natgillin/translations-raw huggingface dataset:
- Директива 2001/43/EО на Европейския парламент и на Съвета от 27 юни 2001 година за изменение на Директива на Съвета 92/23/ЕИО относно гумите за моторни превозни средства и техните ремаркета и техния монтаж
- Directive 2001/43/EC of the European Parliament and of the Council of 27 June 2001 amending Council Directive 92/23/EEC relating to tyres for motor vehicles and their trailers and to their fitting
- Директива 2001/46/ЕО на Европейския парламент и на Съвета от 23 юли 2001 година за изменение на Директива 95/53/ЕО на Съвета относно определяне на принципите, ръководещи организацията на официалните инспекции в областта на храненето на животни и Директиви 70/524/ЕИО, 96/25/ЕО и 1999/29/ЕО за храненето на животни
- 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
– Решение № 676/2002/EО на Европейския парламент и на Съвета от 7 март 2002 година относно регулаторната рамка за политиката на Европейската общност в областта на радиочестотния спектър (Решение за радиочестотния спектър)
– 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)
- Директива 2002/33/EО на Европейския парламент и на Съвета от 21 октомври 2002 година за изменение на Директиви 90/425/ЕИО и 92/118/ЕИО на Съвета по отношение на ветеринарно-санитарните изисквания към страничните животински продукти
- 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
- Директива 2004/3/EО на Европейския парламент и на Съвета от 11 февруари 2004 година за изменение на Директиви 70/156/ЕИО и 80/1268/ЕИО на Съвета относно измерването на емисиите от въглероден двуокис и на разхода на гориво на моторните превозни средства от категория 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
- Директива 2004/41/ЕО на Европейския парламент и на Съвета от 21 април 2004 година за отмяна на някои директиви, отнасящи се до хигиената на храните и здравните условия при производството и пускането на пазара на някои продукти от животински произход, предназначени за консумация от човека, и за изменение на Директиви 89/662/ЕИО и 92/118/ЕИО на Съвета и на Решение 95/408/ЕО на Съвета
- 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
- Директива 2005/33/EО на Европейския парламент и на Съвета от 6 юли 2005 година за изменение на Директива 1999/32/ЕО по отношение на нивото на съдържание на сяра в корабните горива
- 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
- Директива 2005/64/EО на Европейския парламент и на Съвета от 26 октомври 2005 година относно типовото одобрение на моторни превозни средства по отношение на възможната им повторна употреба, рециклиране и оползотворяване и относно изменение на Директива 70/156/ЕИО на Съвета
- 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
- Директива 2006/40/EО на Европейския парламент и на Съвета от 17 май 2006 година относно емисиите на климатични системи в моторни превозни средства и за изменение на Директива 70/156/ЕИО на Съвета
- 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
OВ L 161, 14.06.2006 г., стp.
OJ L 161, 14.6.2006, p.
– Регламент (ЕО) № 1083/2006 на Съвета от 11 юли 2006 година относно определянето на общи разпоредби за Европейския регионален фонд, Европейския социален фонд и Кохезионния фонд и за отмяна на Регламент (EO) № 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
- Регламент (ЕО) № 1905/2006 на Европейския парламент и на Съвета от 18 декември 2006 година за създаване на финансов инструмент за развитие на сътрудничеството
- Regulation (EC) No 1905/2006 of the European Parliament and of the Council of 18 December 2006 establishing a financing instrument for development cooperation
Following the alignment of 26 priority acts, as well as the screening of the existing legislation and on-going procedures
Following the alignment of 26 priority acts, as well as the screening of the existing legislation and on-going procedures
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).
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).
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 ) .
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 ).
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).
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).
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.
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.
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.
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.
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.
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.
The acts identified by various Parliament committees are shown in the Annex to this Report.
The acts identified by various Parliament committees are shown in the Annex to this Report.
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.
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.
