Applicable law

Rules on reporting suspected adverse reactions to EudraVigilance database

The Danish Medicines Agency and holders of a marketing authorisation of a medicinal product for human use must submit suspected adverse reactions electronically to the EudraVigilance database.

The rules on the reporting of suspected adverse reactions by marketing authorisation holders to the EudraVigilance database appear from section 6(1) and (2) and section 7(1) of the Danish Executive Order No. 1191 of 6 November 2017 on the monitoring of adverse reactions of medicinal products, as well as in Article 28(1) of Regulation (EC) No 726/2004 (as amended by Regulation (EU) No 1235/2010).

The rules on the Danish Medicines Agency’s reporting of suspected adverse reactions to the EudraVigilance database appear from section 12(1) and (2) of Executive Order No. 1191 of 6 November 2017 on the monitoring of adverse reactions of medicinal products, as well as in Article 28(1) of Regulation (EC) No 726/2004 (as amended by Regulation (EU) No 1235/2010).

The requirements for the content of an adverse reaction report appear from Article 28 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (as amended by Regulation (EU) 2025/1466).

According to Article 29 of the Implementing Regulation, Member States and marketing authorisation holders must use the format laid down in Article 26 of the Regulation and the terminology laid down in Article 25 of the Regulation for the electronic reporting of suspected adverse reactions to the EudraVigilance database.