natgillin/translations-raw huggingface dataset:
María Badía i Cutchet, Christopher Beazley, Guy Bono, Marielle De Sarnez, Marie-Hélène Descamps, Milan Gaľa, Claire Gibault, Vasco Graça Moura, Lissy Gröner, Erna Hennicot-Schoepges, Luis Francisco Herrero-Tejedor, Ruth Hieronymi, Bernat Joan i Marí, Manolis Mavrommatis, Marianne Mikko, Ljudmila Novak, Doris Pack, Christa Prets, Pál Schmitt, Nikolaos Sifunakis, Hannu Takkula, Helga Trüpel, Tomáš Zatloukal
María Badía i Cutchet, Christopher Beazley, Guy Bono, Marielle De Sarnez, Marie-Hélène Descamps, Milan Gaľa, Claire Gibault, Vasco Graça Moura, Lissy Gröner, Erna Hennicot-Schoepges, Luis Francisco Herrero-Tejedor, Ruth Hieronymi, Bernat Joan i Marí, Manolis Mavrommatis, Marianne Mikko, Ljudmila Novak, Doris Pack, Christa Prets, Pál Schmitt, Nikolaos Sifunakis, Hannu Takkula, Helga Trüpel, Tomáš Zatloukal
Rolf Berend, Emine Bozkurt, Ignasi Guardans Cambó, Gyula Hegyi, Åsa Westlund
Rolf Berend, Emine Bozkurt, Ignasi Guardans Cambó, Gyula Hegyi, Åsa Westlund
o návrhu nařízení Rady, kterým se mění nařízení (ES) č. 297/95 o poplatcích, které se platí Evropské agentuře pro hodnocení léčivých přípravků
on the proposal for a Council regulation amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
VYSVĚTLUJÍCÍ PROHLÁŠENÍ
EXPLANATORY STATEMENT................................................................................................9
STANOVISKO ROZPOČTOVÉHO VÝBORU
OPINION OF THE COMMITTEE ON BUDGETS.................................................................11
o návrhu nařízení Rady kterým se mění nařízení (ES) č. 297/95 o poplatcích, které se platí Evropské agentuře pro hodnocení léčivých přípravků
on the proposal for a Council regulation amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
L 35, 15.2.1995, s.1.
OJ L 35, 15.2.1995, p.1.
– s ohledem na zprávu Výboru pro životní prostředí, veřejné zdraví a bezpečnost potravin a na stanovisko Rozpočtového výboru ( A6‑0264/2005 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Budgets ( A6‑0264/2005 ),
(4a) Aby bylo možno dodržet zásadu přiměřenosti, měl by se na léčivé prostředky, jejichž účinné látky se v lékařství osvědčily a používají se ve Společenství alespoň deset let, vztahovat snížený roční poplatek.
(4a) In order to respect the principle of proportionality, medicinal products in which the active substances have been in well-established medicinal use within the Community for at least ten years should benefit from a reduced annual fee.
Annual fees are intended to cover the costs of the monitoring of existing medicinal products.
Annual fees are intended to cover the costs of the monitoring of existing medicinal products.
In the case of medicinal products where the active substance is well-known, the workload related to their monitoring is smaller than in the case of products with a completely new chemical entity.
In the case of medicinal products where the active substance is well-known, the workload related to their monitoring is smaller than in the case of products with a completely new chemical entity.
Uvedený poplatek pokrývá jednu sílu spojenou s jednou lékovou formou a jednou obchodní úpravou.
That fee shall cover a single strength associated with one pharmaceutical form and one presentation.
The current proposal foresees a full fee of 232,000 € for a bibliographic application.
The current proposal foresees a full fee of 232,000 € for a bibliographic application.
The amount of work involved in assessing a product with a completely new chemical entity compared to a product based on a well-established substance (as defined in Article 10a of Directive 2004/27/EC amending Directive 2001/83/EC) differs significantly.
The amount of work involved in assessing a product with a completely new chemical entity compared to a product based on a well-established substance (as defined in Article 10a of Directive 2004/27/EC amending Directive 2001/83/EC) differs significantly.
In order to respect the principle of proportionality, a reduced fee of 90,000 € should be applied to bibliographical applications, unless there were well-founded reasons to apply a higher fee.
