Position Papers & Publications Archive 1999-2008

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2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999
 
December 2008
12/2008
EuropaBio & Biosimilar Medicines
Joint Industry workshop on the biotech and emerging technologies : HTA in context
How industrial biotechnology can tackle climate change
October 2008
07/10/2008
EuropaBio Submission to the European Commission stakeholder consultation on the Community Health Programme 2009
September 2008
22/09/2008
EuropaBio Position on Biofuels
July 2008
04/07/2008
EuropaBio Submission to the Public Consultation Paper On Certification Quality & Non-Clinical Data For SMEs
June 2008
23/06/2008
EuropaBio Submission of Comments on Biomarkers Qualification: Guidance to Applicants
10/06/2008
EuropaBio input to the Public Consultation on the Proposals to Amend Annex 1 to Directive 2001/83/EC as Regards Advanced Therapy Medicinal Products
01/06/2008
EuropaBio Annual Report 2008
May 2008
14/05/2008
EuropaBio input to the Public Consultation in Preparation of a Legal Proposal to Combat Counterfeit Medicines for Human Use 
April 2008
25/04/2008

EuropaBio comments related to “Labelling of food enzymes, additives and flavourings produced by Genetically Modified Micro-organisms (GMM)”

08/04/2008
Submission to the EU Public Consultation on a Legal Proposal on Information to Patients

02/04/2008 - Brussels Day Issue Sheets

The Lead Market Initiative 

BioFuels & The Renewable Energy Directive 

Coexistence of GM and Non GM Crops – The right to choose

Low Level GM Presence & Why Animal Feed Prices Are on the Rise

Advanced Therapy Medicinal Products Regulation (EC) No 1394/2007

The Clinical Trials Directive 2001/20/EC 

Animal Testing Directive 86/609

Improving the Financial Environment for European Biotechnology 

A snapshot of the EU biotech sector

March 2008
31/05/2008
EuropaBio Comments on the Small Business Act for Europe
24/03/2008
European Patent Litigation reform - the question of exclusivity
February 2008
12/06/2008
EuropaBio input to the public consultation on a Code of Conduct for Interest Representatives
14/02/2008
Farm Animals say yes to Low Level Presence of GM
14/02/2008
Joint EBE-EuropaBio Postition Paper European Commission Public Consultation Rare Diseases: Europe’s Challenges
11/02/2008
Submission of comments on the European Commission’s strategy to better protect health by strengthening and rationalising EU pharmacovigilance
January 2008
21/01/2008
EuropaBio publishes comments on the development of environmental sustainability criteria for biofuels
14/01/2008
Letter of support sent by the Chair of the Healthcare Council to EUnetHTA in response to its proposal for collaboration with stakeholders 2009+
04/01/2008

EuropaBio submission to the European Commission Public Consultation on the comitology part of the revision of the Variations Regulations

October 2007
12/10/2007

Consultation on the Future of Pharmaceuticals for Human Use in Europe - documents : EN  

01/10/2007

Contribution Of the European Taskforce on Bioterrorism to the Green Paper on Bio-Preparedness - documents : EN

August 2007
24/08/2007
EMEA Paediatric Network - documents : EN
17/08/2007
Biofuels in Europe EuropaBio position and specific recommendations - documents : EN
July 2007
13/07/2007
Management of low level presence of GM products approved outside the EU and present in traded commodities entering the EU

documents : EN

WTO Ruling on Biotech Products  - documents : EN
June 2007
29/06/2007

Comments on draft report on current practices with regard to the provision of information to patients on medicinal products

documents : EN

14/06/2007
Biotechnology and the EU - Speech of Peter Mandelson, EU Trade Commissioner to EuropaBio open Day
 documents : EN
01/06/2007
EuropaBio publishes Annual Report 2007 EN
May 2007
04/05/2007

High-Level Pharmaceutical Forum Public Consultation on Health-Related Information to Patients - documents : EN

March 2007
26/03/2007
Adventitious presence - Bringing clarity to confusion - documents : EN
Key messages on adventitious presence in seed - documents : EN

EuropaBio releases the Green Biotechnology Manifesto 2007 - documents: EN

EuropaBio Contributions to the Consultation of the DG Enterprise and Industry Project on Distribution Channels - documents: EN

February 2007
12/02/2007

Discussion Document for a Health Strategy - documents : EN

02/2007

Plant biotechnology for a competitive Europe - documents : EN

02/2007

Ten Years of Biotech Crop Production - documents : EN

January 2007
31/01/2007

Consultation Regarding Community Action on Health Services - documents : EN

December 2006
20/12/2006

EuropaBio key response to the European Commission consultation paper regarding: better regulation of pharmaceuticals towards simpler, clearer and more flexible framework of variations - documents : EN

