2 Amendments of Holger KRAHMER related to 2008/0260(COD)
Amendment 226 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraph 3 – subparagraph 2
Article 107 – paragraph 3 – subparagraph 2
Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event. Marketing authorisation holders of medicines authorised on the basis of Article 10a and holders of registrations for medicinal products referred to in Articles 14 to 16a shall be exempted from the above requirement.
Amendment 245 #
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 b – paragraph 3 – introduction
Article 107 b – paragraph 3 – introduction
3. By way of derogation from paragraph 1 of this Article, hHolders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of registrations for medicinal products referred to in Articles 14 tor 16a, shall not be required to submit periodic safety update reports for such products only. By way of derogation, holders of marketing authorisations for medicinal products shall be required to submit periodic safety update reports in the following cases: