This section includes the latest news from the Pharmacovigilance Inspectorate.
Latest pharmacovigilance news
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21 Nov 2011 | Timeframes for publication and distribution of updated SPCs and PILs
The GPvP Inspectorate publishes its expectations on the timeframes for publication and distribution of updated product information following approval of safety-related changes.
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01 Nov 2011 | Good Clinical Practice (GCP) forum launched
A new Agency discussion forum for Good Clinical Practice (GCP) has been launched.
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19 Sep 2011 | Compliance reports for Good Pharmacovigilance Practice
Marketing authorisation holders (MAHs) will be encouraged to complete a Compliance Report as a biennial activity. An updated version of the Compliance Report for 2011 is now available on the page on risk-based inspections.
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19 Aug 2011 | New page published on the Inspection Action Group
The Inspection Action Group (IAG) is a non-statutory, multi-disciplinary group constituted to advise the Director of the Inspection, Enforcement and Standards Division on any recommendation for regulatory or adverse licensing action appropriate to the Division.
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02 Mar 2011 | Responses to questions raised at the MHRA Good Pharmacovigilance Practice (GPvP) symposium held in November 2010
Answers in response to questions that were either submitted to the MHRA panel prior to the symposium or submitted on the day.
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14 Oct 2010 | New template Summary of Pharmacovigilance Systems (SPS) document and associated guidance for good pharmacovigilance practice (GPvP) inspections
A revised template for the information requested for GPvP inspections has been published, as well as a guide to completing the SPS.
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30 Jun 2010 | Good Pharmacovigilance Practice Consultative Committee meeting minutes and questions and answers
The minutes from the Good Pharmacovigilance Practice Consultative Committee meeting on 20 May have been added to the website, along with the questions for the committee meeting.
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29 Jun 2010 | Pharmacovigilance inspection metrics report - July 2009 to March 2010
The pharmacovigilance inspection metrics report from 1 July 2009 to 31 March 2010 is now available.
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19 May 2010 | Pharmacovigilance inspection metrics
We have set up a page dedicated to the pharmacovigilance inspection metrics reports to make it easier to find these reports.
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19 May 2010 | Updates to frequently asked questions
Our FAQs have been reviewed and updated. The format has also been revised to make it easier to navigate through the questions.