In order to respect the principle of proportionality, a reduced fee of 90,000 € should be applied to bibliographical applications, unless there were well-founded reasons to apply a higher fee.
To zahrnuje hodnocení tradičních bylinných léčivých přípravků , stanovisko k léčivým přípravkům pro soucitné účely („compassionate use“), poradenství o pomocných látkách včetně krevních derivátů začleněných do zdravotnických pomůcek a hodnocení kmenové dokumentace plasmy a kmenové dokumentace antigenů očkovacích látek.
This includes any evaluation of traditional herbal medicinal products, any opinion on medicinal products for compassionate use, any consultation on ancillary substances, including blood derivatives, incorporated in medical devices, and any evaluation of plasma master files and vaccine antigen master files.
To zahrnuje stanovisko k léčivým přípravkům pro soucitné účely („compassionate use“), poradenství o pomocných látkách včetně krevních derivátů začleněných do zdravotnických pomůcek a hodnocení kmenové dokumentace plasmy a kmenové dokumentace antigenů očkovacích látek.
This includes any opinion on medicinal products for compassionate use, any consultation on ancillary substances, including blood derivatives, incorporated in medical devices, and any evaluation of plasma master files and vaccine antigen master files.
Týká-li se humánních léčivých přípravků, činí poplatek 232 000 eur.
When it concerns medicinal products for human use, the fee shall be EUR 232 000.
Týká-li se humánních léčivých přípravků, činí poplatek nejvýše 232 000 eur.
When it concerns medicinal products for human use, the fee shall be not more than EUR 232 000.
Týká-li se veterinárních léčivých přípravků, činí poplatek 116 000 eur.
When it concerns veterinary medicinal products, the fee shall be EUR 116 000.
Týká-li se veterinárních léčivých přípravků, činí poplatek nejvýše 116 000 eur.
When it concerns veterinary medicinal products, the fee shall be not more than EUR 116 000.
Týká-li se hodnocení tradičních bylinných léčivých přípravků, činí poplatek nejvýše 25 000 eur.
When it concerns the evaluation of traditional herbal medicinal products, the fee shall be not more than EUR 25 000.
Ustanovení článku 3 se vztahují na vědecké stanovisko k hodnocení humánních léčivých přípravků určených výlučně pro trhy mimo Společenství podle článku 58 nařízení (ES) č. 726/2004.
The provisions of Article 3 shall apply to any scientific opinion for the evaluation of medicinal products for human use intended exclusively for markets outside the Community pursuant to Article 58 of Regulation (EC) No 726/2004.
Snížený poplatek za vědeckou službu v rozmezí od 2 500 eur do 200 000 eur se vztahuje na některá vědecká stanoviska nebo služby týkající se humánních léčivých přípravků.
A reduced scientific service fee falling within the range of EUR 2 500 to EUR 200 000 shall apply for certain scientific opinions or services concerning medicinal products for human use.
Snížený poplatek za vědeckou službu v rozmezí od 2 500 eur do 100 000 eur se vztahuje na některá vědecká stanoviska nebo služby týkající se veterinárních léčivých přípravků.
A reduced scientific service fee falling within the range of EUR 2 500 to EUR 100 000 shall apply for certain scientific opinions or services concerning veterinary medicinal products.
Snížený poplatek za vědecké služby v rozmezí 2 500 až 25 000 eur se vztahuje na některá vědecká stanoviska nebo služby ohledně tradičních bylinných léčivých přípravků.
A reduced scientific service fee falling within the range of EUR 2 500 to EUR 25 000 shall apply for certain scientific opinions or services concerning traditional herbal medicinal products.
Ensuring proportionality between the amount of fees and the nature of service provided is one of the key objectives of the proposal.
Ensuring proportionality between the amount of fees and the nature of service provided is one of the key objectives of the proposal.
Therefore, the regulation should leave room for flexibility also in the case of scientific services for special medicinal products.
Therefore, the regulation should leave room for flexibility also in the case of scientific services for special medicinal products.
As regards to traditional herbal medicinal products in particular, applying a full fee of 232,000 would be out of proportion.
As regards to traditional herbal medicinal products in particular, applying a full fee of 232,000 would be out of proportion.
In light of the related workload, a fee up to 25,000 € would be appropriate for traditional herbal medicines .
