DKMAnet: Follow-up on adverse reaction reports - questions and answers
Will I receive a receipt if my follow-up request is rejected?
If the Danish Medicines Agency rejects your follow-up request, you will receive a rejection letter. The letter will state the reason for the rejection.
How are our questions communicated to others?
We forward your questions to the person who reported the adverse reaction, unless it is specifically stated that the questions should be sent elsewhere.
When the person who reported the adverse reaction has submitted his or her answers to the Danish Medicines Agency, we update the report and return it to you electronically.
What is ”Safety Report ID/ADR number”?
It is the 8 figures from the DK-DKMA-ADR number, e.g. DK-DKMA-ADR-12345678. This information is mandatory. We use the number to identify the case in our systems.
What should I do if two reports link to each other?
If two reports link to each other – e.g. child/mother reports – please write the other ADR number in the first question field of the form. You can only write one number in the top field "Report ID/ADR numbers".
What is the "Company reference number"?
It is your company's opportunity to state your own reference number. It is solely for your company's internal use.
What is "Contact information" used for?
In connection with the processing of your application for additional information concerning adverse reaction reports, the Danish Medicines Agency may need to contact you. We would therefore like you to fill in the contact details for your contact person.
The name, email and telephone number is already filled in with the contact details related to your profile as a DKMAnet user.
You can change this data before you send the request if you would like a different contact person. You must indicate either a telephone number or an email address.
How should the questions be phrased?
When requesting follow-up, please carefully consider:
- if the questions are already answered in the report,
- if you have asked all of your questions in the first request so that the same report submitter should
only be contacted once,
- if the questions are relevant in relation to the adverse reaction report,
- if your questions are directed at consumers, in which case they should be written in an easily
accessible language, which can be read by anyone,
- that questions for consumers must be written in Danish,
- that it must be clearly indicated if you request a medical reply to questions in connection with a
report submitted by a consumer.
What is the deadline for requesting follow-up?
Please note that you have maximum three weeks to submit your follow-up request to the Danish Medicines Agency from the day you received the adverse reaction report.
Can I request the Danish Medicines Agency to obtain a medical confirmation?
The Danish Medicines Agency will in its own right seek out a medical confirmation for all reports of serious adverse reactions from consumers.
Therefore, you do not need to request the Danish Medicines Agency to obtain a medical confirmation. (A medical confirmation only implies that the doctor considers it possible that there might be a causal relationship between the suspected side effects and the medicine. A medical confirmation does not validate the patient data, etc.).
Please note that you cannot request a medical confirmation of non-serious side effects reported by consumers. The reason for this is that the Danish Medicines Agency does not obtain a medical confirmation of side effects of a non-serious nature, unless they fall within a specific focus area.
Can I request a medical record?
You can ask specific questions about a case report if collection of additional information is relevant and necessary for pharmacovigilance and patient safety. This means that you cannot just request a medical record e.g. a discharge summary, an autopsy report or an x-ray result in a follow-up request.
If you ask for a medical record in a follow-up request, your request will not be forwarded.
How detailed should the questions be?
Always be specific when you formulate your follow-up questions. Experience has shown that too open questions often result in doctors sending a copy of the patient file or discharge summary, in which case you do not get the doctor's medical opinion.
Examples of specific questions:
- What reactions has the patient experienced from prior exposures?
- Has the patient previously experienced similar reactions?
- What was the batch number of the product?
- What was the strength of the product?
- How long after exposure did the patient experience the first symptoms?
- When did the adverse reaction stop?
Can I ask questions about causal relationship when it concerns reports from doctors?
When reports are submitted by doctors, the Danish Medicines Agency takes it for granted that there is a suspected causal relationship between the suspected adverse reactions and the medicine. For this reason, it should generally not be necessary to ask whether a causal relationship exists.
When should I send a reminder for answers to a follow-up?
The Danish Medicines Agency sends reminders to doctors for follow-up replies at appropriate intervals. Therefore, you do not need to send any reminders.
How can I see the requests I have submitted?
On DKMAnet under the tab "Submitted", you can see your submitted requests. If you choose follow-up adverse reactions in the search box, you will only see your follow-up requests.
Can I attach documents to my request?
You cannot attach documents when submitting follow-up requests via the form on DKMAnet. The reason for this is that we would like you to actively decide which questions should be forwarded to the reporter.
RMP forms or forms with specific questions should be submitted via Eudralink in Word format to Send an email
How do I receive a receipt for my submitted request?
We do not send receipts for submitted requests, but under the tab "Submitted" you can see the requests we have received at the Danish Medicines Agency. Here you can also print submitted requests in PDF format.
Will I receive a receipt when my follow-up request is handled and forwarded?
You will not receive a receipt when the Danish Medicines Agency has handled and forwarded your follow-up request. If your follow-up request is not rejected, the Danish Medicines Agency will forward your request, and the case report will be updated if or when the Danish Medicines Agency receives new relevant information.