natgillin/translations-raw huggingface dataset:
27) Необходимите мерки за прилагане на настоящия регламент следва да се приемат в съответствие с Решение 1999/468/ЕО на Съвета от 28 юни 1999 г. за определяне на условията и реда за упражняване на изпълнителните правомощия, предоставени на Комисията.
(27) The measures necessary for the implementation of this Regulation should be adopted in accordance with the Council Decision 1999/468/EC of 28 June 1999 laying down the procedures of the exercise of implementing powers conferred to the Commission.
Процедурата по регулиране с контрол, предвидена в член 5а от посоченото решение, би следвало да се прилага за приемането на изменения на приложения от II до IV към настоящия регламент и на приложение I към Директива 2001/83/ЕО.
The regulatory procedure with scrutiny provided for in Article 5a of that Decision should apply to the adoption of amendments to Annexes II to IV to this Regulation and to Annex I to Directive 2001/83/EC.
Понеже тези мерки са от основно значение за правилното функциониране на цялата регулаторна рамка, те би следвало да се приемат бързо, в срок от 9 месеца след влизането в сила на настоящия регламент.
Since these measures are essential for the proper operation of the whole regulatory framework, they should be adopted swiftly, within 9 months after the entry into force of this Regulation.
Manufacturers will not be in a position to design development protocols until the technical requirements are published and the adaptations of the Good Clinical Practice Directive and the Good Manufacturing Practice Directive are finalised.
Manufacturers will not be in a position to design development protocols until the technical requirements are published and the adaptations of the Good Clinical Practice Directive and the Good Manufacturing Practice Directive are finalised.
Therefore, we propose 9 months time limit for the Commission to adopt the necessary measures.
Therefore, we propose 9 months time limit for the Commission to adopt the necessary measures.
ЧЛЕН 1 А (нов)
ARTICLE 1 A (new)
Член 1а
Article 1a
Настоящият регламент не се прилага за лекарствени продукти за съвременно лечение, които съдържат или са получени от човешки ембрионални или зародишни клетки, първични зародишни клетки или от клетки, получени от такива клетки.
This Regulation shall not apply to advanced therapy medicinal products that contain or are derived from human embryonic or foetal cells, primordial germ cells or cells derived from those cells.
ЧЛЕН 2, ПАРАГРАФ 1, БУКВА Б), УВОДНА ЧАСТ
ARTICLE 2, PARAGRAPH 1, POINT (B), INTRODUCTORY PART
б) продукт, получен чрез тъканно инженерство, означава продукт, който:
(b) tissue engineered product means a product that:
б) продукт, получен чрез тъканно инженерство, означава лекарствен продукт, който:
(b) tissue engineered product means a medicinal product that:
ЧЛЕН 2, ПАРАГРАФ 1, БУКВА Б), АЛИНЕЯ 2 A (нова)
ARTICLE 2, PARAGRAPH 1, POINT (B), SUBPARAGRAPH 2 A (new)
Продукти, които съдържат или са произведени от нежизнеспособни човешки или животински клетки и/или тъкани, които не съдържат никакви жизнеспособни клетки или тъкани и чието основно действие не е фармакологично, имунологично или метаболично, са изключени от това определение.
Products containing or made exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, are excluded from this definition.
ЧЛЕН 2, ПАРАГРАФ 1, БУКВА Г), ТИРЕ 1 A (ново)
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 1 A (new)
- клетъчната или тъканната му част съдържа жизнеспособни клетки или тъкани; или
- its cellular or tissue part contains viable cells or tissues; or
For the purposes of this Regulation, the most important criterion when defining a combined advanced therapy medicinal product should be the viability of its cellular or tissue part.
For the purposes of this Regulation, the most important criterion when defining a combined advanced therapy medicinal product should be the viability of its cellular or tissue part.
For the patient's safety and the high standards of the evaluation of a product, a combined product should be always classified as an advanced therapy medicinal product when it contains viable tissues or cells.
For the patient's safety and the high standards of the evaluation of a product, a combined product should be always classified as an advanced therapy medicinal product when it contains viable tissues or cells.
ЧЛЕН 2, ПАРАГРАФ 1, БУКВА Г), ТИРЕ 2
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 2
– клетъчната или тъканната му част трябва да може да упражнява върху човешкото тяло действие, което не може да се счита за спомагателно на действието на посочените изделия.
– its cellular or tissue part must be liable to act upon the human body with action that cannot be considered as ancillary to that of the devices referred to.
– клетъчната или тъканната му част, която съдържа нежизнеспособни клетки или тъкани , трябва да може да упражнява върху човешкото тяло действие, което може да се счита за основно спрямо действието на посочените изделия.
