2 Amendments of Crescenzio RIVELLINI related to 2008/0260(COD)
Amendment 29 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also those derived from medication errors and from uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
Amendment 65 #
Proposal for a directive – amending act
Recital 20 a (new)
Recital 20 a (new)
(20a) Reporting by healthcare professionals should be particularly encouraged in cases where their contribution is essential in order to understand the significance of the adverse reaction and of adverse reactions derived from medication errors. To facilitate this type of reporting and to protect the citizen, access to data contained in patients’ medical files should be accessible to healthcare professionals.