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December 2006 |
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20/12/2006 |
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EuropaBio key
response to the European Commission consultation paper regarding: better
regulation of pharmaceuticals towards simpler, clearer and more flexible
framework of variations |
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documents
:
EN |
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November
2006 |
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10/11/2006 |
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EuropaBio Position Paper on Naming and Labelling
Requirements for Biosimilar Medicines |
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documents :
EN
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September
2006 |
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27/09/2006 |
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EuropaBio contribution to the Pharmaceutical Forum on
Information to Patients |
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documents :
EN |
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27/09/2006 |
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EuropaBio contribution to the Pharmaceutical Forum on
Relative Effectiveness |
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documents :
EN |
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27/09/2006 |
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EuropaBio contribution to the Pharmaceutical Forum on
Pricing |
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documents :
EN
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August
2006 |
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EuropaBio
position paper: Review of Directive 86/609 on the Protection of Animals Used
for Experimental and Other Scientific Purposes |
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documents
:
EN
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October
2005 |
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30/10/2005 |
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EuropaBio Position paper on Draft
Guideline on Similar Biological Medicinal Products
Containing Biotechnology-Derived Proteins As Active
Substance: Non-Clinical and Clinical Issues ref.
EMEA/CHMP/42832/2005 - Released for consultation in May
2005 |
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documents :
EN |
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September 2005 |
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22/09/2005 |
| |
Patients need innovative medicines, says Manifesto
Healthcare Manifesto special website:
http://www.healthcare-manifesto.org |
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documents :
EN |
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July
2005 |
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19/07/2005 |
| |
Uncertainty reigns as biotech patents remain
unharmonised
> documents :
EN |
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14/07/2005 |
| |
EuropaBio supports the European Pharmaceutical
Industry's position on paediatric medicines and welcomes
yesterday' s vote by the Environment Committee
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June
2005 |
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27/06/2005 |
| |
EuropaBio Position paper on the proposal for a Community
Regulatory Framework on Advanced Therapies of 04 May
2005
- Official text -
Comparisons
- Official text -
Modified |
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documents :
EN |
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13/06/2005 |
| |
The European Biotechnology Industry View on the proposed
Regulation on Medicinal Products for Paediatric Use.
(Joint common position) |
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documents :
EN |
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April
2005 |
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22/04/2005 |
| |
EuropaBio comments on the proposal for a Regulation on
medicinal products for paediatric use. |
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documents :
EN |
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March 2005 |
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04/03/2005 |
| |
EBE and EuropaBio White Paper - “Towards an optimal
Orphan Medicinal Products (OMP) Framework in Europe” |
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documents :
EN |
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29/03/2005 |
| |
EuropaBio and Eucomed paper "Why human cell &
tissue-engineered products (hTEPs) need a specific and
separate Regulation". |
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documents :
EN |
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December
2004 |
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22/12/2004 |
| |
Comments from EuropaBio on the draft Regulation on the
conditional marketing authorisation for medicinal
products. |
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documents :
EN |
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10/12/2004 |
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Rare disease patients treated unequally in Europe, says
study. |
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documents :
EN |
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08/12/2004 |
| |
"Commission Consultation Paper" - Provisions for micro,
small and medium-size enterprises (SMEs), establishing
the circumstances in which SMEs may pay reduced fees,
defer payment of the fee, or receive administrative
assistance.
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documents :
EN |
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October
2004 |
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01/10/2004 |
| |
Joint industry comments on Draft Technical Requirements
for tissues and cells Response Form.
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documents :
EN |
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September
2004 |
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15/09/2004 |
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EuropaBio comments on WHO-Priority medicine project. |
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documents :
EN |
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August
2004 |
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13/08/2004 |
| |
Joint comments on proposal for a harmonised regulatory
framework on human tissue engineered products: DG
Enterprise consultation paper.
|
|
documents :
EN (annex available
here) |
|
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19/08/2004 |
| |
Joint industry position on the draft
Commission Proposal for a Council Regulation on the fees
payable to the European Medicines Agency, replacing
existing Council Regulation (EC) No 297/95.
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documents :
EN |
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June 2004 |
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30/06/2004 |
| |
EuropaBio contribution to the European Medicines Agency
Road Map to 2010: preparing the ground for the future.
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documents :
EN |
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May 2004 |
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01/05/2004 |
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Human Medical Genetic Testing. A EuropaBio Position
Paper
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documents :
EN |
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April 2004 |
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29/04/2004 |
| |
EuropaBio Feedback on Commission’s Consultation Paper on
Tissue Engineered Products Legislation
|
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documents :
EN |
|
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February 2004 |
|
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06/02/2004 |
| |
EuropaBio Position Paper on PROPOSED TECHNOLOGY TRANSFER
BLOCK EXEMPTION REGULATION AND GUIDELINES
|
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documents :
EN |
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December 2003 |
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22/12/2003 |
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EuropaBio position paper on Human Medical Genetic
Testing (December 2003)
|
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documents :
EN |
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November 2003 |
|
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14/11/2003 |
| |
Human stem cell research: a novel technology that will
benefit patients - information and position paper
|
|
documents :
EN |
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October 2003 |
|
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01/10/2003 |
| |
EuropaBio (revised) position paper on Council common
position of DG Sanco Directive (October 2003)
|
|
documents :
EN |
|
| |
EuropaBio position paper on the definition of generic
medicinal products as developed in the common position
on the revision of Directive 2001/83/EC on the Community
Code for Human Medicines
|
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documents :
EN |
FR |
DE |
|
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May 2003 |
|
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13/05/2003 |
|
DG Enterprise - Tissue engineering - Industry letter to
Commissioner Liikanen
|
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documents :
EN |
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September 2002 |
|
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30/09/2002 |
| |
Need for a legislative framework for human tissue
engineering and tissue-engineered products
|
|
documents :
EN |
30/09/2002 |
| |
Second Entry of Biotechnological Medicinal Products -
Remark to Members of the European Parliament Committee
on the Environment, Public Health and Consumer Policy -
Pharmaceutical Review Directive |
|
documents :
EN
|
|
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June 2000 |
|
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13/06/2000 |
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Information paper on ethical, social and public
awareness issues in gene therapy.
|
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documents :
EN |
|
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February 2000 |
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22/02/2000 |
| |
Development and Regulatory Aspects of the Use of
Xenogeneic Cells :A EuropaBio Position Paper
|
|
documents :
EN |
