Read the latest news from DMVO and upcoming events
19.12.2023NMVS Alerts Pilot Project successfully concludes in Autumn 2023
Enhancing Alert Management for a smoother pharmaceutical distribution using NMVS Alerts.
In the spirit of continuous improvement of the alert investigation within the pharmaceutical distribution sector, the NMVS Alerts pilot project reached its conclusion in the fall of 2023. The project, focused on the implementation and assessment of the Alert Management system, received significant participation from various stakeholders, and the outcomes are promising.
DMVO extend our gratitude to all pilot participants for their invaluable contributions to the Alert Management system's pilot phase. Overall, there is satisfaction with the system and the alert handling procedures. Throughout the 3 months pilot period, a total of 763 alerts were generated across six end-user locations, averaging at 42.4 alerts per month per location. Approximately 83% of these alerts resulted from procedural errors, particularly instances where packages already designated for dispensing were mistakenly attempted for dispensing once again. In practical terms, this equates to 2.3 genuine alerts per end-user location per month, necessitating additional investigation.
Feedback from the pilot phase has led to the identification of key areas for system enhancement. The following requests were articulated for further refinement of the Alert Management System:
1. Integration with Pharmacy Systems: Participants expressed the desire for direct integration with pharmacy systems, allowing seamless navigation from the pharmacy system to NMVS-Alert with a simple click.
2. Search Functionality: A request for the capability to search for VNR numbers within NMVS-Alert was highlighted.
3. Customization of Search Criteria: Pilot participants sought the ability to tailor the number of search criteria or fields to suit individual preferences.
DMVO remains committed to optimizing the Alert Management system for the Danish market. Work is already underway to address the identified areas of improvement, ensuring a more streamlined and effective alert handling process. As DMVO continue to refine these systems, we anticipate further advancements that will contribute to the overall efficiency and security of pharmaceutical distribution in Denmark. Stay tuned for updates at www.dmvo.dk as we strive for continuous progress and excellence in the field.
12.10.2023
Annual Fee 2024
The MAH annual fee 2024 to DMVO amounts to EUR 6,700 per MAH.
MAH with an annual turnover of less than DKK 500,000 can obtain a reduced fee provided that documentation of the turnover is sent in time prior to invoicing to DMVO. In the event that revenue exceeds DKK 500,000 annually in 2024, MAH will be invoiced the difference between the reduced fee and the applicable annual fee of EUR 6,700. MAH with a turnover of less than DKK 500,000 must apply for a reduced fee by contacting info@dmvo.dk.
12.10.2023
One off registration fee to DMVO
The one off registration fee for new MAH’s amounts to EUR 20,000 per MAH. The one off registration fee is invoiced immediately after the conclusion of the contract with due net 30 days.
MAH with annual turnover below DKK 500,000 can obtain a reduced one off registration fee provided that documentation of turnover is submitted in connection with the conclusion of a contract with DMVO. If turnover exceeds DKK 500,000 within the following 12 months after the conclusion of the contract, MAH will be invoiced for the difference between the reduced one off registration fee and the applicable one off registration fee per. MAH of EUR 20,000. MAH must apply for a reduced one off registration fee by contacting info@dmvo.dk.
04.12.2023The fight against falsified medicines
From December 4 to 10, Fight the fakes week is marked worldwide to raise awareness about the threat posed by falsified medicines to the global population. This year, the focus is on the continent of Africa, where approximately 1 in 10 medical products is fake, leading to nearly 500,000 deaths annually south of the Sahara.
In Europe, a verification system was implemented in 2019. Unique 2D-codes are printed on each prescription medicine package, allowing it to be traced back to the manufacturer. This is intended to prevent counterfeit medicines, ensuring that patients can trust the safety of the medications they receive at pharmacies and hospital pharmacies.
In recent months, this verification system has uncovered counterfeit medicines in several places in Europe. The system was introduced with the aim of preventing counterfeit medicines from reaching patients, both through the dispensing of prescription medicines at pharmacies and the administration of medications in hospitals. Each medicine package is tracked from the manufacturer to the patient.
