New practice for follow-up information on adverse reaction reports

29 September 2017

The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies’ requests for follow-up information on reports of suspected adverse reactions.

We need to strengthen the practice to ensure that we only receive follow-up requests that are relevant and necessary for pharmacovigilance reasons.

Pharmaceutical companies are encouraged not to request follow-up information, unless the information is considered relevant and necessary for pharmacovigilance and patient safety.

The companies must give a specific reason for each follow-up request, and the request must be relevant, necessary and well-founded in each case. The Danish Medicines Agency will reject follow-up requests from pharmaceutical companies if the criteria for a follow-up request are not met.

Read more about the processing of follow-ups, requirements for the individual requests and our guideline for follow-ups