Reporting of product defects that may lead to a withdrawal

Updated 13 November 2017

The Danish Medicines Agency must be informed if a company considers a product defect may lead to the withdrawal of a medicinal product from the market.

This is stipulated in Executive Order on the manufacturing and import of medicinal products and intermediary products.

In order to ensure the efficiency of the case handling please use this form when reporting:

Reporting of defective medicinal product

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 on telephone +45 44 88 95 95 or by email to rapidalert@dkma.dk and present the available information.

The company must as soon as possible submit the report to the Danish Medicines Agency and should therefore not necessarily wait until all the information is collected.

In case of immediate critical situations outside the normal opening hours of the Danish Medicines Agency, please call our main number at +45 44889595 for information about our emergency line.

The Danish Medicines Agency also receives notifications about medicinal product defects from other national competent authorities via the 'Rapid Alert System'.

The Danish Medicines Agency carefully evaluates such notifications, which (among other things) includes an assessment of the seriousness of the product defect.

The following applies to parallel importers/ distributors

In case of complaints concerning the quality of a repacked product, which can be traced back to the original manufacturer, the parallel importer/distributor must contact the marketing authorisation holder (MAH) of the directly distributed medicine or the MAH's representative.

The MAH of the directly distributed medicinal product is responsible for reporting the product defect to the Danish Medicines Agency if this is deemed necessary.

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