Creating an adverse event report using the online form
How to create an online adverse event report for an animal medicine.
Click ‘Start a new report’ on the application homepage and then select a report type.
From the report screen you will see a number of different report sections.
The section ‘Add Veterinary Surgeon Details’ is optional.
The section ‘Add Product’ allows you to add information about multiple products. Click ‘Add Product’ to input details of each additional product involved in the event.
The ‘Actions’ section allows you to perform various actions on the report itself, such as checking for errors or deleting it.
Each report is split into several sections which will vary depending on the type of event that you are reporting.
Each section has a number of different fields to be completed. Any that are marked with a red asterisk must be completed.
When you have completed a section, click the ‘Save and close’ button either at the top or the bottom of the screen. You can revisit a section at any time just by clicking on the relevant link on the report page.
Include all products to which the animal, person or environment were exposed to prior to the adverse event.
This may include products which were administered at the same time as the main suspect product(s), or that were administered before the main suspect product(s).Â
You do not need to list all products that the animal, person or environment has ever been exposed to but do try to include products that were administered within the weeks or months before the main suspect product.
The MA number is the Marketing Authorisation number assigned to a product when it is authorised in the UK.
It can be found on the product literature, preceded by the symbol ‘Vm’. It can also be found alongside other authorised product information on the VMD’s .
As you progress through your report a number of icons will appear to the left of each section name. These will show which sections need more data.
Mandatory fields
Several sections contain mandatory fields that must be completed. These are highlighted in red and are asterisked. If any of these have been left blank, then an alert icon will be displayed on the report screen.
Progress icons
Once all mandatory fields have been completed within a section, the icons will update to show you how much of the section has been completed.
The more data you supply, the more useful your report will be.
Section labels
As your report builds up, each section will display the key information for that section.
Certain fields have particular requirements for the way in which they are completed. This is so that your data can be captured as accurately as possible. For example, it is essential that a patient’s age also includes its corresponding unit.
Similarly, the start date of an event must be before the end date of the event and so on.
When you submit your report, a number of different system checks will be performed to ensure that each of these requirements have been satisfied. If any errors occur, then you will be asked to fix these and then try again.
You can check your report for errors at any time by clicking the ‘Check report for errors’ button on the report screen.
This will then display any errors, split up into the sections on your report. To correct the errors, you can click the ‘Fix this section’ button for the chosen section and it will take you to the appropriate section.
Once your report is complete you can click the ‘Submit Report’ button at the bottom of the ‘Report’ screen.
System checks will take place to ensure that your report data does not contain any errors.
Occasionally there may be an error that is only identifiable after you have clicked the submit button. A message will be displayed asking you to review certain areas of your report, before attempting submission again. Once any errors have been corrected, you can submit the report again.
If all of the validation checks pass, then the report will be sent into the VMD’s adverse event database.
Upon submission completion, a confirmation screen will be displayed which will include the report’s name and ‘Report ID’ for your reference.
Make a note of the Report ID in case you need to contact us or the Marketing Authorisation Holder (pharmaceutical company), or to identify the applicable report if we contact you for further information.
At this stage, you can submit feedback on the process of the completion of the form by using the .
The report can be printed or emailed as necessary. If you wish to save the report and not print it, you can save it as a PDF by clicking ‘Print summary report’ and selecting ‘Save as PDF’ instead of selecting a printer, depending on your device.
The summary report is only available immediately after submission, and this cannot be accessed again in the future.