4 Amendments of János ÁDER related to 2008/0260(COD)
Amendment 111 #
Proposal for a directive – amending act
Article 1 – point 3
Article 1 – point 3
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 2 a (new)
Article 11 – paragraph 1 – point 3a and Article 11 – paragraph 2 a (new)
(a) the following point 3a is inserted: “(3a) a summary of the essential information necessary to use the medicine safely and effectively;” (b) the following subparagraph is added: “For the purposes of point (3a) of the first subparagraph, fsubparagraph is added: “For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring. All suspected adverse reactions should be reported to <name and web- address of the national competent authority>.”
Amendment 147 #
Proposal for a directive – amending act
Article 1 – point 18 – point a
Article 1 – point 18 – point a
Directive 2001/83/EC
Article 59 – paragraph 1 – point aa
Article 59 – paragraph 1 – point aa
Amendment 164 #
Proposal for a directive – amending act
Article 1 – point 20
Article 1 – point 20
Directive 2001/83/EC
Article 65 – point g
Article 65 – point g
Amendment 266 #
Proposal for a directive – amending act
Article 2 – paragraph 1
Article 2 – paragraph 1
1. With regard to 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 this Directivto state, where necessary, in the summary of the product characteristics and the package leaflet that the medicine is under intensive monitoring, and to indicate any new information concerning the medicine, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.