natgillin/translations-raw huggingface dataset:
For the sake of legal coherence and clarity, it is necessary to include a cross reference to the definition of a tissue engineered product in Directive 2001/83/EC on medicinal products, which already contains the definitions of a gene therapy medicinal product and a somatic cell therapy medicinal product.
For the sake of legal coherence and clarity, it is necessary to include a cross reference to the definition of a tissue engineered product in Directive 2001/83/EC on medicinal products, which already contains the definitions of a gene therapy medicinal product and a somatic cell therapy medicinal product.
ЧЛЕН 28, ТОЧКА 1
ARTICLE 28, POINT 1
Член 3, точка 7, (Директива 2001/83/EО)
Article 3, point 7 (Directive 2001/83/EC)
Всеки лекарствен продукт за съвременно лечение, определен в Регламент (ЕО) № [.../на Европейския парламент и на Съвета (Регламент относно лекарствените продукти за съвременно лечение)*], който изцяло се изготвя и използва в лечебно заведение по лекарско предписание за отделен пациент.
Any advanced therapy medicinal product, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*], which is both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient.
Всеки лекарствен продукт за съвременно лечение, определен в Регламент (ЕО) № [.../на Европейския парламент и на Съвета (Регламент относно лекарствените продукти за съвременно лечение)*], който изцяло се изготвя в болнично заведение, с нестопанска цел , еднократно, съобразно специфичен, нестандартизиран и непатентован процес и се използва в лечебно заведение, за изпълнение на индивидуално лекарско предписание за отделен пациент на изключителната професионална отговорност на медицинско лице или за клинични изследвания .
Any advanced therapy medicinal product, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*], which is prepared in full in a hospital in a non-profit manner 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 .
Точки 1 и2 не се прилагат за лекарствени продукти за съвременно лечение.
Points 1 and 2 do not apply to advanced therapy medicinal products.
For the justification concerning hospitals, see amendment to Recital 5.
For the justification concerning hospitals, see amendment to Recital 5.
Exceptions given in Directive 2001/83/EC (Article 3, points 1 and 2) allow pharmacies to prepare medicinal products in accordance with a medical prescription without complying with medicinal product legislation.
Exceptions given in Directive 2001/83/EC (Article 3, points 1 and 2) allow pharmacies to prepare medicinal products in accordance with a medical prescription without complying with medicinal product legislation.
This exception would also give the in-house pharmacies of hospitals the possibility of producing TEP using standardized methods and on a routine basis.
This exception would also give the in-house pharmacies of hospitals the possibility of producing TEP using standardized methods and on a routine basis.
Therefore this amendment is crucial to ensure that only one-off basis products are excluded from the scope of this Regulation.
Therefore this amendment is crucial to ensure that only one-off basis products are excluded from the scope of this Regulation.
ЧЛЕН 28, ТОЧКА 2Член 4, параграф 5 (Директива 2001/83/EО)
ARTICLE 28, POINT 2 Article 4, paragraph 5 (Directive 2001/83/EC)
Настоящата директива и всички регламенти, посочени в нея, не засягат прилагането на националното законодателство, забраняващо или ограничаващо употребата на който и да е конкретен вид човешки или животински клетки, или продажбата, доставката или използването на лекарствени продукти, съдържащи, състоящи се или получени от такива клетки.
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.
Държавите-членки съобщават на Комисията текстовете на съответните актове от националното законодателство.
The Member States shall communicate the national legislation concerned to the Commission.
Настоящата директива и всички регламенти, посочени в нея, не засягат прилагането на недискриминиращо национално законодателство, забраняващо или ограничаващо употребата на който и да е конкретен вид човешки или животински клетки, или продажбата, доставката или използването на лекарствени продукти, съдържащи, състоящи се или получени от такива клетки поради причини, които не са споменати в горепосоченото законодателство на Общността .
This Directive and all Regulations referred to therein shall not affect the application of non-discriminatory 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, on grounds not dealt with in the aforementioned Community legislation.
Комисията прави тази информация обществено достъпна в регистър.
The Commission shall make this information publicly available in a register.
The reason is that the current wording of Article 28(5) gives a too wide opportunity to restrict the free movement of certain advanced therapy products.
The reason is that the current wording of Article 28(5) gives a too wide opportunity to restrict the free movement of certain advanced therapy products.
The Commission’s proposal does not and should certainly not cover or harmonise aspects of public morality and public policy aspects of advanced therapy.
