Legislative Proposals
EU Pharmaceutical Legislation | The “Pharma Package”
OPENING ADDRESS | 14th EGA Annual Conference | 2 June 2008
To Get the Framework Right—EU Initiatives in Pharmaceuticals
The European Commission's forthcoming work programme for pharmaceuticals, including Variations | Information to Patients | Pharmacovigilance | Counterfeit Medicines | Inquiry into the Pharmaceutical Industry | and more...
• Georgette Lalis, Director, Directorate
for Consumer Goods,
Directorate-General for Enterprise and Industry, European
Commission
COMMISSION COMMUNICATION | 10 December 2008
Safe,
Innovative and Accessible Medicines : A Renewed Vision for the Pharmaceutical
Sector
The European Commission Communication outlining the current
situation of the European pharmaceuticals industry and its vision for the future
of the sector.
• COM(2008)666
 EGA PRESENTATION | 10 April 2009
EU Generic Medicines Industry and the New Pharmaceutical
Package
This presentation to the recent
DIA conference outlines the EGA's full involvement in developing the
new EU pharmaceutical legislation on falsified medicines, pharmacovigilance
and industry information to patients (ITP)
• Julie Marechal-Jamil, Sr Manager Regulatory Affairs, EGA
See also:
• Position Papers on Pharmaceutical Policy
• Papers and Submissions on the Pharma Forum
Pharma Package | Falsified Medicines
a) Official Documents:
DIRECTIVE | 10 December 2008
Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal
products which are falsified in relation to their identity, history or source
• COM(2008)0668 final
b) EGA Positions & Presentations
API Aspects on Falsified Medicines Directive
• 19 November 2009
EGA Position on the EC Legislative Proposal against Falsified Medicines
• 21 January 2008
See also:
• Earlier EGA Papers and Submissions
on Anti-Counterfeiting
Pharma Package | Pharmacovigilance
a) Official Documents:
DIRECTIVE | 10 December 2008
Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• COM(2008)0665 final
REGULATION | 10 December 2008
Proposal for a Regulation of the European Parliament and of the Council amending, as
regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
• COM(2008)0664 final
b) EGA Positions & Presentations
EGA
Position on the EC Legislative Proposal on Pharmacovigilance
• 8 January 2008
See also:
• Earlier EGA Papers
on Pharmacovigilance
Pharma Package | Industry Information to Patients
a) Official Documents:
DIRECTIVE | 10 December 2008
Proposal for a Directive of the European Parliament and of the Council amending, as
regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• COM(2008)0663 final
REGULATION | 10 December 2008
Proposal for a Regulation of the European Parliament and of the Council amending, as
regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
• COM(2008)0662 final
b) EGA Positions & Presentations
EGA Position on the EC Legislative Proposal on Industry Information to Patients
• 8 January 2008
See also:
• Earlier Papers and Submissions
on Information to Patients (PharmaForum)
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