November 2006
10/11/2006

EuropaBio Position Paper on  Naming and Labelling Requirements for Biosimilar Medicines - documents : EN

02/11/2006
EuropaBio Position on the Proposal package for legislation on food additives, flavouring and enzymes - documents : EN
October 2006
10/10/2006

EuropaBio Brussels Day Report - documents : EN

September 2006
27/09/2006

EuropaBio contribution to the Pharmaceutical Forum on Information to Patients - documents : EN

27/09/2006

EuropaBio contribution to the Pharmaceutical Forum on Relative Effectiveness - documents : EN

27/09/2006

EuropaBio contribution to the Pharmaceutical Forum on Pricing - documents : EN

August 2006

EuropaBio position paper: Review of Directive 86/609 on the Protection of Animals Used for Experimental and Other Scientific Purposes

documents : EN

June 2006
01/06/2006
      EuropaBio publishes Annual Report 2006
documents : EN
 
April 2006
06/04/2006

The EU’s approval process for biotechnology derived crops
Letter addressed to Mr. José Manuel Barroso, President of the European Commission
documents : EN

March 2006
23/03/2006

EuropaBio Position on the Reform of the EU Sugar Regime, adopted by the EU Agricultural Ministers (20 February 2006)

documents : EN

10/03/2006

EuropaBio principles for accessing genetic resources   - documents : EN
 

October 2005
30/10/2005

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

documents : EN   

September 2005
22/09/2005
Healthcare Manifesto 2007 
July 2005
27/07/2005

EuropaBio Position paper on the Reform of the EU sugar regime - documents : EN

June 2005
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

 Supporting documents : EN                                                                                                                                           

13/06/2005

The European Biotechnology Industry View on the proposed Regulation on Medicinal Products for Paediatric Use. (Joint common position) - documents : EN

01/06/2005
EuropaBio Position paper: The scope of the EU GM Food & Feed Regulation (EC) 1829/2003 - documents : EN
01/06/2005
     EuropaBio publishes Annual Report 2005  documents: EN
April 2005
22/04/2005

EuropaBio comments on the proposal for a Regulation on medicinal products for paediatric use. - documents : EN

March 2005
04/03/2005

EBE and EuropaBio White Paper - “Towards an optimal Orphan Medicinal Products (OMP) Framework in Europe”

 documents : EN

29/03/2005

EuropaBio and Eucomed paper "Why human cell & tissue-engineered products (hTEPs) need a specific and separate Regulation".   documents : EN

February 2005
01/02/2005
Framework Programme for Competitiveness and Innovation. - documents : EN
01/02/2005
EuropaBio Position paper: Coexistence of GM crops with non-GM crops is possible in the EU. - documents : EN
January 2005
31/01/2005
Consultation Response - The application of the Lamfalussy process to EU securities markets legislation. - documents : EN
28/02/2005
EuropaBio position on the EMEA Guideline on Similar biological medicinal products (ref. EMEA/CHMP/437/04). - documents : EN
December 2004
22/12/2004
Comments from EuropaBio on the draft Regulation on the conditional marketing authorisation for medicinal products.

 documents : EN

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. - documents : EN
October 2004
01/10/2004
Joint industry comments on Draft Technical Requirements for tissues and cells Response Form. - documents : EN
September 2004
15/09/2004
EuropaBio comments on WHO-Priority medicine project. - documents : EN
August 2004
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)
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. - documents : EN
July 2004
07/2004
White Biotechnology in SusChem Technology Platform

European Technology Platform on Sustainable Chemistry

June 2004
30/06/2004
EuropaBio contribution to the European Medicines Agency Road Map to 2010: preparing the ground for the future.

 documents : EN

May 2004
01/05/2004
Human Medical Genetic Testing. A EuropaBio Position Paper - documents : EN
April 2004
29/04/2004
EuropaBio Feedback on Commission’s Consultation Paper on Tissue Engineered Products Legislation - documents : EN
EuropaBio position paper on Draft Commission Decision (EC) No…/.. establishing minimum thresholds for adventitious

 documents : EN

February 2004
10/02/2004
Brussels Day report (14th - 15th October 2003) - documents : EN
06/02/2004
EuropaBio Position Paper on PROPOSED TECHNOLOGY TRANSFER BLOCK EXEMPTION REGULATION AND GUIDELINES

 documents : EN

December 2003
22/12/2003
EuropaBio position paper on Human Medical Genetic Testing (December 2003) - documents : EN
19/12/2003
What is the Young Innovative Company (YIC) status? - documents : EN
November 2003
27/11/2003
The Position of the Plant Biotechnology Unit on the Graefe zu Baringdorf Draft Report on “Coexistence between genetically modified crops and conventional and organic crops” :  2003/2098(INI) - documents : EN
EuropaBio position paper on Proposed Directive on Environmental Liability - documents : EN
26/11/2003

