Activities of Claude TURMES related to 2008/0257(COD)
Plenary speeches (1)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Amendments (1)
Amendment 36 #
Proposal for a regulation – amending act
Article 1 – point 18 – subpoint b
Article 1 – point 18 – subpoint b
Regulation (EC) No 726/2004
Article 67 – paragraph 4
Article 67 – paragraph 4
“4. Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency, and receive public funding commensurate with the scale of the tasks assigned. This shall not preclude the indirect collection of fees to be paid by marketing authorisation holders for theadditional funding to enable the Agency to carrying out of theose activities by the Agency, provided that its independence is strictly guaranteed.”