Reporting of product defects
Companies are required to contact the Danish Medicines Agency and report any product defect that could result in a recall of a medicinal product. This applies also to the manufacture or preparation of a medicinal product at hospital pharmacies.
Reporting via form
Product defects must be reported to the Danish Medicines Agency as soon as possible. If investigations are ongoing, further information may be submitted after the initial notification. If we need further information for our assessment, we will request it.
Product defects are notified using this form:
Reporting of medicinal product defects
Note: Completion of the form must never delay the reporting of potentially serious product defects. Instead, you must provide the Danish Medicines Agency with the available information by calling us on our main telephone line: +45 44 88 95 95.
In case of urgent problems that occur outside the Danish Medicines Agenxy´s normal opening hours (business days from 9am to 3pm), we ask you to call our emergency line.
Product defects involving centrally authorised medicines or medicines marketed in other countries must also be reported to the European Medicines Agency (EMA) and the relevant national competent authorities, respectively.
Product defects of medicines manufactured in Denmark must be reported to the Danish Medicines Agency if they could result in a product recall, even if the affected batches are not marketed in Denmark.
If the affected products have been distributed to several markets, the Danish Medicines Agency may inform the authorities in other countries via the Rapid Alert system.
We assess cases on the basis of the reported information
Before recommending any market actions, we assess the potential risk the product defect may pose to patients or animals. We also assess if the recall may lead to critical supply shortages.
The Danish Medicines Agency requires a range of information in connection with the reporting, including:
- Health hazard assessment (patient risk)
- Root cause analysis
- Delimitation of the product defect
- Corrective and preventive actions
- If a recall is recommended, the expected recall level
In case some of the information is not available at the time of reporting, the company may submit preliminary documents. The company can submit additional information afterwards.
Further information about recall of medicines in Denmark is available at the website of the Danish Medicines Agency regarding recall of medicinal products.
If a product defect – due to, for example, a recall or quarantine – is expected to cause supply shortages, the Danish Medicines Agency should be informed as described here:
Notification duty in the event of medicines supply shortages (laegemiddelstyrelsen.dk).
Reporting concerning parallel imported, parallel traded and parallel distributed medicines
In the case of possible quality defects involving a repackaged product that may be attributed to the original manufacturer, the company importing, trading or distributing the product in parallel must contact the marketing authorisation holder of the directly distributed medicine or the marketing authorisation holder in the export country.
It is the responsibility of the marketing authorisation holder of the directly distributed medicine to report the product defect to the Danish Medicines Agency if this is deemed necessary.