Falsified medicines may include wrong, ineffective or even dangerous ingredients. When ordering medicines from an unlawful source such as an illegal online shop, there is a serious risk to personal health. This is why it’s important to buy medicines from a safe source, a Finnish pharmacy (online or in person).
To protect people from medicines falsifications, the EU Commission compiled the Falsified Medicines Directive (FMD) which came into force in 2011. The Directive sets out procedures to identify the safety of production procedures and to identify legal online pharmacies.
The FMD also states that each pharmaceutical package must be equipped with a unique identifier (UI). That UI consists of a unique serial number and a tamper evidence mechanism. The serial number is downloaded onto a European database and onwards to national systems. The European wide system is called the European Medicines Verification System (EMVS) and must be in place by February 2019.
The entire pharmaceutical supply chain from manufacturers to wholesalers and pharmacies is affected.
The renewed medicines package
Each medicines package will have by 2019 a 2D-matrix which contains some key data elements:
· product code
· batch number
· expiry date
· unique serial number
· national reimbursement number (if applicable).
In addition to this, medicines packages must have a tamper evidence mechanism. The mechanism should indicate if the package has been unlawfully opened before dispensing. The mechanism can be decided by the pharmaceutical company. The CEN standard prEN 16679 Tamper verification features for medicinal product packaging” gives guidance on technical aspects.
The European Medicines Verification System (EMVS)
The EMVS is based on the requirements of the Falsified Medicines Directive, defined by the Delegated Act. These can be found on the Commission website on falsified medicines. It also has a Q&A document which gives further advice on how to interpret the legislation.
The EMVs consists of a European central database and national systems in each EU country. Manufactures of pharmaceuticals download the unique serial numbers on each medicine package to the European database called the Hub. From there the information is transferred to the necessary national databases.
National users of the system; wholesalers, pharmacies and hospital pharmacies connect to the national databases.
If necessary, information can be exchanged between the national databases via the Hub. This may be the case e.g. with multinational packages and parallel imported products. A European wide system is also effective in case of product recalls.
Governance of the system
The FMD states that the pharmaceutical industry is responsible for the setting up the system and financing it. Each player in the pharmaceutical supply chain has responsibilities to ensure that the falsifications do not enter the supply chain.
The system is governed by non-profit organisations throughout Europe. On a European level the governing organization is EMVO (European Medicines Verification Organisation). It consists of members of the European pharmaceutical associations as well as wholesalers and pharmacies:
- EFPIA (The European Federation of Pharmaceutical Industries and Associations)
- Medicines for Europe (the European Generic and Biosimilar Medicines Association)
- EAEPC (the European Association of Euro-Pharmaceutical Companies)
- PGEU (the Pharmaceutical Group of the European Union)
- GIRP (the European Healthcare Distribution Association)
In Finland the system will be governed by the Finnish Medicines Verification Organisation FiMVO (Suomen Lääkevarmennus Oy in Finnish). The founding members of the organization are Pharma Industry Finland, Orion Coorporation, the Finnish Generic Pharmaceutical Association, Suppliers of Parallel Imported Medicines in Finland, the Association of Finnish Pharmacies as well as the Association of Pharmaceutical Distributors.
The Finnish Medicines Agency Fimea supervises the operations of FiMVO.