natgillin/translations-raw huggingface dataset:
B. whereas the agreement foresaw the setting up of a directorate for the implementation of police force restructuring, with representatives from all levels of authority (state, entity and cantons), whose task would be to submit a proposal for the implementation of the reform, including the demarcation of the new territorial units,
B. whereas the agreement foresaw the setting up of a directorate for the implementation of police force restructuring, with representatives from all levels of authority (state, entity and cantons), whose task would be to submit a proposal for the implementation of the reform, including the demarcation of the new territorial units,
C. whereas the directorate should have submitted its proposals by 30 September 2006, a deadline which it failed to respect, given that the representatives of the Republika Srpska refused to cooperate further on this issue,
C. whereas the directorate should have submitted its proposals by 30 September 2006, a deadline which it failed to respect, given that the representatives of the Republika Srpska refused to cooperate further on this issue,
D. whereas during the campaign the Republika Srpska leadership repeatedly issued statements which questioned the proposed police reform and the agreement reached by the parties in October last year,
D. whereas during the campaign the Republika Srpska leadership repeatedly issued statements which questioned the proposed police reform and the agreement reached by the parties in October last year,
E. whereas the Parliament of Bosnia and Herzegovina failed by only two votes to reach the qualified majority required for the adoption of the constitutional amendments agreed by the main political parties,
E. whereas the Parliament of Bosnia and Herzegovina failed by only two votes to reach the qualified majority required for the adoption of the constitutional amendments agreed by the main political parties,
F. whereas the main opponent of the 'no' vote was elected President of Bosnia and Herzegovina,
F. whereas the main opponent of the 'no' vote was elected President of Bosnia and Herzegovina,
G. whereas during the election campaign representatives of the Republika Srpska called for an independence referendum, should the negotiations on the future status of Kosovo result in a legal and territorial separation from Serbia,
G. whereas during the election campaign representatives of the Republika Srpska called for an independence referendum, should the negotiations on the future status of Kosovo result in a legal and territorial separation from Serbia,
H. whereas the decision to close down the Office of the High Representative could have an impact on the pace of the administrative and constitutional reforms, which are an essential prerequisite for the country's European integration process,
H. whereas the decision to close down the Office of the High Representative could have an impact on the pace of the administrative and constitutional reforms, which are an essential prerequisite for the country's European integration process,
I. whereas the election campaign confirmed the persistence of strong ethnic divisions within Bosnia and Herzegovina and the need for a more integrated, non-segregationist, modern education system in the country,
I. whereas the election campaign confirmed the persistence of strong ethnic divisions within Bosnia and Herzegovina and the need for a more integrated, non-segregationist, modern education system in the country,
Addresses the following recommendations to the Council:
Addresses the following recommendations to the Council:
(a) welcomes the Council's call for the new governments to be formed quickly, so as to allow the rapid resumption of legislative activity;
(a) welcomes the Council's call for the new governments to be formed quickly, so as to allow the rapid resumption of legislative activity;
(b) invites the Council, through the good offices of the EU Special Representative, to relaunch the talks on much-needed constitutional reform in Bosnia and Herzegovina;
(b) invites the Council, through the good offices of the EU Special Representative, to relaunch the talks on much-needed constitutional reform in Bosnia and Herzegovina;
(c) urges the Council to exert pressure on the Government of the Republika Srpska to recommit to the work of the directorate for police reform implementation and to remind all parties that police force restructuring is a key prerequisite for the conclusion of the Stabilisation and Association Agreement;
(c) urges the Council to exert pressure on the Government of the Republika Srpska to recommit to the work of the directorate for police reform implementation and to remind all parties that police force restructuring is a key prerequisite for the conclusion of the Stabilisation and Association Agreement;
Instructs its President to forward this recommendation to the General Affairs Council and, for information, to the Commission, the EU Special Representative/High Representative for Bosnia and Herzegovina and the governments of Bosnia and Herzegovina, the Republika Srpska and the Federation of Bosnia and Herzegovina.
Instructs its President to forward this recommendation to the General Affairs Council and, for information, to the Commission, the EU Special Representative/High Representative for Bosnia and Herzegovina and the governments of Bosnia and Herzegovina, the Republika Srpska and the Federation of Bosnia and Herzegovina.