The Commission’s proposal does not and should certainly not cover or harmonise aspects of public morality and public policy aspects of advanced therapy.
However, the current wording allows restrictions not only related to these subsidiary aspects and should, therefore, be amended in line with suggestions of Parliament’s legal service.
However, the current wording allows restrictions not only related to these subsidiary aspects and should, therefore, be amended in line with suggestions of Parliament’s legal service.
ЧЛЕН 29, ПАРАГРАФ 1
ARTICLE 29, PARAGRAPH 1
Лекарствените продукти за съвременно лечение, които са законосъобразно пуснати на общностния пазар в съответствие с националното или общностното законодателство към датата на влизане в сила на настоящия регламент, се привеждат в съответствие с настоящия регламент не по-късно от 2 години след влизането му в сила.
Advanced therapy medicinal products which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 2 years after its entry into force.
Лекарствените продукти за съвременно лечение, които не са получени от тъканно инженерство и са законосъобразно пуснати на общностния пазар в съответствие с националното или общностното законодателство към датата на влизане в сила на настоящия регламент, се привеждат в съответствие с настоящия регламент не по-късно от 4 години след влизането му в сила.
Advanced therapy medicinal products , other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 4 years after its entry into force.
Today companies are already producing and marketing TEP at national level through national authorisation systems.
Today companies are already producing and marketing TEP at national level through national authorisation systems.
In order for a company to obtain a centralised marketing authorisation (e.g. design the new trials together with the EMEA, to conduct the trials, to develop the dossier and to submit it to the EMEA for evaluation) the proposed timeframe of 2 years is too short.
In order for a company to obtain a centralised marketing authorisation (e.g. design the new trials together with the EMEA, to conduct the trials, to develop the dossier and to submit it to the EMEA for evaluation) the proposed timeframe of 2 years is too short.
Taking into account the time required for the above-mentioned steps and in order to avoid products that have been safely treating patients up to now being removed from those patients during the transitional period, we suggest a period of 4 years.
Taking into account the time required for the above-mentioned steps and in order to avoid products that have been safely treating patients up to now being removed from those patients during the transitional period, we suggest a period of 4 years.
ЧЛЕН 29, ПАРАГРАФ 1 А (нов)
ARTICLE 29, PARAGRAPH 1 A (new)
Продуктите, получени от тъканно инженерство, които са били законно на пазара на Общността в съответствие с националното или общностното законодателство към датата на прилагане, определена във втория параграф на член 30, трябва да се приведат в съответствие с настоящия регламент не по-късно от 4 години след тази дата.
Tissue engineered products which were legally on the Community market in accordance with national or Community legislation at the date of application specified in the second paragraph of Article 30 must comply with this Regulation no later than 4 years after that date.
Manufacturers will not be in a position to design development protocols until all the requirements specific to tissue engineering products are published.
Manufacturers will not be in a position to design development protocols until all the requirements specific to tissue engineering products are published.
The transitional period for these products must therefore take into account the time to publish all these necessary requirements.
The transitional period for these products must therefore take into account the time to publish all these necessary requirements.
ЧЛЕН 29, ПАРАГРАФ 2
ARTICLE 29, PARAGRAPH 2
В отклонение от разпоредбите на член 3, параграф 1 от Регламент (ЕО) № 297/95, не се заплащат такси на Агенцията за подадени заявления за издаване на разрешение за лекарствените продукти за съвременно лечение по параграф 1.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraph 1.
В отклонение от разпоредбите на член 3, параграф 1 от Регламент (ЕО) № 297/95, не се заплащат такси на Агенцията за подадени заявления за издаване на разрешение за лекарствените продукти за съвременно лечение по параграфи 1 и 1а .
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 1a .
See the amendment for Article 29, paragraph 1a (new).
See the amendment for Article 29, paragraph 1a (new).
ЧЛЕН 29, ПАРАГРАФ 2 А (нов)
ARTICLE 29, PARAGRAPH 2 A (new)
По отношение на автологичните продукти, при обосновано искане на дадена държава-членка и в отклонение от разпоредбите на член 3 от Регламент (ЕО) No 726/2004, Комисията може, в съответствие с процедурата, установена в член 26, параграф 2, и след консултация с Комитета за съвременни лечения, да одобри за период от пет години национално разрешение в съответствие с принципите на настоящия регламент.
W ith regard to autologous products, on the reasoned request of a Member State and by way of derogation from Article 3 of Regulation (EC) No 726/2004, the Commission may in accordance with the procedure laid down in Article 26(2) and after consultation of the Committee on Advanced Therapies approve for a period of five years a national authorisation in accordance with the principles of this Regulation.
