4 Amendments of Ioannis A. TSOUKALAS related to 2008/0261(COD)
Amendment 77 #
Proposal for a directive – amending act
Article 1 – point 3 - point b
Article 1 – point 3 - point b
Directive 2001/83/EC
Article 46 – point g
Article 46 – point g
'(g) to inform the competent authority of products he gets knowledge of which are or which are reliably suspected to be falsified in relation to the identity, history or source of products manufactured by him.'
Amendment 79 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46 b – paragraph 2 – point b
Article 46 b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance and the control mechanisms are at least equivalent to those laid down by the Community, and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented.
Amendment 101 #
Proposal for a directive – amending act
Article 1 – paragraph 9
Article 1 – paragraph 9
Directive 2001/83/EC
Article 77 – paragraph 4
Article 77 – paragraph 4
'4. The Member States shall forward to the Agency a copy of the authorization referred to in paragraph 1. The Agency shall enter that information in the Community database referred to in Article 111(6). At the request of the Commission or any Member State, Member States shall supply, within a reasonable period of time, all appropriate information concerning the individual authorization which they have granted under paragraph 1.'
Amendment 112 #
Proposal for a directive – amending act
Article 1 – point 15 – point c
Article 1 – point 15 – point c
Directive 2001/83/EC
Article 111 – paragraph 7
Article 111 – paragraph 7
7. If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by Community legislation, the information shall be entered in the Community database referred to in paragraph 6 and the manufacturing and distribution processes must cease forthwith.'