Reporting suspected adverse reactions from biological medicinal products

Updated 06 April 2016

The Danish Medicines Agency has increased focus on the monitoring of adverse reactions from biological medicinal products, including any adverse reactions that occur when switching between biosimilar medicinal products and reference medicinal products. To be able to monitor the safety in the best possible way, we must monitor biological medicinal products on product level.

On 1 January 2016, a new executive order (no. 1823 of 15 December 2015) on the reporting of adverse reactions from medicinal products etc. became effective. The executive order repeals the former executive order no. 381 of 9 April 2014 on the reporting of adverse reactions from medicinal products etc.

The new executive order includes a new rule that an adverse reaction report from a doctor, dentist or midwife must, to the extent possible, include the name and batch number of the medicinal product if the report concerns a biological medicinal product appearing from the list made by the Danish Medicines Agency. The list is published on the Danish Medicines Agency’s website.

Applies to certain biological medicinal products only

The Danish Medicines Agency has made the below list of biological medicinal products. An adverse reaction report concerning one of these medicinal products must contain the name and batch number of the medicinal product, to the extent possible. The list is dynamic and will be updated on an ongoing basis. The requirements for the contents of an adverse reaction report are laid down in section 7 of the executive order.

Moreover, the executive order on registered healthcare professionals’ patient records has also been amended. Patient records must include the name and batch number of a prescribed biological medicinal product if the medicine appears from a list prepared by the Danish Medicines Agency. The list is made available to the Danish Patient Safety Authority that publishes the list on its website. The list contains the same medicinal products as those mentioned above. Read more on the Danish Patient Safety Authority’s website (in Danish).

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