3 Amendments of Patrizia TOIA related to 2008/0260(COD)
Amendment 38 #
Proposal for a directive – amending act
Recital 10 a (new)
Recital 10 a (new)
(10a) The Commission should, without delay, and in collaboration with EMEA, following consultations with patient and consumer organisations, medical and pharmacist organisations, social health insurance organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and to healthcare professionals. Following an analysis of the above data, the Commission should, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and for healthcare professionals.
Amendment 43 #
Proposal for a directive – amending act
Article 1 – point 12 – point a
Article 1 – point 12 – point a
Directive 2001/83/EC
Article 24 – paragraph 2 – subparagraph 2
Article 24 – paragraph 2 – subparagraph 2
To this end, the marketing authorisation holder shall provide the national competent authority with a consolidated version of the file in respect of quality, safety and, efficacy, and added value, such as reduced toxicity. This version shall includinge the evaluation of data contained in adverse reactions reports and periodic safety update reports submitted in accordance with Title IX, and all variations introduced since the marketing authorisation was granted, at least nine months before the marketing authorisation ceases to be valid in accordance with paragraph 1.
Amendment 44 #
Proposal for a directive – amending act
Article 1 – point 14 – point b
Article 1 – point 14 – point b
Directive 2001/83/EC
Article 27 – paragraph 2 – subparagraph 3
Article 27 – paragraph 2 – subparagraph 3
Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination group as regards the transparency and independence of its members from both the Agency and marketing authorisation holders.