In light of the related workload, a fee up to 25,000 € would be appropriate for traditional herbal medicines .
Following the recent revision of the pharmaceutical legislation, the Commission has made a proposal to update Regulation 297/95 on fees payable to the European Medicines Agency (EMEA).
Following the recent revision of the pharmaceutical legislation, the Commission has made a proposal to update Regulation 297/95 on fees payable to the European Medicines Agency (EMEA).
The revision is necessary, as the tasks of the EMEA have not only been modified but also enlarged.
The revision is necessary, as the tasks of the EMEA have not only been modified but also enlarged.
Post-authorisation activities have been substantially strengthened and new scientific services will be provided to the pharmaceutical industry.
Post-authorisation activities have been substantially strengthened and new scientific services will be provided to the pharmaceutical industry.
New types of fees will have to be created and determined in accordance with the new provisions.
New types of fees will have to be created and determined in accordance with the new provisions.
Moreover, ten years of experience of the current system has shown some shortcomings in the financial base of the Agency.
Moreover, ten years of experience of the current system has shown some shortcomings in the financial base of the Agency.
The most important one is its heavy dependence on the payment of initial fees related to new applications.
The most important one is its heavy dependence on the payment of initial fees related to new applications.
It has made the Agency vulnerable to market fluctuations in the pharmaceutical industry.
It has made the Agency vulnerable to market fluctuations in the pharmaceutical industry.
Even if the number of new applications were very low, the Agency would need to carry out a number of tasks not directly linked to the assessment of new medicines.
Even if the number of new applications were very low, the Agency would need to carry out a number of tasks not directly linked to the assessment of new medicines.
Key elements of the proposal
Key elements of the proposal
The Commission proposal maintains the overall structure and level of the fees.
The Commission proposal maintains the overall structure and level of the fees.
To cover the costs related to all post-authorisation activities, an increase of 10% is proposed to the annual fee both in the human and veterinary sectors.
To cover the costs related to all post-authorisation activities, an increase of 10% is proposed to the annual fee both in the human and veterinary sectors.
On the other hand, the fee for generic medicinal products is reduced to better reflect the actual costs of evaluation.
On the other hand, the fee for generic medicinal products is reduced to better reflect the actual costs of evaluation.
The Commission also proposes the harmonisation of certain other fees.
The Commission also proposes the harmonisation of certain other fees.
All fees related to veterinary medicinal products are proposed to be kept at the same level, apart from the annual fee and one of the variation fees, which is reduced.
All fees related to veterinary medicinal products are proposed to be kept at the same level, apart from the annual fee and one of the variation fees, which is reduced.
The proposal defines new types of fees concerning the provision of scientific services related to, inter alia, traditional herbal medicinal products and medicinal products intended exclusively for markets outside the Community.
The proposal defines new types of fees concerning the provision of scientific services related to, inter alia, traditional herbal medicinal products and medicinal products intended exclusively for markets outside the Community.
A specific fee has been established also for bio-similar products.
A specific fee has been established also for bio-similar products.
The implementing powers of the Management Board and the Executive Director are further extended as regards to fee reductions.
The implementing powers of the Management Board and the Executive Director are further extended as regards to fee reductions.
One of the leading principles of the proposal is to ensure proportionality between the amount of the fees and the real workload related to services provided.
One of the leading principles of the proposal is to ensure proportionality between the amount of the fees and the real workload related to services provided.
The proposal aims to alleviate the financial pressure put on applicants, without undermining the Agency’s ability to perform its tasks.
The proposal aims to alleviate the financial pressure put on applicants, without undermining the Agency’s ability to perform its tasks.
Rapporteur 's remarks
Rapporteur's remarks
Your rapporteur welcomes the Commission proposal as a necessary step forward following the adoption of the new pharmaceutical legislation and considering other changes in its working environment and activities.
Your rapporteur welcomes the Commission proposal as a necessary step forward following the adoption of the new pharmaceutical legislation and considering other changes in its working environment and activities.
It is important to create a solid and up-to-date financial framework for the Agency, which plays a key role in European health policy and which strongly contributes to the achievement of the internal market for the pharmaceutical sector.
