Product defects and withdrawals of medicinal products
Practice for the assessment of reports on product defects at the Danish Medicines Agency
In total, the Danish Medicines Agency may receive reports on medicinal product defects or non-compliance with GMP from one or several of the following sources:
- pharmaceutical companies
- authorities in other countries (Rapid Alert System)
- Danish Medicines Agency, internally
When the Danish Medicines Agency receives a report, we initiate and perform comprehensive procedures, which, among other things, include an assessment of the seriousness of the defect. 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
As part of our procedures and to assess where the defective batch(es) are being used, the Danish Medicines Agency also investigates the following questions:
- Is the medicinal product marketed in Denmark?
- Who is the holder of the marketing authorisation/importer/manufacturer?
- Is the medicinal product parallel-imported/distributed?
- Has the medicinal product been authorised centrally?
- Is the medicinal product being clinically tested?
- Has a compassionate use permit been issued?
- Is the medicinal product being exported from Denmark?
If the defective product is marketed on or exported from the Danish market, the Danish Medicines Agency effects withdrawal of the concerned batches in collaboration with the company. We assess how far down the chain of distribution the withdrawal should be effected (wholesaler, pharmacy, consumer). We also assess whether the authorities in other countries need to be informed via the Rapid Alert System.
In cases where we assess that a defect may have profound implications for patients (withdrawal on patient level), we place a warning on the website of the Danish Medicines Agency.
In the event of a withdrawal, the company must submit the following documentation to the Danish Medicines Agency:
- Copy of the withdrawal letter
- An account of preventive measures
- Any other relevant data.
Withdrawal and suspension of Certificates of Suitability (CEP)
If the EDQM withdraws or suspends a 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 any medicines on the market contain these active substances from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect to the Danish Medicines Agency by email to firstname.lastname@example.org
You can find more information about withdrawn and suspended CEPs on the EDQM´s website