All manufacturers and parallel importers of prescriptive medicine (Marketing Authorisation Holders - MAHs) wishing to place their products on the Danish market from 9th. February 2019 will have to enter a contract with DMVO
The EU Directive states that the pharmaceutical industry (original and generic manufacturers and parallel importers) will have to fund the establishment and operation of a pan-European verification system, which will also include setting up the Danish system (DMVS). This means that every company wishing to have a product sold on the Danish market from 9th. February 2019 will have to pay a one time set-off fee and an annual verification fee to DMVO.
>>DMVO is a non-profit organization and will not be run to make profit<<
All manufacturers and parallel importers, who hold a marketing authorization in Denmark, received letters from the Danish Medicines Agency and DMVO in June 2017 with a request to send their contact information to DMVO about who the DMVO should contact in order to enter into a dialogue on the conclusion of a contract. Read the letter here.
October 24, 2017 an information meeting for all MAHs, manufacturer and parallel importers were held at DMVOs premises in Copenhagen. DMVO hosted the meeting and among guest speakers was EMVO, who covered the topic of onboarding to EMVO. You will find the invite here and the presentations from the meeting here.
Also, all MAHs, manufacturer and parallel importers who have registered with DMVO received a letter by 30th. of November 2017 regarding entering a contract and payment to the DMVO, covering both the one time set-off fee and the annual fee.
Read the letter here
Find the contract here
See the Step-by-Step guide to the Contract Management System here
The MAH contract is handled digitally in DMVO. Therefore, it´s a prerequisite that companies/MAH´s register at DMVO. When registering, you must provide DMVO with the name of the company that will enter into an agreement with DMVO, the name of contact person, title, telephone number and e-mail address. It is possible to register up to two contacts in the contract management system. Once DMVO has received the required information, an account for the contact person will be created in the contract management system and further information send by email.
The contracts with DMVO will be signed digital by both parties. In order to ensure that the right person signs the contract, please send the name, title and email address of the authorized person or persons to sign the contract to email@example.com.
Once the contract is ready for signature, the person to sign will receive an email with notification to sign the contract. Please find the procedure for signing the document here.
The participation agreement with DMVO can be entered in 3 waves. The first wave has been closed. MAH’es entering the agreement with DMVO until September 30, 2018 will be part of wave 2. Please note the pre-request of your company or your Onboarding Business Partner to have signed an agreement with EMVO, prior to entering a contract with DMVO and in order to obtain the financial discount. The deadline for Wave 2 is September 30, 2018. In order to get the discount of 25% of the One off registration fee, the agreement must be signed by both parties by the 30th. of September 2018. In order to make this deadline, the contract must be filled in and uploaded to the contract management system of DMVO at the latest September 15, 2018. DMVO ensures that all contracts received by this date, will be handled and finalized within the 2nd. Wave. Contracts received outside the contract management system or after September 15, 2018, we can’t guarantee will be finalized by 30th. September 2018, due to the procedure of reviewing and signing the contract.
In case there are updates to Exhibit C or D in the participation agreement after it has been entered by both parties, kindly use the Amendment to participation agreement. An example is shown here
The amendment to participation agreement is also found in the contract management folder of DMVO in a word version for your update. Only fill in the amendment when there are changes to either Exhibit C or D. If the changes only applies for one of the exhibits, please feel free to remove the other exhibit from the amendment before you upload the document to the contract management folder. Once filled in, kindly send an email to firstname.lastname@example.org that an amendment has been filled in for your company. Hereafter we will initiate the signature process.
February 2015 a non-profit organization was set up, The European Medicines Verification Organization (EMVO), responsible for administration, operation and management of the verification system on European level. For manufacturer and parallel importers it means that they will also have to upload their data onto the European hub (EMVS). This is necessary since the Danish database will not have 'national uploads'. Since July 14, 2017 it has been possible to enter an agreement with EMVO and to upload product data to the European database (EMVS).
You can read more about this on the EMVO website.
Since July 14, 2017 it has been possible to enter an agreement with EMVO and since 16th of April 2018 to upload product data to the Danish Verification System which is now connected to the European Hub.
Read the official announcement from DMVO here
Additional information for manufacturers and parallel importers who have not yet started the onboarding process for EMVO, please read below:
News from EMVO: