Product defects and recalls

Updated 11 July 2019

The Danish Medicines Agency receives reports of medicinal product defects and non-compliance with GMP. This could be errors in the quantity of the active substance contained in the product, product contamination or errors involving the packaging or labelling.

We review the reports quickly and thoroughly. If necessary, we may recall medicines in collaboration with the companies involved.

Who report product defects?

  • Pharmaceutical companies
  • Authorities in other countries (via the Rapid Alert System)
  • Danish Medicines Agency, internally (through laboratory control, inspection or in connection with the review of variation applications)
  • Healthcare professionals (usually doctors and pharmacies)
  • Consumers

The procedure for reporting a product defect

When the Danish Medicines Agency receives a report of a product defect, we assess the gravity of the product defect for patient safety. We also consider how the population would be affected by potential supply difficulties caused by defects that are not classified as critical.

We assess patient risk based on the following classification:

  • Class 1: The defect is potentially life-threatening – immediate action
  • Class 2: The defect may cause disease or mistreatment of the patient – action within 24 hours
  • Class 3: Other, the defect entails no patient risk – action within 2-3 working days

In addition, we find out where the defective batches of the medicine are used, if the medicine is marketed in Denmark, who has authorisation to import and manufacture the medicine, if compassionate use permits have been issued, and if it is exported from Denmark.

Recall of medicinal products

If an error is discovered involving a medicine that is on the Danish market or is exported from Denmark, the Danish Medicines Agency initiates a recall of the affected batches together with the company.

The Danish Medicines Agency assesses how far down the chain of distribution the recall should be effected (wholesaler, pharmacy, patient). We also assess whether the authorities in other countries need to be informed via the Rapid Alert System.

In the event of a recall, the company must submit the following documentation to the Danish Medicines Agency:

  • Copy of the recall letter
  • An account of preventive measures
  • Any other relevant data

In cases where we assess that a defect may have profound implications for patient safety, and a recall at patient level must be effected, we will communicate the recall, e.g. on the website of the Danish Medicines Agency.

Withdrawal and suspension of Certificates of Suitability (CEP)

If the EDQM withdraws or suspends a Certificate of Suitability (CEP), the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.

If there are medicines on the market containing these active substances from the concerned active substance manufacturer, the company must report the product defect to the Danish Medicines Agency by email to rapidalert@dkma.dk.

At the website of the EDQM, you can find more information about withdrawn and suspended CEPs.

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