natgillin/translations-raw huggingface dataset:
В случаите на малки и средни предприятия или предприятия, които имат не повече от 500 служители и оборот до 100 милиона евро или обща сума на баланса до 70 милиона евро, се прилага също параграф 1, без ограничения на срока, по отношение на таксите, събирани от Агенцията за дейности след издаването на разрешение.
In the case of small and medium-sized enterprises or enterprises which employ not more than 500 persons and have a turnover not exceeding EUR 100 million, or a balance-sheet total not exceeding EUR 70 million, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.
Reductions of the fee for marketing authorisations is necessary in cases of ATMPs serving public interest like orphan drugs or where the applicant is an SME.
Reductions of the fee for marketing authorisations is necessary in cases of ATMPs serving public interest like orphan drugs or where the applicant is an SME.
For those products and enterprises the centralised procedure is a big administrative burden which should be eased by minimised fees.
For those products and enterprises the centralised procedure is a big administrative burden which should be eased by minimised fees.
The stipulated cost reductions are also necessary in case of autologous ATMPs and those for intended use because these products can only be introduced into the market to a limited extent.
The stipulated cost reductions are also necessary in case of autologous ATMPs and those for intended use because these products can only be introduced into the market to a limited extent.
ЧЛЕН 19 В (нов)
ARTICLE 19 C (new)
Член 19в
Article 19c
Техническа подкрепа
Technical support
Държавите-членки предоставят, с оглед на прилагането на настоящия регламент, специфична техническа подкрепа на заявителите и притежателите на разрешение за пускане на пазара.
Member States shall, with regard to the application of this Regulation, provide specific technical support for applicants and marketing authorisation holders.
Тази подкрепа се предоставя посредством компетентните национални органи и е съсредоточена по-специално върху подкрепа на индивидуални болнични заведения или други малки институции, например университетски катедри, които не отговарят на условията по член 3, параграф 7 на Директива 2001/83/ЕО.
This support shall be made available through the competent national authorities and focus in particular on support for individual hospitals or other small-scale institutions, e.g. departments of universities, which do not fulfil the conditions of Article 3(7) of Directive 2001/83/EC.
Подкрепата се предоставя, при условие че лекарствените продукти за съвременно лечение се приготвят и използват на техническата отговорност на лекар специалист и по лекарско предписание за отделни пациенти.
Support shall be provided under the condition that advanced therapy medicinal products are prepared and used under the technical responsibility of a specialised physician and in accordance with a medical prescription for individual patients.
Exemptions from the scope of the Directive shall be as limited as possible in order to bring the benefit of new medicines quickly to all patients in Europe.
Exemptions from the scope of the Directive shall be as limited as possible in order to bring the benefit of new medicines quickly to all patients in Europe.
However, special support shall be given to groups of possible applicants with regard to the particularities of this highly innovative sector.
However, special support shall be given to groups of possible applicants with regard to the particularities of this highly innovative sector.
This can be best achieved at the national level.
This can be best achieved at the national level.
ЧЛЕН 21, ПАРАГРАФ 1, БУКВА В)
ARTICLE 21, PARAGRAPH 1, POINT (C)
в) четирима членове, назначени от Комисията въз основа на публична покана за изразяване на интерес, двама от които представляват сдружения на хирурзи и двама - сдружения на пациенти.
(c) four members appointed by the Commission, on the basis of a public call for expressions of interest, two of them to represent surgeons and two of them to represent patients associations.
в) двама членове и двама заместници , назначени от Комисията въз основа на публична покана за изразяване на интерес и след консултация с Европейския парламент , които представляват лекарски сдружения ;
(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 ;
ва) двама членове и двама заместници, назначени от Комисията въз основа на публична покана за изразяване на интерес и след консултация с Европейския парламент, които представляват сдружения на пациенти.
(ca) 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 patients associations.
In order to cover all medical fields which the advanced therapies may relate to, more general medical expertise, i.e. physicians with clinical expertise, should be represented in the Committee for Advanced Therapies.
In order to cover all medical fields which the advanced therapies may relate to, more general medical expertise, i.e. physicians with clinical expertise, should be represented in the Committee for Advanced Therapies.
In addition, by introducing alternate members, we would like to ensure a permanent representation of the groups involved.
In addition, by introducing alternate members, we would like to ensure a permanent representation of the groups involved.
The appointment of these members and their alternates should take place in consultation with the European Parliament.
The appointment of these members and their alternates should take place in consultation with the European Parliament.