The system establishes a unique connection between the manufacturer and the dispenser (pharmacy or hospital department) of the medicine package by assigning a unique serial number to each medicine pack. The manufacturer registers the unique serial number in the European database along with the drug's product code, batch ID, and expiration date of the package. The European database then transfers this information to the national databases in the countries where the medicine is to be sold.
Upon dispensing to the patient, the pharmacy checks the package against the national database for the verification system. This ensures that the medicine is produced by a licensed manufacturer and is therefore genuine and safe. If the package is not found in the national database or the databases of other European countries, the pharmacy receives a warning and cannot dispense the medicine until further investigations are conducted.
In addition to this information, each medicine package has a seal that, when broken, clearly indicates signs of tampering. This ensures that patients do not receive counterfeit medicines at pharmacies or during hospital admissions.
Even though the issue with counterfeit medicines is not an immediate problem in Europe, it also requires an effective system here, that both deters forgers from operating within our continent and detects them in their attempts.
23.05.2023
The alert handling
process for end users (pharmacies, hospital pharmacies, wholesalers)
As a pharmacist, you probably experience from time to time that an alert is triggered when you scan the new 2D Datamatrix code, i.e., verifies the package for its authenticity.
In DK as well as in the EU, many resources are used to reduce and stabilize the number of alerts, and in this connection EMVO (European Medicines Verification Organisation) has developed an alert handling portal for manufacturers, implemented in February 2023.
In DK we are not yet connected to this system, but in the long run we will be. It is therefore important that all end users in DK have access to handle alerts in one common system, so that full benefit of the connection is achieved through transparency of alert status and handling of alerts from end users to MAH and authority.
In accordance with requirements from the Danish Medicines Agency, all alerts must be investigated and subsequently documented, thereby ensuring that it is authentic medicine that is dispensed to the patient.
In Denmark, the DMVO as well as the hospital pharmacies have used an alert management system (NMVS Alerts) for the past 2 years to support the investigation of alerts and their subsequent documentation. It is now the pharmacies', i.e., your turn to get the opportunity to connect to NMVS Alerts - the alert management system.
NMVS Alerts contributes to a more flexible and transparent process from end user to MAH. A flexible and quick clarification of the cause of an alert means that the pharmacies avoid placing too many packages in quarantine and can thus deliver the medicine to the patient/customer faster and more easily, within a shorter time frame than if it is put aside and examined on afterwards.
23rd. of May 2023, DMVO held a meeting with pharmacies across the country, where NMVS Alerts were introduced. For further information regarding the introduction meeting on NMVS Alerts please contact DMVO as presentation will be in Danish.
16.02.2023
Celebrating the 4th. anniversary of EMVS and FMD
9th. of February 2023 the EMVS community could celebrate the 4th. anniversary of the EMVS and the FMD.
The celebration was kicked of February 9th. where EMVO held a reception for all their stakeholders at the Royal Library of Belgium.
The celebration was followed by the 1st. Annual EMVS Forum, hosted by EMVO. DMVO was well represented in the 1st. Annual EMVS Forum with the participation of our Director, Tina Hou Marer, Business Operation Manager, Lars Martinussen and Business Support Coordinator, Linn Chrestoft.
The 1st. Annual EMVS Forum took place on February 10th. 2023, a forum where all stakeholders around FMD, participated. The stage was set in the European Parliament, hosted by MEP Marisa Matias, with excellent speakers such as Sylvain Giraud (DG SANTE), Maija Gohlke (FiMVO), Adrian van den Hoven (Medicines for Europe), Kasper Ernest (Affordable Medicines Europe), Ilaria Passarani (PGEU), Monika Derecque-Pois (GIRP), Marco Farinelli (EFPIA), Andreas Walter (EMVO), Philippe De Buck (Belgian NCA), Marcus Wittstock (BfArM & WGEO), Morgane Gaudiau (OECD), Claudia Louati (FDA), Max Kabalisa (UNICEF), Grant Courtney (UNICEF), Geraldine Lissalde Bonnet (GS1).
