Marketing authorisation holders are encouraged to complete a Compliance Report every two years. MAHs were last requested to submit a compliance report in November 2011.
It is planned that the 2013 Compliance Report will be made available during November 2013 with a deadline for submission at the end of end of March 2014. Details will be posted on our website in due course. For the majority of questions any time-specific data will cover the period 01 January 2013 to 31 December 2013.
The Compliance Report will be in an MS-Excel format that contains the questions that need to be completed and guidance notes to clarify the information that should be provided. Completed Compliance Reports should be submitted to the GPvP risk-based inspections mailbox (email@example.com) in MS-Excel format.
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 any MAH who has not previously submitted a Compliance Report, please await the new version of the Compliance Report to be released later in 2013.