An example for such a situation is Directive 2005/36 on the recognition of professional qualifications
An example for such a situation is Directive 2005/36 on the recognition of professional qualifications
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)
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)
vide jurisprudence of the Court of Justice: Case C-168/93, Government of Gibraltar and Gibraltar Development Corporation v Council [1993] ECR I-4009, paragraph 13; Joined Cases 103/78 to 109/78, Société des Usines de Beauport v Council [1979] ECR 17, paragraphs 15 to 19. .
vide jurisprudence of the Court of Justice: Case C-168/93, Government of Gibraltar and Gibraltar Development Corporation v Council [1993] ECR I-4009, paragraph 13; Joined Cases 103/78 to 109/78, Société des Usines de Beauport v Council [1979] ECR 17, paragraphs 15 to 19. .
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.
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.
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.
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.
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).
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).
Marek Aleksander Czarnecki, Bert Doorn, Monica Frassoni, Lidia Joanna Geringer de Oedenberg, Othmar Karas, Piia-Noora Kauppi, Klaus-Heiner Lehne, Katalin Lévai, Antonio Masip Hidalgo, Hans-Peter Mayer, Manuel Medina Ortega, Hartmut Nassauer, Aloyzas Sakalas, Francesco Enrico Speroni, Daniel Strož, Rainer Wieland, Jaroslav Zvěřina, Tadeusz Zwiefka
Marek Aleksander Czarnecki, Bert Doorn, Monica Frassoni, Lidia Joanna Geringer de Oedenberg, Othmar Karas, Piia-Noora Kauppi, Klaus-Heiner Lehne, Katalin Lévai, Antonio Masip Hidalgo, Hans-Peter Mayer, Manuel Medina Ortega, Hartmut Nassauer, Aloyzas Sakalas, Francesco Enrico Speroni, Daniel Strož, Rainer Wieland, Jaroslav Zvěřina, Tadeusz Zwiefka
Vicente Miguel Garcés Ramón, Jean-Paul Gauzès, Georgios Papastamkos, Gabriele Stauner, József Szájer, Jacques Toubon, Ieke van den Burg
Vicente Miguel Garcés Ramón, Jean-Paul Gauzès, Georgios Papastamkos, Gabriele Stauner, József Szájer, Jacques Toubon, Ieke van den Burg
PE 409.420v02-00
PE 409.420v02-00
СТАНОВИЩЕ на комисията по земеделие и развитие на селските райони Error!
OPINION of the Committee on Agriculture and Rural Development ...20
– като взе предвид предложението на Комисията до Европейския парламент и до Съвета ( COM(2008)0123 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0123 ),
– като взе предвид член 251, параграф 2 и член 95 от Договора за ЕО, съгласно които предложението е внесено от Комисията ( 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 ),
– като взе предвид доклада на комисията по околна среда, обществено здраве и безопасност на храните и становището на комисията по земеделие и развитие на селските райони ( 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) От съображения, свързани с общественото здраве, правната съвместимост и предсказуемостта за икономическите оператори, измененията във всички видове разрешителни за пускане на пазара следва да бъдат предмет на хармонизирани правила.
(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) От съображения, свързани с общественото здраве, правната съвместимост , намаляването на административната тежест и засилването на предсказуемостта за икономическите оператори, измененията във всички видове разрешителни за пускане на пазара следва да бъдат предмет на хармонизирани правила.
(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.
(6а) Възможността за подаване на единно заявление за едно или повече идентични изменения на условията на няколко разрешителни за пускане на пазара трябва да се разшири, така че да обхване всички видове промени, с цел опростяване и оптимизиране на процедурите.
(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.
Възможността за подаване на единно заявление за едно или повече идентични изменения на условията на няколко разрешителни за пускане на пазара, дадени от един и същ компетентен орган, е важно да се разшири и за други категории изменения.
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.
Тази система ще олекоти значително административната тежест, ще улесни разглеждането на заявленията и ще облагодетелства пациентите чрез едновременното прилагане на приетите изменения.
