Suspension of the stockpile obligation

A company can have the stockpile obligation suspended in two cases: either by reporting a shortage to the Danish Medicines Agency or by notifying the Danish Medicines Agency of a need to use the stockpile for a limited period.

The stockpile obligation can also be suspended if the Danish Medicines Agency has granted permission for the company to use the stockpile to address supply difficulties in another country. However, this will always be initiated by the Danish Medicines Agency.

Suspension due to shortage

The company's stockpile obligation is suspended when the company reports a shortage of a given package covered by the stockpile requirement to the Danish Medicines Agency. The stockpile obligation is suspended for as long as the shortage lasts, and the company can use the stockpile throughout the period. When the shortage ends, the company has 3 months to rebuild the stockpile.

Read more about reporting shortages here: Medicine shortages

Suspension due to use of the stockpile

If a company needs to use the stockpile for a limited period of time to avoid a supply difficulty, the stockpile obligation can be suspended if the company notifies the Danish Medicines Agency before using the stockpile. The following conditions must be met:

• The company has notified The Danish Medicines Agency
• Use of the stockpile lasts for a maximum of 3 months
• The company can supply the market during the period
• The company has rebuilt the stockpile no later than 3 months after the end date of the suspension

Notification of the use of the stockpile can be made using the form below. It is only possible to notify the use of one package per form.

Form to notify about use of stock obligation.

Notifications are not processed, and the use of the stockpile can proceed immediately after a notification is made. The suspension is valid from the time specified in the form until the stated end date, but for a maximum of three months.