ЧЛЕН 21, ПАРАГРАФ 2
ARTICLE 21, PARAGRAPH 2
Всички членове на Комитета за съвременни лечения се избират с оглед на тяхната научна квалификация или опит по отношение на лекарствени продукти за съвременно лечение.
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
По смисъла на параграф 1, буква б), държавите-членки си сътрудничат под координацията на изпълнителния директор на Агенцията, с цел да се гарантира, че окончателният състав на Комитета за съвременни лечения целесъобразно и балансирано обхваща научните области, които са относими към съвременните лечения, в т.ч. медицински изделия, тъканно инженерство, генно лечение, клетъчно лечение, биотехнологии, фармакологична бдителност, управление на риска и етика.
For the purposes of point (b) of paragraph 1, the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies appropriately and in a balanced way covers the scientific areas relevant to advanced therapies, including medical devices, tissue-engineering, gene therapy, cell therapy, biotechnology, pharmacovigilance , risk management and ethics.
Всички членове и заместник-членове на Комитета за съвременни лечения се избират с оглед на тяхната научна квалификация или опит по отношение на лекарствени продукти за съвременно лечение.
All members and alternates of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
По смисъла на параграф 1, буква б), държавите-членки си сътрудничат под координацията на изпълнителния директор на Агенцията, с цел да се гарантира, че окончателният състав на Комитета за съвременни лечения целесъобразно и балансирано обхваща научните области, които са относими към съвременните лечения, в т.ч. медицински изделия, тъканно инженерство, генно лечение, клетъчно лечение, биотехнологии, фармакологична бдителност, управление на риска и етика.
For the purposes of point (b) of paragraph 1, the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies appropriately and in a balanced way covers the scientific areas relevant to advanced therapies, including medical devices, tissue-engineering, gene therapy, cell therapy, biotechnology, pharmacovigilance, risk management and ethics.
Поне двама членове и двама заместник-членове на Комитета по съвременно лечение притежават научни познания в областта на медицинските изделия.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
The alternate members of the Committee for Advanced therapies introduced in paragraph 1 shall comply with the same criteria of scientific qualification or experience in the field of advanced therapy medicinal products as its members.
The alternate members of the Committee for Advanced therapies introduced in paragraph 1 shall comply with the same criteria of scientific qualification or experience in the field of advanced therapy medicinal products as its members.
In order to ensure an appropriate level of expertise, it would be important to include experts as members that have a background in the evaluation of medical devices, as many of the products concerned share many characteristics of medical devices.
In order to ensure an appropriate level of expertise, it would be important to include experts as members that have a background in the evaluation of medical devices, as many of the products concerned share many characteristics of medical devices.
ЧЛЕН 21, ПАРАГРАФ 5
ARTICLE 21, PARAGRAPH 5
Агенцията публикува имената и научните квалификации на членовете.
The names and scientific qualifications of the members shall be published by the Agency .
Имената и научните квалификации на членовете се публикуват на Интернет страницата на Агенцията при първа възможност .
The names and scientific qualifications of the members shall be published on the Agency’s website at the earliest opportunity.
It seems essential for the information on the members of the Committee to be made public and disseminated via the Agency’s website.
It seems essential for the information on the members of the Committee to be made public and disseminated via the Agency’s website.
ЧЛЕН 22
ARTICLE 22
Членовете на Kомитета за съвременни лечения и неговите експерти се задължават да изпълняват функциите си независимо и в полза на обществото.
Members of the Committee for Advanced Therapies and its experts shall undertake to act in the public interest and in an independent manner.
Те нямат финансови или други интереси във фармацевтичния сектор , сектора на медицинските изделия или биотехнологичния сектор , които биха могли да се отразят на тяхната безпристрастност.
They shall not have financial or other interests in the pharmaceutical sector, medical device sector or biotechnology sector that could affect their impartiality.
In addition to the requirements laid down in Article 63 of Regulation (EC) No 726/2004, members and alternates of the Committee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and medical device sector that could affect their impartiality.
In addition to the requirements laid down in Article 63 of Regulation (EC) No 726/2004, members and alternates of the Committee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and medical device sector that could affect their impartiality.
All indirect interests that could relate to these sectors shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004.
All indirect interests that could relate to these sectors shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004.
Всички косвени интереси, които биха могли да са свързани с фармацевтичния сектор, сектора на медицинските изделия или биотехнологичния сектор , се вписват в регистъра по член 63, параграф 2 от Регламент (ЕО) № 726/2004.
