Towards a New EU Falsified Medicines Directive
06. February 2019.

Hemofarm has already been supplying pharmaceuticals in line with the upcoming EU regulation

After three years of intensive work and an investment worth about five million euros, Hemofarm is readily waiting for the EU Falsified Medicines Directive to take effect on 9th of February. The regulation, which will be binding on all EU market pharmaceutical supply chain participants as of the specified date, will protect manufacturers and patients from falsified medicines which are dispensed on prescription.

‘Not only that Hemofarm is 100 percent ready for the application of this regulation, but it has already been supplying the European Union predominantly with medicines which meet the requirements of this Directive to contain a unique identifier and a tamper-proof security seal. EU market is one of the most significant markets for us and we are therefore willing to invest several-year-long effort in the application of the required standards’, Ronald Seeliger, Hemofarm’s Chief Executive Officer, said regarding this matter.

The use of falsified medicines represents a major threat to the public health. By the Falsified Medicines Directive (FMD), the European Union introduces the system for tracking legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack, which will be previously authenticated. These identification data will be stored in a database managed by the European Medicines Verification Organisation, and their authenticity will be checked in pharmacy by 2D barcode scanning.

The total investment of Hemofarm in the implementation of the system required by the relevant EU Directive amounts to approximately five million euros and refers to the procurement of the required equipment and servers. Hemofarm currently has 2,662 FMD-relevant products, and it has been packing all these products in line with the new regulation since 1st of January this year.

More about Falsified Medicines Directive (FMD)

EU passed the Falsified Medicines Directive in 2016 for the purpose of preventing primarily patients, as well as manufacturers, from falsified medicines. The regulation encompasses Rx medicines (prescription medicines), as well as all other medicines the manufactures want to protect for whatever reason. EU has given a three-year deadline to our industry for implementing the solution that will enable the application of safety features to cartons. The system implementation costs are borne by pharmaceutical manufacturers.

The Directive refers to EU market exclusively, with the exception of Greece, Italy and Switzerland (although not an EU member state, it has the access to the single market), which are given the grace period till 9 February 2025. The market of Serbia and other markets of the neighbouring non-EU member countries, are not encompassed by this regulation, but the manufacturers from these countries are obliged to observe it if they want to export to EU countries.

Through this regulation, EU keeps unique records of all unique numbers in a particular central repository (EU hub) which is shared with the National Medicines Verification Organization (NMVO) of each EU member country. Only authorized manufacturers are allowed to input data on serial numbers of medicines to the EU repository. As pharmacies in EU will be connected with the relevant country’s NMVO, when dispensing a medicine, a pharmacist will scan a code which is immediately authenticated in the database of the relevant country’s NMVO, and the feedback on medicine authenticity is received instantly.