6 Amendments of Thomas ULMER related to 2008/0225(COD)
Amendment 5 #
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) To ensure the adequate funding of these activities related to informationthe monitoring of the marketing authorisation holder's communications to the public, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.
Amendment 7 #
Proposal for a regulation – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point a
Article 9 – paragraph 4 – point a
(-1a) In Article 9(4), point (a) shall be replaced by the following: "(a) a draft of the summary of product characteristics, as referred to in Article 11 of Directive 2001/83/EC. It shall list other therapeutic options available and indicate whether the new medicinal product brings about a therapeutic advance. It shall also mention the voting results within the Agency’s scientific committees, notably the number of votes approving the medicine;"
Amendment 9 #
Proposal for a regulation – amending act
Article 1 – point -1 b (new)
Article 1 – point -1 b (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e
Article 9 – paragraph 4 – point e
(-1b) In Article 9(4), point (e) shall be replaced by the following: "(e) the assessment report, which shall include as an annex the preliminary report on the medicinal product prepared by the rapporteurs as well as the marketing authorisation holder’s comments;"
Amendment 11 #
Proposal for a regulation – amending act
Article 1 – point -1 c (new)
Article 1 – point -1 c (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e a (new)
Article 9 – paragraph 4 – point e a (new)
Amendment 14 #
Proposal for a regulation – amending act
Article 1 – point -1 e (new)
Article 1 – point -1 e (new)
Regulation (EC) No 726/2004
Article 13 – paragraph 3 – subparagraph 2
Article 13 – paragraph 3 – subparagraph 2
(-1e) In Article 13(3), the second subparagraph shall be replaced by the following: " The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain [...] a section relating to the conditions of use of the medicinal product as well as a section listing other therapeutic options available and indicating whether the new medicinal product brings about a therapeutic advance."
Amendment 20 #
Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
(2a) In Article 57(1), the following point is added: "(ua) promoting existing sources of independent reliable health information."