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News about companies' reporting of side effects
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28 February 2012
Delay in ACKs for adverse reaction reports due to IT maintenance
EMA is performing maintenance of the EudraVigilance database, including the gateway, from 29 February 2012 to 5 March 2012. There will therefore be a delay in the dispatch of acknowledgement messages (ACKs) for adverse reaction reports.
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29 June 2011
Problems with dispatching acknowledgement messages (ACKs) for adverse reaction reports from comapanies
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway. Unfortunately, as a result of our problems with the gateway, a considerable number of reports have piled up (backlog). Therefore, there will most likely be delays in dispatching ACKs. We hope to straighten out the situation by the end of the weekend.
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23 June 2011
Errors in the dating and the number of adverse reaction reports
The Danish Medicines Agency had network problems on Wednesday 15 June 2011. Consequently, a very large number of adverse reaction reports failed in our EudraVigilance Gateway.
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16 June 2011
Problems with dispatching adverse reaction reports and acknowledgement messages (ACK) on 15-16 June
In connection with a clean up of failed adverse reaction reports Thursday morning 16 June 2011, some reports may have been dispatched more than once.
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12 April 2011
Implementation of MedDRA version 14.0
MedDRA is updated every six months, and on 1 March 2011, MedDRA version 14.0 was released. Therefore, MedDRA version 14.0 will be implemented the night before Monday 2 May 2011.
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01 April 2011
Companies' (MAH) handling of adverse reaction reports received via E2B from the Danish Medicines Agency
When the Danish Medicines Agency sends adverse reaction reports via E2B to marketing authorisation holders (MAHs), it sometimes happens that an MAH returns the adverse reaction report to Danish Medicines Agency via E2B.
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29 March 2011
Acknowledgement Message (ACK) for receipt of an adverse reaction report
The Danish Medicines Agency's new pharmacovigilance system now dispatches ACKs in batch runs. That is why you will no longer receive an ACK immediately after you have submitted an adverse reaction report to the Danish Medicines Agency.
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25 January 2011
EMA changes domain name 7 February 2011
Please note that, as part of the European Medicines Agency’s domain name change from 'EMEA’ to 'EMA’, adverse reaction reporting systems will need to be updated in order to still send E2B files.
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17 January 2011
No acknowledgement message is currently dispatched when companies submit electronic adverse reaction reports
Since Thursday 13 January, the Danish Medicines Agency has experienced problems with dispatching acknowledgement messages (ACKs) for electronic adverse reaction reports submitted by companies. We are doing all we can to solve the problem fast so that we can send the ACKs that are awaiting.
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10 December 2010
Update of validation rules for electronic reporting of adverse reactions
We are updating the validation rules in connection with the implementation of the Danish Medicines Agency's new adverse reaction database. The changes, which entered into force on 6 December 2010, are.
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29 November 2010
Delay in acknowledgements for adverse reactions submitted from 1 December to 6 December 2010
Companies submitting electronic adverse reaction reports to the Danish Medicines Agency in the period from 1 Dece´mber up to and including 6 December are advised that the electronic acknowledgement will be delayed.
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29 October 2010
Implementation of MedDRA version 13.1
MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by ICH (International Conference on Harmonisation).
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25 October 2010
Adjustment of new validation rules for electronic exchange of adverse reaction data
On 11 October, the Danish Medicines Agency, implemented the updated validation rules for electronic exchange of E2B files ((ICH E2B (R2)) EV7 Release 1.
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06 October 2010
Implementation of new validation rules for electronic exchange of adverse reaction data
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.
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06 July 2010
New validation rules for electronic exchange of adverse reaction data via E2B from 15 September 2010
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.
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04 May 2010
Upgrade of the Danish Medicines Agency’s system for electronic transmission of adverse reaction reports via Eudravigilance gateway
On 5 May 2010, the Danish Medicines Agency will perform an upgrade of the system for transmission of adverse reaction reports between the European Medicines Agency and the pharmaceutical companies (Cyklone to Axway version 5.2.2)
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05 November 2009
Problem regarding receipt of adverse reaction reports now solved
Yesterday and the day before, the Danish Medicines Agency had problems receiving ICSRs and SUSARs via the EudraVigilance gateway, due to an error that occurred in the update of the message format release version.
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03 July 2009
Mandatory electronic submission of adverse reaction reports
The Danish Medicines Agency is always looking for ways to improve the processes of adverse reaction reporting. The vast majority of adverse reaction reports associated with medicinal products for human use are submitted electronically by the holders of marketing authorisations in compliance with the provisions of executive order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports.
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22 December 2008
From New Year the Danish Medicines Agency will take over the contact to doctors who report adverse reactions
In the new year, the contact between doctors reporting adverse reactions and the pharmaceutical companies responsible will take place via the Danish Medicines Agency.
