Updated 19 April 2012
Marketing authorisation holders have the opportunity of submitting follow-up questions to side effects (adverse reactions) reported by consumers, doctors or other healthcare professionals.
Send your follow-up questions to the Danish Health and Medicines Authority
If you need to follow-up on a reported adverse reaction that you received from the Danish Health and Medicines Authority, you must send your questions to the Danish Health and Medicines Authority. We then forward your questions to the person who reported the adverse reaction, unless specifically stated otherwise.
When the person who reported the adverse reaction has submitted his or her answers to the Danish Health and Medicines Authority, we write them into the report and send the updated report back to you.
Follow-up questions via DKMAnet
On our extranet, DKMAnet, you can find a form to submit follow-up questions to reported adverse reactions.
To gain access to DKMAnet, your company must appoint a Security Administrator (please see the form in the box to the right). Before appointment, the security administrator must have an employee signature from DanID installed on the computer. The employee signature must be registered in the name of the company.
You can order a Digital Signature from the Nets DanID website.
Security administrators and users working for companies that do not have a Danish company registration number must be issued a CUG certificate from the Danish Health and Medicines Authority (please see the form in the box to the right).
If you experience problems using the form, please contact DKMAnet Support (see DKMAnet – questions and answers for contact details).
Follow-up requests containing personal data
You are not allowed to send a follow-up request that contains personal details by email. All personal details must be submitted via a secure connection. Therefore, we advise you to send them via DKMAnet. Please consult our guidelines for follow-up on adverse reaction reports in the right-hand box.