1 Amendments of Dagmar ROTH-BEHRENDT related to 2008/0260(COD)
Amendment 118 #
Proposal for a directive – amending act
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
Directive 2001/83/EC
Article 16c – paragraph 4 – subparagraph 2
Article 16c – paragraph 4 – subparagraph 2
3a. In Article 16c(4), subparagraph 2 is replaced by the following: The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be complied with by the Member State when taking its final decision.