Position Papers
 Position Papers & Other Policy Documents
This area provides users with a handy collection of
all current EGA policy documents, even though these may also be referenced
in some other section.
| Pharmaceutical Policy
| Pharmaceutical Forum |
| Biosimilar Medicines
| Pharmacovigilance
| Regulatory |
| Technical & Scientific
| Good Manufacturing Procedure & Inspections |
| Paediatrics
| Marketing Authorisation & Englargement
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| Data Exclusivity
| Anti-Counterfeiting |
| IP - Patents
| Criminal Measures to Enforce IP Rights (IPRED2) |
| IP Enforcement
| TRIPS - Doha Agreement |
• Pharmaceutical Policy
THE FUTURE OF PHARMACEUTICALS:
Challenges and Opportunities for Generic Medicines Companies
Elke Grooten, Director Pharmaceutical Policy, EGA
Presentation to the DIA Conference
• March 2008, Barcelona
Generic Medicines Enhancing Pharmaceutical Competition
and Ensuring Healthcare Sustainability
EGA Contribution to the Public Consultation Process Initiated by the European Commission on “The Future of Pharmaceuticals for Human Use in Europe”
• October 2007
• Pharmaceutical Forum
a) GENERAL ISSUES:
EGA General Position on Pharma Forum Issues
EGA Position
• 26 June 2007
Generic Medicines and Innovation
EGA Policy Presentation
• 19 June 2006
b) INFORMATION TO PATIENTS:
EGA Position Paper on Patient Information
In response to the European Commission Report on current
practices with regard to the provision of information to
patients on medicinal products
• 26 June 2007
c) RELATIVE EFFECTIVENESS:
EGA Contribution to the Pharmaceutical Forum Relative Effectiveness Working Group
EGA Position
• 20 January 2007
d) PRICING:
How Did the New Generic Medicines Provisions Influence Generic Substitution in Europe?
Elke Grooten, Director Pharmaceutical Policy, EGA
Presentation to the DIA Conference
• March 2008, Barcelona
Second EGA Contribution to the Pharmaceutical Forum Pricing Working Group
EGA Position
• 7 November 2006
EGA Contribution to the Pharmaceutical Forum Pricing Working Group
EGA Position
• 19 June 2006
• Biosimilar Medicinal Products
See the page on:
Positions Papers on Biosimilar Medicines
• Pharmacovigilance
EGA Response to the European Commission's Public Consultation on Pharmacovigilance Legislative Proposals
EGA Position Paper
• 29 Jan 2008
EGA Response to the European Commission Public Consultation: An Assessment of the Community System of Pharmacovigilance
EGA Position Paper
• 12 May 2006
• Regulatory Issues
Position Paper on the Draft Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use, Revision September 2006
EGA Position Paper
• October 2006
• Technical & Scientific Aspects
EGA Position Statement on EDQM General Monograph on Products of Fermentation
EGA Position
• 13 March 2008
• Good Manufacturing Procedure & Inspections
Latest EU GMP Developments Affecting Starting Materials
EGA Presentation | Julie Maréchal, Sr Manager Regulatory Affairs
• April 2008
Inspections at Manufacturers of Active Substances — Guidance on Grounds (Triggers) for Inspection (EMEA/INS/GMP/50288/2005)
EGA Position
• April 2005
• The Paediatrics Regulation
Paediatric Medicines Regulation
EGA Briefing Paper
• November 2004
EGA Comments on the Proposed Regulation on Incentives for the Development of Medicines for Paediatric Use
EGA response to the second public consultation
• 8 April 2004
• Marketing Authorisation and Enlargement
EGA Questions MRP procedure after Enlargement
EGA examines some practical aspects of the MRP and their impact on the activity of producers and Authorities during Enlargement.
• February 2004
EGA Comments on Phasing-in Procedure: MRP & Referrals
REPR Acquis Group Reflection Paper.
• May 2003
• Data Exclusivity
Data Exclusivity and the 2001 Review
An EGA Discussion Paper.
• July 2001
Data Exclusivity: A Major Obstacle to Innovation and Competition in the EU Pharmaceutical Sector
An EGA Position Paper.
• December 2000
• Anti-Counterfeiting
Position Paper on Anti-Counterfeit Policy
In response to the European Commission’s Consultation for DG ENTR Study on Distribution Channels - Part I ‘Combating Counterfeit Medicines’
• April 2007
"Business with Certified Partners Only": Position Paper on Anti-counterfeit Policy
An important means to fight against counterfeiting
is to secure the supply chain by introducing safer business processes.
• 19 July 2006
• IP - Patents
The European
Generic medicines Association's View of the European Patent Litigation
Agreement (EPLA)
The EGA favours the principle of harmonising court decisions that lies behind the EPLA, but we are not sure if the EPLA is the right instrument to achieve this.
EGA Position Paper
• December 2006
• Criminal Measures to Enforce IP Rights (IPRED2)
EGA POSITION on the draft Directive on criminal measures aimed a ensuring the enforcement of Intellectual Property Rights
Once again, EGA asks for patents to be excluded from the scope of this draft legislation; generic producers are not criminals!
EGA Position Paper
• May 2006
• The IP Enforcement Directive
Scenario for Generic Medicine “A” under the EU Directive on Enforcement of Intellectual Property Rights
EGA asks to exclude patents from the scope; generic producers are not criminals!
EGA Reaction to the Fourtou Report on IP Enforcement Directive
• 2004
The Proposal for a Directive on the Enforcement of Intellectual Property Rights
EGA Proposal for amendments to the Commission Propsal.
• June 2003
The Proposal for a Directive on the Enforcement of Intellectual Property Rights
A Preliminary EGA Position Paper.
• April 2003
• TRIPS / Doha Agreement (paragraph 6)
Outcome of the WTO Ministerial Conference, Doha, November 2001 Declaration on the TRIPS agreement and Public Health
EGA Position Paper
• February 2002
Outcome of the WTO Ministerial Conference, Doha, November 2001 Declaration on the TRIPS agreement and Public Health
EGA Position Paper
• 20 December 2001
TRIPS Article 34 and 50 do not require Automatic Interlocutory Injunctions
EGA Position Paper
• February 2001
TRIPS Article 39.3 Does not require Data Exclusivity Provisions: A critical issue for access to medicines
EGA Position Paper
• July 2000
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