New EU Pharmacovigilance Legislation
L. Auclert-Val Simmons â EFPIA Presentation - EUCOPE
L. Auclert-Val Simmons â EFPIA Presentation - EUCOPE
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EFPIA Proposals – PRAC<br />
• Transparency with MAHs appears to be selective:<br />
o Prior to web portal availability, easily identified area on EMA<br />
website to find this information<br />
o MAHs notified 24 hours ahead of publication if significant signal<br />
o All signals published on a predefined date<br />
o Clear scientific rationale provided<br />
o Transparent communication of prioritisation<br />
• Proportionality principle does not seem to apply :<br />
o Timeframe for responses to take into account medical<br />
importance and public health impact of the signal<br />
11/8/2012 13
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