Guidance

Send and receive information on adverse drug reactions (ADRs)

How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.

From:
Medicines and Healthcare products Regulatory Agency
Published
18 December 2014
Last updated
30 April 2024 — See all updates

Reporting arrangements

Marketing authorisation holders (MAHs) must send all UK individual case safety reports (ICSRs) and serious non-UK ICSRs directly to MHRA via either ICSR Submissions or Gateway.

For cases in respect to Northern Ireland the country code XI should be used to send ICSRs to MHRA.

MHRA accepts E2B R2 and R3 format XMLs and will convert E2B R3 cases to E2B R2 for processing into the database. MHRA will transmit Adverse Drug Reaction (ADR) reports received directly to relevant MAH. This will be decided using the suspect drug in the report.

Those wishing to report to MHRA need to register with MHRA and should do so by following the guidance on registering to make submissions to MHRA.

A list of reports received via the EMA from 28 December to 31 December (MS Excel Spreadsheet, 105 KB)

New MHRA systems

We are replacing our legacy IT systems, including a new adverse incident database. Our new system will be deployed over the weekend of 11 and 12 May 2024 and will be live from Monday 13 May 2024. Any files received after Thursday 11.59pm on 9 May 2024 will be queued and loaded into our new database and will receive acknowledgements in the E2B R3 format.

R3 standard compliant systems: what’s changing for vigilance reporting for MAHs?

The new MHRA database is compliant with the ICH ICSR R3 standard and conforms with EU implementation guidance.​

While the database will be based on the R3 standard, our new system will be able to convert R2 standard XMLs into the R3 standard for ingestion. After go-live of our new systems we will continue to accept ICSRs in both R2 and R3 standards.

All XML files sent from MHRA will be in the R3 standard format. This includes both ASPRs and acknowledgements. It is important that your systems and/or procedures can receive and manage files in the R3 standard effectively as our new systems will not be able to send R2 files. ​

No updates are necessary to the sender or receiver ID in XMLs. The MHRA receiver ID will continue to be MHRAUK.​

There will not be a transition period between databases. Any ICSRs sent before 23.59pm on Thursday 9 May 2024 will be acknowledged in R2. Any sent after will be acknowledged in R3.

MHRA gateway users

The gateway will continue to accept R2 and R3 XMLs both for ICSRs and acknowledgements.

You do not need to make any changes to your application programming interface (API) connection to our systems. You do not need to inform us that your organisation is R3 ready.

ASPRs will be sent as individual files rather than in batches.

No testing is required. However, if you wish to test the system it is now available to do so.

As with production, no changes are necessary for using the test environment to either the API or to the sender/receiver ID. The test receiver ID continues to be MHRAUKTEST. 

If you would like to receive an R3 ASPR via the gateway, contact david.sullivan@mhra.gov.uk.

ICSR submissions portal users

The portal will continue to accept R2 and R3 XMLs via Post XML.

Portal users will be able to create new reports using either the R2 or R3 form.

Acknowledgements and ASPRs sent from MHRA will be in the R3 format.

Portal users will continue to be able to download ASPRs as a PDF file, but these will now be in the R3 standard.

Literature monitoring

We will not publish a literature monitoring list. Instead, MAHs will be responsible for conducting relevant literature searches and sending these to MHRA. These should include reports received from the EMA Medical Literature Monitoring (MLM) service. Email vigilanceservice@mhra.gov.uk if you have any queries on reporting new literature for ADRs.

Signals

A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. MHRA is responsible for detecting and managing safety signals in regards to UK products.

In line with GVP IX requirements, standalone notifications of signals should be sent to signalmanagement@mhra.gov.uk.

Standalone signal notification form (MS Word Document, 132 KB)

When an MAH becomes aware of an emerging safety issue, they should notify it in writing to MHRA (signalmanagement@mhra.gov.uk). For guidance on emerging safety issues, see GVP IX.

Contact

Email E2B.support@mhra.gov.uk with technical queries or to escalate an E2B issue you can speak to a member of the E2B team:

If your query specifically relates to ASPRs email vigilanceservice@mhra.gov.uk.

Or, if you’re unhappy with how your query is dealt with, contact the pharmacovigilance service coordinator, Faiza Farooq, 0203 080 6312.

Published 18 December 2014
Last updated 30 April 2024 + show all updates

  1. Updated with information about new MHRA systems.

  2. Reporting arrangement sections updated to include a list of reports received via the EMA from the 28 December to the 31 December

  3. Reflecting the end of the transition period, removed old information about changes to reporting arrangements. Added new information on literature monitoring and signals.

  4. Updated literature report list

  5. updated literature report

  6. New sections added and text removed

  7. Updated literature list

  8. Updated literature report list

  9. Updated literature report.

  10. Updating lit report list.

  11. Updated literature report list

  12. Literature report document updated.

  13. New literature report list added to the page.

  14. Updated literature report list added to the page.

  15. Updated literature list.

  16. New literature report list.

  17. Updated literature report

  18. New literature report list added to the page.

  19. Updated literature report list added to the page.

  20. Updated literature report.

  21. Updated literature report list.

  22. Updated Literature report.

  23. New literature report list added to the page.

  24. Updated literature report list

  25. Updated Literature report list.

  26. Updated Literature report list.

  27. new literature report list added to the page.

  28. Updated the literature report list.

  29. Up-to-date literature report added to the page.

  30. Updated the Literature report list

  31. Updated literature report

  32. Updated literature reference list

  33. updated literature reference list

  34. Updated literature list

  35. Updated literature reference list

  36. Updated literature report list

  37. Updated literature report.

  38. updated literature report list added to the page

  39. updated literature reference list

  40. updated literature report list

  41. New literature report list published

  42. updated literature reference list

  43. Updated literature report list

  44. Updated literature list

  45. Updated literature report list

  46. updated literature list

  47. Updated literature reference list

  48. Updated literature reporting list

  49. Updated literature reference list

  50. updated literature reference list

  51. Updated literature report.

  52. Updated literature report added to the page.

  53. Updated literature report.

  54. updated literature report list

  55. Updated literature report list.

  56. Updated literature list

  57. Updated literature list

  58. Updated literature list

  59. Updated literature report added to the page.

  60. Updated literature list.

  61. Updated PV literature

  62. updated literature list

  63. Updated literature list

  64. Updated literature list

  65. Updated literature list

  66. Updated literature report.

  67. Updated literature list

  68. Updated literature reference list.

  69. Updated literature reference list

  70. Updated literature list

  71. Updated literature material

  72. Updated literature list

  73. Updated literature report list.

  74. updated literature list

  75. Updated literature list

  76. Updated literature report list

  77. updated literature list

  78. updated literature list

  79. Updated literature report list

  80. new reference material

  81. Updated literature report list.

  82. new literature list

  83. Updated literature report.

  84. new literature list

  85. Updated literature list

  86. Updated literature report list.

  87. Updated literature report list.

  88. Updated literature report list.

  89. Updated literature report list.

  90. Updated literature report list.

  91. Updated literature report list

  92. Updated literature report list.

  93. Updated literature report list

  94. Updated literature report list

  95. Updated literature report list

  96. First published.

Contents

Related content