All pharmaceutical manufacturers and parallel importers who hold marketing authorisations in Denmark (MAHs) and market products on the Danish market are obliged to enter into a contract with DMVO.

When you are ready to proceed, please send an email to info@dmvo.dk. You should set aside approximately 14 days for the process and ensure that you have a contract with EMVO in place.

If you want to read the contract in advance, you can find it here.

The EU directive states that it is the industry, i.e. originator manufacturers, generic manufacturers and parallel distributors, that shall fund the establishment and operation of the common European verification system.  This means that all companies that market prescription drugs in Denmark are required to pay a registration fee and an annual fee to DMVO.  You can read about the annual fee under the tab invoicing on this page.

The registration fee amounts to EUR 20,000 per MAH. In addition, there is an annual fee, which is invoiced at the same time as the registration fee.  The annual fee is EUR 6,700.   The annual fee covers one calendar year.  DMVO will issue an invoice for both fees immediately after the contract is signed.  The payment terms are 30 days.

MAH with an annual turnover of less than DKK 500,000 can apply for a reduced registration and annual fee.  You can apply by contacting info@dmvo.dk.  You cannot apply after the invoice has been issued.  The application is valid for one calendar year, after which you must apply again.

Should you have any changes to the contract details or the affiliates or MAHs specified in the contract – Exhibit C – after the contract is signed,  an amendment to the contract must be completed.  Please contact info@dmvo.dk if you have changes to Exhibit C in the contract.