natgillin/translations-raw huggingface dataset:
To ensure legal consistency, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
To ensure legal consistency, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
By way of exception, the prohibition of authorisation should not apply to products intended to treat cancers of the gonads.
By way of exception, the prohibition of authorisation should not apply to products intended to treat cancers of the gonads.
1 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p.
1 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p.
2 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p.
2 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p.
Nevertheless, products for the treatment of cancer of the gonades should be permitted to have European marketing authorisation.
Nevertheless, products for the treatment of cancer of the gonades should be permitted to have European marketing authorisation.
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this Regulation.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this Regulation.
RECITAL 10
RECITAL 10
(10) The Committee for Advanced Therapies should gather the best available Community expertise on advanced therapy medicinal products.
(10) The Committee for Advanced Therapies should gather the best available Community expertise on advanced therapy medicinal products.
The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue-engineering, medical devices, pharmacovigilance and ethics.
The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue-engineering, medical devices, pharmacovigilance and ethics.
Patient associations and surgeons with scientific experience of advanced therapy medicinal products should also be represented.
Patient associations and surgeons with scientific experience of advanced therapy medicinal products should also be represented.
Patient associations and physicians with scientific experience of advanced therapy medicinal products should also be represented.
Patient associations and physicians with scientific experience of advanced therapy medicinal products should also be represented.
For the sake of being more precise it is necessary to apply the technical term.
For the sake of being more precise it is necessary to apply the technical term.
This recital shall be deleted as a consequence to the introduction of a new recital 7(a) and new Articles 3(a) and 28(a).
This recital shall be deleted as a consequence to the introduction of a new recital 7(a) and new Articles 3(a) and 28(a).
(16) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use , and adapted, where necessary, to reflect the specific nature of the products .
(16) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use , and adapted, where necessary, to reflect the specific nature of the products .
RECITAL 28
RECITAL 28
(28) Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency should therefore be amended accordingly,
(28) Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency should therefore be amended accordingly,
(28) Directive 2001/83/EC , Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency and Directive 2004/23/EC should therefore be amended accordingly,
(28) Directive 2001/83/EC , Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency and Directive 2004/23/EC should therefore be amended accordingly,
This is a consequential amendment to the introduction of Article 28(a) (new) modifying Directive 2004/23/EC on tissues and cells.
This is a consequential amendment to the introduction of Article 28(a) (new) modifying Directive 2004/23/EC on tissues and cells.
This Regulation shall not apply to any advanced therapy medicinal products that contain or are derived from human embryonic and foetal cells, primordial germ cells and cells derived from those cells.
This Regulation shall not apply to any advanced therapy medicinal products that contain or are derived from human embryonic and foetal cells, primordial germ cells and cells derived from those cells.
– 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.
– 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.
ARTICLE 2, PARAGRAPH 1, POINT (D A) (new)
ARTICLE 2, PARAGRAPH 1, POINT (D A) (new)
(da) chimera means:
(da) chimera means:
- an embryo into which a cell of any non-human life form has been introduced; or
- an embryo into which a cell of any non-human life form has been introduced; or
- an embryo of any non-human life form into which a human cell has been introduced; or
- an embryo of any non-human life form into which a human cell has been introduced; or
- an embryo that consists of cells of more than one embryo, foetus or human being;
- an embryo that consists of cells of more than one embryo, foetus or human being;
This definition is introduced for the purpose of Article 3(c)(new) of the present Regulation.
This definition is introduced for the purpose of Article 3(c)(new) of the present Regulation.
ARTICLE 2, PARAGRAPH 1, POINT (D B) (new)
ARTICLE 2, PARAGRAPH 1, POINT (D B) (new)
(db) hybrid means:
(db) hybrid means:
- a human ovum that has been fertilised by a sperm of a non-human life form;
- a human ovum that has been fertilised by a sperm of a non-human life form;
- an ovum of a non-human life form that has been fertilised by a human sperm;
- an ovum of a non-human life form that has been fertilised by a human sperm;
- a human ovum into which the nucleus of a cell of a non-human life form has been introduced;
- a human ovum into which the nucleus of a cell of a non-human life form has been introduced;
- an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or
- an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or
- a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.
- a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.
