Applicable law

The Danish Medicines Agency and all holders of a marketing authorisation of a medicinal product for human use must submit suspected adverse reactions in electronic format to the EudraVigilance database. This follows from:

• Article 29 of the European Commission's Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in 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.

Requirements for the contents of an adverse reaction report are laid down in Article 28 of the Implementing Regulation.

The rules on the reporting of suspected adverse reactions by holders of a marketing authorisation 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 from medicinal products as well as Article 28(1) of regulation 726/2004 (as amended by regulation 1235/2010).

The rules on the reporting of suspected adverse reactions by the Danish Medicines Agency to the EudraVigilance database appear from section 12(1) and (2) of the Danish executive order no. 1191 of 6 November 2017 on the monitoring of adverse reactions from medicinal products as well as Article 28(1) of regulation 726/2004 (as amended by regulation 1235/2010).