The challenges that EMVS community has overcome over the past 4 years were covered, as well as highlighting the results achieved through collaborations and joint efforts. It was an inspiring and eventful day, where we gained insight into some of the side benefits, for example in connection with reimbursement, which the system helps to uncover, as well as how the system has inspired other solutions that extend beyond the EU.
Lessons learned and future challenges were discussed in a roundtable panel, we heard the perspective of the authorities regarding fighting the fakes, global trends of how to tackle falsified medicines, and finally, new members joining the EMVS community.
Kasper Ernest (EMVO president) concluded the day and summarised all the topics covered.
11.01.2023
Recall and withdrawal in NMVS - Nordic recommendations
The Nordic NMVOs have jointly published recommendations on how pharmaceutical companies, wholesalers and pharmacies best handle a recall or withdrawal through the NMVS to further add efficiency, quality and value to the supply chain as well as strengthen patient safety.
The National Medicines Verification System safeguards the supply chain and patients from falsified medicines. When the systems functionality is handled correctly, the NMVS also adds security and quality to the supply chain by preventing withdrawn or recalled packs from reaching patients without causing unnecessary disruptions in the distribution.
The Nordic NMVOs govern the National Medicines Verification System in the Nordic countries:
Find the recommendations here
12.10.2022
Annual Fee 2023
The MAH annual fee 2023 to DMVO amounts to EUR 6,700 per MAH.
MAH with an annual turnover of less than DKK 500,000 can obtain a reduced fee provided that documentation of the turnover is sent in time prior to invoicing to DMVO. In the event that revenue exceeds DKK 500,000 annually in 2023, MAH will be invoiced the difference between the reduced fee and the applicable annual fee of EUR 6,700. MAH with a turnover of less than DKK 500,000 must apply for a reduced fee by contacting info@dmvo.dk.
Kindly update any changes to existing participation agreements and/or amendments prior to the invoice for 2023, being sent out the 16th. of December 2022. DMVO will gladly receive P0 numbers in advance, which can be sent to info@dmvo.dk.
12.10.2022
One off registration fee to DMVO
The one off registration fee for new MAH’s amounts to EUR 20,000 per MAH. The one off registration fee is invoiced immediately after the conclusion of the contract with due net 30 days.
MAH with annual turnover below DKK 500,000 can obtain a reduced one off registration fee provided that documentation of turnover is submitted in connection with the conclusion of a contract with DMVO. If turnover exceeds DKK 500,000 within the following 12 months after the conclusion of the contract, MAH will be invoiced for the difference between the reduced one off registration fee and the applicable one off registration fee per. MAH of EUR 20,000. MAH must apply for a reduced one off registration fee by contacting info@dmvo.dk.
Annual Fee 2022
The annual fee of MAH to DMVO is unchanged and set for EUR 7,800 per MAH.
MAH with an annual turnover of less than DKK 500,000 can obtain a reduced fee provided that documentation of the turnover is sent in time prior to invoicing to DMVO. In the event that revenue exceeds DKK 500,000 annually in 2022, MAH will be invoiced the difference between the reduced fee and the applicable annual fee of EUR 7,800. MAH with a turnover of less than DKK 500,000 must apply for a reduced fee by contacting
info@dmvo.dk.
Kindly update any changes to existing participation agreements and/or amendments prior to the invoice for 2022, being send out the 16th. of December 2021. DMVO will gladly receive P0 numbers in advance, which can be send to
info@dmvo.dk.
09.11.2021
One off registration fee to DMVO for 2022
One off registration fee for 2022 will remain unchanged at EUR 20.000 per MAH. The one off registration fee is invoiced immediately after the conclusion of the contract with due net 30 days.
