natgillin/translations-raw huggingface dataset:
(c) four members appointed by the Commission, on the basis of a public call for expressions of interest, two of them to represent physicians and two of them to represent patients associations.
(c) four members appointed by the Commission, on the basis of a public call for expressions of interest, two of them to represent physicians and two of them to represent patients associations.
ARTICLE 21, PARAGRAPH 1, POINT (C) AND POINT (C A) (new)
ARTICLE 21, PARAGRAPH 1, POINT (C) AND POINT (C A) (new)
(c) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consultation of the European Parliament , to represent physicians ;
(c) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consultation of the European Parliament , to represent physicians ;
(a) to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise it on any data generated in the development of such a product;
(a) to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise it on any data generated in the development of such a product;
(aa) to provide advice, pursuant to Article 18, to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product;
(aa) to provide advice, pursuant to Article 18, to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product;
Having specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should assist the CHMP in its classification task of whether a product is or is not an advanced therapy medicinal product.
Having specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should assist the CHMP in its classification task of whether a product is or is not an advanced therapy medicinal product.
ARTICLE 23, PARAGRAPH 1 A (new)
ARTICLE 23, PARAGRAPH 1 A (new)
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
Report and review
Report and review
In that report, the Commission shall also assess the impact of technical progress on the application of this Regulation and, if necessary, submit a legislative proposal for a review of its scope to include novel therapies which are neither gene therapy, nor cell therapy nor tissue engineering.
In that report, the Commission shall also assess the impact of technical progress on the application of this Regulation and, if necessary, submit a legislative proposal for a review of its scope to include novel therapies which are neither gene therapy, nor cell therapy nor tissue engineering.
It would be in the interest of patients for these to be included at some future date in order to allow European authorisation of the resulting products.
It would be in the interest of patients for these to be included at some future date in order to allow European authorisation of the resulting products.
ARTICLE 25 A (new)
ARTICLE 25 A (new)
Article 25a
Article 25a
The Commission shall by no later than the end of 2007 submit a legislative proposal in order to ensure that products used for cosmetic purposes which contain human or animal cells or tissues are also covered by adequate Community legislation.
The Commission shall by no later than the end of 2007 submit a legislative proposal in order to ensure that products used for cosmetic purposes which contain human or animal cells or tissues are also covered by adequate Community legislation.
Until now products used for cosmetic purposes containing human or animal cells or tissues, although already being placed on the market, are not regulated under Community law.
Until now products used for cosmetic purposes containing human or animal cells or tissues, although already being placed on the market, are not regulated under Community law.
This regulation gap needs to be closed.
This regulation gap needs to be closed.
ARTICLE 26, PARAGRAPH 2, SUBPARAGRAPH 1
ARTICLE 26, PARAGRAPH 2, SUBPARAGRAPH 1
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Where reference is made to this paragraph, and without prejudice to Article 26a, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Where reference is made to this paragraph, and without prejudice to Article 26a, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
This is a consequential amendment to the introduction of the new Article 26(a) below.
This is a consequential amendment to the introduction of the new Article 26(a) below.
ARTICLE 26 A (new)
ARTICLE 26 A (new)
Article 26a
Article 26a
Without prejudice to the implementing measures already adopted, on 1 April 2008 at the latest, the application of the provisions of this Regulation requiring the adoption of technical rules, amendments and decisions shall be suspended.
Without prejudice to the implementing measures already adopted, on 1 April 2008 at the latest, the application of the provisions of this Regulation requiring the adoption of technical rules, amendments and decisions shall be suspended.
Acting on a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the date referred to above.
Acting on a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the date referred to above.
The first paragraph shall apply until such time as it is superseded by a new agreement on comitology.
The first paragraph shall apply until such time as it is superseded by a new agreement on comitology.
This amendment is preliminary tabled until the new comitology procedure is adopted which ensures more control by the Parliament.
This amendment is preliminary tabled until the new comitology procedure is adopted which ensures more control by the Parliament.
Annex, point 1 a (Regulation (EC) No 726/2004)
Annex, point 1 a (Regulation (EC) No 726/2004)
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*].
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*].
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure in accordance with the criteria of this Regulation as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level.
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure in accordance with the criteria of this Regulation as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level.
Afterwards an application for a single renewal within the centralised procedure shall be necessary, with the effect that, after the renewal, the national marketing authorisation will become a centralised marketing authorisation .
Afterwards an application for a single renewal within the centralised procedure shall be necessary, with the effect that, after the renewal, the national marketing authorisation will become a centralised marketing authorisation .
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells .
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells .
The Member States shall communicate the national legislation concerned to the Commission .”
The Member States shall communicate the national legislation concerned to the Commission .”
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , by virtue of the Article 30 of the Treaty establishing the European Community .”
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , by virtue of the Article 30 of the Treaty establishing the European Community .”
As this regulation is a partially harmonizing measure, it should be made clear that Member States has the right to refer to the Article 30 of the TEC when it comes to the access of certain medicinal products to their market.
