5 Amendments of Marian-Jean MARINESCU related to 2008/0260(COD)
Amendment 46 #
Proposal for a directive – amending act
Article 1 – point 18 – point a a (new)
Article 1 – point 18 – point a a (new)
Directive 2001/83/EC
Article 59 – paragraph 1 – point h a (new)
Article 59 – paragraph 1 – point h a (new)
(aa) the following point (ha) is inserted: “(ha) a detachable portion of the leaflet that the patient can tear off, including the following statement: “suspected adverse reactions should be reported to your doctor, pharmacist, or to <name, web- address, postal address and/or telephone and fax number of the national competent authority>";”
Amendment 50 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1
Article 102 – paragraph 1 – point 1
(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing author. Those measures shall include training for healthcare professionals and for patients, and a public information campaign for patients. Patient organisation s shoulder be involved in providing information and training to patients;
Amendment 51 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 1 – point 1 a (new)
Article 102 – paragraph 1 – point 1 a (new)
(1a) facilitate direct patient reporting, in addition to web-based formats, through the provision on the patient information leaflet of a detachable portion that can be reported to the doctors, pharmacists or the national competent authority;
Amendment 62 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107i – paragraph 1 – points a, b, c
Article 107i – paragraph 1 – points a, b, c
(a) it considers, as a result of the evaluation of pharmacovigilance data: - suspending or revoking of a marketing authorisation; (b) it considers- prohibiting the supply of a medicinal product; (c) it considers- refusing the renewal of a marketing authorisation;
Amendment 63 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107k – paragraph 1 - subparagraph 1
Article 107k – paragraph 1 - subparagraph 1
1. Following the information referred to in Article 107i(1), the Agency shall notify the concerned marketing authorisation holders and publicly announce the initiation of the procedure by means of the European medicines safety web-portal.