Follow-up on adverse reaction reports

Pharmaceutical companies can request follow-up information on reports of suspected adverse reactions (side effects) when it is relevant and necessary for the monitoring of medicine safety (pharmacovigilance).

When the Danish Medicines Agency receives a request for follow-up information from a pharmaceutical company, it assesses if it is relevant and necessary to collect follow-up information.

• In order to request follow-up information from the Danish Medicines Agency, pharmaceutical companies must have full access (level 2B) to the case report via EudraVigilance (narrative included)
• The companies must provide a specific reason for each follow-up request
• The request must be relevant, necessary and well-founded in each case
• The criteria for submitting a follow-up request must always be met before submitting a written well-founded follow-up request to the Danish Medicines Agency

Specific reason

• Companies must submit a written request to the Danish Medicines Agency giving a specific reason for the requested information and detailing why the information is relevant and necessary for pharmacovigilance and patient safety
• All questions in a follow-up request must be formulated clearly as specific questions that are easily comprehensible for the recipient (experience shows that imprecise questions lead to imprecise answers)
• Follow-up questions must be written in a way that they can be forwarded to the recipient without being further edited or explained
• Questions to citizens should be in Danish
• RMP forms or forms with targeted questions should be submitted in Word format and pre-completed with already known information
• Requests for medical records such as epicrises, autopsies and X-rays are not possible
• In the case of reports submitted by doctors, the Danish Medicines Agency will assume that there is a suspected causal relationship between the suspected adverse reactions and the medicinal product. For this reason, it will usually not be necessary to enquire about a causal relationship in reports from doctors.

Recommendations

• Please write questions to healthcare professionals in Danish
• Please provide the recipient with a professionally justified reason, explaining briefly why collecting the information is relevant and necessary.
• Consider how to present questions in a clear and precise manner, for example in a table
• Consider whether the follow-up reply can be coded in structured fields

Submission of requests for follow-up information

We prefer written requests and questions to be sent via EudraLink to Send an email. The advantage of this solution is that the sender and recipient do not need to have a digital signature associated with their email accounts. Remember not to include the case number in the subject field as this field is not encrypted.

You can gain access to EudraLink by creating a user on the website of the EMA.

Link to EudraLink

An alternative to EudraLink for the submission of personal data is using the encrypted form. However, since this requires an employee signature, the form may only be relevant for people employed at a Danish workplace.

You can find information about the encrypted form on this page here.

Link to encrypted form

Please note that the request must be sent to the Danish Medicines Agency no later than three weeks after the adverse reaction report was received.

Rejection

The Danish Medicines Agency will reject follow-up requests from pharmaceutical companies in the following situations:

• A request that does not include a specific reason for each question will be returned, and the pharmaceutical company will be asked to submit a new reasoned request that meets the above criteria.
• A request that does not include precise questions will be returned, and the company will be asked to submit a new request with questions that meet the above criteria.
• In the opinion of the Danish Medicines Agency, the collection of additional information is not relevant and necessary for monitoring the safety of a medicinal product (signal detection and assessment of the medicinal product’s risk-benefit balance)
• A follow-up request on known adverse reactions described in the summary of product characteristics will usually be rejected. Follow-up may, in exceptional cases, be relevant, for example if there is a strong suspicion that a known adverse reaction occurs more frequently than expected, and a signal has been raised.
• Non-serious reports (unless a signal has been raised, and the information is relevant in. relation to the raised signal).

If the follow-up request is rejected, the Danish Medicines Agency will send a letter to the submitter stating the reasons why.

Examples of situations where it may be relevant and necessary to request follow-up information

• PSUR pharmacovigilance assessment procedure
• Pharmacovigilance assessment procedure required by the PRAC
• Pharmacovigilance referral assessment procedure
• Pharmacovigilance signal assessment procedure
• RMP obligation

Forwarding of follow-up requests

If the follow-up request is considered relevant and necessary for patient safety, the Danish Medicines Agency will forward the follow-up request and update the case report if or when it receives new relevant information. If no reply is received, the Danish Medicines Agency will send out reminders at appropriate intervals.

The Danish Medicines Agency does not issue receipts when follow-up requests have been handled and forwarded. Follow-up requests that are not rejected will be forwarded and the case updated if/when the Danish Medicines Agency receives new relevant information.