Proposal for a European Parliament recommendation to the Council on Bosnia–Herzegovina
Proposal for a European Parliament recommendation to the Council on Bosnia–Herzegovina
Proposal(s) for recommendation(s) considered
Proposal(s) for recommendation(s) considered
AFET 12.2.2007
AFET 12.2.2007
Doris Pack 28.11.2006
Doris Pack 28.11.2006
Roberta Alma Anastase, Panagiotis Beglitis, Bastiaan Belder, Marco Cappato, Philip Claeys, Véronique De Keyser, Bronisław Geremek, Maciej Marian Giertych, Ana Maria Gomes, Klaus Hänsch, Jana Hybášková, Anna Ibrisagic, Ioannis Kasoulides, Bogdan Klich, Helmut Kuhne, Joost Lagendijk, Vytautas Landsbergis, Eugen Mihaescu, Emilio Menéndez del Valle, Willy Meyer Pleite, Francisco José Millán Mon, Pasqualina Napoletano, Annemie Neyts-Uyttebroeck, Baroness Nicholson of Winterbourne, Raimon Obiols i Germà, Vural Öger, Justas Vincas Paleckis, Ioan Mircea Pascu, Tobias Pflüger, João de Deus Pinheiro, Mirosław Mariusz Piotrowski, Bernd Posselt, Michel Rocard, Raül Romeva i Rueda, Libor Rouček, Katrin Saks, José Ignacio Salafranca Sánchez-Neyra, Jacek Saryusz-Wolski, György Schöpflin, Gitte Seeberg, Marek Siwiec, Hannes Swoboda, Konrad Szymański, Antonio Tajani, Charles Tannock, Paavo Väyrynen, Inese Vaidere, Geoffrey Van Orden, Luis Yañez-Barnuevo García, Josef Zieleniec
Roberta Alma Anastase, Panagiotis Beglitis, Bastiaan Belder, Marco Cappato, Philip Claeys, Véronique De Keyser, Bronisław Geremek, Maciej Marian Giertych, Ana Maria Gomes, Klaus Hänsch, Jana Hybášková, Anna Ibrisagic, Ioannis Kasoulides, Bogdan Klich, Helmut Kuhne, Joost Lagendijk, Vytautas Landsbergis, Eugen Mihaescu, Emilio Menéndez del Valle, Willy Meyer Pleite, Francisco José Millán Mon, Pasqualina Napoletano, Annemie Neyts-Uyttebroeck, Baroness Nicholson of Winterbourne, Raimon Obiols i Germà, Vural Öger, Justas Vincas Paleckis, Ioan Mircea Pascu, Tobias Pflüger, João de Deus Pinheiro, Mirosław Mariusz Piotrowski, Bernd Posselt, Michel Rocard, Raül Romeva i Rueda, Libor Rouček, Katrin Saks, José Ignacio Salafranca Sánchez-Neyra, Jacek Saryusz-Wolski, György Schöpflin, Gitte Seeberg, Marek Siwiec, Hannes Swoboda, Konrad Szymański, Antonio Tajani, Charles Tannock, Paavo Väyrynen, Inese Vaidere, Geoffrey Van Orden, Luis Yañez-Barnuevo García, Josef Zieleniec
Laima Liucija Andrikienė, Robert Atkins, Alexandra Dobolyi, Árpád Duka-Zólyomi, Jaromír Kohlíček, Janusz Onyszkiewicz, Doris Pack, Rihards Pīks, Józef Pinior, Lapo Pistelli, Miguel Portas, Aloyzas Sakalas, Pierre Schapira, Csaba Sándor Tabajdi
Laima Liucija Andrikienė, Robert Atkins, Alexandra Dobolyi, Árpád Duka-Zólyomi, Jaromír Kohlíček, Janusz Onyszkiewicz, Doris Pack, Rihards Pīks, Józef Pinior, Lapo Pistelli, Miguel Portas, Aloyzas Sakalas, Pierre Schapira, Csaba Sándor Tabajdi
Hiltrud Breyer , Комисия по правни въпроси
Hiltrud Breyer , Committee on Legal Affairs
(*) Засилено сътрудничество между комисиите – член 47 от Правилника за дейността
(*) Enhanced cooperation between committees - Rule 47 of the Rules of Procedure
PE 380.740v02-00
PE 380.740v02-00
ЗАКОНОДАТЕЛНА ПРОЕКТОРЕЗОЛЮЦИЯ НА ЕВРОПЕЙСКИЯ ПАРЛАМЕНТ…5
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION.....................................5
ИЗЛОЖЕНИЕ НА МОТИВИТЕ.............................................................................................44
EXPLANATORY STATEMENT..............................................................................................40
СТАНОВИЩЕ НА КОМИСИЯТА ПО ПРОМИШЛЕНОСТ, ИЗСЛЕДВАНИЯ И ЕНЕРГЕТИКА ………………………………………………………………………………46
OPINION of the Committee on Industry, Research and Energy ...............42
СТАНОВИЩЕ НА КОМИСИЯТА ПО ПРАВНИ ВЪПРОСИ (*) ........................................71
OPINION of the Committee on Legal Affairs (*) ................................................66
(*) Засилено сътрудничество между комисиите - член 47 от Правилника за дейността
(*) Enhanced cooperation between committees - Rule 47 of the Rules of Procedure
– като взе предвид предложението на Комисията до Европейския парламент и до Съвета ( COM(2005)0567 )
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2005)0567 )
– като взе предвид член 251, параграф 2 и член 95 от Договора за ЕО, съгласно които предложението му е представено от Комисията ( C6‑0401/2005 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0401/2005 ),
– като взе предвид доклада на Комисията по околна среда, обществено здраве и безопасност на храните и становищата на Комисията по промишленост, изследвания и енергетика и на Комисията по правни въпроси (А6-0031/2007)
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on Legal Affairs ( A6‑0031/2007 ),
2) Доколкото за тези продукти за съвременно лечение се твърди, че притежават свойства за лечение или профилактика на заболявания при хора, или че могат да се използват при хора с цел възстановяване, коригиране или изменение на физиологични функции чрез упражняване на фармакологично, имунологично или метаболично действие, те са биологични лекарствени продукти по смисъла на член 1, параграф 2 от Директива 2001/83/ЕО на Европейския парламент и на Съвета от 6 ноември 2001 г. за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба и на приложение І към нея.
