Testing the exchange of E2B files
Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017. The reason is that our test environment will be reconfigured to tests with the EMA in connection with the preparations for the changed reporting process for ICSRs that will take effect on 22 November 2017.
Tests with sponsors will be resumed after 22 November 2017 since the applicable reporting process for SUSARs will not be changed.
Companies that want to send test files to us should write to us at E2B@dkma.dk as soon as possible so that we can agree on the details for the test. You should allow two weeks to complete a test.