It is important to create a solid and up-to-date financial framework for the Agency, which plays a key role in European health policy and which strongly contributes to the achievement of the internal market for the pharmaceutical sector.
In view of the Agency's double role, a part, though a relatively small one, of its budget must to be covered by the European Union and another part by fees for services rendered to pharmaceutical companies.
In view of the Agency's double role, a part, though a relatively small one, of its budget must to be covered by the European Union and another part by fees for services rendered to pharmaceutical companies.
The services provided by the Agency form an essential part of the process relating to the placing of a new pharmaceutical product on the market.
The services provided by the Agency form an essential part of the process relating to the placing of a new pharmaceutical product on the market.
The key question is how to determine the right level of fees so that they cover the actual costs of services provided to companies but do not hamper innovation and the introduction of new medicinal products and thus the competitiveness of the European pharmaceutical industry.
The key question is how to determine the right level of fees so that they cover the actual costs of services provided to companies but do not hamper innovation and the introduction of new medicinal products and thus the competitiveness of the European pharmaceutical industry.
The pharmaceutical industry is not monolithic.
The pharmaceutical industry is not monolithic.
Alongside the huge multinational companies there are a number of SMEs as well as companies that fall between the two categories.
Alongside the huge multinational companies there are a number of SMEs as well as companies that fall between the two categories.
Moreover, the products that may make use of the centralised authorisation procedure can differ considerably as regards their innovativeness and complexity of composition.
Moreover, the products that may make use of the centralised authorisation procedure can differ considerably as regards their innovativeness and complexity of composition.
Therefore a certain flexibility in fees is justified.
Therefore a certain flexibility in fees is justified.
Your rapporteur supports the principle of extending the system of setting maximum fees and leaving the decision on possible reductions to those who possess the best expertise in the field, i.e. the EMEA Management Board and the Executive Director.
Your rapporteur supports the principle of extending the system of setting maximum fees and leaving the decision on possible reductions to those who possess the best expertise in the field, i.e. the EMEA Management Board and the Executive Director.
The principle of setting maximum fees and reduced fees could be, however, extended a bit further without jeopardising the financial basis of the Agency.
The principle of setting maximum fees and reduced fees could be, however, extended a bit further without jeopardising the financial basis of the Agency.
This applies in particular to fees for scientific advice for traditional herbal medicinal products.
This applies in particular to fees for scientific advice for traditional herbal medicinal products.
Their evaluation, compared to many other medicinal products, requires far less work.
Their evaluation, compared to many other medicinal products, requires far less work.
The level of the fee should correspond to the real workload related to their evaluation.
The level of the fee should correspond to the real workload related to their evaluation.
Another remark relates to well-established substances.
Another remark relates to well-established substances.
This change would set the fee for most bibliographic applications at the same level as that of a generic medicinal product.
This change would set the fee for most bibliographic applications at the same level as that of a generic medicinal product.
The same aspect should also be taken into account when defining the annual fee, which is intended to cover the costs of the monitoring of existing medicinal products.
The same aspect should also be taken into account when defining the annual fee, which is intended to cover the costs of the monitoring of existing medicinal products.
Předseda Výboru
President of the Committee
pro životní prostředí, veřejné zdraví a bezpečnost potravin
Environment, Public Health and Food Safety
naše stávající navrhovatelka paní Jutta Haugová posoudila návrh Komise o „Poplatcích, které se platí Evropské agentuře pro hodnocení léčivých přípravků“ a domnívá se, že není potřeba vypracovat stanovisko, jelikož v této fázi ještě nelze posoudit finanční dopad.
After having analysed the Commission's proposal on "Fees payable to the European Medicines Agency", our standing draftswoman on Agencies, Mrs Jutta Haug, has considered that it is not necessary to do an opinion as such since the financial impact has not and cannot be identified at that stage.
Paní Haugová si uvědomuje, že zvýšení poplatků je způsobeno dalšími úkoly, jež Rada zadává Evropské agentuře pro hodnocení léčivých přípravků, připomíná však, že takové rozhodnutí by mohlo vážně ovlivnit finanční situaci okruhu 3 a okruhu 2 nového finančního výhledu na období 2007-2013, jež dosud nebyly přijaty.
