3 Amendments of Oreste ROSSI related to 2008/0260(COD)
Amendment 176 #
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 authorisation holder; such measures shall include the training of health-care workers and a public information campaign aimed at patients;
Amendment 181 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – point 1 a (new)
Article 102 – point 1 a (new)
(1a) take appropriate measures to ensure that spontaneous reports by patients are properly presented and guided efficiently by health-care professionals;
Amendment 194 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 102 – paragraph 2 a (new)
Article 102 – paragraph 2 a (new)
The reporting of suspected adverse reactions due to medication errors should not be the subject of – nor give rise to – legal action against persons reporting them.