Q & A

It is a pan-European system intended to make it possible for wholesalers and pharmacies to check or verify the genuineness of medicines. This is why it is called a verification system. It means that there is a greater certainty that there are no falsified medicines in the legal distribution chain.

​The EU Directive on Falsified Medicines (2011/62/EU) requires special security measures to be in place for (practically) all prescription medicines. Compliance with these requirements means setting up a pan-European verification system. The aim is to improve patient safety by preventing falsified medicines from getting into the legal distribution chain and then out to the general public.

The verification system is based on establishing a central European database to which manufacturers upload the relevant data from all the packs to be sold in the EU. The data is then sent from the central database to the regional /national databases.

Before medicines are dispensed to the general public by pharmacies or hospitals, there has to be a security check - so-called verification of the product - in the European database via the national enterprise. This check ensures that the medicine has not been sold before or found elsewhere in the system and that it is thus genuine.

​You probably will not. You may see packs with a different layout and may have to get used to having to break a special seal.

​Two security systems are involved

• A unique 2D Barcode on the pack making it possible to identify the specific pack. The data from this barcode is stored on the database.
• A special seal that makes it possible to see whether the seal has been broken/tamped.

​The system is being set up to protect all of us against falsified medicines getting into the legal distribution chain. This means that everybody can feel safe when getting medicine from a pharmacy or ordering it from an approved pharmacy on the internet.

​The system must be running from 9th February 2019

​No. 

• The rules are basically only for prescription products. However, there are exceptions to this in Annex 1 of the delegated acts of the directive. 
• The rules basically do not apply to non-prescription products. However, there are exceptions to this in Annex 2 of the delegated acts of the directive.

You can find the above annexes here: http://eur-lex.europa.eu/legal-content/DA/TXT/PDF/?uri=CELEX:32016R0161&from=DA

​No, the rules only apply to human medicine.

​The rules on security measures do not apply to medicines produced for use in trials or research. Immediately it becomes clear that a product is to be used for these purposes, it falls outside the scope of the directive.

​The directive states that the pharmaceutical industry (original and generic manufacturers and parallel importers) will have to fund the establishment and operation of the pan-European verification system, which will also include setting up the Danish system (DMVO).

This means that every company wishing to have a product sold on the Danish market after 9th February 2019 will have to pay annual verification fees to DMVO.

Please follow the video here.

The video is only in Danish.

​The verification system will return with the message, that the package is not found in the database (error 404 Not fournd). Pharmacies’ systems must report errors, and a procedure for how to respond must be defined/established.

​The pharmacy system must include the option of selecting scan or manual entry. Thus you must manually enter product code + serial number from the packet (both numbers must be entered).

​When a pharmacist or wholesaler performs a scan of prescription drugs, the verification system may return with an error. In this case, the package must not be dispensed and must be handled according to working procedures.

Each alert ID is a unique message, which is automatically forwarded to the drug manufacturer, which will then initiate an investigation.

​Yes, scanners must be able to handle barcodes black on white and white on black.

​Yes, the implementation of the IT system are running in co-operation with the IT provider of the verification system, wholesalers, pharmacies IT providers and the DMVO. Pilot will start 1st. of March 2018, on a representative basis with the participation of pharmacies, hospital pharmacies, wholesalers, producers and parallel importers.

​No.

Packing status "Stolen", "Destroyed", "Recalled" or "Withdrawn" can’t be cancelled and the package can hereafter not be re-entered the market. If by mistake a package is marked "Stolen" or "Destroyed", the package must be sent back to the manufacturer for repackaging with new safety features.

If a package has been given the status as ”Supplied” you have 10 days to undo/change the status of the package, so the package can be sold again. Note that the medicine should not have been revoked, withdrawn, intended for destruction, stolen or passed over to the public. If the status of the package is changed back, the package can be re-sold and hereafter the 10 days rule will apply again.

In case the package status has been changed to “Exported” it can only be re-entered into the system as “Import” and must be re-packed, re-serialized and re-uploaded to the Hub.

​The alert management process, including who shall do what, when and how and whom to contact is described at the website of the National Competent Authority. Please find the answer here

​No, according to the EU rules they will not basically have to, although special national rules might also apply. The Danish Medicines Agency has stated that they do not currently have any plans for special rules.

Yes, it is, and it is recommended to start the process now.

​Yes there can. The Danish Medicines Agency has stated that there is nothing in the legislation to prevent barcodes from differing but that the codes must not contain mutually contradictory information or be otherwise misleading.

​The entire supply chain 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 and an illustration of the implemention of 2D Datamatrix here.

​Basically yes. The Danish Medicines Agency calls for these to be submitted together with other variations.

​Yes there can. The Danish Medicines Agency has stated that there is nothing in the legislation to prevent barcodes from differing but that the codes must not contain mutually contradictory information or be otherwise misleading.

​The same national rules apply for returning products that have applied up till now. This also applies with respect to funding.

​This is done the first time the seal is broken, regardless of whether the whole pack is used or only part of it.

​The Danish Medicines Agency is responsible for regulatory issues and they have Q&As about this which you can view here: http://laegemiddelstyrelsen.dk/da/godkendelse/godkendelse-af-medicin/sikkerhedselementer-paa-laegemidler/

​No.

No registration is required in the system. The multipack has to be treated as today, that is, as a complaint.

​Manufacturer/parallel importers are required to upload their product data onto the European hub (EMVO). This is necessary since the Danish database will not have 'national uploads'.  EMVO refers to this process as “Onboarding” and manufacturer/ parallel importers are referred to as “Onboarding Partners” (OBPs). You can read more about this on the EMVO website.

​The European Verification Organisation (EMVO) has posted an ‘Onboarding’ video on their website. The video explains the requirements imposed on manufacturer/parallel importers and the steps they need to take to be able to upload data to the European database/hub. Click here: https://www.emvo-medicines.eu/eu-hub-on-boarding/training-videos/

​As a manufacturer/parallel importer, you must not do anything towards DMVO, but you must sign a contract with EMVO and upload your product data to the European hub in order to continue your products on the Danish market from February 9, 2019.

​It is the Marketing Authorisation Holder who shall register and enter an agreement with the DMVO. Manufacturer/parallel importers must enter a contract with EMVO.

​Yes, you can. The pilot phase is based on real data, ie. packs applied with the safety rules where data is uploaded to the European database and distributed to wholesalers and pharmacies that are part of the pilot.

​Please write to DMVO at info@dmvo.dk and enter into a contract with EMVO, apply its packages to new safety rules and upload data to the European Hub in 2017.

​Only when the DMVS is available a manufacturer can upload it’s product data for the Danish market. The DMVS is now available and has been since April 11th. 2018.  Kindly visit our website for more information at  the “News” section.

​When the QP has released the product.

"Release" is a well-known and unique regulatory concept, which means that the company's QP certifies that the batch in question complies with the rules/marketing authorization. Only when medicines have been released by the QP, it can be distributed or sold. 

​No.

​Yes, you must inform about the new GTINs to the wholesalers. 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 barcode@nomeco.dk or stregkoder@tmj.dk

In case you have any questions, kindly contact Nomeco email barcode@nomeco.dk or TMJ email stregkoder@tmj.dk directly.

​A MAH (Marketing Authorisation Holder) is the company/representative who holds the marked autorisation for a specific product in Denmark.

As a marketing authorization holder, you will have to pay a one time set-off registration fee per MAH to DMVO in order to market your products on the Danish marked. The one time set-off registration fee requires that you have signed a contract with DMVO and is due by January 31, 2019. The One time set-off fee is progressive, which means that you will pay 10.000€. 15.000€ or 20.000€ per MAH, depending on the time, you sign the contract with DMVO.

In addition, you will have to pay an annual verification fee per. MAH, first time in 2019. The annual fee will be EURO 8.500,00 per MAH and will be due by March 1st. 2019.

​The one time set-off registration fee will be due January 31, 2019

It is possible to enter a contract with DMVO now. The MAH contract is available at our website, and by contacting the DMVO by email info@dmvo.dk, you will receive all necessary information directly.

​The annual verification fee adheres to the model chosen at European level, which is, as a flat fee per MAH.

In June 2017, all marketing authorization holders in Denmark received a letter from the Danish Medicines Agency and DMVO requesting you to forward your contact information to DMVO. This letter was followed up with a reminder in September 2017, and an information meeting was held for all MAHs was held in Fall 2017.

You will find the letter here
You will find the presentations from the information meeting here

It is the Marketing authorization holders who shall register and enter an agreement with the DMVO, but representatives, manufacturers and parallel importers can enter the contract on behalf of their  MAHs, by listing the MAHs in the contract.
Manufacturer/parallel importers must enter a contract with EMVO.

​By end of 2018. The onboarding fee will be due by January 31st. 2019.

​The annual fee for 2019 will be fixed by end of 2018. It will be announced immediately hereafter. It’s estimated to be in the range of EURO 6,500-9,500 and will have to be paid by March 1st. 2019.

​Yes.

You can enter the participation agreement with DMVO as a parent company, MAH or as a representative.

​The information about authorized manufacturers and intermediaries can be requested through the portal as a report.

Yes.

There is no change to the process of destroying medicine in that regard.

​Yes.

Wholesalers can do so, as long as the medicine was released before February 9, 2019.

​Yes.

If it is a pack uploaded to the European hub, then the wholesaler must deactivate the package before distribution outside the EU.