– its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.
A combined product should always be considered as advanced therapy medicinal product when it contains non-viable cells or tissues which act upon human body in a manner that is considered as primary to the action of the device part of the product concerned.
A combined product should always be considered as advanced therapy medicinal product when it contains non-viable cells or tissues which act upon human body in a manner that is considered as primary to the action of the device part of the product concerned.
ЧЛЕН 2, ПАРАГРАФ 1, АЛИНЕЯ 1 А (нова)
ARTICLE 2, PARAGRAPH 1, SUBPARAGRAPH 1 A (new)
Когато даден продукт съдържа жизнеспособни клетки или тъкани, фармакологичното, имунологично или метаболично действие на тези клетки или тъкани се счита за основен способ на действие на продукта.
Where a product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues shall be considered as the primary mode of action of the product.
This new provision clarifies the rule concerning products which contain viable cells or tissues, whilst maintaining in principle the criterion of “primary mode of action” for borderline classification.
This new provision clarifies the rule concerning products which contain viable cells or tissues, whilst maintaining in principle the criterion of “primary mode of action” for borderline classification.
For the patient's safety and the high standards of the evaluation of a combined product, the most important criterion should be the viability of the cellular or tissue part of such a product.
For the patient's safety and the high standards of the evaluation of a combined product, the most important criterion should be the viability of the cellular or tissue part of such a product.
ЧЛЕН 4, ПАРАГРАФИ 2 И 3
ARTICLE 4, PARAGRAPHS 2 AND 3
Комисията, в съответствие с процедурата, посочена в член 26, параграф 2, изменя Директива 2005/28/ЕО с цел да се отчетат специфичните характеристики на лекарствените продукти за съвременно лечение.
The Commission shall, in accordance with the procedure referred to in Article 26(2), amend Directive 2005/28/EC in order to take account of the specific characteristics of advanced therapy medicinal products.
Комисията, след консултиране с Агенцията и в съответствие с процедурата, посочена в член 26, параграф 2, изменя Директива 2005/28/ЕО с цел да се отчетат специфичните характеристики на лекарствените продукти за съвременно лечение.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2), amend Directive 2005/28/EC in order to take account of the specific characteristics of advanced therapy medicinal products.
Комисията изготвя подробни насоки за добра клинична практика, която е специфична за лекарствените продукти за съвременно лечение.
The Commission shall draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
Комисията, след консултиране с Агенцията , изготвя подробни насоки за добра клинична практика, която е специфична за лекарствените продукти за съвременно лечение.
The Commission shall , after consultation of the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
The Regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever good clinical practice requirements need to be amended or guidelines related to advanced therapy medicinal products need to be drawn up.
The Regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever good clinical practice requirements need to be amended or guidelines related to advanced therapy medicinal products need to be drawn up.
ЧЛЕН 5, ПАРАГРАФ -1 (нов)
ARTICLE 5, PARAGRAPH -1 (new)
Комисията, в съответствие с процедурата, посочена в член 26, параграф 2, изменя Директива 2003/94/ЕО с цел да се отчетат специфичните характеристики на лекарствените продукти за съвременно лечение и по-специално на продукти, получени чрез тъканно инженерство.
The Commission shall, in accordance with the procedure referred to in Article 26(2), amend Directive 2003/94/EC to take into account the specific characteristics of advanced therapy medicinal products and in particular tissue engineered products.
Advanced therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products.
Advanced therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products.
It is, however, difficult to consider expiry dates for certain classes of ATMPs).
It is, however, difficult to consider expiry dates for certain classes of ATMPs).
Комисията публикува подробни насоки, които са в съответствие с принципите на добрата производствена практика и са специфични за лекарствените продукти за съвременно лечение.
Detailed guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products shall be published by the Commission .
Комисията съставя подробни насоки, които са в съответствие с принципите на добрата производствена практика и са специфични за лекарствените продукти за съвременно лечение.
The Commission shall draw up detailed guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.
For the sake of consistency, the wording should be put in line with the equivalent provision in Article 4(3).
For the sake of consistency, the wording should be put in line with the equivalent provision in Article 4(3).
Специфични изисквания за продуктите, получени чрез тъканно инженерство
Specific requirements for tissue engineered products
Специфични изисквания за лекарствените продукти за съвременно лечение, които съдържат изделия
Specific requirements for advanced therapy medicinal products containing devices
В допълнение към изискванията, предвидени в член 6, параграф 1 от Регламент (ЕО) № 726/2004, заявленията за разрешаване на продукт, получен чрез тъканно инженерство , включват описание на физичните характеристики и действието на продукта, както и описание на методите за създаване на продукта, в съответствие с приложение І към Директива 2001/83/EО.
