1 Amendments of János ÁDER related to 2008/0257(COD)
Amendment 84 #
Proposal for a regulation – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
1. The requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by Directive …/…/ECprovided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by Directive …/…/EC for the summary of the product characteristics and the package leaflet to indicate that the medicinal product is under intensive monitoring or that new information must be appropriately indicated, which applies to medicinal products authorised pursuant to Regulation (EC) No 726/2004 by virtue of its Article 9(4)(a) and (d), shall apply to a marketing authorisation granted before the date set out in the second paragraph of Article 3 of this Regulation from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.