Implementing the EU’s Falsified Medicines Directive – new line of INFAI packaging
The EU’s Falsified Medicines Directive (2011/62/EU) has been in force since February 9, 2019. The directive is expected to protect the well-being of patients by putting an end to the criminal counterfeiting of medicine
. The Falsified Medicines Directive affects all medicinal products available on prescription.
To implement the directive, the outer packaging of every product shall be furnished with a certificate of authenticity. For the Helicobacter Test INFAI®, this certificate of authenticity is guaranteed by the cellophane wrapping around the single test sampling tubes, and the safety seal on packaging intended for hospital use.
Furthermore, every packet will be furnished with an individual serial number. The serial numbers will be stored in the verification system database of the country in question. Before the product is given out to a patient, usually by a pharmacy, the serial number on the packaging is compared with the serial numbers stored in the database. If the serial number is stored there, the product is authentic, and will be given out to a patient. But if the serial number is not stored there, the product is a counterfeit. The pharmacy will bar these from being given out to patients.
To implement the Falsified Medicines Directive, INFAI has furnished its line of packaging with the latest technology. That way, INFAI can apply all the required safety features, including individual serial numbers, in high quality, and to transmit all the necessary data to the databases of the national verification systems. Thanks to these measures, we can guarantee patients the highest possible level of protection against counterfeits of our products.