Комисията може да вземе такова решение само ако сметне, че:
The Commission may only take such a decision if it judges that:
- регулаторният орган на съответната държава-членка притежава достатъчно познания в областта на лекарствените продукти за съвременно лечение; и
- the regulatory authority of the Member State concerned has sufficient expertise in the field of advanced therapy medicinal products; and
- пускането на пазара на специфичния лекарствен продукт извън дадената държава-членка е невъзможно.
- the marketing of the specific medicinal product outside the given Member State is not possible.
Подробните процедурни правила за приложение на настоящия член се установяват от Комисията и се публикуват в Официален вестник на Европейския съюз.
Detailed procedural rules for the application of this Article shall be laid down by the Commission and published in the Official Journal of the European Union.
ЧЛЕН 30, ПАРАГРАФИ 2 А И 2 Б (нови)
ARTICLE 30, PARAGRAPHS 2 A AND 2 B (new)
За продукти, получени от тъканно инженерство, настоящият регламент се прилага от влизането в сила на всички изисквания, посочени в членове 4, 5 и8.
For tissue engineered products this Regulation shall apply as of the entry into force of all the requirements referred to in Articles 4, 5 and 8.
Изпълнителните мерки, предвидени в членове 4, 5 и 8, се приемат възможно най-скоро и, във всеки случай, не по-късно от 9 месеца след влизането в сила на настоящия регламент.
The implementing measures envisaged in Articles 4, 5 and 8 shall be adopted as soon as possible and, in any event, no later than 9 months after the entry into force of this Regulation .
ПРИЛОЖЕНИЕ II, ТОЧКА 2.2.
ANNEX II, POINT 2.2.
2.2. качествен и количествен състав на активните вещества и другите съставки на продукта, чието познаване е от съществено значение за правилната употреба, прием или имплантиране на продукта.
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.
Когато продуктът съдържа клетки или тъкани, се предоставя подробно описание на тези клетки или тъкани и на техния точен произход.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin shall be provided.
Когато продуктът съдържа клетки или тъкани, се предоставя подробно описание на тези клетки или тъкани и на техния точен произход, включително на животинските видове в случаите на нечовешки произход .
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.
This amendment aims at ensuring that potential recipients having various cultural considerations are duly informed before taking their decision.
This amendment aims at ensuring that potential recipients having various cultural considerations are duly informed before taking their decision.
ПРИЛОЖЕНИЕ III, БУКВА Б)
ANNEX III, POINT (B)
б) Описание на активното(ите) вещество(а), изразени качествено и количествено, включително, когато продуктът съдържа клетки или тъкани, текстът „Този продукт съдържа клетки от човешки/животински [в зависимост от случая] произход“, заедно с кратко описание на тези клетки или тъкани и на техния специфичен произход;
(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;
б) Описание на активното(ите) вещество(а), изразени качествено и количествено, включително, когато продуктът съдържа клетки или тъкани, текстът „Този продукт съдържа клетки от човешки/животински [в зависимост от случая] произход“, заедно с кратко описание на тези клетки или тъкани и на техния специфичен произход, включително на животинските видове в случаите на нечовешки произход .
(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 ;
ПРИЛОЖЕНИЕ IV, БУКВА A), ПОДТОЧКА (III)
ANNEX IV, POINT (A) (III)
(iii) когато продуктът съдържа клетки или тъкани, описание на тези клетки или тъкани и на техния специфичен произход;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin;
(iii) когато продуктът съдържа клетки или тъкани, описание на тези клетки или тъкани и на техния специфичен произход, включително на животинските видове в случаите на нечовешки произход.
(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 ;
Rapid development in the fields of biology, biotechnology and medicine and attempts to achieve sustainable growth of health protection within the European Union lead to the development of new treatments and highly innovative medicinal products.
Rapid development in the fields of biology, biotechnology and medicine and attempts to achieve sustainable growth of health protection within the European Union lead to the development of new treatments and highly innovative medicinal products.
In this context, products which involve intervention in gene therapy, cell therapy and tissue engineering are of great importance, having a high potential in the treatment of diseases such as cancer, cartilage or bone diseases or injuries, repair of genetic disorders, repair of post heart attack damage as well as skin replacement in burn victims.