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of a tissue engineered product shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
В допълнение към изискванията, предвидени в член 6, параграф 1 от Регламент (ЕО) № 726/2004, заявленията за разрешаване на лекарствен продукт за съвременно лечение, който съдържа медицински изделия, био-материали, структури или матрици , включват описание на физичните характеристики и действието на продукта, както и описание на методите за създаване на продукта, в съответствие с приложение І към Директива 2001/83/EО.
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
The scope of this article should be clarified and amended to encompass all those products in need of these specific requirements.
The scope of this article should be clarified and amended to encompass all those products in need of these specific requirements.
Restricting the requirements to tissue engineered products would exclude those advanced therapy medicinal products that also have special physical characteristics possibly affecting the performance of the product.
Restricting the requirements to tissue engineered products would exclude those advanced therapy medicinal products that also have special physical characteristics possibly affecting the performance of the product.
However, extending these requirements to all advanced therapy products would create unnecessary work for enterprises; all advanced therapy products do not have special physical characteristics that could affect their performance.
However, extending these requirements to all advanced therapy products would create unnecessary work for enterprises; all advanced therapy products do not have special physical characteristics that could affect their performance.
Комисията, в съответствие с процедурата, посочена в член 26, параграф 2 от настоящия регламент, изменя приложение І към Директива 2001/83/ЕО, за да се определят специфични технически изисквания за продуктите, получени чрез тъканно инженерство, по-конкретно посочените в член 7, с оглед отчитане на еволюцията в областта на науката и техниката.
The Commission shall, in accordance with the procedure referred to in Article 26(2) of this Regulation, amend Annex I to Directive 2001/83/EC in order to lay down technical requirements that are specific to tissue engineered products, in particular those referred to in Article 7, with a view to taking account of scientific and technical evolution.
Комисията, след консултиране с Агенцията и в съответствие с процедурата, посочена в член 26, параграф 2а от настоящия регламент, изменя приложение І към Директива 2001/83/ЕО, за да се определят специфични технически изисквания за продуктите, получени чрез тъканно инженерство, по-конкретно посочените в член 7, с оглед отчитане на еволюцията в областта на науката и техниката.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2a) of this Regulation, amend Annex I to Directive 2001/83/EC in order to lay down technical requirements that are specific to tissue engineered products, in particular those referred to in Article 7, with a view to taking account of scientific and technical evolution.
The Regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever the technical requirements laid down in Annex I to Directive 2001/83/EC need to be amended.
The Regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever the technical requirements laid down in Annex I to Directive 2001/83/EC need to be amended.
ЧЛЕН 9, ПАРАГРАФ 2
ARTICLE 9, PARAGRAPH 2
Докладчикът или съдокладчикът, определен от Комитета за лекарствени продукти за хуманна употреба съгласно член 62 от Регламент (ЕО) № 726/2004, е член на Комитета за съвременни лечения.
The rapporteur or co-rapporteur appointed by the Committee for Medicinal Products for Human Use pursuant to Article 62 of Regulation (EC) No 726/2004 shall be a member of the Committee for Advanced Therapies.
Този член действа и в качеството на докладчик или съдокладчик за Комитета за съвременни лечения.
This member shall also act as rapporteur or co-rapporteur for the Committee for Advanced Therapies.
Докладчикът или съдокладчикът, определен от Комитета за лекарствени продукти за хуманна употреба съгласно член 62 от Регламент (ЕО) № 726/2004, е член на Комитета за съвременни лечения, който се предлага от Комитета за съвременни лечения и притежава специални експертни познания за продукта.
The rapporteur or co-rapporteur appointed by the Committee for Medicinal Products for Human Use pursuant to Article 62 of Regulation (EC) No 726/2004 shall be a member of the Committee for Advanced Therapies, proposed by the Committee for Advanced Therapies and having specific expertise for the product.
In order to ensure the highest level of expertise, the rapporteur and co-rapporteur appointed by the CHMP should be proposed by the Committee for Advanced Therapies and should have specific expertise for the relevant product.
In order to ensure the highest level of expertise, the rapporteur and co-rapporteur appointed by the CHMP should be proposed by the Committee for Advanced Therapies and should have specific expertise for the relevant product.
ЧЛЕН 9, ПАРАГРАФ 2 А (нов)
ARTICLE 9, PARAGRAPH 2 A (new)
Когато подготвя проектостановище за окончателно одобрение от Комитета за лекарствени продукти за хуманна употреба, Комитетът за съвременни лечения се стреми да постигне научно единодушие.
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.