EuropaBio position paper on draft technology transfer regulation - documents : EN

14/11/2003
Human stem cell research: a novel technology that will benefit patients - documents : EN
13/11/2003

Comments on CX/FICS 03 /4- “Discussion Paper on Traceability/Product Tracing in the Context of Food Import and Export Inspection and Certification Systems” - documents : EN

October 2003
14/10/2003

EuropaBio Brussels Day Report - documents : EN

01/10/2003

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 - documents : EN | FR | DE

EuropaBio position on biosimilar medicinal products as regulated in the common position on the revision of Directive 2001/83/EC on the community code for human medicines - documents : EN | FR | DE
EuropaBio (revised) position paper on Council common position of DG Sanco Directive (October 2003) - documents : EN
July 2003
14/07/2003
Coexistence of GM crops with Non GM crops in the EU - documents : EN
11/07/2003
How to boost innovation and research in Europe?
A EuropaBio proposal to the EU Competitiveness Council of Ministers, Rome, 11-12 July 2003 - documents : EN
June 2003
02/06/2003
Environmental Liability - position paper following 1st Reading - documents : EN
01/06/2003
Food Feed & Traceability Labelling - position paper on centralised procedure - documents : EN
Food Feed & Traceability Labelling - position paper on coexistence - documents : EN
Food Feed & Traceability Labelling - position paper on pre-approved events - documents : EN
Food Feed & Traceability Labelling- position paper on GMOs labelling threshold - documents : EN
May 2003
28/05/2003
CODEX - Europabio position on Animal Feeding - documents : EN
13/05/2003
DG Enterprise - Tissue engineering - Industry letter to Commissioner Liikanen - documents : EN
12/05/2003
Environmental Liability - EuropaBio letter on GMOs - documents : EN
07/05/2003
Environmental Liability - industry joint position paper - documents : EN
April 2003
15/04/2003
CODEX - EuropaBio position on Food Labeling - documents : EN
01/04/2003
CODEX - EuropaBio position on Risk Assessment for Food Safety paper - documents : EN
February 2003
20/02/2003
Emerging Enterprises Board Priorities for 2003 - documents : EN
06/02/2003
EuropaBio comments on EMEA annex for "guidance on comparability containing biotech-derived proteins as drug substances" Ref. CPMP/3097/02 - documents : EN
January 2003
14/01/2003
Questions and Answers on Environmental Liability - documents : FR
13/01/2003
Clean, sustainable and white.... -  documents : EN
November 2002
21/11/2002
EuropaBio position on Environmental Liability Proposal - documents : EN
September 2002
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

October 2001
23/10/2001
Key Issues raised in the Commission’s proposal for a Regulation concerning Traceability and Labelling of GMOs - documents : EN
08/10/2001
Plant Biotechnology Unit Comments on the Commission Proposal for a Regulation concerning Genetically Modified Food and Feed documents : EN
June 2001
23/06/2001
GMO Fact Sheet - documents : EN
13/06/2000
Information paper on ethical, social and public awareness issues in gene therapy. - documents : EN
March 2000
06/03/2000
Assuring Consumer Confidence in the Safety of Biotechnology and Food Products.
Comments on the Commission Proposal to Establish a Food Safety Authority.
A Paper by the Plant Biotechnology Unit of EuropaBio
  -
documents : EN
February 2000
22/02/2000
Development and Regulatory Aspects of the Use of Xenogeneic Cells :A EuropaBio Position Paper - documents : EN
December 1999
03/12/1999

Discussion Paper on the Precautionary Principle - documents : EN

October 1999
22/10/1999
Biotechnology companies welcome EU-agreement on threshold for G.M.labelling - documents : EN
10/10/1999
Why the article in nature magazine on ‘substantial equivalence ’ is irrelevant - documents : EN
April 1999
15/04/1999
Biotechnology Industry Channeling Program helps US farmers to sell novel trait corn crops which have not yet obtained EU import clearance. - documents : EN
February 1999
19/02/1999
Stringent safety tests in place for genetically modified foods - documents : EN
 
January 1999
25/01/1999

UK House of Lords Second Report on the EU regulation of biotechnology in Agriculture - An important contribution to the discussion on effective EU regulation - documents : EN
 

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