pregledu obstoječe zakonodaje in postopkov, ki so v teku
Following the alignment of 26 priority acts, as well as the screening of the existing legislation and on-going procedures
KOM(2007)0740 . , je Evropska komisija predstavila nekaj predlogov, po katerem se novemu regulativnemu postopku s pregledom prilagodi skupaj 225 zakonodajnih aktov.
COM(2007)0740 . , the European Commission presented a number of proposals, covering all together 225 legislative acts to be adapted to the new regulatory procedure with scrutiny (RPS).
Konferenca predsednikov je v sklepu z dne 12. decembra 2007 Odbor za pravne zadeve načeloma imenovala za glavni odbor za prilagoditve s komitologijo, medtem ko so bili področni odbori imenovani za odbore za mnenja (pri imenovanju odborov za akte iz drugega dela seznama 2 v sporočilu Komisije KOM(2007)0740 je konferenca ravnala obratno.
In its decision of 12 December 2007 the Conference of Presidents designated in principle the Committee on Legal Affaires as the lead Committee to deal with this 'comitology alignment' and the specialized committees as opinion-giving committees (with the inverse designation for acts making up second part of List 2 in the Commission Communication COM(2007)0740 ).
Poročevalec je drugim odborom predlagal, da se čim hitreje določijo paketi za prilagoditev, da bi se regulativni postopek s pregledom lahko začel uporabljati za obstoječi pravni red Skupnosti še pred začetkom veljavnosti lizbonske pogodbe (v kateri člen 290 Pogodbe o delovanju Evropske unije vsebuje pomembne določbe o „delegiranih aktih“, ki bodo nadomestili regulativni postopek s pregledom in za sprejetje katerih – s soodločanjem –bo treba več časa).
The Rapporteur proposed to other committees that the alignment packages should be adopted as soon as possible, in order for the RPS procedure to start applying to the existing acquis before the entry into force of the Treaty of Lisbon (where Article 290 of the Treaty on the functioning of the European Union contains important provisions on ‘delegated acts’, which will replace RPS, but which will take time to be adopted via codecision).
Nato so štiri poročila o t.i. predlogih omnibus ter poročila, ki so obravnavala predloge za prenovitev, vsebovala omejeno število predlogov sprememb, ki so jih drugi odbori predlagali v svojih mnenjih in so bili prejeti v obliki pisem.
Subsequently, four Reports on the so-called Omnibus proposals, as well as those dealing with recast proposals, contained a limited number of amendments that were suggested by other committees in their opinions, received mostly in form of letters.
Pred končnim glasovanjem na plenarnem zasedanju je bilo predstavljenih nekaj tehničnih predlogov sprememb, katerih namen je bil pojasniti nekatere določbe, ki sta jih izbrala Parlament ali Svet.
A number of technical amendments, aiming at clarification of some provisions identified by the Parliament or the Council, have been proposed before the final vote in plenary.
Poročevalec je tudi predlagal, da se za veljavne akte, ki niso zajeti v obstoječih predlogih Komisije za prilagoditev in vsebujejo določbe o komitologiji, ki sodijo pod regulativni postopek s pregledom, izdela in čimprej sprejme INI poročilo, kot to določa člen 192 PES.
The Rapporteur also proposed that any legal acts in force that were not covered by the Commission existing proposals for alignment and that contain comitology provisions falling under the RPS procedure shall be subject to an INI Report based on Article 192 TEC, to be adopted as soon as possible.
Akti, ki so jih določili razni parlamentarni odbori, so navedeni v prilogi k temu poročilu.
The acts identified by various Parliament committees are shown in the Annex to this Report.
Glede na kompromise, ki bodo morebiti potrebni v okviru posameznih predlogov omnibus, je treba zahtevati, da Komisija obstoječe predloge dopolni z novimi in začne z obravnavo izbranih pravnih aktov, ki še niso bili obravnavani, obenem pa zahtevati, da Komisija jasno izjavi, da potekajoča prilagoditev nikakor ne bi smela predstavljati precedenčnega primera za prihodnje prilagoditve pravnega reda Skupnosti ustreznim določbam lizbonske pogodbe.