(2) Insofar as these advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Article 1(2) and Annex I 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.
Поради това, основната цел на всички норми, уреждащи тяхното производство, разпространение и употреба, трябва да бъде защитата на общественото здраве.
Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health.
2) Доколкото за тези продукти за съвременно лечение се твърди, че притежават свойства за лечение или профилактика на заболявания при хора, или че могат да се използват при хора с цел възстановяване, коригиране или изменение на физиологични функции чрез упражняване главно на фармакологично, имунологично или метаболично действие, те са биологични лекарствени продукти по смисъла на член 1, параграф 2 от Директива 2001/83/ЕО на Европейския парламент и на Съвета от 6 ноември 2001 г. за утвърждаване на кодекс на Общността относно лекарствени продукти за хуманна употреба и на приложение І към нея.
(2) Insofar as these advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Article 1(2) and Annex I 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.
The Medical Devices Directives (MDD) provide a regulatory framework which is readily adapted to the control of devices containing or made of tissue engineered products.
The Medical Devices Directives (MDD) provide a regulatory framework which is readily adapted to the control of devices containing or made of tissue engineered products.
If a tissue engineered product falls within the definition of ‘medical device’ in Article 1 of the MDD (and therefore does not have a mode of action which is primarily pharmacological, immunological or metabolic), it should be regulated under the MDD although additional specific requirements may be necessary.
If a tissue engineered product falls within the definition of ‘medical device’ in Article 1 of the MDD (and therefore does not have a mode of action which is primarily pharmacological, immunological or metabolic), it should be regulated under the MDD although additional specific requirements may be necessary.
5) Лекарствените продукти за съвременно лечение следва да се регулират, доколкото са предназначени за пускане на пазара в държавите-членки и се приготвят по промишлен способ или се произвеждат по метод, предполагащ промишлен процес по смисъла на член 2, параграф 1 от Директива 2001/83/ЕО.
(5) Advanced therapy medicinal products should be regulated in so far as they are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, within the meaning of Article 2(1) of Directive 2001/83/EC.
Следователно, лекарствените продукти за съвременно лечение, които изцяло се приготвят и използват в болнично заведение по лекарско предписание за отделен пациент, следва да бъдат изключени от приложното поле на настоящия регламент.
Advanced therapy medicinal products which are both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient, should thus be excluded from the scope of the present Regulation.
5) Настоящият регламент е специален законов акт, чрез който се въвеждат допълнителни разпоредби към посочените в Директива 2001/83/ЕО.
(5) This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC .
Приложното поле на настоящия регламент е да регламентира лекарствените продукти за съвременно лечение , които са предназначени за пускане на пазара в държавите-членки и се приготвят по промишлен способ или се произвеждат по метод, предполагащ промишлен процес в съответствие с общото приложно поле на законодателството на Общността в областта на фармацевтиката по дял II от Директива 2001/83/ЕО.
The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legislation laid down in Title II of Directive 2001/83/EC .
Следователно, лекарствените продукти за съвременно лечение, които изцяло се приготвят в болнично заведение, с нестопанска цел и еднократно, съгласно специфичен, нестандартизиран и непатентован процес и се използват в болнично заведение с цел изпълнение на отделно лекарско предписание за отделен пациент на изключителната професионална отговорност на медицинско лице или за клинични изследвания , следва да бъдат изключени от приложното поле на настоящия регламент.
Advanced therapy medicinal products which are prepared in full in a hospital in a non-profit manner and on a one-off basis according to a specific, non-standardised and non-patented process , and used in a hospital , in order to comply with an individual medical prescription for an individual patient under the exclusive professional responsibility of a medical practitioner or for clinical research , should thus be excluded from the scope of this Regulation.
It should be clarified that this Regulation is a lex specialis in relation to Dir.