This definition is introduced for the purpose of Article 3(c) of the present Regulation.
This definition is introduced for the purpose of Article 3(c) of the present Regulation.
Source: Canadian assisted human reproduction act 2004.
Source: Canadian assisted human reproduction act 2004.
Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with the provisions laid down in Directive 2004/23/EC.
Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with the provisions laid down in Directive 2004/23/EC.
The Committee for Medicinal Products for Human Use of the European Medicines Agency, hereinafter “the Agency”, shall verify the assurances (or the documentation) of the holder of the marketing authorisation with regard to the voluntary and unpaid donation of tissues and cells as laid down in Directive 2004/23/EC.
The Committee for Medicinal Products for Human Use of the European Medicines Agency, hereinafter “the Agency”, shall verify the assurances (or the documentation) of the holder of the marketing authorisation with regard to the voluntary and unpaid donation of tissues and cells as laid down in Directive 2004/23/EC.
Prohibition of commercialisation of the human body and its parts as such
Prohibition of commercialisation of the human body and its parts as such
To that end, and for the purposes of this Regulation, Member States shall ensure that:
To that end, and for the purposes of this Regulation, Member States shall ensure that:
- the procurement of tissues and cells as such is carried out on a non-profit basis.
- the procurement of tissues and cells as such is carried out on a non-profit basis.
Rapid developments in biotechnology and biomedicine must not undermine the protection of fundamental rights.
Rapid developments in biotechnology and biomedicine must not undermine the protection of fundamental rights.
These rights, of which a very important one is the person's integrity, are laid down in the the patenting directive, the Oviedo Convention and the Charter of Fundamental Rights.
These rights, of which a very important one is the person's integrity, are laid down in the the patenting directive, the Oviedo Convention and the Charter of Fundamental Rights.
Prohibition of products modifying the human germ line.
Prohibition of products modifying the human germ line.
No authorisation shall be granted for products which modify the germ line genetic identity of human beings, except for those intended to treat cancers of the gonads.
No authorisation shall be granted for products which modify the germ line genetic identity of human beings, except for those intended to treat cancers of the gonads.
Products which are neither properly subject to clinical trials under Directive 2001/20/EC nor legally patentable under Directive 98/44/EC should not be eligible for authorisation under this Regulation, with the exclusion of cancer treatment.
Products which are neither properly subject to clinical trials under Directive 2001/20/EC nor legally patentable under Directive 98/44/EC should not be eligible for authorisation under this Regulation, with the exclusion of cancer treatment.
ARTICLE 3 C (new)
ARTICLE 3 C (new)
Prohibition of products derived from human-animal hybrids or chimeras
Prohibition of products derived from human-animal hybrids or chimeras
No authorisation shall be granted for products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
No authorisation shall be granted for products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
This provision shall not preclude the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, in so far as it does not interfere with the germ line.
This provision shall not preclude the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, in so far as it does not interfere with the germ line.
The physical and mental integrity of the person and human dignity must be respected, as underlined by the Charter of fundamental rights of the EU.
The physical and mental integrity of the person and human dignity must be respected, as underlined by the Charter of fundamental rights of the EU.
The creation of human-animal hybrids or chimeras is a breach of the right to integrity of a person and a violation of human dignity.
The creation of human-animal hybrids or chimeras is a breach of the right to integrity of a person and a violation of human dignity.
In addition, the Directive 98/44/EC on the legal protection of biotechnological inventions stresses that the production of chimeras from germ cells is excluded from patentability.
In addition, the Directive 98/44/EC on the legal protection of biotechnological inventions stresses that the production of chimeras from germ cells is excluded from patentability.
Therefore, no authorisation under this regulation should be granted to products containing or derived from such tissues and cells.
Therefore, no authorisation under this regulation should be granted to products containing or derived from such tissues and cells.
ARTICLE 5, PARAGRAPH -1 (new)
ARTICLE 5, PARAGRAPH -1 (new)
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 product and, especially, tissue engineered products.
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 product and, especially, tissue engineered products.