All indirect interests that could relate to the pharmaceutical sector, medical device sector or biotechnology sector shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004 .
It should be clarified that an identical level of transparency as for existing Committees within the EMEA (pursuant to Article 63 of Regulation (EC) No 726/2004) applies for the new Committee for Advanced Therapies.
It should be clarified that an identical level of transparency as for existing Committees within the EMEA (pursuant to Article 63 of Regulation (EC) No 726/2004) applies for the new Committee for Advanced Therapies.
It should also be clarified that interests in the biotechnology or medical device sector are forbidden.
It should also be clarified that interests in the biotechnology or medical device sector are forbidden.
ЧЛЕН 23, БУКВА А)
ARTICLE 23, POINT (A)
а) предоставяне на консултации на Комитета за лекарствени продукти за хуманна употреба относно всички данни, събрани при разработване на даден медицински продукт за съвременно лечение , с оглед формулиране на становище относно неговото качество, безопасност и ефикасност ;
(a) to advise the Committee for Medicinal Products for Human Use on any data generated in the development of an advanced therapy medicinal product, for the formulation of an opinion on its quality, safety and efficacy ;
а) да изготви проектостановище относно качеството, безопасността и ефикасността на даден лекарствен продукт за съвременно лечение, което да представи за окончателно одобрение на Kомитета за лекарствени продукти за хуманна употреба и да информира Kомитета относно всички данни, събрани при разработване на такъв продукт;
(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 the latter on any data generated in the development of such a product;
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 qualification 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 qualification or experience in this highly innovative and quickly developing field.
ЧЛЕН 23, БУКВА А А) (нова)
ARTICLE 23, POINT (A A) (new)
аа) да предостави консултация, съгласно член 18, относно това дали продуктът отговаря на определението за лекарствен продукт за съвременно лечение;
(aa) to provide advice, pursuant to Article 18, 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 have a prominent role in the 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 have a prominent role in the classification task of whether a product is or is not an advanced therapy medicinal product.
ЧЛЕН 23, БУКВА Д А) (нова)
ARTICLE 23, POINT (E A) (new)
да) да подпомага процедурите за научни консултации, посочени в член 17 на настоящия регламент и в член 57, параграф 1, буква н) на Регламент (ЕО) No 726/2004;
(ea) to contribute to the scientific advice procedures referred to in Article 17 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004;
The Committee on Advanced Therapies should consist of the best possible experts from Member States.
The Committee on Advanced Therapies should consist of the best possible experts from Member States.
Their expertise should therefore be drawn upon for any advice issued regarding an advanced therapy medicinal product.
Their expertise should therefore be drawn upon for any advice issued regarding an advanced therapy medicinal product.
ЧЛЕН 24
ARTICLE 24
В съответствие с процедурата по член 26, параграф 2 , Комисията изменя приложения от І до ІV , за да ги адаптира към научно-техническото развитие.
The Commission shall, in accordance with procedure referred to in Article 26(2), amend Annexes I to IV in order to adapt them to scientific and technical evolution.
В съответствие с процедурата по член 26, параграф 2а , Комисията, след консултация с Агенцията , изменя приложения от ІI до ІV , за да ги адаптира към научно-техническото развитие.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2a), amend Annexes II to IV in order to adapt them to scientific and technical evolution.
Annex I contains a fundamental and substantial definition.
Annex I contains a fundamental and substantial definition.
We therefore consider that it should not be subject to any changes through comitology.
We therefore consider that it should not be subject to any changes through comitology.
Should any changes be necessary due to scientific progress, they should be adopted in co-decision, fully involving the European Parliament.
Should any changes be necessary due to scientific progress, they should be adopted in co-decision, fully involving the European Parliament.
The regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever adaptation of the Annexes to technical progress is required.
The regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever adaptation of the Annexes to technical progress is required.
The adaptation of Annexes II to IV should fall under the new regulatory procedure with scrutiny.
The adaptation of Annexes II to IV should fall under the new regulatory procedure with scrutiny.
ЧЛЕН 25, ЗАГЛАВИЕ
ARTICLE 25, TITLE
Доклад и преразглеждане
Report and review
Scientific advances may make additional novel therapies possible which are neither gene therapy, nor cell therapy nor tissue engineering.
Scientific advances may make additional novel therapies possible which are neither gene therapy, nor cell therapy nor tissue engineering.
It would be in the interests 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 interests of patients for these to be included at some future date in order to allow European authorisation of the resulting products.
