Reporting suspected adverse drug reactions

Reports received from healthcare professionals
All individual reports of serious suspected adverse reactions associated with the use  of the product in the UK must be reported to the Medicines and Healthcare products Regulatory Agency within 15 calendar days of receipt.

Individual reports of serious suspected adverse reactions occurring elsewhere in the European Economic Area (EEA) must be reported to the regulatory authority in the Member/EFTA state in which the incident occurred within 15 calendar days of receipt.

For mutually recognised products, reports of serious suspected adverse reactions should be made additionally to the Reference Member State.

For suspected adverse reactions occurring outside the EEA individual reports of serious and unexpected adverse reactions must be reported to the Medicines and Healthcare products Regulatory Agency within 15 calendar days of receipt. Additionally reports should be made to the EMEA and all other Member/EFTA states where the medicinal product is authorised.

Reports from worldwide literature
World-wide literature should be screened in accordance with sections 1.2.1 and 1.2.2.2 of Volume 9. Reports of serious adverse reactions identified from such literature must be reported as follows. Serious adverse reactions that have occurred in the UK and satisfy the reporting criteria must be reported to the Medicines and Healthcare products Regulatory Agency. Such reactions occurring elsewhere in the EEA must be reported to the regulatory authority in the Member/EFTA state in which the incident occurred. All serious and unexpected reactions from outside the EEA should be reported to the Medicines and Healthcare products Regulatory Agency and additionally to the EMEA and all other EEA states where the medicinal product is authorised. Marketing authorisation holders should expedite reporting 15 calendar days from awareness of the relevant publication by any personnel of the holder.

Reports from post-authorisation studies
Serious adverse reactions occurring in post-authorisation studies should be reported in accordance with section 1.2.2.3 of Volume 9. In particular, serious unexpected reactions occurring in studies in the UK should be reported to the Medicines and Healthcare products Regulatory Agency within 15 calendar days of receipt.

You should be aware that in addition to these requirements, adverse reactions occurring in clinical trials must be reported by the trial sponsor in accordance with the requirements of Directive 2001/20/EC and, in the UK, Part 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004.

Additional points
Reports should reach the Medicines and Healthcare products Regulatory Agency by the 15th calendar day.

In addition to the requirements stated above, the Medicines and Healthcare products Regulatory Agency requests that the marketing authorisation holder submits to the Agency expedited reports of serious suspected unexpected adverse reactions of which the holder is informed by regulatory authorities outside the EEA.

All suspected adverse reactions associated with a product, whether or not subject to expedited reporting requirements, must be reported in a periodic safety update report
submitted as follows:
- six monthly for the first two years following authorisation.
- annually for the subsequent three years.
- then five yearly at the time of renewal of the authorisation.

These periods may be altered by agreement with the Agency. If your licence was granted via a change of ownership application then the frequency of the periodic safety update report will be the same as that of the licence in issue prior to the change of ownership.

The marketing authorisation holder should note that in addition to the requirements set out above, they must have at their disposal an appropriately qualified person responsible for pharmacovigilance. Any change in the qualified person must be reported to the Medicines and Healthcare products Regulatory Agency. In accordance with Article 103 of Directive 2001/83/EC, that person must:

• establish and maintain a system to ensure that suspected adverse reactions reported to the company are collected and collated at a single point in the Community; 
• prepare the expedited reports required by Article 104 of the Directive;
•  ensure requests from the Agency for information relating to the evaluation of benefit and risks afforded by a medicinal product are answered fully and promptly;
• and report to the Agency any information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorisation studies.

Mandatory electronic ICSR reporting
Earlier this year the MHRA published an update on our preparation for the introduction of mandatory electronic ICSR reporting between marketing  authorisation holders (MAHs) and the MHRA. This update, which includes technical information on MHRA specific additional requirements to incorporate when submitting electronic reports, can be found in the document below.

› Mandatory electronic ICSR reporting (20Kb)

Implementation status at the MHRA
We are ready to begin testing the two way transmission of electronic ICSRs with MAHs.

All MAHs will be required to successfully test electronic transmission with the MHRA prior to switching from paper to electronic reporting. Testing will be conducted with test reports on a dedicated testing environment at the MHRA. Paper reporting of real reports in fulfillment of reporting obligations should continue in parallel during the testing period. Once testing has been completed to the satisfaction of the MHRA and the MAH, paper reporting can stop and electronic reporting of real reports can begin. It is not intended to have a transition period of parallel paper and electronic reporting of real reports.

If an MAH has already successfully tested electronic reporting with the EMEA EudraVigilance system or intends to submit reports via the EMEA EVWEB tool, then it is envisaged that a truncated testing process can be followed.

Registering to test
If you are ready to begin testing with the MHRA please send an e-mail to ICSRTesting@mhra.gsi.gov.uk including the following information:

• Name of MAH
• MAH company numbers
• Business contact (including name, position, phone, fax and e-mail details)
• Technical contact (including name, position, phone, fax and e-mail details)
• EudraVigilance Gateway ID (testing and live IDs if applicable)
• Earliest date when available to begin testing
• Preferred date to begin testing

We will contact you to agree a slot in the testing schedule and a testing plan. We will endeavour to test with all MAHs as soon as possible. Until testing is completed, paper reporting should continue in line with reporting obligations.

Further information
If you require any further information please e-mail your query to ICSRInformation@mhra.gsi.gov.uk