Mrs Haug recognises that the increase in fees is due to additional tasks given to EMEA by the Council but reminds that such a decision could have a serious impact on the financial situation of heading 3 and of heading 2 of the new financial perspective 2007-2013 which are still not adopted.
Finanční orgán musí být proto co nejdříve informován o finančního dopadu, jakmile bude znám.
Therefore, the budget authority must be made aware at the earliest possible stage of the financial impact andas soon as it will be identified.
Byl bych vděčný, kdybychom mohli v této otázce spolupracovat a vyměnit si informace, jakmile budou dostupné.
I would be grateful if we could work closely together on this issue and exchange information as soon as it is available.
S pozdravem,
Yours sincerely,
Návrh nařízení Rady, kterým se mění nařízení (ES) č. 297/95 o poplatcích, které se platí Evropské agentuře pro hodnocení léčivých přípravků
Proposal for a Council regulation amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
článek 12 nařízení Rady (ES) č. 297/95 ze dne 10.2.1995
Article 12 of Council Rgulation (EC) No 297/95 of 10.2.1995
ENVI 26.5.2005
ENVI 26.5.2005
BUDG 26.5.2005
BUDG 26.5.2005
Karl-Heinz Florenz 24.5.2005
Karl-Heinz Florenz 24.5.2005
43 0 1
43 0 1
Georgs Andrejevs, Liam Aylward, Irena Belohorská, Johannes Blokland, John Bowis, Dorette Corbey, Chris Davies, Mojca Drčar Murko, Edite Estrela, Anne Ferreira, Karl-Heinz Florenz, Norbert Glante, Françoise Grossetête, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Roberto Musacchio, Riitta Myller, Péter Olajos, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Evangelia Tzampazi, Anja Weisgerber, Åsa Westlund
Georgs Andrejevs, Liam Aylward, Irena Belohorská, Johannes Blokland, John Bowis, Dorette Corbey, Chris Davies, Mojca Drčar Murko, Edite Estrela, Anne Ferreira, Karl-Heinz Florenz, Norbert Glante, Françoise Grossetête, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Roberto Musacchio, Riitta Myller, Péter Olajos, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Evangelia Tzampazi, Anja Weisgerber, Åsa Westlund
Datum předložení – A[5]
Date tabled
PE 357.759v02-00
PE 357.759v02-00
o návrhu nařízení Rady kterým se stanoví technická opatření pro zachování rybolovných zdrojů ve vodách Baltského moře, Velkého a Malého Beltu a Øresundu a mění nařízení (ES) č. 1434/98
on the proposal for a Council regulation for the conservation of fishery resources through technical measures in the Baltic Sea, the Belts and the Sound and amending Regulation (EC) No 1434/98
– s ohledem na návrh Komise předložený Radě ( KOM(2005)0086 )
– having regard to the Commission proposal to the Council ( COM(2005)0086 )
– s ohledem na článek 37 Smlouvy o ES, podle kterého Rada konzultovala s Parlamentem ( C6‑0094/2005 ),
– having regard to Article 37 of the EC Treaty, pursuant to which the Council consulted Parliament,
– s ohledem na zprávu Výboru pro rybolov ( A6‑0265/2005 ),
– having regard to the report of the Committee on Fisheries ( A6‑0265/2005 ),
(11) Vědecké informace naznačují, že pro lov tresky jsou vlečná rybolovná zařízení bez únikového okna méně selektivní než zařízení s únikovým oknem typu „BACOMA“.
(11) Scientific information indicates that, for cod, towed gears without exit window are less selective than those with the “BACOMA” type exit window.
Proto je vhodné ve vodách Společenství a na plavidlech Společenství nepovolit při lovu tresky používání vlečných lovných zařízení bez únikového okna typu „BACOMA“.
It is therefore appropriate not to allow within Community waters and for Community vessels the use of towed gears without the “BACOMA” type exit window when cod is a target species.
(11) Vědecké informace naznačují, že pro lov tresky jsou vlečná rybolovná zařízení bez únikového okna méně selektivní než zařízení s únikovým oknem typu „BACOMA“ nebo typu T90, u kterého jsou oka kapsy a nástavce vykroucena o 90 o .
(11) Scientific information indicates that, for cod, towed gears without exit window are less selective than those with the “BACOMA” type exit window or the T90 type in which the mesh in the codend and extension piece is turned 90 o .