Activities of Linda McAVAN related to 2008/0260(COD)
Reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use PDF (700 KB) DOC (973 KB)
Amendments (2)
Amendment 54 #
Proposal for a directive – amending act
Recital 16
Recital 16
(16) Member States should operate a pharmacovigilance system to collect information useful in the surveillance of medicinal products including information on suspected adverse drug reactions, on occurring from normal conditions of use, off-label use, misuse, abuse and medication errors, and ensure its quality through the follow up of suspected adverse drug reaction cases.
Amendment 259 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 108 – paragraph 1 – point 5
Article 108 – paragraph 1 – point 5
(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders, including the presentation of the collected information. The collected information must distinguish adverse reactions due to overdose, misuse, abuse, medication errors, and those occurring in the course of studies with the medicinal product or after occupational exposure;