Denmark: Additional Criteria Requirement to Notify Medicines Supply Shortage

ARQon
Jun 19, 2023
1 min read

Medicines supply shortage in the healthcare market is an event that must be avoided from happening. The Danish Medicines Agency (DMA) updated new criteria to notify the medicines supply shortage on 6 June 2023.

As stated in Section 22(2) of the Danish Medicines Act, only the marketing authorization holder (MAH) or the designated Danish market representatives are responsible to submit the notifications to the DMA. The medicines supply shortage notification is applicable for temporary supply shortages or permanent discontinuation of the medicines. The notification must be submitted 2 months prior to the expected shortage to occur.

DMA is in the process of consulting the new list of critical medicines which requires notification of the expected shortage. Advisable for manufacturers to refer to the critical medicines list so the manufacturers acknowledge which medicines require notifications. Below are some shortage events that require notification:

All the medicines listed in the critical medicines except for medicines supply shortage that last less than 7 business days with no effect on any medical treatment
MAH estimates the supply shortage is critical for the patients
The medicines supply shortage could last for more than 60 days

The notification submission can be done by filling in the new designated form so the input given to the DMA is accurate. This will escalate the reviewing process and reduce the shortage effects in the market.

Source: Danish Medicines Agency (DMA)