Companies which report adverse reaction data to the Danish Medicines Agency are advised that on Monday 11 October 2010, we will be implementing the updated (ICH E2B (R2)) validation rules for the exchange of E2B files, which entered into force on 1 June 2010.
The validation rules are to ensure that we receive correct and adequate data when you submit an adverse reaction report to us. If your report does not comply with the validation rules, you will receive an error message advising you in detail about what caused the error.
A list of the updated rules has been compiled by the European Medicines Agency, which you can download in the factbox to the right.
We expect the following error messages to be prevalent:
- failure to indicate (yes/no) value for seriousness criteria,
- failure to indicate qualification value,
- failure to enter a valid company number (companynum). The number must start with a country code followed by a hyphen (-), e.g. ‘DK-‘.
- failure to enter valid MedDRA codes (e.g. if they have not been updated),
- failure to enter ’reaction outcome’.
If you have any questions about the new validation rules, please contact the Danish Medicines Agency on +45 4488 9595 or E2B@dkma.dk.
Danish Medicines Agency, 6 October 2010