natgillin/translations-raw huggingface dataset:
(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 , adapted where appropriate to take account of specific characteristics of advanced therapy medicinal products, especially tissue engineered 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 , adapted where appropriate to take account of specific characteristics of advanced therapy medicinal products, especially tissue engineered products .
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as properly to reflect the particular nature of their manufacturing process.
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as properly to reflect the particular nature of their manufacturing process.
The existing Good Manufacturing principles established by Directive 2003/94/EC may not be fully appropriate as regards to advanced therapy products.
The existing Good Manufacturing principles established by Directive 2003/94/EC may not be fully appropriate as regards to advanced therapy products.
A new GMP Directive, especially focusing on Advanced Therapy products, would be appropriate, not just guidance on existing GMP.
A new GMP Directive, especially focusing on Advanced Therapy products, would be appropriate, not just guidance on existing GMP.
RECITAL 24
RECITAL 24
(24) In order to take into account scientific and technical developments, the Commission should be empowered to adopt any necessary changes regarding the technical requirements for applications for marketing authorisation of advanced therapy medicinal products, the summary of product characteristics, labelling, and package leaflet.
(24) In order to take into account scientific and technical developments, the Commission should be empowered to adopt any necessary changes regarding the technical requirements for applications for marketing authorisation of advanced therapy medicinal products, the summary of product characteristics, labelling, and package leaflet.
The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay.
The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay.
RECITAL 25
RECITAL 25
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised.
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised.
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised and the measures provided for in Chapter 6 and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised and the measures provided for in Chapter 6 and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
The report on the implementation of this Regulation should cover the whole scope of the present regulation, including the incentive measures for SMEs, the 'fast-track' approvals and the appeal procedure.
The report on the implementation of this Regulation should cover the whole scope of the present regulation, including the incentive measures for SMEs, the 'fast-track' approvals and the appeal procedure.
ARTICLE 1 A (new)
ARTICLE 1 A (new)
Article 1a
Article 1a
Exclusion from the scope
Exclusion from the scope
This Regulation shall not apply to any advanced therapy medicinal product which is prepared in full in a hospital 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.
This Regulation shall not apply to any advanced therapy medicinal product which is prepared in full in a hospital 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 .
Where hospitals or other institutions prepare products by using an established process to create treatments for patients on a serial and routine basis, they should have to comply with the provisions of this Regulation, ensuring quality, safety and efficacy of products.
Where hospitals or other institutions prepare products by using an established process to create treatments for patients on a serial and routine basis, they should have to comply with the provisions of this Regulation, ensuring quality, safety and efficacy of products.
However, when hospitals produce ATPs for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation process.
However, when hospitals produce ATPs for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation process.
To ensure the coherence with the Article 28, paragraph 1 we introduce the exclusion from the scope in the present Regulation.
To ensure the coherence with the Article 28, paragraph 1 we introduce the exclusion from the scope in the present Regulation.
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 1 A (new)
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 1 A (new)
- its cellular or tissue part contains viable cells or tissues; or
- its cellular or tissue part contains viable cells or tissues; or
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 2
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 2
– 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.
– 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.
- 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 3 A (new)
ARTICLE 3 A (new)
Ban on commercialisation of the human body
Ban on commercialisation of the human body
Where an advanced therapy medicinal product contains human tissues or cells, every stage of the authorisation procedure shall be carried out in accordance with the principle of non-commercialisation of the human body or its parts as such.
Where an advanced therapy medicinal product contains human tissues or cells, every stage of the authorisation procedure shall be carried out in accordance with the principle of non-commercialisation of the human body or its parts as such.
To this end, and for the purposes of this Regulation, Member States shall ensure that:
To this end, and for the purposes of this Regulation, Member States shall ensure that:
- the donation of human cells and tissues is voluntary and unpaid and is made of the donor's free will without payment except compensation; and
- the donation of human cells and tissues is voluntary and unpaid and is made of the donor's free will without payment except compensation; and
- the procurement of tissues and cells is carried out on a non-profit basis.
- the procurement of tissues and cells is carried out on a non-profit basis.
Rapid developments in biotechnology and biomedicine shouldn't compromise the protection of fundamental rights.
Rapid developments in biotechnology and biomedicine shouldn't compromise the protection of fundamental rights.
These rights, including the right to the integrity of the person, are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
These rights, including the right to the integrity of the person, are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
These standards can only be upheld if they are carefully observed at every stage of the authorisation process.
These standards can only be upheld if they are carefully observed at every stage of the authorisation process.
Therefore, EMEA should be subject to this specific obligation.
Therefore, EMEA should be subject to this specific obligation.
Member States should have an obligation to ensure voluntary and unpaid donation and to guarantee the procurement of tissues or cells on a non-profit basis.
Member States should have an obligation to ensure voluntary and unpaid donation and to guarantee the procurement of tissues or cells on a non-profit basis.
ARTICLE 3 B (new)
ARTICLE 3 B (new)
Ban on products modifying the human germ line
Ban on products modifying the human germ line
No authorisation shall be granted to products modifying the germ line genetic identity of human beings.
