Activities of Benedek JÁVOR related to 2015/2171(DEC)
Shadow reports (1)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2014 PDF (303 KB) DOC (105 KB)
Shadow opinions (1)
OPINION on Discharge 2014: European Medicines Agency (EMA)
Amendments (4)
Amendment 4 #
Draft opinion
Paragraph 9
Paragraph 9
9. Notes with concern that, despite the Agency’s fee regulation2 providing due dates for the collection of fees from applicants and the Agency’s related payments to national competent authorities, these due dates were not respected for most of the transactions audited by the Court of Auditors and calls on the Agency to no longer undermine its pharmacovigilance responsibilities and effectively respect those dates; 2 Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 035, 15.2.1995, p. 1).
Amendment 5 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes from the Court’s report that the Agency’s Fee Regulation13 provides due dates for the collection of fees from applicants and the Agency’s related payments to national competent authorities; notes that these due dates were not respected for most of the transactions audited by the Court; ascertains from the Agency that it has redesigned and streamlined its main operational processes including financial authorisations and fee collections; takes note that the further automation of these processes was planned to be implemented by the Agency by the end of 2015; calls on the Agency to take all further steps needed in order to ensure that its pharmacovigilance responsibilities are fully met and to effectively report to the discharge authority on measures implemented to remedy this issue; __________________ 13 Article 10(1) and 11(1) of Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products.
Amendment 5 #
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Is therefore extremely concerned that despite the identified weakness in the functioning of pharmacovigilance, the Agency launched in March 2014 a pilot project on adaptive licencing - endorsed neither by the Parliament nor by the Council, as implementing adaptive pathways would shift the burden of evidence from pre-marketing to post- marketing, leading to a situation where premature marketing authorisations could become the rule, therefore putting Union citizens' health unnecessarily at risk;
Amendment 13 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Is extremely concerned that despite the identified weakness in the functioning of pharmacovigilance, the Agency launched in March 2014 a pilot project on adaptive licencing - endorsed neither by the Parliament nor by the Council, as implementing adaptive pathways would shift the burden of evidence from pre- marketing to post-marketing, leading to a situation where premature marketing authorisations could become the rule;