MAH with annual turnover below DKK 500,000 can obtain a reduced one off registration fee provided that documentation of turnover is submitted in connection with the conclusion of a contract with DMVO. If turnover exceeds DKK 500,000 within the following 12 months after the conclusion of the contract, MAH will be invoiced for the difference between the reduced one off registration fee and the applicable one off registration fee per. MAH of EUR 20,000. MAH must apply for a reduced one off registration fee by contacting
info@dmvo.dk and is only valid for MAH which enters into an agreement with DMVO per. January 1, 2022 and thereafter.
10.09.2021
Robots
The majority of robots have been updated with the new interface, however there are still a few in outstanding. It is not mandatory for MAH to maintain the Linear barcode on the packages but as long as there are robots not updated, it would be helpful for the end users to maintain the Liniar barcode. The robots are expected to be fully updated first quarter of 2022.
08.07.2021
Lack of registration of designated wholesalers
It has come to the attention of DMVO that most MAHs/manufacturer do not register designated wholesalers correctly in DK when uploading data to the European hub. The designated wholesaler must be listed.
If not, the wholesaler is obliged to verify all packs if received from a non-designated wholesaler to be in compliance with FMD.
As Onboarding Business Partner, kindly list the designated wholesaler/3PL via the European hub not to strain the wholesalers.
In Denmark there are few actors and those 3PLs that operate on the Danish market are also few and they must be registered as designated wholesalers when uploading data to the European hub.
If you as OBP/MAH have further questions, you are welcome to contact DMVO via info@dmvo.dk
02.06.2021
In week 17, Denmark reached the alert rate of 0,05% which has only been possible due to joint efforts between all stakeholders in Denmark. DMVO would like to thank you and wish us all good luck when maintaining the "green" status.
30.03 2021
Information regarding dispensation given by the Danish Medicines Agency
DMVO will appreciate receiving information from marketing authorisation holders/On-Boarding Partners regarding given exeption(s) from the Danish Medicines Agency on the same terms as pharmacies and hospital pharmacies etc. This will greatly facilitate the investigation process, when packages with dispensation trigger alerts. Kindly send the information to
info@dmvo.dk containing the cause of the dispensation, the batch number and the product code. Thank you in advance.
15.02.2021
Addition to summary of root causes for alerts
DMVO has made an addition to the original summary of root causes by stating the investigation requirements by MAHs on the overview. For more see
here
08.02.2021
Keyboard Wedge Configuration Test
DMVO would like to draw the attention to the: “Keyboard Wedge Configuration Test” on the page of EMVO. The tests allows for check of scanner configuration, amongst others with respect to Caps Lock, the speed your scanner reads at, if your scanner can read the GS1 Group Separator, that your scanner can read an inverse barcode and that your scanner can read all the special characters allowed by GS1. The test can be found
here
08.02.2021
DMVO sends out a monthly newsletter, subscription can be made here
02.02.2021
The first virtual meeting of the year hosted by DMVO will be in Danish and will take place the 11th of February 2021, 08:30 - 09:15. It will evolve around more stakeholders`, hereunder: The Danish Pharmaceutical Association, a hospital pharmacy and a wholesaler´s experiences with FMD. The meeting will thereby be a mixture of posts and as a participant in the meeting, you have the possibility to ask about the experiences put forward. Sign up by sending an email to
info@dmvo.dk
27.01.2021
DMVO virtual meetings 2021
DMVO is planning a series of online meetings in 2021, which you are invited to join.The purpose of the meetings is to keep DMVO's stakeholders informed of new updates on the DMVS verification system, alarm procedures and alarm handling, etc. The meetings will be held over the coming months and will cover several topics, first online meeting will take place in February.
Read more here
17.11.2020
Yearly fee 2021
The yearly fee for 2021 has been settled and amounts to 7.800 Euro. Kindly update any potential changes to existing participation agreements and/or amendments prior to the invoice(s) for 2021 being send out the 16th of December 2020. DMVO will gladly receive P0 numbers in advance, which can be send to
info@dmvo.dk.
16.11.2020
Cancellation
Unfortunately, DMVO will cancel the upcoming virtual meeting:” Review of dashboard in the Alert Management Tool – NMVS Alert”; the 24th of November 2020. - It has come to light that in order to access the dashboard, one must be a “premium subscriber” by TCK.