ЧЛЕН 25, ПАРАГРАФ 1 А (нов)
ARTICLE 25, PARAGRAPH 1 A (new)
В този доклад Комисията оценява влиянието на техническия напредък върху приложението на настоящия регламент.
In this report, the Commission shall assess the impact of technical progress on the application of this Regulation.
Тя също така изготвя, ако е необходимо, законодателно предложение за включване на нови лечения, които не включват нито генно лечение, нито клетъчно лечение, нито тъканно инженерство.
It shall also, if necessary, make a legislative proposal to include novel therapies which involve neither gene therapy, cell therapy nor tissue engineering.
Scientific advances may make additional novel therapies possible which are neither gene therapy, cell therapy nor tissue engineering.
Scientific advances may make additional novel therapies possible which are neither gene therapy, cell therapy nor tissue engineering.
It would be in the interests 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 interests of patients for these to be included at some future date, in order to allow European authorisation of the resulting products.
ЧЛЕН 26, ПАРАГРАФ 2 А (нов)
ARTICLE 26, PARAGRAPH 2 A (new)
Когато се прави позоваване на настоящия параграф, се прилагат член 5а, параграфи 1-4 и член 7 от Решение 1999/468 ЕО, като се вземат предвид разпоредбите на член 8 от него.
Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
This amendment is in line with the new comitology provisions (regulatory procedure with scrutiny).
This amendment is in line with the new comitology provisions (regulatory procedure with scrutiny).
ЧЛЕН 27, ТОЧКА -1 (нова)
ARTICLE 27, POINT -1 (new)
Член 13, параграф 1 (Регламент (ЕО) No 726/2004)
Article 13, paragraph 1 (Regulation (EC) No 726/2004)
(-1) В член 13, първото изречение на параграф 1 се заменя със следния текст:
(-1) In Article 13, the first sentence of paragraph 1 is replaced by the following:
"Без да накърнява разпоредбите на член 4, параграфи 4 и 5 на Директива 2001/83/EО, разрешението за пускане на пазара, което е предоставено съгласно настоящия регламент, е валидно за цялата Общност."
"Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community."
This is a consequential amendment to Article 28(2) to ensure legal coherence.
This is a consequential amendment to Article 28(2) to ensure legal coherence.
ЧЛЕН 27, ТОЧКА 2 А (нова)
ARTICLE 27, POINT 2 A (new)
Приложение, точка 3, алинея 2 (Регламент (ЕО) No 726/2004)
Annex, point 3, subparagraph 2 (Regulation (EC) No 726/2004)
2а) В приложението алинея втора от точка 3 се заменя, както следва:
(2a) In the Annex, the second subparagraph of point 3 is replaced by the following:
"След 20 май 2008 г. Комисията, след като се консултира с Агенцията, може да представи всякакво подходящо предложение за изменение на настоящата точка и Европейският парламент и Съветът вземат решение за него съгласно Договора."
"After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point, and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty."
This part of Regulation 726/2004 determines when a Community authorisation must be obtained.
This part of Regulation 726/2004 determines when a Community authorisation must be obtained.
Under the present proposal, it may be that certain AT products will not require Community authorisation either because they do not involve one of the processes referred to in point 1 of the Annex to Reg.
Under the present proposal, it may be that certain AT products will not require Community authorisation either because they do not involve one of the processes referred to in point 1 of the Annex to Reg.
726/2004, or because they are not used for the treatment of any of the diseases referred to in point 3 of that Annex.
726/2004, or because they are not used for the treatment of any of the diseases referred to in point 3 of that Annex.
Currently, the list of diseases in point 3 can be extended by the Council on a Commission proposal, without recourse to the EP.
Currently, the list of diseases in point 3 can be extended by the Council on a Commission proposal, without recourse to the EP.
Decisions determining the scope of legislative acts must be dealt with by co-decision.
Decisions determining the scope of legislative acts must be dealt with by co-decision.
ЧЛЕН 28, ТОЧКА -1 (нова)
ARTICLE 28, POINT -1 (new)
Член 1, точка 4 а (нова) (Директива 2001/83/EО)
Article 1, point 4 a (new) (Directive 2001/83/EC)
(-1) Към член 1 се добавя следната точка 4а:
(-1) In Article 1, the following point 4a is added:
Продукт, получен от тъканно инженерство:
Tissue engineered product:
продукт, както е определен в член 2 от Регламент (ЕО) No **/** относно лекарствените продукти за съвременно лечение."
A product as defined in Article 2 of Regulation (EC) No **/** on advanced therapy medicinal products."