In this context, products which involve intervention in gene therapy, cell therapy and tissue engineering are of great importance, having a high potential in the treatment of diseases such as cancer, cartilage or bone diseases or injuries, repair of genetic disorders, repair of post heart attack damage as well as skin replacement in burn victims.
Nowadays, the legal framework at the Community level related to these advanced therapies remains fragmented, as only gene therapy and somatic cell therapy medicinal products benefit from a legal definition.
Nowadays, the legal framework at the Community level related to these advanced therapies remains fragmented, as only gene therapy and somatic cell therapy medicinal products benefit from a legal definition.
Tissue engineered products remain unregulated, which leads to the fragmentation of the market and which does not allow patients to have easy access to the necessary treatments.
Tissue engineered products remain unregulated, which leads to the fragmentation of the market and which does not allow patients to have easy access to the necessary treatments.
The current proposal introduces a single harmonising regulatory framework for the evaluation, authorisation and supervision of advanced therapy medicinal products: marketing authorisation requirements and procedure, post-authorisation vigilance and traceability.
The current proposal introduces a single harmonising regulatory framework for the evaluation, authorisation and supervision of advanced therapy medicinal products: marketing authorisation requirements and procedure, post-authorisation vigilance and traceability.
The proposed Regulation should be seen within the wider perspective of the existing legislation in this field, such as Directive 2001/83/EC on medicinal products, Regulation (EC) No 726/2004 on the European Medicines Agency (EMEA) or Directive 2004/23/EC laying down quality and safety standards of human tissues and cells.
The proposed Regulation should be seen within the wider perspective of the existing legislation in this field, such as Directive 2001/83/EC on medicinal products, Regulation (EC) No 726/2004 on the European Medicines Agency (EMEA) or Directive 2004/23/EC laying down quality and safety standards of human tissues and cells.
The proposal introduces a European centralised marketing authorisation procedure and creates a new Committee for Advanced Therapies within EMEA, composed of highly qualified and experienced experts in all fields related to these products.
The proposal introduces a European centralised marketing authorisation procedure and creates a new Committee for Advanced Therapies within EMEA, composed of highly qualified and experienced experts in all fields related to these products.
In addition, the proposed Regulation sets up a strengthened requirement for the post-authorisation monitoring system and for traceability of the patient and foresees specific technical requirements for tissue engineered products.
In addition, the proposed Regulation sets up a strengthened requirement for the post-authorisation monitoring system and for traceability of the patient and foresees specific technical requirements for tissue engineered products.
Moreover, additional specific incentives for the applicants and especially for SMEs are introduced, in order to promote competitiveness within the EU.
Moreover, additional specific incentives for the applicants and especially for SMEs are introduced, in order to promote competitiveness within the EU.
The rapporteur welcomes this proposal for a Regulation and the introduction of a new coherent legal framework for these innovative, specific and complex medicinal products.
The rapporteur welcomes this proposal for a Regulation and the introduction of a new coherent legal framework for these innovative, specific and complex medicinal products.
He agrees on the necessity of a centralised authorisation procedure in order to facilitate the market access and to ensure the free movement of advanced therapy medicinal products within the Community.
He agrees on the necessity of a centralised authorisation procedure in order to facilitate the market access and to ensure the free movement of advanced therapy medicinal products within the Community.
Priority should be given to the demonstration of quality, safety and efficacy of these products in order to ensure a high level of health protection within the EU.
Priority should be given to the demonstration of quality, safety and efficacy of these products in order to ensure a high level of health protection within the EU.
The highest possible level of legal certainty should be guaranteed while allowing sufficient flexibility at the technical level.
The highest possible level of legal certainty should be guaranteed while allowing sufficient flexibility at the technical level.
Nevertheless, the rapporteur would like to underline the importance of clear definitions in order to avoid a legal uncertainty or grey zones, particularly as regards the definition of combined advanced therapy medicinal products and their evaluation.
Nevertheless, the rapporteur would like to underline the importance of clear definitions in order to avoid a legal uncertainty or grey zones, particularly as regards the definition of combined advanced therapy medicinal products and their evaluation.
It should also be made crystal clear that products prepared in a hospital, on a one-off basis for an individual patient, should not comply with the centralised authorisation procedure.
It should also be made crystal clear that products prepared in a hospital, on a one-off basis for an individual patient, should not comply with the centralised authorisation procedure.
Moreover, products applied in the production of advance therapy medicinal products for clinical trials and products for clinical research should not be forgotten.
Moreover, products applied in the production of advance therapy medicinal products for clinical trials and products for clinical research should not be forgotten.