The intended purpose of the meeting is therefore defeated as DMVO has no “premium subscribers” and it is not a precondition in order to access and use the system. Any questions in relation to subscription of NMVS Alert, can be addressed directly to TCK:
support@nmvs-alerts.com
DMVO is looking forward to inviting you to more virtual meetings in 2021. The topics will be posted on the
homepage
18.08.2020
Summary of the root causes for alerts
DMVO has prepared a summary of the root causes for alerts that can help to quickly investigate an alert. Read more here
20.04.2020
DMVO virtual meetings DMVO has planned a series of online meetings that you are invited to join. The purpose of the meetings is to keep DMVO's stakeholders informed of new updates on the DMVS verification system, alarm procedures and alarm handling, etc.
The meetings will be held over the coming months and will cover several topics. Read more here
25.03.2020DMVO´s alert handling procedure for Marketing Authorisation Holders
DMVO would like to draw attention to DMVO´s alert handling procedure for Marketing Authorisation Holders. Kindly retrieve here
13.03.2020
Service announcement:
DMVO's availability in conjunction with the Covid-19 pandemic
As usual, DMVO can be reached by phone +45 39 27 60 60 and email: info@dmvo.dk.
Staffing is unchanged, although the necessary measures have been taken with a proper distance to ensure our employees.
12.02.2020
1 year birthday
DMVO would like to take the opportunity to once again thank all of you for your outstanding collaboration efforts which have resulted in 28 connected countries and more than 2500 Marketing Authorization Holders (MAHs) and over 100000 wholesalers, pharmacists and hospitals being linked together across Europe in EMVS. In Denmark all stakeholdes are onboarded and no falsified medicines have been detected. A remarkable achievement that has proven to be a success due to cooperability with patient safety as highest aim.
28.01.2020
Robots
Last year DMVO wrote about the status of the implementation of the pharmacy robots. Most of the robots have been updated with the new interface, however approximately 10 robots are still in outstanding due to errors that need attendance from the robot suppliers. Manufacturers are still encouraged to maintain the Linear barcode on the packages in order to have both the Linear- and the 2D data matrix barcodes present on the packages until all robots are updated. DMVO will get back with further information.
07.01.2020
Alert investigation
When triggering alerts, DMVO encourages to take a pricture(s) of the 2d matrix barcode and send it to info@dmvo.dk as it will facilitate the investigation work and ease the consultation with the manufacturers.
20.12.2019
Christmas greetings from DMVO
Christmas is all around us, and soon it will be time for a well deserved break.
2019 has truly been an exiting year for us. We have accomplished much, most importantly to continue delivery of medicines to patients throughout Europe with patient safety as highest priority.
This we could not have done without exemplary collaboration and without supporting and believing in each other.
DMVO thank you all, and wishes you and your family a great holiday and a Happy New Year.
02.10.2019
Annual fee to DMVO for 2020
The annual fee to DMVO for MAH is set at EUR 7.800,00 per MAH. The fee will be invoiced December 16, with payment net 30. days. The fee is applicable for 2020.
02.10.2019
One time setoff fee/entrance fee to DMVO for 2020
The one time setoff fee/entrance fee to DMVO for 2020 is set at EUR 20.000,00 per MAH. The Fee is invoiced immediately after the conclusion of the contract with payment net 30 days.
02.10.2019
Significant increase of 'Expiry Date Mismatch'
Beginning last week (39) DMVO experienced many alerts from one specific location in Denmark. The location was generating high numbers of the Expiry Date Mismatch alert. In collaboration with the location affected, root cause has been identified and a permanent solution will be implemented by end next week (40).
In the meantime, a temporary solution will be implemented effective by tomorrow, Thursday 3rd. of October, using a stand alone system for verifications.
DMVO is sorry for the inconvenience this may have caused the MAH/OBPs.
