Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether it is possible to inform the Medicines and Healthcare Products Regulatory Agency of signs and symptoms that arise after a Yellow Card report has been submitted; and if so, how this should be done.

Additional information can be submitted directly by the original reporter or by the pharmaceutical company as new information becomes available following the submission of the original report. Furthermore, follow-up information is frequently requested by the Medicines Healthcare products Regulatory Agency (MHRA) in order to assess Adverse Drug Reaction (ADR) reports more effectively and to improve the quality of information on the database.

Once a Yellow Card (YC) report is submitted and entered onto the database, an acknowledgment letter or email is sent to the reporter to confirm receipt and advise of the ADR reference number.

Additional information can be provided to the MHRA at any time following the submission of a YC report. The ADR reference number is required together with any additional information to ensure that this is added to the correct report. However, every effort is made to identify the correct report in instances where the ADR reference number has not been provided.