Public Consultation on Implementing Measures of New PV Legislation

The European Commission is seeking the views of stakeholders on the implementing measures for the performance of the new activities that were introduced by the amended Pharmacovigilance legislation.

The public consultation on these measures is open to all – do not miss the opportunity to have your say and gain further insight into the new Pharmacovigilance legislation that comes into force in July 2012.

The concept paper and more information on how to provide your feedback can be found by following the link below.  The deadline for comments is 7th November 2011.

http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm

MHRA GPvP Risk Based Inspection Compliance Reports – Due 4th November!

The GPvP Risk Based Inspection Compliance Reports are due for submission to the MHRA by 4th November 2011 – please mark this date in your diary! Completion of the report is not mandatory but the MHRA recommend that Marketing Authorisation Holders do complete one.  If you do not submit a completed report the MHRA will assign your company a high risk rating, increasing your chances of a Pharmacovigilance Inspection.  More information can be found at

www.mhra.gov.uk/…GoodPharmacovigilancePractice/Riskbasedinspections/index.htm

Purple Vigilance Limited established

We are very proud to announce that Purple Vigilance Limited, a Pharmacovigilance Consultancy, was established in September 2011. This website is under construction and will be completed soon, please check back regularly for updates. Please see the About Us and PV Services page for more information.  Please feel free to contact us to discuss your current or future requirements.