Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council
Corrected by
Corrigendum to Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council(Official Journal of the European Union L 150 of 9 June 2012)On page 69, in Article 1, point 7:for:"the obligation to provide, at the request of the Agency, any data demonstrating that the risk-benefit balance remains favourable, as provided for in Article 16(4) and Article 41(4) of Regulation (EC) No 726/2004;",read:"the obligation to provide, at the request of the Agency, any data demonstrating that the risk-benefit balance remains favourable, as provided for in Articles 16(3a) and 41(4) of Regulation (EC) No 726/2004;";on page 69, in Article 1, point 12:for:"the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 16(4) of Regulation (EC) No 726/2004;",read:"the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 16(3a) of Regulation (EC) No 726/2004;".