Exchange of adverse reaction reports - Q and A

Updated 03 May 2018

Which types of adverse reaction reports should we send directly to the Danish Medicines Agency (DKMA)?

A: The Danish Medicines Agency only receives Suspected Unexpected Serious Adverse Reactions (SUSARs).

Who sends the acknowledgement (ACK) for the reports, EMA or DKMA?

A: The Danish Medicines Agency sends the acknowledgment (ACK) for SUSARs. EMA sends the acknowledgement (ACK) for spontaneous reports.

When should the MAH send an update to a DKMA case to EudraVigilance?

A: Never. If the MAH has new information that is relevant to the case, they should send an email via Eudralink to ADR@dkma.dk. Subsequently, the Danish Medicines Agency will update the case, if necessary and relevant.

Should the MAH also send an email if the MAH wants to update a case that was originally created by the MAH?

A: No. 

If we as the MAH have an update to one of our own adverse reaction reports (not SUSARs) that were sent to the DKMA before 22 November 2017, who do we send the update to?

A: All adverse reaction reports, except SUSARs, must be sent to the EMA. This includes all updates to reports previously sent directly to the DKMA, regardless of severity.

How does the MAH upgrade a DK-DKMA case from a non-serious case to a serious case?

A: If the MAH wants to upgrade a report from the Danish Medicines Agency from non-serious to serious, the MAH must send an email via Eudralink to ADR@dkma.dk. If the Danish Medicines Agency agrees with the MAH, the case will be upgraded and sent to EudraVigilance.

In connection with an audit, how does the MAH upgrade a non-serious case to a serious case?

A: The Danish Medicines Agency’s inspectors accept the email that the MAH sends to ADR@dkma.dk, see above, to be sufficient documentation for timely upgrading of a case. The receipt date of the new version of the case will be the date of receipt of the email with arguments from the MAH.

Which email address should we use for enquiries concerning adverse reaction cases?

A: If your enquiry contains personal information or reference to personally identifiable data, we advise that you send the enquiry via Eudralink. Please note that responses to such enquiries will be provided via Eudralink. Link to Eudralink (EMA)

Enquiries about adverse reaction cases should be sent to ADR@dkma.dk. Regular follow-up requests should be submitted via DKMAnet.

Can the MAH disregard a report about capsules if the MAH only holds an authorisation for tablets?

A: Yes.

Does the Danish Medicines Agency use the IME list?

A: Yes, we use the IME list to a wide extent, however, not all terms (e.g. infections), and not only terms on the IME list, can make a case Serious Other.

Does the Danish Medicines Agency search for duplicates?

A: Yes.

Will the case narrative in reports from the Danish Medicines Agency be in Danish?

A: Yes, descriptive text fields in reports that the Danish Medicines Agency sends to EudraVigilance will be in Danish. 

Should the Danish case narrative appear from the case even though it may reduce the quality of global cases?

A: No, the Danish text may be replaced by an English text (translation) in the MAH’s local database, providing the same information as the Danish text. The case should not be sent to EudraVigilance.

The MAH has received a case from the Patient Compensation Association with a case number XX-XXXX. The case is similar to a case that we have previously received/downloaded with case number DK-DKMA-ADR XXXXXXXX. Would you please confirm or rule out that the case is a follow-up?

A: The Patient Compensation Association sends a copy of all decisions in cases about compensation for medicinal injuries to the Danish Medicines Agency. The Danish Medicines Agency is responsible for ensuring that all information is registered and sent to the EudraVigilance database of the European Medicines Agency. The marketing authorisation holder of a medicinal product should not submit adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Patient Compensation Association. Similarly, the marketing authorisation holder should not ask questions as to whether a case received from the Patient Compensation Association is a follow-up or an initial case, but wait for it to be available for download from the EudraVigilance database.

Do we have to send cases involving compensation for medicinal injuries, in which a decision is made in favour of the patient, to both the MAH and DKMA?

A: Section 3(1) of the executive order no. 428 of 9 May 2011 on the administration of cases involving compensation for medicinal injuries (BEK 428) provides that The Patient Insurance Association’s (now: the Patient Compensation Association) decisions are communicated to the injured person and the Danish Medicines Agency, and depending on the circumstances, the health authorities or healthcare professionals with a justified interest in the case. In cases where the Patient Compensation Association has decided that the injured person is entitled to compensation or reimbursement, the relevant manufacturer or importer will be informed, see section 3(2) of the executive order.”

Thus, the Danish Medicines Agency receives all decisions made by the Patient Compensation Association, and the MAH receives cases in which a decision is made in favour of the patient.

Pregnancy and follow-up: is it correct that the MAH does not have to ask about the outcome of pregnancy on DKMA cases if there is no need for asking any follow-up questions?

A: Yes, that is correct. The Danish Medicines Agency collects information on the outcome of pregnancy on cases created/reported by the Danish Medicines Agency to the EudraVigilance database.

Is it possible to include questions about e.g. dose and route of administration if we ask other relevant follow-up questions?

A: Yes, if you suspect that the dose or (incorrect) route of administration may have an impact on the adverse reaction.

Can the MAH request a follow-up on cases to which they do not have access to the case narrative?

A: No

How do we submit Risk Management forms via DKMAnet?

A: Since it is not possible to send Risk Management forms via DKMAnet, please send the form in Word format to this email address: ADR@dkma.dk. The form must be filled in with already known information so that only new information is requested. Before or at the same time, you need to submit a follow-up request via DKMAnet, in which all other relevant questions are asked. If the only question is completion of the Risk Management form, two questions are created via the form. The first question should be: Risk Management form sent via email today or on the relevant date. This is not a question, but information to us that the form has been sent via Eudralink to ADR@dkma.dk. The second question should be: ’Please fill in the enclosed form’. It is important that the form is in Word format so that it can be merged into our letter.

Does Danish legislation permit MAHs to include patient initials and date of birth in ICSRs submitted to Eudravigilance?

A: Yes. Danish legislation permits the inclusion of patient initials and date of birth in ICSRs submitted to Eudravigilance. Therefore, please include this information if it is known.

What should we do if our system is down and we need to submit a Danish report to the Eduravigilance Database? 

A: You should refer to the website of the EMA for guidance on emergency procedures: What to do in case of system failure.

EMA: EMA IT Service Desk (Tel. +44 (0)20 2660 7523)

What should we do if the Eduravigilance Database is down and we need to submit a Danish report? 

A: You should refer to the website of the EMA for guidance on emergency procedures: What to do in case of system failure.

EMA: EMA IT Service Desk (Tel. +44 (0)20 2660 7523)

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