No authorisation shall be granted to products modifying the germ line genetic identity of human beings.
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.
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.
ARTICLE 4, PARAGRAPH 3
ARTICLE 4, PARAGRAPH 3
The Commission shall draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
The Commission shall draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
The Commission shall draw up detailed guidelines on clinical trial authorization procedures and good clinical practice specific to advanced therapy medicinal and in particular tissue engineered products.
The Commission shall draw up detailed guidelines on clinical trial authorization procedures and good clinical practice specific to advanced therapy medicinal and in particular tissue engineered products.
This amendment recognizes that in particular for tissue engineered products for which no legislation and hence no guidelines exist today, these need to be developed, not only with regard to Good Clinical Practice but also related to Clinical trial authorizations.
This amendment recognizes that in particular for tissue engineered products for which no legislation and hence no guidelines exist today, these need to be developed, not only with regard to Good Clinical Practice but also related to Clinical trial authorizations.
ARTICLE 9, PARAGRAPH 3
ARTICLE 9, PARAGRAPH 3
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.
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.
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.
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.
ARTICLE 9, PARAGRAPH 4
ARTICLE 9, PARAGRAPH 4
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5, paragraphs 2 and 3 of Regulation (EC) No 726/2004 is not in accordance with the advice of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5, paragraphs 2 and 3 of Regulation (EC) No 726/2004 is not in accordance with the advice of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be evaluated by the Agency.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be evaluated by the Agency.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be subject to final evaluation by the Agency.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be subject to final evaluation by the Agency.
Where the medical device or active implantable medical device which is part of a combined advanced therapy medicinal product has already been assessed by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC , the Agency shall take account of the results of that assessment in its evaluation of the medicinal product concerned.
Where the medical device or active implantable medical device which is part of a combined advanced therapy medicinal product has already been assessed by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC , the Agency shall take account of the results of that assessment in its evaluation of the medicinal product concerned.
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include an assessment by a notified body identified in conjunction with the applicant in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device or active implantable medical device which forms part of the combined advanced therapy medicinal product.
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include an assessment by a notified body identified in conjunction with the applicant in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device or active implantable medical device which forms part of the combined advanced therapy medicinal product.
The Agency shall incorporate the results of that assessment in its evaluation of the medicinal product concerned.
The Agency shall incorporate the results of that assessment in its evaluation of the medicinal product concerned.
In order to ensure the continuous utilisation of the vast experience and expert knowledge of the notified bodies concerning the evaluation of medical devices or active implantable medical devices, the notified bodies should assess the medical device or the active implantable medical device part of the combined advanced therapy medicinal product.
In order to ensure the continuous utilisation of the vast experience and expert knowledge of the notified bodies concerning the evaluation of medical devices or active implantable medical devices, the notified bodies should assess the medical device or the active implantable medical device part of the combined advanced therapy medicinal product.
The Agency should incorporate these assessments in its final evaluation of the combined product in accordance with paragraph 1.
The Agency should incorporate these assessments in its final evaluation of the combined product in accordance with paragraph 1.
ARTICLE 14, PARAGRAPH 2
ARTICLE 14, PARAGRAPH 2
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use .
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use .
Where products are exclusively applied to patients by medical practitioners, the summary of product characteristics pursuant to Article 11 of Directive 2001/83/EC can be used as 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 can be used as package leaflet .
ARTICLE 15, PARAGRAPH 2, SUBPARAGRAPH 1
ARTICLE 15, PARAGRAPH 2, SUBPARAGRAPH 1
Where there is particular cause for concern, the Commission may , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Where there is particular cause for concern, the Commission may , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Where there is particular cause for concern, the Commission shall , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Where there is particular cause for concern, the Commission shall , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
ARTICLE 15, PARAGRAPH 4
ARTICLE 15, PARAGRAPH 4
The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.
The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.
They shall be based on the principles of regulatory cooperation and dialogue with the marketing authorisation holder.
They shall be based on the principles of regulatory cooperation and dialogue with the marketing authorisation holder.
When drawing up post-authorisation risk management guidelines, principles of regulatory cooperation and dialogue with the marketing authorization holder should be enacted in order to allow a pooling of the limited expertise in this area.
When drawing up post-authorisation risk management guidelines, principles of regulatory cooperation and dialogue with the marketing authorization holder should be enacted in order to allow a pooling of the limited expertise in this area.
ARTICLE 17, PARAGRAPH 2
ARTICLE 17, PARAGRAPH 2
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 90% reduction 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 90% reduction 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 small and medium-sized enterprises and 80% 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 small and medium-sized enterprises and 80% 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.
Therefore, special fee-waivers should be introduced for SME's on scientific advice.
Therefore, special fee-waivers should be introduced for SME's on scientific advice.
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 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 system.
To support applicants which are not SMEs and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
To support applicants which are not SMEs and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
ARTICLE 18, PARAGRAPH 1
ARTICLE 18, PARAGRAPH 1