1 Amendments of Jiří MAŠTÁLKA related to 2008/0225(COD)
Amendment 15 #
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 6120 days after receipt of the notification. If the Agency does not object within 6120 days, the information shall be deemed accepted and may be published. The marketing authorisation holder remains fully liable and responsible for the information provided in all cases.