Moreover, in view of the compromises that might be necessary within each of the Omnibus proposals, it is not only necessary to ask the Commission to supplement its existing proposals with new ones, addressing the identified legal acts that were not treated so far, but also to express clearly that the present alignment should not in any way constitute a precedent for the future alignment of acquis to the relevant provisions of the Lisbon Treaty.
Primer takšne situacije je Direktiva 2005/36/ES o priznavanju poklicnih kvalifikacij
An example for such a situation is Directive 2005/36 on the recognition of professional qualifications
22. (pravni akt, obravnavan pod točko 7.1 omnibusa 1
22. (legal act treated under point 7.1 of Omnibus 1
KOM(2007)0741 . ), in sicer njen člen 61, v zvezi s katerim je Parlament menil, da bi moral veljati regulativni postopek s pregledom, ob upoštevanju, da bo splošno odstopanje za eno od držav članic pomenilo ukrep splošnega dosega (zaradi njegovih učinkov na zainteresirane strani iz drugih držav članic)
COM(2007)0741 . ), for the Article 61 of which the Parliament considered that RPS should apply, taking into account that a general derogation for any Member State will constitute a measure of general scope (because of its effects on any interested party from any other Member State)
Po nadaljnjih razpravah med institucijami je Parlament ob upoštevanju razmisleka, da bi z zadevnimi odstopanji temeljni akt izvajali (in ne spreminjali), za ta člen sprejel standardni regulativni postopek.
Following further discussion between the institutions, Parliament accepted standard regulatory procedure in this article, on the basis of consideration that the derogations in question would implement (and not amend) the basic act.
Komisija je predlagala izjavo o prihodnjem pregledu direktive 2005/36, Parlament pa bi si moral pridržati pravico zakonodajalca, da v omenjeni direktivi spremeni določbe o komitologiji, ko bo ta prilagojena lizbonski pogodbi.
The Commission proposed a declaration addressing future review of the Directive 2005/36, and the Parliament should reserve itself the legislature's right to modify this directive's comitology provisions at the time of alignment to the Lisbon Treaty.
Komisija bi morala predstaviti ustrezne zakonodajne predloge za vse akte, ki iz kateregakoli razloga niso bili ustrezno in pravočasno prilagojeni regulativnemu postopku s pregledom, pa tudi konkretne predloge za prilagoditev celotnega pravnega reda Skupnosti lizbonski pogodbi (glede na člen 290 Pogodbe o delovanju Evropske unije o delegiranih aktih in na uredbo o „izvedbenih aktih“ iz člena 291).
Lastly, the Commission should present legislative proposals adequate for all acts that for any reasons are not properly aligned to RPS in due time, as well as concrete proposals to align the whole acquis to the Treaty of Lisbon (as regards Article 290 of the Treaty on the functioning of the European Union on delegated acts and the Regulation concerning the ‘implementing acts’ dealt with by Article 291).
o predlogu Direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/82/ES in Direktive 2001/83/ES v zvezi s spremembami pogojev dovoljenj za promet z zdravili
on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products
MNENJE Odbora za kmetijstvo in razvoj podeželja .......................................19
OPINION of the Committee on Agriculture and Rural Development ...20
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0123 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0123 ),
– ob upoštevanju člena 251(2) in člena 95 Pogodbe o ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0137/2008 ),
– having regard to Articles 251(2) and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0137/2008 ),
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenja Odbora za kmetijstvo in razvoj podeželja ( A6-0346/2008 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development ( A6‑0346/2008 ),
(6) Zaradi javnega zdravja, pravne doslednosti in predvidljivosti za nosilce gospodarskih dejavnosti morajo za vse vrste dovoljenj za promet veljati usklajena pravila.
(6) For reasons of public health, legal consistency and predictability for economic operators, variations to all types of marketing authorisations should be subject to harmonised rules.
