29. Pharmacovigilance (amendment of Directive 2001/83/EC) ***I - Pharmacovigilance (amendment of Regulation (EC) No 726/2004) ***I (debate)

Verbatim reports

Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance [COM(2012)0052 - C7-0033/2012- 2012/0025(COD)] - Committee on the Environment, Public Health and Food Safety. Rapporteur: Linda McAvan (A7-0165/2012)

Report on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance [COM(2012)0051 - C7-0034/2012- 2012/0023(COD)] - Committee on the Environment, Public Health and Food Safety. Rapporteur: Linda McAvan (A7-0164/2012)

Linda McAvan introduced the reports.

The following spoke: John Dalli (Member of the Commission).

The following spoke: Pilar Ayuso, on behalf of the PPE Group, Karin Kadenbach, on behalf of the S&D Group, Antonyia Parvanova, on behalf of the ALDE Group, Marina Yannakoudakis, on behalf of the ECR Group, Oreste Rossi, on behalf of the EFD Group, Jiří Maštálka, on behalf of the GUE/NGL Group, Franz Obermayr, Non-attached Member, Peter Liese, Monika Flašíková Beňová, Frédérique Ries, Tadeusz Cymański, Marisa Matias, Françoise Grossetête, Anja Weisgerber, Erik Bánki and Róża Gräfin von Thun und Hohenstein.

The following spoke under the 'catch-the-eye' procedure: Miroslav Mikolášik, Elena Băsescu and Zuzana Roithová.

The following spoke: John Dalli and Linda McAvan.

The debate closed.

Vote: minutes of 11.9.2012, item 10.10 and minutes of 11.9.2012, item 10.11.