As this regulation is a partially harmonizing measure, it should be made clear that Member States has the right to refer to the Article 30 of the TEC when it comes to the access of certain medicinal products to their market.
With regard to the Article 95, paragraph 4 of the TEC, the obligation to communicate the national legislation concerned to the Commission is only appropriate if the community measure is a fully harmonizing one.
With regard to the Article 95, paragraph 4 of the TEC, the obligation to communicate the national legislation concerned to the Commission is only appropriate if the community measure is a fully harmonizing one.
ARTICLE 28 A (new)
ARTICLE 28 A (new)
Article 2, paragraph 1 (Directive 2004/23/EC)
Article 2, paragraph 1 (Directive 2004/23/EC)
Article 28a
Article 28a
Amendment to Directive 2004/23/EC
Amendment to Directive 2004/23/EC
In Article 2(1) of Directive 2004/23/EC, the second subparagraph shall be replaced by the following:
In Article 2(1) of Directive 2004/23/EC, the second subparagraph shall be replaced by the following:
"Where such manufactured products are covered by other Community legislation, this Directive shall apply only to donation, procurement and testing.
"Where such manufactured products are covered by other Community legislation, this Directive shall apply only to donation, procurement and testing.
However, the donation, procurement and testing provisions of this Directive shall be without prejudice to more specific provisions contained in other Community legislation."
However, the donation, procurement and testing provisions of this Directive shall be without prejudice to more specific provisions contained in other Community legislation."
According to the existing legislation, the donation, procurement and testing of human tissues and cells should comply with high standards of quality and safety in order to ensure a high level of health protection in the Community.
According to the existing legislation, the donation, procurement and testing of human tissues and cells should comply with high standards of quality and safety in order to ensure a high level of health protection in the Community.
Moreover, it also has to be ensured that the human body or its parts as such are not commercialised.
Moreover, it also has to be ensured that the human body or its parts as such are not commercialised.
Therefore, for the purposes of this Regulation, Member States shall have an imperative obligation to ensure voluntary and unpaid donation and to guarantee that the procurement of tissues or cells is carried out on a non-profit basis.
Therefore, for the purposes of this Regulation, Member States shall have an imperative obligation to ensure voluntary and unpaid donation and to guarantee that the procurement of tissues or cells is carried out on a non-profit basis.
ARTICLE 29, PARAGRAPH 1
ARTICLE 29, PARAGRAPH 1
Otherwise, it could deprive patients from these important new medicinal products.
Otherwise, it could deprive patients from these important new medicinal products.
ARTICLE 29, PARAGRAPH 1 A (new)
ARTICLE 29, PARAGRAPH 1 A (new)
ANNEX II, POINT 2.2.
ANNEX II, POINT 2.2.
2.2. qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product.
2.2. qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin shall be provided.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin shall be provided.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin, shall be provided.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin, shall be provided.
ANNEX III, POINT (B)
ANNEX III, POINT (B)
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin;
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin;
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
ANNEX IV, POINT (A), POINT (III)
ANNEX IV, POINT (A), POINT (III)
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
JURI 23.3.2006
JURI 23.3.2006
Hiltrud Breyer 19.4.2006
Hiltrud Breyer 19.4.2006
Maria Berger, Carlo Casini, Monica Frassoni, Giuseppe Gargani, Piia-Noora Kauppi, Katalin Lévai, Hans-Peter Mayer, Aloyzas Sakalas, Daniel Strož, Diana Wallis, Rainer Wieland, Tadeusz Zwiefka
Maria Berger, Carlo Casini, Monica Frassoni, Giuseppe Gargani, Piia-Noora Kauppi, Katalin Lévai, Hans-Peter Mayer, Aloyzas Sakalas, Daniel Strož, Diana Wallis, Rainer Wieland, Tadeusz Zwiefka
Hiltrud Breyer, Manuel Medina Ortega, Marie Panayotopoulos-Cassiotou, Michel Rocard
Hiltrud Breyer, Manuel Medina Ortega, Marie Panayotopoulos-Cassiotou, Michel Rocard
Sharon Bowles, Esther Herranz García, Mieczysław Edmund Janowski, Peter Liese, Maria Martens, Miroslav Mikolášik
Sharon Bowles, Esther Herranz García, Mieczysław Edmund Janowski, Peter Liese, Maria Martens, Miroslav Mikolášik
COM(2005)0567 – C6 0401/2005 – 2005/0227(COD)
COM(2005)0567 – C6 0401/2005 – 2005/0227(COD)
ENVI 30.11.2005
ENVI 30.11.2005
ITRE 30.11.2006
ITRE 30.11.2006
IMCO 30.11.2006
IMCO 30.11.2006
IMCO 30.1.2006
IMCO 30.1.2006
JURI 18.5.2006
JURI 18.5.2006
Miroslav Mikolášik 14.12.2005
Miroslav Mikolášik 14.12.2005
55 6 3
55 6 3
Adamos Adamou, Georgs Andrejevs, Liam Aylward, Tiberiu Barbuletiu, Irena Belohorská, Johannes Blokland, John Bowis, Frieda Brepoels, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Chris Davies, Avril Doyle, Edite Estrela, Anne Ferreira, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Mary Honeyball, Caroline Jackson, Dan Jørgensen, Christa Klaß, Eija-Riitta Korhola, Urszula Krupa, Marie-Noëlle Lienemann, Peter Liese, Jules Maaten, Linda McAvan, Miroslav Ouzký, Antonyia Parvanova, Vittorio Prodi, Frédérique Ries, Dagmar Roth-Behrendt, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Kathy Sinnott, Bogusław Sonik, Evangelia Tzampazi, Thomas Ulmer, Anja Weisgerber, Åsa Westlund, Anders Wijkman
Adamos Adamou, Georgs Andrejevs, Liam Aylward, Tiberiu Barbuletiu, Irena Belohorská, Johannes Blokland, John Bowis, Frieda Brepoels, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Chris Davies, Avril Doyle, Edite Estrela, Anne Ferreira, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Mary Honeyball, Caroline Jackson, Dan Jørgensen, Christa Klaß, Eija-Riitta Korhola, Urszula Krupa, Marie-Noëlle Lienemann, Peter Liese, Jules Maaten, Linda McAvan, Miroslav Ouzký, Antonyia Parvanova, Vittorio Prodi, Frédérique Ries, Dagmar Roth-Behrendt, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Kathy Sinnott, Bogusław Sonik, Evangelia Tzampazi, Thomas Ulmer, Anja Weisgerber, Åsa Westlund, Anders Wijkman
Pilar Ayuso, Niels Busk, Philippe Busquin, Hélène Goudin, Umberto Guidoni, Karin Jöns, Henrik Lax, Caroline Lucas, Jiří Maštálka, Miroslav Mikolášik, Bart Staes
Pilar Ayuso, Niels Busk, Philippe Busquin, Hélène Goudin, Umberto Guidoni, Karin Jöns, Henrik Lax, Caroline Lucas, Jiří Maštálka, Miroslav Mikolášik, Bart Staes
Iles Braghetto, Ioannis Gklavakis, Mieczyslaw Janowski, Maria Petre, Zita Plestinská, Konrad Szymanski
Iles Braghetto, Ioannis Gklavakis, Mieczyslaw Janowski, Maria Petre, Zita Plestinská, Konrad Szymanski
относно ”Биотехнологиите: перспективи и предизвикателства пред селското стопанство в Европа”
on Biotechnology: Prospects and Challenges for Agriculture in Europe
PE 380.655v02-00
PE 380.655v02-00
MINORITY OPINION.............................................................................................................19
MINORITY OPINION.............................................................................................................18
OPINION of the Committee on International Trade ......................................20
OPINION of the Committee on International Trade ......................................19
OPINION of the Committee on Industry, Research and Energy ...............25
OPINION of the Committee on Industry, Research and Energy ...............24
– като взе предвид Договора за създаване на Европейската общност,
– having regard to the Treaty establishing the European Community,
– като взе предвид съобщението на Комисията, озаглавено „Науки за живота и биотехнологии: стратегия за Европа“
– having regard to the Commission Communication on Life Sciences and Biotechnology – a Strategy for Europe
- като взе предвид Решение № 2004/869/EО на Съвета от 24 февруари 2004 г. за сключване, от името на Европейската общност, на Международния договор за растителни генетични ресурси за прехрана и земеделие
- having regard to Council Decision No 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the European Community, of the International Treaty on Plant Genetic Resources for Food and Agriculture
- като взе предвид Международния договор за растителни генетични ресурси за прехрана и земеделие,
- the International Treaty on Plant Genetic Resources for Food and Agriculture,
- като взе предвид Директива 98/95/EО на Съвета от 14 декември 1998 г. за изменение на Директиви 66/400/ЕИО, 66/401/ЕИО, 66/402/ЕИО, 66/403/ЕИО, 69/208/ЕИО, 70/457/ЕИО и 70/458/ЕИО, която въвежда правна основа за запазване на генетичната изменчивост,
- having regard to Council Directive 98/95/EC of 14 December 1998, amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC, which introduced a legal basis enabling genetic variability,
– като взе предвид Протокола от Картахена по биобезопасност към Конвенцията за биологично разнообразие от 29 януари 2000 г.
– having regard to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity of 29 January 2000
– като взе предвид Директива 2001/18/EО на Европейския парламент и на Съвета от 12 март 2001 г. относно съзнателното освобождаване на генетично модифицирани организми в околната среда и за отмяна на Директива 90/220/ЕИО на Съвета
– having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
– като взе предвид Регламент (ЕО) № 1829/2003 на Европейския парламент и на Съвета от 22 септември 2003 г. относно генетично модифицираните храни и фуражи
– having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed