Important information on changes to the submission of Individual Case Safety Reports (ICSRs) for adverse drug reactions

Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

The MHRA is now receiving 97% of all UK Individual Case Safety Reports (ICSRs) electronically via E2B. In order to support the MHRA's move to a paperless working environment from 1 March 2010, the MHRA will no longer be accepting paper Council for International Organizations of Medical Sciences (CIOMS) forms.

Marketing authorisation holders (MAHs) who do not have electronic reporting in place will need to email PDF copies of the CIOMS forms to ICSRSubmissions@mhra.gsi.gov.uk You will then receive an automated email which should be used as confirmation that the MHRA has successfully received your case.

The ultimate aim is to have all MAHs reporting electronically via E2B. Therefore, if you have not already registered for testing please contact us at ICSRTesting@mhra.gsi.gov.uk

Page last modified: 09 February 2010