The Danish Health and Medicines Authority 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 section 30 of Executive Order no. 1242 of 12 December 2005 on the manufacturing and import of medicinal products and intermediary products.
The Danish Health and Medicines Authority also receives notifications about product defects in medicines from foreign medicinal authorities via the so-called 'Rapid Alert System'.
Before a decision is made to withdraw a medicinal product, the Danish Health and Medicines Authority carefully considers such notifications, including an assessment of the consequences of the product defect.
Companies are to report medicinal product defects to the Danish Health and Medicines Authority to the e-mail address of email@example.com or by contacting the Department for Planning and Development on +45 4488 9779.
In case of urgent problems outside the normal opening hours of the Danish Health and Medicines Authority, we refer to our emergency line.
When a report is made the following information should, to the extent possible, be specified:
- The name of the marketing authorisation holder and the manufacturer (if the latter is not the marketing authorisation holder)
- The name of the medicinal product, pharmaceutical form, active ingredient, strength and pack size
- Batch number, number of packages involved, manufacturing date and expiry date
- Information about the product defect, including any adverse reactions the defect may have caused
- The countries to which the medicinal product has been distributed
- The corrective actions the company has initiated or expects to initiate
The company must as soon as possible submit the report to the Danish Health and Medicines Authority and should therefore not wait until all the information has been collected.
The following applies to parallel importers/ distributors
As regards complaints about 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.
It is the MAH of the directly distributed medicinal product which has the responsibility to report the product defect to the Danish Health and Medicines Authority if it considers it necessary.