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 was lanched the 9th. of 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 (EMVS), which also includes establishment and operation of the Danish verification system (DMVS).

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.

​When dosage dispencing medicine, only using parts of a package, the package must be "dispenced" the first time the ATD is broken. This, whether the entire content or parts of the content is used.  

​When a pack is "supplied" you have 10 days to reactivate the pack(s). The exception is, packs that have been recalled/redrawned, destroyed, stolen or supplied to the public. A pack with the status: "exported" cannot be returned in the system.

If it is to be returned, it is considered as import and thereby it has to be repacked, reserialized and uploaded to the hub again.

Please follow the video here.

The video is only in Danish.

​DMVO is monitoring alerts generated in DMVS. The alert handling process is described on the homepage of the Danish Medicines Agency, here. 

​No, 3rd scan showing "supplied" will trigger an alert.

​Yes, to the extent DMVO has acess to data in the system, DMVO will be able to assist in investigation of a specific alert. If applicable,  pls. send an email to: info@dmvo.dk. DMVO draws attention to the fact that DMVO cannot deliver information regarding the pharmacy. However, DMVO can  - if needed - supply the contact to the pharmacy. 

Informing DMVO can never substitute informing the Danish Medicines Agency. See the alert handling process here.

​If a scanner is incorrectly configured it will not read the barcode correctly and it will trigger an alert.

You must contact your IT supplier and solve the configuration issue.

​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 includes the option of selecting scan or manual entry. Thus you must manually enter product code + serial number from the package (both numbers must be entered).

​When a pharmacist or wholesaler performs a scan of prescription drugs, the verification system may trigger an alert and the package cannot be handed out. The package must be handled according to the alert handling procedure of the Danish Medicines Agency, pls. see here. If an alert is triggered it is automatically send to the manufacturer and DMVO. 

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

The European Medicines Verification System and the national system was launched the 9th. of February, 2019.

​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.

​Repacking is required. You will find answer to your questions at the Danish Medicines Agency´s webpage 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. For more see here.

​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. Please note that up to July 1st. 2019, it is recommended that manufacturers retain the linear barcode on the package, as not all robots in Danish pharmacies can handle the new  2D Data matrix yet.

​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/

​Nothing in regards to the verification 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 marketing 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.

Now.

​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. Megros, the wholesaler association in Denmark, has prepared guidelines for manufacturer on how to register the new  GTINs. Please find the attached description here.  The excell sheet, that is being refered to in the letter, can be required by writting an email to: stregkoder@tmj.dk or barcode@nomeco.dk. Questions can be adressed directly to Nomeco: barcode@nomeco.dk og TMJ: stregkoder@tmj.dk.

​Denmark is not operating with a "soft launch" period. A solution to handle prescription medicin, released prior to the 9th of February 2019, was implemented from the get go. The solution implies that prescripted medicines, released prior to the 9th of February 2019, do not trigger alerts noticed by the end users. Hence the prescripted medicine can be handed over to the patient up untill all packages of a given type of medicine, released prior to the 9th of February 2019, expire. For more information pls. see the homepage og the Danish Medicines Agency here. 

​DMVO will not charge for transferred MAH´es. Only new ones in terms of onboarding fee. The yearly fee follows the MAH, so even if it will be transferred, it will only be charged once per year. 

​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 market. The one time set-off fee is 20.000 EURO per MAH. Additionally a yearly fee of EURO 8.500 is charged per MAH.

​The one time set-off registration fee will be invoiced in the immediate extension of the conclusion of the contract with DMVO and due within 30 days.

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.

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.

The one time set-off fee will be invoiced in the immediate extension of the conclusion of the contract with DMVO and due within 30 days.

​The annual fee for 2019 is fixed to EUR. 8.500.

​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.

​As a 3PL you must complete and sign a Non-Disclosure Agreement (NDA) which is to be send to the Blueprint provider of DMVO before gaining access to the system.

​No.

​No. Only 3PL´s acting as a designated wholesaler by a MAH, having a written contract to store and distribute products, can connect to DMVS.

​Yes. If you have access to DMVS you will be able to decommission all products.