When a health professional or citizen has reported an adverse reaction, the company submits follow-up questions regarding the adverse reaction to the Danish Health and Medicines Authority, which then contacts the person having reported the adverse reaction.
A template has been designed by the Danish Health and Medicines Authority, the Danish Association of the Pharmaceutical Industry and the Danish Generic Medicines Industry Association in unison for the companies' follow-up questions to reported adverse reactions. The companies fill in this template and send it to the Danish Health and Medicines Authority. You can download the template in the right-hand factbox.
The template has two pages. The first page concerns the pharmaceutical company's contact details, whereas the second page contains the questions that the pharmaceutical company wishes to be answered by the person who reported the adverse reaction.
You can send the template to the email address: fos-biv-tast@dkma.dk. Please remember that you are required to encrypt any health information concerning identifiable persons.
You can also send it by ordinary post to:
Consumer Safety
Adverse Reactions
Danish Health and Medicines Authority
Axel Heides Gade 1
2300 Copenhagen S
Denmark
