The Danish Medicines Verification Organisation (DMVO) was founded on November 21, 2016. It is a limited liability partnership set up to establish, administer and operate a national data storage system in accordance with the requirements of EU legislation.
DMVO has thus been set up to implement an EU Directive in Denmark for an IT system intended to identify falsified medicines. All packs of prescription medicine must have a 2D barcode. This is then checked into the manufacturer's (or parallel importer's) listing on a big European database before being marketed in Europe. When a pack is being dispensed to patients at Danish pharmacies or hospitals, it has to be checked out of the system again.
>>Ensuring even better protection for patients against falsified prescription medicines. <<
DMVO is headed up by a board consisting of six members appointed by
- Danish Association of the Pharmaceutical Industry (Lif)
- Danish Generic Medicines Industry Association (IGL)
- Danish Association of Parallel Importers (PFL) and The Association of Parallel Importers of Pharmaceuticals – jointly one member
- Danish Pharmaceutical Association
The board is required to ensure that the company operates in accordance with the EU Directive, relevant national and international legislation and the company's articles of association. According to the articles of association, the board is required in addition to its duties associated with the company's operations, strategies and objectives, also to delegate day-to-day management to an Executive Director/Head of Secretariat and the board has accordingly decided to appoint a small secretariat with three fulltime staff. DMVO’s secretariat will head up the project, undertake the involvement of the regulatory authorities and stakeholders, deal with financial issues, etc.
An external provider is responsible for the actual IT system in dialogue with the pharmacies' IT provider in charge of setting up equipment at pharmacies nationwide.
All pharmacies/hospitals will be linked to a central Application Program Interface (API) for Denmark. The directive takes effect on 9th February 2019 by which time the system must be operational.
DMVO has initiated the implementation of the verification system. The implementation consists of two phases, a pilot phase and a ramp-up phase. The pilot was launched April 16, 2018, and includes a small number of manufacturers and parallel importers who upload their packages to the European Hub. The pilot participants are the two largest wholesalers of medicine in DK, Tjellesen Max Jenne and Nomeco, a pharmacy IT provider and six pharmacies. The mentioned pilot participants are located on Zealand and Fyn. The first part of the pilot phase is planned run until beginning of September 2018, after which DMVO will publish the experiences gained on the DMVO website.
DMVO is located at the premises of Lif Group's at Lersø Park Allé 101 in Copenhagen.
See information from The Danish Medicines Verification Organisation ApS to Marketing Authorization Holders (MAHs) in connection with the EU General Data Protection Regulation.