Exchange of adverse reaction reports - Q and A

Which mailbox should we use for inquiries concerning adverse reaction reports and the MAH’s pharmacovigilance obligations?

Inquiries should be emailed to Send an email.

If the inquiry contains personal/personally identifiable data, including the case number, you must send the inquiry via Eudralink. Please note that replies to this type of inquiry will only be answered via Eudralink.

Please be aware that case numbers, e.g. ADR number and Worldwide Unique Case Identification Number, constitute personally identifiable data, and therefore the inquiry must be submitted via Eudralink.

Which mailbox should we use for inquiries concerning the data quality of adverse reaction cases?

The inquiry should be emailed to Send an email via Eudralink.

According to the ‘Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency’ (EMA/533039/2019, Rev1), the MAH may send questions if a report submitted by the Danish Medicines Agency to the EudraVigilance database contains clear discrepancies.

This could happen if the report pertaining to a suspect medicine of the MAH includes a batch number that does not belong to the MAH, of if the MAH has downloaded two or more reports from the Danish Medicines Agency from the EudraVigilance database that the MAH suspects are duplicates of one another.

Which mailbox should we use for inquiries concerning E2B reporting of SUSARs?

Inquiries should be emailed to Send an email.

Please be aware that case numbers, e.g. ADR number and worldwide case identification number, constitute personally identifiable data, and therefore the inquiry must be submitted via Eudralex.

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

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. + +31(0)88 781 7523)

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

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. + +31(0)88 781 7523)

Which type of adverse reaction reports should the MAH send directly to the Danish Medicines Agency?

The Danish Medicines Agency only accepts Suspected Unexpected Serious Adverse Reactions (SUSARs).

Who sends the acknowledgement (ACK) for the reports – the EMA or the Danish Medicines Agency?

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

How should the MAH proceed if wanting to upgrade a DK-DKMA case from non-serious to serious?

In case 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 Send an email. If the Danish Medicines Agency agrees with the MAH, the case will be upgraded and submitted to EudraVigilance.

How should the MAH proceed in connection with an audit related to an upgrade from non-serious to serious?

The email that the MAH sends to Send an email, cf. the above, will be accepted by the inspectors as adequate documentation for the timely upgrading of a case. The receipt date of the new version of the case will be the date of receipt of the email containing the MAH’s argumentation.

What mailbox should we use to send a follow-up to an adverse reaction case?

Regular follow-ups should be sent via DKMAnet. It is not possible to send risk management forms via DKMAnet

Risk management forms must be emailed to Send an email via Eudralink.

Before doing so, a follow-up request must be submitted via DKMAnet which should also include any other relevant questions. 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 has been sent by email today or on the relevant date.” So this is not a question but information letting us know that a form has been submitted via EudraLink to Send an email. The next question should be: “Please fill in the enclosed form”.

The form must be in Word format and must be pre-populated with all known information so that only new information is requested.

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

No. This would require that the MAH has access to all information of the case, including the case narrative.

Is it possible to include questions to other adverse reactions than those covered by the risk management plan?

Yes, if information likely to impact the adverse reaction’s causality assessment is missing.

Is it possible to include questions about, for example, the dose and route of administration if we ask other relevant follow-up questions?

Yes, if you suspect the dose or (incorrect) route of administration to have a bearing on the adverse reaction.

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

Yes, that is correct. The Danish Medicines Agency will collect information about the outcome of pregnancy for cases created/reported by the Danish Medicines Agency to the EudraVigilance database.

Does the Danish Medicines Agency use the IME list?

Yes, we will upgrade the case to serious (other medically significant) if the MedDRA term is on the IME list.

Does the Danish Medicines Agency search for duplicates?

Yes.