(6) Zaradi javnega zdravja, pravne doslednosti , zmanjšanja upravnega bremena in povečanja predvidljivosti za nosilce gospodarskih dejavnosti morajo za vse vrste dovoljenj za promet veljati usklajena pravila.
(6) For reasons of public health, legal consistency , reducing the administrative burden and strengthening predictability for economic operators, variations to all types of marketing authorisations should be subject to harmonised rules.
(6a) Možnost, da se vloži ena sama zahteva za eno ali več enakih sprememb različnih dovoljenj za promet z zdravili, je treba razširiti na vse vrste sprememb, zato da se poenostavi in optimizira postopke.
(6 a ) The possibility of filing a single application for one or more identical changes to the terms of a number of marketing authorisations must be extended to all the types of change in order to simplify and optimise the procedure s.
Pomembno je možnost vložitve ene zahteve za eno ali več enakih sprememb različnih dovoljenj za promet z zdravili, ki jih je odobril isti pristojni organ, razširiti na druge kategorije sprememb.
It is important to extend to the other categories of change this possibility of submitting a single application for one or more identical changes made to the terms of several marketing authorisations granted by the same competent authority.
Ta sistem bi zelo zmanjšal upravno breme, olajšal obravnavo zahtev ter bi s hkratno uporabo sprejetih sprememb koristil bolnikom.
This system would lighten the administrative burden considerably, facilitate consideration of applications and benefit patients by the simultaneous implementation of accepted changes.
(6b) Veljavne upravne postopke, določene v Uredbi (ES) št. 1084/2003 in Uredbi Komisije (ES) št. 1085/2003 z dne 3. junija 2003 o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93 1 (uredbi o spremembah), je treba ponovno pregledati in se zlasti osredotočiti na njihovo poenostavitev.
(6 b ) It is necessary to revisit current administrative procedures as laid down in Regulation (EC) No 1084/2003 and Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 1 (Variations Regulations), with a focus, in particular, on simplifying administrative procedures.
(6c) V zvezi z razširitvijo dovoljenja za promet bi bilo treba na podlagi utemeljitve dati možnost, da se predloži popolno in jasno vlogo za pridobitev dovoljenja za promet z zdravilom, ki je že odobreno, vendar pod drugim imenom in z drugačnim povzetkom značilnosti proizvoda.
(6 c ) As regards extensions of marketing authorisations, the possibility should be left open, on the basis of arguments presented, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary.
V sedanjem sistemu uredbi (ES) št. 10/84/2003 (uvodna izjava 8) in št. 1085/2003 (uvodna izjava 6) predvidevata, da se za razširitev dovoljenja za promet z zdravilom predloži popolno in jasno vlogo za zdravilo, ki je že odobreno, vendar pod drugim imenom in z drugačnim povzetkom značilnosti proizvoda.
Under the current system, Regulations (EC) No 1084/2003 (recital 8) and No 1085/2003 (recital 6) provide for the possibility, in the case of an extension of a marketing authorisation, of filing a complete, separate request for authorisation for a medicinal product that has already been authorised, but under another name and with a different product characteristic summary.
To možnost je treba ohraniti.
It is essential that this possibility should be retained.
Nekatera imena zdravil so zelo povezana z določeno boleznijo, zato bi lahko bilo škodljivo za bolnika, če bi bilo treba ohraniti isto ime za drugačno bolezen.
Some names of medicines have strong associations to a certain pathology, and it could have a damaging effect on patients if the same name were kept when the pathology treated by the medicine had changed completely.
Direktiva 2001/82/ES
Directive 2001/82/EC
(1) Člen 10(3) se nadomesti z naslednjim:
(1) Article 10(3) is replaced by the following:
Z odstopanjem od člena 11 Komisija sestavi seznam snovi, ki so bistvenega pomena za zdravljenje kopitarjev in za katere je karenca najmanj šest mesecev v skladu z nadzornimi mehanizmi iz odločb Komisije 93/623/EGS in 2000/68/ES.
By way of derogation from Article 11, the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Decisions 93/623/EEC and 2000/68/EC.
