Public consultation on the guidelines on the advertising of medicinal products

The Danish Medicines Agency has sent two new draft guidelines on the advertising of medicinal products for respectively humans and animals out for consultation with a deadline of 1 March 2022. The drafts contain specifications within several areas, including in relation to the use of SoMe and vaccination campaigns.

Article  -  16.02.2022

Medical device news

The European Commission’s extended transition period regarding in vitro diagnostic medical devices has come into force, and new guidelines have been issued regarding clinical evidence for in vitro diagnostic medical devices and regarding electronic instructions for use.

Article  -  14.02.2022

News regarding the Danish Medicines Council - conditional recommendations to be used as of 2022

The board of the Danish Regions has decided that as of 1 January 2022, and for a limited period, the Danish Medicines Council can issue conditional recommendations regarding medicinal products.

Article  -  03.11.2021

Medical device news

The European Commission launches modules 2 and 3 of EUDAMED, and the Medical Device Coordination Group has published two new guidance documents.

Article  -  12.10.2021

News from the Danish Medicines Council - reassessments must be made according to the QALY measure as of 1 June 2022

The Danish Medicines Council has just announced that come 1 June 2022, the Council will make reassessments according to the new assessment methods comprising the QALY measure. This will apply for all recommendations - regardless of when they were made.

Article  -  13.09.2021

New executive orders and guidelines on medical devices

On 26 May 2021, Regulation (EU) 2017/745 on medical devices entered into force. Consequently, the authorities have updated a number of Danish executive orders and guidelines and have also issued several new sets of rules in this field.

Article  -  08.06.2021

The new regulation on medical devices has now entered into force - what does that entail?

The new regulation (EU) 2017/745 on medical devices came into force on 26 May 2021 repealing the former directives in the field. With the new regulation, operators within the medical devices industry face more stringent obligations. In the following, we describe what these operators will have to pay attention to. 

Article  -  25.05.2021

New rules on HCP relationships and economic support to HCPs come into force on 26 May 2021

The amendments to the rules on HCP relationships with companies and economic support to HCPs come into force on 26 May 2021. Among other things, the amended rules concern the group of comprised companies, the obligation to report economic support, and the obligation to make notifications or seek permission regarding HCP relationships.

Article  -  25.05.2021