Reporting of defective medicinal product

The Danish Medicines Agency

Support: +4544889595

Please note that the completion of this form must never delay the reporting of critical product defects. In critical situations, please contact us as quickly as possible by e-mail to rapidalert@dkma.dk (only within The Danish Medicines Agency’s opening hours) or by telephone +45 44 88 95 95, and present the available information.

If the quality defect concerns several products, the reporting company decides whether the information should be submitted in a single form, whether several forms should be submitted, or whether an overview of products and batches should be provided as appendices.

In order not to loose data, it is important that you are active at least once per hour, and that the form has been completed and sent within 8 hours, according to recommendations from the Danish Agency for Digital Government.

You will receive a copy of the submitted form in the case of a succesfull submission. It is important that you control that this copy is received, and if you do not receive one, please contact rapidalert@dkma.dk. Submitted forms with attachments cannot exceed 50 MB.

Origin of report

Reporting company *

Foreign address

Address

Adresseopslag

Contact information

Name and title of contact person *

Email of contact person * We will send a receipt

Telephone number for contact person *

Cause of reporting

The Danish Medicines Agency is informed due to

The product is distributed to Denmark
The product is released in Denmark
One or more manufacturing steps take place in Denmark
Other reasons

If other, please elaborate

Product details

Name(s) of product(s) *

Strength(s) *

Pharmaceutical form(s) *

Pack size(s) and type(s)

Marketing authorisation number

Marketing authorisation holder (MAH)

Company name

Foreign address

Address

Adresseopslag

Danish MAH representative, if relevant

Company name

Foreign address

Address

Adresseopslag

Product registration

How is the product registered?

Denmark's role

Reference member state (RMS)
Supervisory authority (SA)
Concerned member state (CMS)
Rapporteur or co-rapporteur
None of the above

Domain of use

Human
Veterinary

Short description of the (primary) use of the product E.g. indication, specific patient groups etc..

Where is the product QP released?

Name of the company responsible for the product release

Foreign address

Address of the company responsible for the product release

Adresseopslag

Which authorities will be informed regarding the product defect? Please provide a reason

Where is the product manufactured?

Should be filled in for relevant manufacturing steps, including API manufacturing. Please state the manufacturing step performed at each site. If there are more than two manufacturing steps, please provide the information in an appendix.

Manufacturing step 1

Company name and manufacturing step

Foreign address

Address

Adresseopslag

Manufacturing step 1

Manufacturing step 2

Company name and manufacturing step

Foreign address

Address

Adresseopslag

Manufacturing step 2

A more detailed description may be attached as an appendix

Uploaded Files

Information about the product defect

Short description of the defect or problem

A more detailed description may be attached as an appendix

Uploaded Files

What is the extent of the problem? This could include details about batch numbers and number of batches affected. If a large number of batches are affected, please provide the information in an appendix

Information about affected batches may be attached as an appendix.

Uploaded Files

Summary of investigations

What is the root cause?

Describe corrective and preventive actions

A more detailed description may be attached as an appendix an appendix

Uploaded Files

What is the patient risk?

Risk assessment etc. may be attached as an appendix.

Uploaded Files

Preliminary risk classification of the defect/problem

Class 1 – The defect is potentially life threatening
Class 2 – The defect may cause illness or mistreatment of the patient
Class 3 – The defect may not pose a significant hazard to health. However, actions may be relevant for other reasons

Please state the reason for the selected risk class

Has any adverse reactions/events that may be related to the defective product been observed?

If yes, please elaborate

Where are the affected batches distributed to?

Wholesalers
Pharmacies
Hospital Pharmacies
Retailers
Other

If other, please elaborate

Have affected batches been distributed to other countries?

If yes, please state which countries:

Which actions has currently been done?

None
Quarantine, own stock
Quarantine, own stock and at wholesalers
Other

If other, please elaborate

Which market actions do you suggest?

None
Distribution stop from own stock
Recall
Other

If other, please elaborate

Reason for proposed actions

Level of possible recall

Wholesaler
Pharmacy /retailer
End user (ie. patients, veterinarians and animal owners)

Consequences of a potential recall (regardless of a recall is proposed or not) *

None as other batches/presentations are available
Possible supply issues
Other reasons

If other, please elaborate

Other relevant information

Other relevant information may be attached as an appendix

Uploaded Files

File generation

MailConfiguration