The Danish Health and Medicines Authority encourages pharmaceutical companies (marketing authorisation holders) to start testing the exchange of E2B files with the Danish Health and Medicines Authority.
This note outlines the testing procedure for ICSRs (Individual Case Safety Reports).
Electronic transmission of ICSRs is mandatory
Electronic transmission of ICSRs to and from the former Danish Medicines Agency, now the Danish Health and Medicines Authority, became mandatory on 20 November 2005. This follows from:
Executive Order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports, etc. (Danish title: Bekendtgørelse nr. 1214 af 7. december 2005 om krav til udformning af bivirkningsindberetninger og periodiske sikkerhedsopdateringer m.v.)
Executive Order no. 822 of 1 June 2012 on monitoring of adverse reactions from medicinal products (Danish title: Bekendtgørelse nr. 822 af 1. juni 2012 om bivirkningsovervågning af lægemidler)
The links for the executive orders are linked to the Danish legal texts.
Prerequisites for testing the electronic transmission
- In order to complete the test, your company must have a profile on the EMA EudraVigilance test gateway. If you do not already have one, please contact the EMA. All testing will be conducted via the EMA Eudravigilance test gateway. Our test ID is TDKMAEUDRA.
- The IT system of the Danish Health and Medicines Authority only supports ICH ICSR DTD Version 2.1. Please make sure that your test files match this standard.
Practical test arrangements
Please contact E2B@dkma.dk or call Consumer Safety on +45 4488 9757 to arrange the practical aspects of testing before you send an E2B test file to the Danish Health and Medicines Authority.
You will be asked to provide the following information:
- the name of the contact person in your company,
- whether your company wants to test either sending or receiving E2B files or both,
- your company's profile ID on the EMA EudraVigilance gateway – both production and test ID.
We will also schedule a suitable time for the test. Any alterations made to this plan, whether made by your company or us, should be communicated immediately.
Please note that the electronic transmission of SUSARs (Suspected Unexpected Serious Adverse Reactions) is also included in the test if relevant.
If you have questions about electronic transmission of SUSARs, please send them to E2B@dkma.dk.
Transmission of E2B files
- If you are sending E2B test files to the Danish Health and Medicines Authority, please indicate the report number either in the field A.1.0.1 Sender's (case) safety report unique identifier or A.1.10.2 Other sender's case report number. Then send your E2B file to TDKMAEUDRA via the EMA EudraVigilance test gateway.
- If you are receiving an E2B file from the Danish Health and Medicines Authority, it will have the number DK-DKMA-ADR 12345678 or DK-DKMA-EFO1234 in the field A.1.10.1 Regulatory authority's case report number. All data in the report are fictitious. Please note that if you are generating cases online and sending using EVWeb, we do not require a prior testing. However, you have to contact us in advance in order to configure the sender ID in our system.
- Please notice that the Danish Health and Medicines Authority will send multiple ICSRs in one message if we have more than one report to declare the same day. Therefore your system has to be able to accept multiple cases in one message.
Both the Danish Health and Medicines Authority and the companies are required to evaluate the contents of the acknowledgement messages within two business days after completion of the test.
Please contact the Danish Health and Medicines Authority two business days after completion of the test to compare data.
If your company requests a retest, please contact us at E2B@dkma.dk or call Consumer Safety on +45 4488 9757.
If you need further information about electronic transmission of ICSRs, please go to the frequently asked questions. You can also send your questions to E2B@dkma.dk.