Contributed by: Tara Isherwood, Manager, Late Stage Submissions Group, inVentiv Health Clinical
Marketing authorisation holders are encouraged to complete a Good Pharmacovigilance Practice (GVP) compliance report every two years. The 2013 compliance report is now available for completion, the deadline for submissions is 30 May 2014.
The Compliance Report is in an MS-Excel format and contains the questions that need to be completed. Guidance notes on completing the questionnaire are also available and should be read before completing the questionnaire.
Completed compliance reports should be submitted to the GPvP risk-based inspections mailbox in MS-Excel format.
MHRA good pharmacovigilance practice RBI questionnaire – December 2013
Guidance for completing the MHRA good pharmacovigilance practice RBI questionnaire 2013 (29Kb)
The following key points should be noted:
- only one compliance report should be completed per pharmacovigilance system
- if applicable, please use the same Company Group Name you provided in your 2011 Compliance Report (see ‘Section 1. General Information’)
- every question should be answered (failure to do so will result in a maximum risk score being assigned for that question)
- if your company or company group holds marketing authorisations the compliance report should be completed even if you are not currently marketing product in the UK
- when the compliance report has been completed this should be saved as an MS-Excel file with a standard file name – ‘Company Group Name’ (DD-MMM-YYYY)
- when the compliance report is submitted to the risk based inspection mailbox a standard email subject header should be used – RBI 2013 ‘Company Group Name’
- for the majority of questions, any time-specific data requested will cover the period 1 January 2013 to 31 December 2013.