DKMAnet: Follow-up on adverse reaction reports - questions and answers
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 Health and Medicines Authority, 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 Health and Medicines Authority 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 Health and Medicines Authority from the day you received the adverse reaction report.
Can I request the Danish Health and Medicines Authority to obtain a medical confirmation?
The Danish Health and Medicines Authority 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 Health and Medicines Authority 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 Health and Medicines Authority does not obtain a medical confirmation of side effects of a non-serious nature, unless they fall within a specific focus area.
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 Health and Medicines Authority 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 Health and Medicines Authority 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.
Our experience shows that the possibility of attaching documents means that this issue is not always considered sufficiently.
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 Health and Medicines Authority. Here you can also print submitted requests in PDF format.
How do I report my new address to the Danish Health and Medicines Authority?
You can log in to DKMAnet and apply for a change to the application (indicate change of address in the comment field).
As usual, you can also apply by email to firstname.lastname@example.org.
Note that to change the address, it costs an administrative fee equivalent to the application fee.
Can I apply for authorisation of retail sale for several shops?
On DKMAnet, you can apply for authorisation to sell medicines by retail in all the shops for which you are company administrator.
Who can apply for authorisation of retail sale?
Anyone who wishes to sell medicines by retail outside pharmacies.
Can I also report sales of over-the-counter medicines on DKMAnet?
No, not yet.
How long is my retail authorisation valid?
Authorisations are valid for three or five years at a time, and the expiry date is indicated on the authorisation.
When do I have to apply to renew my retail authorisation?
You must apply for renewal at least three months before the authorisation expires. The expiry date is indicated on the authorisation and can also be seen on DKMAnet.
What happens when I have applied for a retail authorisation?
When you submit an application for authorisation to sell medicines by retail, a new case is started in the Danish Health and Medicines Authority.
We will then plan an inspection at the retailer. We cannot issue a retail authorisation for medicines until we have made an inspection. The authorisation can only be issued if the company meets the applicable rules.
Why must I state information on a contact person in the application?
The contact person is used for contacting the applicant if we have any questions for the company.
The person responsible is indicated on the authorisation and bears the overall responsibility for ensuring that the terms and conditions for retail sale are met.
I have linked a package leaflet to too many strengths by mistake, how do I detach the package leaflet from a strength?
If your company no longer markets the strength concerned, change the status to ‘Not marketed’.
This will make the package leaflet disappear from indlaegsseddel.dk after six months.
If the package leaflet no longer applies to the specific strength, you must upload a new package leaflet for that strength.
We have received permission not to insert a package leaflet in the package. How do I remove it from indlaegsseddel.dk?
Set the status to ‘Not marketed’. This will make the package leaflet disappear from indlaegsseddel.dk after six months.
Which package leaflets must be uploaded to DKMAnet – Package Leaflets?
All package leaflets supplied with a package of medicine must be uploaded to DKMAnet - Package Leaflets.
How do I remove a package leaflet from indlaegsseddel.dk?
Set the status to ‘Not marketed’ if the medicine is no longer on the market. The Danish Medicines Agency removes medicines with the status ‘Not marketed’ from indlaegsseddel.dk after six months.
If you only need to update a package leaflet, simply upload the correct version instead.
What format should I use for package leaflets?
The package leaflet must be uploaded in PDF format. The size must not exceed 1MB in order not to take too long for you to upload or too long for the user to open. For this reason, we also recommend you to limit the resolution used for graphic elements to no more than 1200 dpi.
The file must be text based, and the text must be accessible to screen readers for the blind and visually impaired.
We accept crop marks as long as they do not interfere with readability.
What should I do to display my company’s package leaflets on indlaegsseddel.dk?
When you upload a package leaflet via DKMAnet - Package Leaflets, it will be displayed on indlaegsseddel.dk.