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2 Amendments of Claude TURMES related to 2008/0260(COD)

Amendment 36 #
Bernadette VERGNAUD, Claude TURMES, Antonyia PARVANOVA, Philippe JUVIN
Proposal for a directive – amending act
Article 1 – point 8
Directive 2001/83/EC
Article 21 a – introductory part
AIn addition to the provisions of Article 19, marketing authorisation may be granted subject to one or more of the following conditions:
2010/02/03
Committee: IMCO
Amendment 54 #
Bernadette VERGNAUD, Claude TURMES
Proposal for a directive – amending act
Article 1 – point 21
Directive 2001/83/EC
Article 105
The management of funds intended for activities connected with Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall receive adequate public funding commensurate with the tasks conferred. Management of the funds to finance such activities shall be under the permanent control of the national competent authorities in order to guarantee their independence. The first paragraph shall not preclude theindirect collection of fees to be paid by marketing authorisation holderby the national authorities of further resources for the carrying out of those activities by the national competent authorities, provided that their independence is strictly guaranteed.
2010/02/03
Committee: IMCO
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