EGA Scientific & Regulatory - Post-Authorisation Surveillance

EGA - European Generic medicines Association ... “ Making Medicines Affordable”

Docs & Positions

Facts & Figures

Science and Regulatory

Post-Authorisation Surveillance

• Revisions of Product Labelling

Revision of Product Labelling for Antidepressants

Antidepressants and suicidal thoughts and behaviour

Pharmacovigilance Working Party
• January 2008

ACE Inhibitors & Angiotensin II Receptor Antagonists (AIIRAs) in Pregnancy - PhVWP Recommended SmPC Wording

Pharmacovigilance Working Party
• January 2008

• Harmonised Birth Date Initiative

UPDATED | Additional list of EU HBDs and DLPs (alphabetic order) and Explanatory notes

Heads of Medicines Agencies (HMA)
• 21 August 2007 | Updated July 2008

Questions and Answers on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures

Heads of Medicines Agencies (HMA)
• 21 August 2007

EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures

Heads of Agencies (HMA)
• 21 August 2007

• EGA Positions and Papers

EGA Submission of Comments on the Revised Text of Volume 9A with Regard to Pharmacovigilance and Biosimilar Medicines

EGA Position
• May 2008

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