ARTICLE 7 A (new)
ARTICLE 7 A (new)
Article 7a
Article 7a
Specific requirements for products containing animal cells
Specific requirements for products containing animal cells
In addition to the requirements laid down in this Regulation and the Annexes hereto, products containing non-human cells or tissues shall be authorised only where it is guaranteed that they will not give rise to problems relating to the identification of endogen retroviruses in the external cells and in the recipients, the possible creation of new viruses, possible immune reactions or the possible development of cancer.
In addition to the requirements laid down in this Regulation and the Annexes hereto, products containing non-human cells or tissues shall be authorised only where it is guaranteed that they will not give rise to problems relating to the identification of endogen retroviruses in the external cells and in the recipients, the possible creation of new viruses, possible immune reactions or the possible development of cancer.
It is therefore necessary to exclude from the scope of this regulation products using materials which are ethically controversial and for which differing Member States legislative provisions are intended to remain.
It is therefore necessary to exclude from the scope of this regulation products using materials which are ethically controversial and for which differing Member States legislative provisions are intended to remain.
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.
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.
This member shall also act as rapporteur or co-rapporteur for the Committee for Advanced Therapies.
This member shall also act as rapporteur or co-rapporteur for the Committee for Advanced Therapies.
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 , shall be proposed by the Committee for Advanced Therapies and shall possess specific expertise in relation to the product concerned .
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 , shall be proposed by the Committee for Advanced Therapies and shall possess specific expertise in relation to the product concerned .
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 deadlines laid down in Articles 6(3) or 9(2) of Regulation (EC) No 726/2004 can be met.
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 deadlines laid down in Articles 6(3) or 9(2) of Regulation (EC) No 726/2004 can be met.
Where products are exclusively applied to patients by medical practitioners, the summary of product characteristics pursuant to Article 11 of Directive 2001/83/EC may be used as the package leaflet .
Where products are exclusively applied to patients by medical practitioners, the summary of product characteristics pursuant to Article 11 of Directive 2001/83/EC may be used as the package leaflet .
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 95% reduction for SMEs and 70% for other applicants shall apply to the fee payable to the Agency for any advice referred to in paragraph 1 and in Article 57(1)(n) of Regulation (EC) No 726/2004 in respect of advanced therapy medicinal products.
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 95% reduction for SMEs and 70% for other applicants shall apply to the fee payable to the Agency for any advice referred to in paragraph 1 and in Article 57(1)(n) of Regulation (EC) No 726/2004 in respect of advanced therapy medicinal products.
The 5% of the basic fee which the SME's should cover themselves is a symbolic amount, in order to prevent any abuse of the totally gratis system.
The 5% of the basic fee which the SME's should cover themselves is a symbolic amount, in order to prevent any abuse of the totally gratis system.
Moreover, to support the applicants which do not fall under the SME criteria and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
Moreover, to support the applicants which do not fall under the SME criteria and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission , within 60 days after receipt of the request .
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission , within 60 days after receipt of the request .
Manufacturers of advanced therapy medicinal products 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, shall be eligible for all incentives which are granted to small and medium–sized enterprises as defined in Commission Recommendation 2003/361/EC 1 .
Manufacturers of advanced therapy medicinal products 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, shall be eligible for all incentives which are granted to small and medium–sized enterprises as defined in Commission Recommendation 2003/361/EC 1 .
The same shall apply to enterprises in which other enterprises have an interest up to 50%, if those enterprises invest more than 15% of their annual turnover in research and development activities.
The same shall apply to enterprises in which other enterprises have an interest up to 50%, if those enterprises invest more than 15% of their annual turnover in research and development activities.
1 OJ L 124, 20.5.2003, p.
1 OJ L 124, 20.5.2003, p.
The fee for marketing authorisation shall be reduced by 50% if the applicant can prove that there is a particular public interest in the Community in the advanced therapy medicinal product or if the return on investment to be expected from the marketing of that product is small.
The fee for marketing authorisation shall be reduced by 50% if the applicant can prove that there is a particular public interest in the Community in the advanced therapy medicinal product or if the return on investment to be expected from the marketing of that product is small.
Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the medicinal product.
Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the medicinal product.
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.
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.
In the case of an enterprise in which other enterprises have an interest up to 50% and which invests more than 15% of its annual turnover in research and development activities, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.
In the case of an enterprise in which other enterprises have an interest up to 50% and which invests more than 15% of its annual turnover in research and development activities, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.