The European Medicines Agency has released an implementation plan for the pharmacovigilance legislation, which sets out milestone dates for different aspects, with several items scheduled for 2012, and others to be phased in afterwards. Technical insights into the impacts on the Agency and on Marketing Authorisation Holders of the implementation of the legislation are also provided, with updates on areas including the following:
· RMPs, PSURs and PASS/PAES studies
· Submission to EVMPD in XEVPRM form
· EV and Signal Detection
· Medicines Subject to Additional Monitoring
· Scientific committees and decision-making
· Referral Procedures
If you need any help in interpreting how the new PV legislation will impact your company, or what steps you need to prepare for at this point, one of our consultants would be pleased to discuss; please email enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.
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