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 9 February 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.

Video link: Falsified medicines


In 2017, INFAI has installed a new state-of-the-art production line for the manufacture of the Helicobacter Test INFAI, see video.

Currently, INFAI is performing the following clinical trails:

Study: PPI; Eudra CT Number: 2008-008010-39
The Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dypepsia Taking Proton Pump Inhibitors. Sponsor: INFAI

Study: Gastromotal; Eudra CT Number: 2011-002782-38

Gastromotal 1-¹³C-Caprylic Acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed emptying. Sponsor: INFAI

Study: HEAT
; Eudra CT Number: 2011-003425-96
Helicobacter eradiation to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial (HEAT). Sponsor: University of Nottingham

News & Termine

INFAI at the BSG Annual Meeting in Liverpool 2018

INFAI will be present at the BSG (British Society of Gastroenterology) Annual Meeting from June 4th till 7th 2018 in Liverpool, UK. The exhibition is taking place at the ACC Liverpool. You can find us on booth #A2.  


INFAI at the European Helicobacter and Microbiota Study Group (EHMSG) - XXXIst International Workshop in Kaunas 2018

INFAI will be present at the European Helicobacter and Microbiota Study Group (EHMSG) - XXXIst International Workshop on Helicobacter & Microbiota in Inflammation & Cancer from September 14th till 15th 2018 in Kaunas, Lithuania. The exhibition is taking place at the Park Inn Hotel Kaunas.

INFAI at the UEG week in Vienna 2018

INFAI will be present at the 26th UEG (United European Gastroenterology) Week from October 20th till 24th 2018 in Vienna, Austria. The exhibition is taking place at the Austria Center Vienna. You can find us on booth #69. 

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