natgillin/translations-raw huggingface dataset:
Any applicant developing a product based on cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product.
Any applicant developing a product based on cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product.
The Agency shall deliver this recommendation after consultation with the Commission.
The Agency shall deliver this recommendation after consultation with the Commission.
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission, within 60 days of receipt of the request.
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission, within 60 days of receipt of the request.
The proposed amendment foresees that an applicant will get clarity on the classification of the concerned product in a timely manner, thus facilitating business planning and further development of the product.
The proposed amendment foresees that an applicant will get clarity on the classification of the concerned product in a timely manner, thus facilitating business planning and further development of the product.
ARTICLE 19 A (new)
ARTICLE 19 A (new)
Article 19a
Article 19a
Incentives for small and medium-sized biotech enterprises
Incentives for small and medium-sized biotech enterprises
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 granted to small and medium–sized enterprises under Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises 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 granted to small and medium–sized enterprises under Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises 1 .
The same shall apply to 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.
The same shall apply to 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.
1 L 124, 20.5.2003, p.
1 L 124, 20.5.2003, p.
One of the reasons is that a purchase or sale of a patent or platform technology may generate a big one-off turnover which exceeds the current limitations.
One of the reasons is that a purchase or sale of a patent or platform technology may generate a big one-off turnover which exceeds the current limitations.
Another reason is that many enterprises don't comply with the current criteria of independence (interests below 25 %), since they built up alliances with other companies.
Another reason is that many enterprises don't comply with the current criteria of independence (interests below 25 %), since they built up alliances with other companies.
These problems are likely to have the greatest relevance for biotech enterprises.
These problems are likely to have the greatest relevance for biotech enterprises.
ARTICLE 19 B (new)
ARTICLE 19 B (new)
Article 19b
Article 19b
Reduction of the fee for marketing authorisation
Reduction of the fee for marketing authorisation
The fee for marketing authorisation shall be reduced to 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 such a product is small.
The fee for marketing authorisation shall be reduced to 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 such a product is small.
The first paragraph shall also apply to fees for post-authorisation activities by the Agency in the first year following the granting of the marketing authorisation for the medicinal product.
The first paragraph shall also apply to fees for post-authorisation activities by the Agency 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, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
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, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
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, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
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, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
ARTICLE 21, PARAGRAPH 1, POINT (C)
ARTICLE 21, PARAGRAPH 1, POINT (C)
(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.
(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.
(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 medical doctors;
(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 medical doctors;
In order to cover all medical fields which the advanced therapies may relate to, more general medical expertise, i.e. medical doctors, 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. medical doctors, should be represented in the Committee for Advanced Therapies .
ARTICLE 21, PARAGRAPH 1, POINT (C A) (new)
ARTICLE 21, PARAGRAPH 1, POINT (C A) (new)
(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.
(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.
By introducing alternate members, we would like to ensure a permanent representation of the groups involved.
By introducing alternate members, we would like to ensure a permanent representation of the groups involved.
ARTICLE 21, PARAGRAPH 2
ARTICLE 21, PARAGRAPH 2
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
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.
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.
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.
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.
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.
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.
ARTICLE 23, POINT (A)
ARTICLE 23, POINT (A)
(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 ;
(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 ;
(a) to draw up a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product submitted for review; this draft opinion shall be transmitted to the Committee for Medicinal Products for Human Use for approval.
(a) to draw up a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product submitted for review; this draft opinion shall be transmitted to the Committee for Medicinal Products for Human Use for approval.
The Committee for Advanced Therapies shall advise the Committee for Medicinal Products for Human Use on any data generated in the product’s development ;
The Committee for Advanced Therapies shall advise the Committee for Medicinal Products for Human Use on any data generated in the product’s development ;
Their expertise should therefore form the basis of any product opinion delivered by the CHMP.
Their expertise should therefore form the basis of any product opinion delivered by the CHMP.
ARTICLE 23, POINT (A A) (new)
ARTICLE 23, POINT (A A) (new)
(aa) to advise the Committee for Medicinal Products for Human Use on the amendments provided for in Articles 4(2),8, 19 and 24;
(aa) to advise the Committee for Medicinal Products for Human Use on the amendments provided for in Articles 4(2),8, 19 and 24;
The assessment of advanced therapy medicinal products often requires very specific expertise, for which reason the specialised Committee for Advanced Therapies is created.
The assessment of advanced therapy medicinal products often requires very specific expertise, for which reason the specialised Committee for Advanced Therapies is created.
Therefore, it is logical that this specialised committee should have an advisory role in the comitology procedure to amend the Annexes and other technical requirements.
Therefore, it is logical that this specialised committee should have an advisory role in the comitology procedure to amend the Annexes and other technical requirements.
