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)
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Address https://gelex.eu/eli/EU/corrigendum/oj/L/2012/338/12@2012-12-12/en
Contents
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;.