This system would lighten the administrative burden considerably, facilitate consideration of applications and benefit patients by the simultaneous implementation of accepted changes.
(6б) Необходимо е отново да бъдат разгледани действащите административни процедури, предвидени в Регламент (ЕО) № 1084/2003 и в Регламент (ЕО) № 1085/2003 на Комисията от 3 юни 2003 година относно проучване на измененията в условията на разрешителните за търговия с лекарствени продукти за хуманна употреба и ветеринарни лекарствени продукти, попадащи в обхвата на Регламент (ЕИО) № 2309/93 на Съвета (регламенти за измененията), по-специално с оглед опростяването на тези процедури.
(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.
1 ОВ L 159, 27.6.2003 г., стр.24.
1 OJ L 159, 27.6.2003, p.24.
Съображение 6 в (ново)
Recital 6 c (new)
(6в) По отношение на разширяването на обхвата на разрешителните за пускане на пазара следва да се предостави възможност, въз основа на предоставена обосновка, за подаване на отделно, пълно заявление за разрешение за лекарствен продукт, който вече е получавал разрешение под друго наименование и с различно обобщение на характеристиките на продукта.
(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.
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.
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.
It is essential that this possibility should be retained.
It is essential that this possibility should be retained.
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.
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.
Директива 2001/82/EО
Directive 2001/82/EC
(1) Член 10, параграф 3 се заменя със следния текст:
(1) Article 10(3) is replaced by the following:
Чрез дерогация от член 11 Комисията изготвя списък на веществата, които са съществено необходими за лечението на нечифтокопитни животни и за които карентният срок не трябва да бъде по-малък от шест месеца, съгласно мерките за контрол, определени в Решения 93/623/ЕИО и 2000/68/ЕО.
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.
Тази мярка, предназначена да измени несъществени елементи на настоящата директива, като я допълва, се приема в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.“
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).”
Тези изменения (6-16№, които са от чисто правно естество, имат за цел единствено Директива 2001/82/ЕО да бъде приведена в съответствие с относимата нова процедура по комитология (процедура по регулиране с контрол).
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).
Те не са пряко свързани с предмета на предложението, т.е. измененията на разрешителните за пускане на пазара.
They are not directly related to the subject of the proposal, that is to say, changes to marketing authorisations.
Освен това те вече са налице във „всеобхватното“ предложение на Комисията ( COM(2008)0071 – 2008/0032(COD) ) и вследствие на това не са необходими в настоящото предложение.
They already appear, moreover, in the Commission’s ‘all-inclusive’ proposal ( COM(2008)0071 – 2008/0032(COD) ) and are consequently redundant in this proposal.
Затова те следва да се заличат.
They should therefore be deleted.
Член 11 – параграф 2 – алинея 3
Article 11 – paragraph 2 - subparagraph 3
„Въпреки това Комисията може да променя тези специфични карентни периоди.
“However, the Commission may modify these specific withdrawal periods.
Тези мерки, предназначени да изменят несъществени елементи на настоящата директива, се приемат в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.“
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).”
Член 13 – параграф 1 – алинея 4
Article 13 – paragraph 1 - subparagraph 4
„Въпреки това при ветеринарни лекарствени продукти за риба и пчели или за други животински видове, определени от Комисията, десетгодишният срок, предвиден в алинея втора, се удължава до 13 години.
“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.
Тази мярка, предназначена да измени несъществени елементи на настоящата директива, като я допълва, се приема в съответствие с процедурата по регулиране с контрол, посочена в член 89, параграф 2а.“
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).”
Член 17 – параграф 1 – алинея 2
Article 17 – paragraph 1 - subparagraph 2
„Ако се счита за обосновано в светлината на нови научни доказателства, Комисията може да адаптира точки б) и в) от алинея първа.
“If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph.
Член 50 а – параграф 2
Article 50a – paragraph 2