Navedeni ukrep, ki je namenjen spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“
This measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Edini namen predlogov sprememb (6-16), ki so zgolj pravne narave, je uskladitev Direktive 2001/82/ES z ustreznim postopkom komitologije (regulativnim postopkom s pregledom).
The amendments concerned here (6-16), which are of a purely legal nature, are intended solely to bring Directive 2001/82/EC into line with the relevant new comitology procedure (the regulatory procedure with scrutiny).
Na tem mestu so torej odveč in bi jih bilo smiselno črtati.
They should therefore be deleted.
Člen 11 – odstavek 2 – pododstavek 3
Article 11 – paragraph 2 - subparagraph 3
(2) V členu 11(2) se tretji pododstavek nadomesti z naslednjim besedilom:
(2) In Article 11(2), the third subparagraph is replaced by the following:
„Vendar lahko Komisija spremeni te posamezne karence.
“However, the Commission may modify these specific withdrawal periods.
Navedeni ukrepi za spremembo nebistvenih določb te direktive se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Člen 13 – odstavek 1 – pododstavek 4
Article 13 – paragraph 1 - subparagraph 4
(3) V členu 13(1) se četrti pododstavek nadomesti z naslednjim besedilom:
(3) In Article 13(1), the fourth subparagraph is replaced by the following:
„Vendar se desetletno obdobje iz drugega pododstavka podaljša na 13 let v primeru zdravil za uporabo v veterinarski medicini za ribe ali čebele ali druge vrste, ki jih določi Komisija.
“However, the ten-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated by the Commission.
Navedeni ukrep, ki je namenjen spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“
That measure designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Člen 17 – odstavek 1 – pododstavek 2
Article 17 – paragraph 1 - subparagraph 2
(17) V členu 17(1) se drugi pododstavek nadomesti z naslednjim:
(4) In Article 17(1), the second subparagraph is replaced by the following:
„Če je utemeljeno v smislu novih znanstvenih dokazov, lahko Komisija prilagodi točki (b) in (c) prvega pododstavka.
“If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph.
Člen 50 a – odstavek 2
Article 50a – paragraph 2
(7) Člen 50a(2) se nadomesti z naslednjim:
(7) Article 50a (2) is replaced by the following:
Komisija sprejme vse spremembe, potrebne za prilagoditev določb iz odstavka 1 zaradi upoštevanja znanstvenega in tehničnega napredka.
The Commission shall adopt any amendments which may be necessary to adapt the provisions of Paragraph 1 to take account of scientific and technical progress.
Navedeni ukrepi za spremembo nebistvenih določb te direktive se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“
Those measures, designed to amend non-essential elements of this directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Člen 51 – odstavek 1
Article 51 - paragraph 1
(8) V členu 51 se prvi pododstavek nadomesti z naslednjim:
(8) In Article 51, the first subparagraph is replaced by the following:
„Načela in smernice dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini iz člena 50(f) sprejme Komisija v obliki direktive, naslovljene na države članice.
“The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States.
Navedeni ukrepi za spremembo nebistvenih določb te direktive z njeno dopolnitvijo se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“
Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).”
Člen 67 – točka a a
Article 67 – point a a
(9) V členu 67 se točka (aa) nadomesti z naslednjim:
(9) In Article 67, point (aa) is replaced by the following:
„(aa) zdravila za uporabo v veterinarski medicini za živali za proizvodnjo hrane.
“(aa) veterinary medicinal products for food-producing animals.
Vendar lahko države članice odobrijo izjeme od te zahteve glede na merila, ki jih določi Komisija.
However, Member States may grant exemptions from this requirement according to criteria established by the Commission.
Določitev navedenih meril, ki je ukrep, namenjen spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).
The establishment of those criteria, a measure designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).
Države članice lahko še naprej uporabljajo nacionalne predpise do:
Member States may continue to apply national provisions until either:
– datuma začetka uporabe sklepa, sprejetega v skladu s prvim pododstavkom; ali
– the date of application of the decision adopted in accordance with the first subparagraph; or