11 Amendments of Anja WEISGERBER related to 2008/0260(COD)
Amendment 25 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs with all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 34 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11
Article 11
“For the purpose of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product is under intensivehas been proven to be of benefit for patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“
Amendment 38 #
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs applies to all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 49 #
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1
Article 59 – paragraph 1
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “This medicinal product is under intensivehas been proven to be of benefit for patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >“.
Amendment 55 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 1
Article 106 – point 1
(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;
Amendment 57 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 2
Article 106 – point 2
(2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements;
Amendment 61 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 a (new) and point 3 b (new)
Article 106 – point 3 a (new) and point 3 b (new)
(3a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products; (3b) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the information set out in points 1 to 3b, shall be presented in an understandable way for the general public.
Amendment 115 #
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
Article 11 – paragraph 3
“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product is under intensivehas been proven to be of benefit to patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“.”
Amendment 155 #
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2
Article 59 – paragraph 1 – subparagraph 2
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. form that is clearly legible, prominent and clearly distinguishable from the rest of the text. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”.
Amendment 161 #
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 3
Article 59 – paragraph 1 – subparagraph 3
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “‘This medicinal product is under intensivehas been proven to be of benefit to patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >”’.”
Amendment 215 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106
Article 106
(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive; (2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements; (3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004. ; (4) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products; (5) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the above, shall be presented in a manner that is comprehensible to the general public.