27.09.2019
Update on 2D barcodes and pharmacy robots
2/3 of the pharmacies that are exerting robot technology are yet to be updated. It is expected that all pharmacy robots are updated by the end of 2019. Up until then, manufacturers are encouraged to maintain the Linear barcode on the packages in order to have both the Linear- and the 2D data matrix barcodes present on the packages.
12.04.2019
2D barcodes and pharmacy robots
On behalf of the Danish Pharmacy Association, we hereby pass on some information regarding the 2D barcodes and the pharmacy robots. In case you have any questions, kindly contact the Danish Pharmacy Association directly. Read the letter here.
12.04.2019
Follow DMVO on LinkedIn
DMVO regularly posts on LinkedIn. For fast updates follow us here.
24.01.2019
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.
03.01.2019
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.
20.12.2018
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.
20.12.2018
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.
20.11.2018
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.
29.10.2018
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
lma@dmvo.dk.
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.
02.10.2018
Registration of the new GTINs at the wholesalers
01.08.2018
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
lma@dmvo.dk, 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
dmvo.support@reply.eu with a copy to Lars Martinussen
lma@dmvo.dk 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.
11.07.2018
Enter the participation agreement with DMVO within the 2nd. Wave
MAH’es who wants to enter the participation agreement with DMVO within the 2nd. Wave, kindly be aware of the deadline for upload of the filled in contract to the contract management system of DMVO, being
September 15. 2018. For more information, please see
Onboarding DMVO & EMVO.
14.06.2018
Workshop for wholesalers/3PLs on Tuesday, June 26, 2018
DMVO will organize an IT Workshop for wholesalers/3PLs on Tuesday, June 26, 2018. According to the directive, wholesalers are obliged to connect to the DMVS system.
For further information regarding the workshop, see
EVENT
The registration deadline is
21 of June 2018.
04.05.2018
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?
View programme
Register here
16.04.2018
The pilot is officially launchedThe pilot is officially launched. This implies that the first phase of the implementation of the verification system in Denmark has begun. The pilot consists of a limited number of stakeholders within the legal distribution chain and includes five manufacturers and parallel importers, one IT supplier, six pharmacies and two wholesalers. The pilot participants expects to share their experiences during September 2018.
11.04.2018
Approval of the Danish Verification System
Effective from today, DMVS has been approved for production environment among one of the first countries, and will be connected to the European hub (EMVS). The approval of the Danish Verification System means that as a manufacturer or parallel importer you can start upload of product data for the Danish market.
See official announcement
here
10.04.2018
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.
09.03.2018
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
info@dmvo.dk. 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 info@dmvo.dk.
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.
09.03.2018
The MAH participation agreement with DMVO - 1. Wave
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.
16.01.2018
Recommendations to Manufacturer/Parallel Importers from now until February 9, 2019
A Manufacturer/Parallel Importer can put serialized packs on the Danish market from January 2018 and onwards. In such cases the DMVO, aligned with the legal distribution chain in Denmark, recommends manufacturer/parallel importers to save their batched with serialized packs, and as soon as the Danish verification system is available, most likely by March 1, 2018, to upload the serialized packs (the batched with packs aimed for the Danish market) to the EMVS.
This ensures that manufacturer/parallel importers will not have serialized products on the market once the system is running in full operation.
16.01.2018
MAH Contract
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
info@dmvo.dk to ensure that the process of contracting with us is as smooth as possible.
16.01.2018
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.
27.10.2017
Information Meeting
DMVO hosted an information meeting for MAH’s, manufacturer and parallel importers on October 24, 2017 at Lersø Parkalle 101, København Ø. Link to invitation is here and the presentations from the meeting are here.
13.10.2017
Joint Guidelines for the Transition from Linear Barcodes (EAN-13) to 2D Data Matrix
In cooperation with the entire supply chain, DMVO have prepared joint guidelines for the transition from linear barcodes (EAN-13) to 2D Data Matrix. We recommend that all manufacturers and parallel importers follow the principles as mentioned here.
Also you will find an illustration of the implemention of 2D Datamatrix here.