ARTICLE 23, POINT (E A) (new)
ARTICLE 23, POINT (E A) (new)
(ea) to provide advice on the scientific advice procedures referred to in Article 17;
(ea) to provide advice on the scientific advice procedures referred to in Article 17;
ARTICLE 23, POINT (E B) (new)
ARTICLE 23, POINT (E B) (new)
(eb) to provide advice on product classification as referred to in Article 18.
(eb) to provide advice on product classification as referred to in Article 18.
Their expertise should therefore be drawn upon for any advice issued regarding the classification of an advanced therapy medicinal product.
Their expertise should therefore be drawn upon for any advice issued regarding the classification of an advanced therapy medicinal product.
ARTICLE 24
ARTICLE 24
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.
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.
The Commission shall, in accordance with procedure referred to in Article 26(2), amend Annexes II to IV in order to adapt them to scientific and technical evolution.
The Commission shall, in accordance with procedure referred to in Article 26(2), amend Annexes II to IV in order to adapt them to scientific and technical evolution.
Therefore, it should not be subject to any changes through comitology.
Therefore, it should not be subject to any changes through comitology.
Should any changes be necessary due to scientific progress, they should be adopted in codecision, fully involving the European Parliament.
Should any changes be necessary due to scientific progress, they should be adopted in codecision, fully involving the European Parliament.
ARTICLE 25
ARTICLE 25
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation and on the use and effect of the measures provided for in Chapter 6 of this Regulation and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation and on the use and effect of the measures provided for in Chapter 6 of this Regulation and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
On the basis of that report, the Commission may propose amendments to this Regulation and Regulation (EC) No 726/2004.
On the basis of that report, the Commission may propose amendments to this Regulation and Regulation (EC) No 726/2004.
On the basis of this report, the Commission should re-evaluate the current provisions and propose amendments to improve them, also with a view of harmonizing the different provisions and procedures currently in use within the EMEA.
On the basis of this report, the Commission should re-evaluate the current provisions and propose amendments to improve them, also with a view of harmonizing the different provisions and procedures currently in use within the EMEA.
ARTICLE 26, PARAGRAPH 2 A (new)
ARTICLE 26, PARAGRAPH 2 A (new)
The Commission shall ensure that relevant information about envisaged measures is made available to all interested parties in due time.
The Commission shall ensure that relevant information about envisaged measures is made available to all interested parties in due time.
This is necessary to ensure that Industry and other stakeholders are involved from the very beginning in the elaboration of secondary legislation as well as of guidance documents.
This is necessary to ensure that Industry and other stakeholders are involved from the very beginning in the elaboration of secondary legislation as well as of guidance documents.
This is a concept already introduced in Community legislation (see art.
This is a concept already introduced in Community legislation (see art.
15.5 of Directive 2004/22/EC of 21 March 2004 on measuring instruments).
15.5 of Directive 2004/22/EC of 21 March 2004 on measuring instruments).
ARTICLE 27, POINT 2
ARTICLE 27, POINT 2
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)].
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)].
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level .
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level .
Afterwards an application for renewal within the centralised procedure is necessary with the effect that after the renewal the national marketing authorisation becomes a centralised marketing authorisation.
Afterwards an application for renewal within the centralised procedure is necessary with the effect that after the renewal the national marketing authorisation becomes a centralised marketing authorisation .
In order to facilitate the stage of market entry for many SMEs wanting to market their product only in one member state, a marketing authorisation at national level for products marketed at national level should be rendered possible.
In order to facilitate the stage of market entry for many SMEs wanting to market their product only in one member state, a marketing authorisation at national level for products marketed at national level should be rendered possible.
This national marketing authorisation should be limited to a period of five years.
This national marketing authorisation should be limited to a period of five years.
The renewal after this first period of five years can be conducted through a centralised marketing authorisation.
The renewal after this first period of five years can be conducted through a centralised marketing authorisation.
ARTICLE 28, POINT 1
ARTICLE 28, POINT 1
Article 3, paragraph 7 (Directive 2001/83/EC)
Article 3, paragraph 7 (Directive 2001/83/EC)
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.
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.
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 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.
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 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.
Paragraphs 1 and 2 do not apply to advanced therapy medicinal products.
Paragraphs 1 and 2 do not apply to advanced therapy medicinal products.
Exceptions given in Directive 2001/83/EC 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 allow pharmacies to prepare medicinal products in accordance with a medical prescription without complying with medicinal product legislation.
This exception would as well give the in-house pharmacies of hospitals the possibility producing TEP using standardized methods and on routinely basis.
This exception would as well give the in-house pharmacies of hospitals the possibility producing TEP using standardized methods and on routinely basis.
ARTICLE 28, POINT 2
ARTICLE 28, POINT 2
Article 4, paragraph 5 (Directive 2001/83/EC)
Article 4, paragraph 5 (Directive 2001/83/EC)
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.
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.
The Member States shall communicate the national legislation concerned to the Commission.”
The Member States shall communicate the national legislation concerned to the Commission.”