Reporting of stock levels
Who must report stock levels?
All companies (including parallel importers and distributors) that market a medicine covered by Annex 1 to the executive order on medicines subject to mandatory stockpiles must report their stock levels intended for the Danish market to the Danish Medicines Agency. It is possible to delegate the reporting obligation to a third party. This may be relevant if the stock is stored by another actor. It is only possible to delegate the reporting obligation to one other reporting company per medicine package.
When must stock levels be reported?
The reporting obligation comes into effect on the 1st of January 2025, and must be fulfilled every other Monday when a new Medicine Price Period begins. The stock levels must be recorded at 8 AM and reported by 8 PM at the latest. The first stock level report is on the 6th of January 2025.
If the relevant Monday for reporting falls on a public holiday, Christmas Eve, or New Year's Eve, the company must report the stock levels on the next working day by 8 PM, recorded at 8 AM on the same day.
If the company has been granted a dispensation from the requirement for stock location in Denmark or from the stock size, or if the company has had its stockpile obligation suspended, the company is still required to report the stock levels to the Danish Medicines Agency.
How must stock levels be reported?
Reporting of stock levels is done via a form where an Excel overview of the stock levels is attached. The form can be accessed in either Danish here or English here.
The reporting solution is still under development, and therefore changes in content, setup, and format are reserved.
Overall, the process can be divided into four steps:
1. Login with MitID
2. Enter Contact Information in the Form
In the form, enter the contact information of the reporting company. Enter the name, phone number, and email address of the contact person, as well as the name of the company the contact person is employed by. If applicable, the name of the company they are reporting for should also be entered if reporting for another company.
This information is needed in case the Danish Medicines Agency needs to contact the reporting company, for example, if there are questions about the report.
3. Submit Stock Levels via an Excel File
In an Excel file, enter data about the stock levels. The Excel file can be opened directly from the form via a link.
The Excel file is set up with predefined columns to be used to enter data about the stock levels for the individual packages. The following data is entered:
- Item number for the package
- Stock level (number of packages)
- Storage country
It is important that all three columns are filled out for all rows in a report.
If a dispensation has been granted to store some of the packages in one or more other countries, two or more rows are entered for this item number. That is, there is one row per country.
The Excel template is not "marked" for a specific report, so it is possible to save the file locally at the company, enter the item numbers you have, and then use the same file for all reports. This way, the company only needs to update the columns with stock levels.
4. Attach the Completed Excel File to the Form Before Submitting to the Danish Medicines Agency
When the Excel file is completed, attach the file to the form, and then submit everything together to the Danish Medicines Agency.
The company will receive a receipt at the email address provided under contact information in the form. This email receipt confirms that the Danish Medicines Agency has received a report on stock levels.