See latest news from DMVO and upcoming events
– updated January 24th 2019
Presentation from the information meeting on January 18th 2019
On the 18th of January 2019 DMVO held an
information meeting for stakeholders in DK. You will find the presentation from
the meeting here and the presentation from the NCA here.
Supporting video for Pharmacies to connect to the verification system
DMVO has created a supporting video for Pharmacies on how to create a connection to the verification system. The video is only available in Danish and can be found here.
Annual fee for MAHs
The annual fee for MAHs to DMVO will be EURO 8.500,00 per MAH. The annual fee is due for payment first time by March 1st. 2019 and includes the new EMVO contribution for the NMVO.
Presentation from the information meeting on December 14. 2018
On the 14th of December 2018 DMVO held an information meeting for stakeholders in DK. You will find the presentation from the meeting here.
Presentation from the information meeting on November 16. 2018
On the 16th of November 2018 DMVO held an information meeting for stakeholders in DK. You will find the presentation from the meeting here.
Information meetings at DMVO prior to 9th February 2019
Is your company ready for the EU Directive (2011/62 / EU) on Falsified Medicines to enter into force by 9th February 2019?
In exactly 102 days the EU directive comes into force, and countdown has started. DMVO wants to ensure that everyone has access to the latest news in the implementation of the directive here in Denmark.
Therefore, we invite you to join our Friday good morning meetings. The meetings take place at Lersoe Parkallé 101 in Copenhagen from 8:00am to 9:55am. We offer a cup of coffee and a croissant as well as information about the latest news. The Danish Medicines Agency will be present at all meetings and there will be an opportunity to ask questions to both the Danish Medicines Agency and DMVO. The tone will be informal, so please feel free to join and raise any question you may have, in order to help you get your business ready by February 9, 2019.
Meeting dates are:
Friday, November 16, 2018
Friday, December 14, 2018
Friday, January 18, 2019
Seats are limited, it is the first come first served principle and registration can be done by sending an email to Lars Martinussen at firstname.lastname@example.org.
At the first meeting, taking place 16th November 2018, DMVO will provide feedback on the experience gained by all pilot participants during the Pilot which has taken place from April 2018 until now.
Looking forward to seeing you.
Registration of the new GTINs at the wholesalers from now and until go live of the FMD by February 9, 2019
Megros, the wholesaler association in Denmark, has prepared guidelines for manufacturer on how to register the new GTINs prior to receiving the goods until ‘go live’ of FMD by 9th. February 2019.. Please find the attached description here on how to act in this situation.
The excel file referred to in the letter, can be requested by sending an email to email@example.com or firstname.lastname@example.org
In case you have any questions, kindly contact Nomeco email email@example.com or TMJ email firstname.lastname@example.org directly.
25 September 2018
DMVO IT Workshop for wholesalers, pharmacies and 3PLs.
On Tuesday, September 25, 2018, DMVO organizes an IT workshop for wholesalers/3PLs who is required to connect to the National Verification System under the EU Pharmaceutical Directive (2011/62 / EU).
Note: the workshop is for IT savvy individuals.
Read the agenda and invitation here
Registration to be send to email@example.com, stating the participant's name, role, company and clarification for the need to connect to DMVS.
In addition, each participating company must complete and sign a Non-Disclosure Agreement (NDA). Please send the NDA to DMVO's Blueprint Provider, Solidsoft Reply, e-mail address firstname.lastname@example.org with a copy to Lars Martinussen email@example.com no later than two working days before the workshop.
Find Non-Disclosure Agreement here
Registration deadline for the IT workshop is on 18 September 2018.
Invitation- Free event on the responsibilities of pharmaceutical companies
THIS EVENT IS IN DANISH
In the fight against counterfeit medicine, a national data storage system for prescription drugs is implemented.
On Tuesday, June 19, 2018 at 14.00 - 16.30 DMVO organizes a free event for companies wishing to know the new rules which will become effective on February 9, 2019.
Learn about the following:
- What significance will the establishment of a national data storage system for prescription drugs have for the Danish pharmaceutical companies?
- What are the responsibilities of the various actors and how are the new challenges handled?
- What is the strategy of the Danish Medicines Agency?
- Where do companies find relevant information online?
- What is the perspective of the wholesaler?
Approval from EMVO (European Medicines Verification Organization)
On April 10, 2018, DMVO received formal approval from EMVO (European Medicines Verification Organization) that the Danish Medicine Verification System (DMVO) can be connected to the production environment. This is an important milestone, which means that DMVO can start Pilot on Monday, and thus the implementation of the IT system to support the EU Directive 2011/62/EU on Falsified Medicines. Together with Slovenia, Ireland and Sweden, Denmark are among the first countries to receive production approval. DMVO could not have reached this milestone without active support from the many stakeholders involved and without close cooperation with the other countries with the same blueprint provider.
Process for the conclusion of the MAH contract
All marketing authorization holders of products covered by FMD on the Danish market by February 9, 2019, must enter into an agreement with DMVO.
If you are a marketing authorization holder and have not previously been in contact with DMVO, please send an email with your contact information to firstname.lastname@example.org. Information must include name, title, telephone number, mobile number and email address of your contact person, as well as corresponding information for the person who will sign the agreement.
Followingly the contact person will receive an email as well as login information to our contract management system where your agreement will be created. The contract will be filled out by you with your data via the contract management system, and when the agreement has been updated from your side, please inform us by email to email@example.com.
DMVO handles and signs the agreement, and the person who signs the agreement on your behalf is notified that your contract is ready for your signature. Link to contract is sent directly to the signatory. This step does not require access to the contract management system for signing. Once the agreement has been signed by both parties, the agreement is finalized.
For more information please see Onboarding DMVO & EMVO.
DMVO is currently processing all MAH contracts received through our contract management system. All contracts received before March 15 will be handled so that contracts have been finalized within the first wave by the DMVO. Contracts received outside the contract management system or after March 15, we can not guarantee will be finalized by 31 March.
December 1, 2017, DMVO send out contracts to all DMVO registered MAHs, manufacturer and parallel Importers. The contract can be found here.
The contract with DMVO must be entered through our Contract Management System. A Step-by-Step guide for use of the Contract Management System can be found here.
If you have not yet been in contact with DMVO and you need to enter an agreement with us, please contact us by email to firstname.lastname@example.org to ensure that the process of contracting with us is as smooth as possible.
Adjustments of the Onboarding Fee to EMVO
A manufacturer and parallel importer must conclude an agreement with EMVO to upload product data to the European system. In this regard, EMVO has announced new prices for onboarding.
The adjustments of the Onboarding Fee is described in the letter from EMVO here.
Also, please be aware that end of June 2018 should be considered at the very last opportunity to onboard timely to EMVO. Read the Letter of Announcement – Last opportunity for a timely onboarding here.