В случай че такова единодушие не може да се постигне, Комитетът за съвременни лечения приема позицията на мнозинството от членовете си.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
В проектостановището се посочват различните позиции и основанията за тях.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
In order to guarantee transparency in the process of preparation of a draft opinion, a clear decision procedure should be defined within Committee for Advanced Therapies.
In order to guarantee transparency in the process of preparation of a draft opinion, a clear decision procedure should be defined within Committee for Advanced Therapies.
Consequently, we suggest that a scientific consensus should be reached by its members.
Consequently, we suggest that a scientific consensus should be reached by its members.
ЧЛЕН 9, ПАРАГРАФ 2 Б (нов)
ARTICLE 9, PARAGRAPH 2 B (new)
Докладчикът и съдокладчикът имат право да задават въпроси директно на заявителя.
The rapporteur or co-rapporteur shall be entitled to question the applicant directly.
Заявителят също може да предложи да му бъдат задавани въпроси.
The applicant may also offer to be questioned.
Докладчикът и съдокладчикът информират незабавно заинтересуваните комитети в писмена форма за подробностите за контактите със заявителя.
The rapporteur or co-rapporteur shall inform the Committees involved in writing without delay of the details of contacts with the applicant.
В случай на несъгласие с проектостановището на Комитета за съвременни лечения, в срок от 15 дни от получаване на проектостановището заявителят може да представи писмени бележки пред Комитета за лекарствени продукти за хуманна употреба.
In case of disagreement with the draft opinion of the Committee for Advanced Therapies, the applicant may submit, within 15 days of receipt of the draft opinion, written observations to the Committee for Medicinal Products for Human Use.
Преди да издаде становището си, Комитетът за лекарствени продукти за хуманна употреба изслушва заявителя, в случай че в своите писмени бележки заявителят пожелае така.
The applicant shall be heard by the Committee for Medicinal Products for Human Use before it issues its opinion, if the applicant so requests in its written observations.
The amendment aims at enhancing a more transparent procedure.
The amendment aims at enhancing a more transparent procedure.
Due to Article 9 (2) of Regulation (EC) No 726/2004 where the applicant is given the opportunity to request a re-examination of the opinion of the Committee for Medicinal Products for Human Use in giving written notice to the agency, an applicant receiving an opinion from the Committee of Advanced Therapies shall also receive the opportunity of appeal in order to ensure consistency within the Agency.
Due to Article 9 (2) of Regulation (EC) No 726/2004 where the applicant is given the opportunity to request a re-examination of the opinion of the Committee for Medicinal Products for Human Use in giving written notice to the agency, an applicant receiving an opinion from the Committee of Advanced Therapies shall also receive the opportunity of appeal in order to ensure consistency within the Agency.
ЧЛЕН 9, ПАРАГРАФ 3
ARTICLE 9, PARAGRAPH 3
Съветът на Комитета за съвременни лечения по параграф 1 се изпраща своевременно на председателя на Комитета за лекарствени продукти за хуманна употреба, така че да се гарантира, че може да бъде спазен срокът, определен в член 6, параграф 3 от Регламент (ЕО) № 726/2004.
The advice given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) of Regulation (EC) No 726/2004 can be met.
Проектостановището на Комитета за съвременни лечения по параграф 1 се изпраща своевременно на председателя на Комитета за лекарствени продукти за хуманна употреба, така че да се гарантира, че може да бъде спазен срокът, определен в член 6, параграф 3 или член 9, параграф 2 от Регламент (ЕО) № 726/2004.
The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or 9(2) of Regulation (EC) No 726/2004 can be met.
Due to the highly specific and unique character of the advanced therapy medicinal products, a new Committee for Advanced Therapies is established within EMEA, composed of experts having specific qualifications or experience in this highly innovative and quickly developing field.
Due to the highly specific and unique character of the advanced therapy medicinal products, a new Committee for Advanced Therapies is established within EMEA, composed of experts having specific qualifications or experience in this highly innovative and quickly developing field.
Therefore, this new structure should be responsible for drafting an opinion on the quality, safety, and efficacy of products for the final approval by the CHMP.
Therefore, this new structure should be responsible for drafting an opinion on the quality, safety, and efficacy of products for the final approval by the CHMP.
The draft opinion should be given in a timely manner so the deadline laid down in Article 9(2) of Regulation (EC) No 726/2004 can also be met.
The draft opinion should be given in a timely manner so the deadline laid down in Article 9(2) of Regulation (EC) No 726/2004 can also be met.
Изменение 3
Amendment 3
ЧЛЕН 9, ПАРАГРАФ 4
ARTICLE 9, PARAGRAPH 4