This section provides information for pharmaceutical companies on the reporting of suspected adverse drug reaction (ADR) reports.
Please click the links on the left side for information on the following:
- information on company receipt of Anonymised Single Patient Reports (ASPRs)
- questions and answers on E2B reporting
|
Important information on changes to the submission of Individual Case Safety Reports (ICSRs) |
|---|
|
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 |
Pharmacovigilance Service Desk
The aim of the Pharmacovigilance Service Desk is to be the first port-of-call for marketing authorisation (MA) holders and their representatives, enquiring about any pharmacovigilance related matters and any associated regulatory activity.
We aim to provide an answer to all enquiries within seven working days of receipt. If we are unable to respond directly we will refer to other relevant areas of the Agency. In such cases, we may need to revise the response timeframe and will keep you informed.
The Pharmacovigilance Service Desk will be manned between the hours of 9:00 and 17:00, Monday to Friday and can be contacted by telephone or preferably by email at:pharmacovigilanceservice@mhra.gsi.gov.uk
|
Contact telephone numbers
|
|
|---|---|
| MA holders A-L: MA holders M-S: MA holders T-Z: |
020 3080 6550 020 3080 6153 020 3080 7730 |
The service desk aims to be a one-stop shop for MA holder enquiries relating to Pharmacovigilance. For submitting suspected adverse drug reaction reports, we ask that you continue to follow previously issued guidelines. Should there be any questions about this new service, please contact Zamshed Harun, Service Desk Coordinator, on 020 3080 6242 or by email at zamshed.harun@mhra.gsi.gov.uk. Alternatively, the Service Desk Team Leader, Lance Smithson on 020 3080 6764 or by email at lance.smithson@mhra.gsi.gov.uk
