Companies that report adverse reaction data to the Danish Medicines Agency are advised that new validation rules for electronic exchange of E2B files soon enter into force.
New rules implemented as of 15 September 2010
As from 15 September 2010, the Danish Medicines Agency will have implemented the new validation rules in the Danish pharmacovigilance database.
By this date at the latest, companies that exchange E2B files with the Danish Medicines Agency must have completed testing and implementation of the new validation rules.
Briefly about the new rules for exchange of E2B files
The updated (ICH E2B (R2)) validation rules for the exchange of E2B files entered into force on 1 June 2010. You can read about the rules via the link in the factbox to the right (Note for Guidance EudraVigilance Human – Processing of Safety Messages and Individual Case Safety Reports (ICSRs).
An implementation plan containing a list of changes has also been drawn up (see the link in the box to the right).
Paper form reports will not be accepted from 15 September 2010
From 15 September 2010, the Danish Medicines Agency will no longer accept spontaneous adverse reaction reports from pharmaceutical companies sent by ordinary post, fax or email. Paper form reports will be returned together with a request for resubmission via the EudraVigilance Gateway. The Danish Medicines Agency will also send adverse reaction reports to pharmaceutical companies via the EudraVigilance Gateway. This is done in efforts to enhance the handling of adverse reaction data.
You can find guidance on access to and use of the EudraVigilance Gateway on EMA's website (see the link in the box to the right).
Small and medium-sized companies can submit adverse reaction reports electronically via an interface called EVWEB. EVWEB is specifically designed for small and medium sized companies which do not have a fully 'ICH E2B (R2)' compliant pharmacovigilance system for electronic exchange of adverse reaction reports and which do not have access to the EudraVigilance Gateway.
Guidance on EVWEB is available at EMA's website (see the link in the factbox to the right).
The practice for reporting SUSARs is unchanged, so the above does not apply to SUSAR reporting.
Test of exchange with the Danish Medicines Agency
All companies must test the exchange of E2B files with the Danish Medicines Agency. This test involves the dispatch and receipt of E2B files. Companies that already exchange, i.e. dispatch and receive, E2B files with the Danish Medicines Agency have already been authorised and do not need to perform a test again as a result of the new rules (see the above).
You can read more about the procedure for testing exchange of E2B files with the Danish Medicines Agency via the link in the factbox to the right.
The requirement for electronic transfer of adverse reaction reports is specified in the following Danish executive orders:
- 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. 1238 of 12 December 2005 on monitoring of adverse reactions from medicinal products (Danish title: Bekendtgørelse nr. 1238 af 12. december 2005 om bivirkningsovervågning af lægemidler).
If you have any questions or need to test exchange of E2B files with the Danish Medicines Agency, please contact us at E2B@dkma.dk.
Danish Medicines Agency, 6 July 2010