It should be clarified that this Regulation is a lex specialis in relation to Dir.
2001/83/EC, as it introduces additional requirements that are specific to ATMP.
2001/83/EC, as it introduces additional requirements that are specific to ATMP.
The scope of this Regulation is the general scope of the pharmaceutical legislation, as laid down in Dir.
The scope of this Regulation is the general scope of the pharmaceutical legislation, as laid down in Dir.
Where hospitals or other institutions prepare products using an established process to create treatments for patients on a routine basis, they should have to comply with the provisions of this Regulation.
Where hospitals or other institutions prepare products using an established process to create treatments for patients on a routine basis, they should have to comply with the provisions of this Regulation.
However, when hospitals produce ATMP for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
However, when hospitals produce ATMP for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
6) Регулирането на лекарствените продукти за съвременно лечение на общностно равнище не следва да съставлява вмешателство в решения на държавите-членки относно даването на разрешения за употреба на специфичен тип човешки клетки, като например ембрионални стволови клетки или животински клетки.
(6) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells , such as embryonic stem cells, or animal cells .
То не следва да засяга и прилагането на националното законодателство, което забранява или ограничава продажбата, доставката или употребата на лекарствени продукти, съдържащи, състоящи се или получени от такива клетки.
It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.
6) Действащото законодателство в държавите-членки относно употребата на определени типове клетки, като например ембрионални стволови клетки, значително се различава.
(6) Legislation in force in Member States concerning the use of certain types of cells, such as embryonic stem cells, varies considerably.
Регулирането на лекарствените продукти за съвременно лечение на общностно равнище не следва да съставлява вмешателство в решения на държавите-членки относно даването на разрешения за употреба на специфичен тип клетки.
The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of cells.
Освен това, невъзможно е да се прецени кога, ако изобщо някога, изследванията за тези клетки ще достигнат етапа, на който търговските продукти, получени от тези клетки, могат да бъдат пуснати на пазара.
Moreover, it is impossible to assess when, if ever, research on these cells will reach the stage at which commercial products made from these cells could be placed on the market.
С цел спазване на основните принципи и правилното функциониране на вътрешния пазар и за да се гарантира правна сигурност, настоящият регламент би следвало да се прилага само по отношение на продукти, получени от клетки, за които пускането на пазара е реалистично в близко бъдеще и които не предизвикват значими спорове.
In order to respect the basic principles and the proper functioning of the internal market and to ensure legal certainty, this Regulation should apply only to products made of cells, for which marketing is feasible in the near future and which do not raise major controversies.
JURI amendment, which was incorporated in the report without vote following Rule 47.
JURI amendment, which was incorporated in the report without vote following Rule 47.
The legal base of this regulation (Article 95 TEC) is a single market harmonisation measure.
The legal base of this regulation (Article 95 TEC) is a single market harmonisation measure.
It is not designed to cover situations in which significant national legislative differences are intended to remain (c.f.
It is not designed to cover situations in which significant national legislative differences are intended to remain (c.f.
ECJ Case C-376/98).
ECJ Case C-376/98).
It is therefore necessary to exclude from the scope of this regulation products using materials which are controversial and for which differing Member States legislative provisions are intended to remain.
It is therefore necessary to exclude from the scope of this regulation products using materials which are controversial and for which differing Member States legislative provisions are intended to remain.
In any case, products using these materials are unlikely to be ready to be placed on the market in the foreseeable future.
In any case, products using these materials are unlikely to be ready to be placed on the market in the foreseeable future.
9) Оценката на лекарствени продукти за съвременно лечение често изисква много специфични експертни познания, които излизат извън рамките на традиционната фармацевтична област и обхващат области на границата с други области, като например биотехнология и медицински изделия.
(9) The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas on the borderline to other sectors such as biotechnology and medical devices.
Поради това е целесъобразно в рамките на Агенцията да се създаде Комитет за съвременни лечения, до който Комитетът за лекарствени продукти за хуманна употреба да се допитва относно оценката на данни, свързани с лекарствени продукти за съвременно лечение, преди да издаде окончателното си научно становище.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which the Committee for Medicinal Products for Human Use of the Agency should consult on the assessment of data related to advanced therapy medicinal products, before issuing its final scientific opinion.
В допълнение, допитване до Комитета за съвременни лечения може да се извършва и за оценката на всеки друг лекарствен продукт, която изисква специфични експертни познания в кръга на неговата компетентност.
In addition, the Committee for Advanced Therapies may be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
Поради това е целесъобразно в рамките на Агенцията да се създаде Комитет за съвременни лечения, който би следвало да отговаря за подготовката на проектостановище относно качеството, безопасността и ефикасността на всеки лекарствен продукт за съвременно лечение за окончателно одобрение от Комитета за лекарствени продукти за хуманна употреба на Агенцията.
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use of the Agency.