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: 2017-001369-25
The Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dypepsia Taking Proton Pump Inhibitors. 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

Due to the Covid-19 pandemic, INFAI has cancelled its attendance at several conferences and trade fairs.

Thank you for your comprehension and stay healthy.

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 HealthPlusCare in London 2020

INFAI will be present at the HealthPlusCare from June 24th till 25th 2020 in London, UK. The exhibition is taking place at the ExCeL London.

INFAI at the European Helicobacter and Microbiota Study Group (EHMSG) – XXXIIIrd International Workshop in Glasgow 2020

INFAI will be present at the  European Helicobacter and Microbiota Study Group (EHMSG) – XXXIIIrd International Workshop on Helicobacter & Microbiota in Inflammation & Cancer from September 10th till 12th 2020  in Glasgow, UK. The exhibition is taking place at the Scottish Event Campus (SEC) in Glasgow.

INFAI at the United European Gastroenterology (UEG) – 28th United European Gastroenterology Week in Amsterdam 2020

INFAI will be present at the 28th UEG Week (United European Gastroenterology) from October 10th till 15th 2020 in Amsterdam, Netherlands. The exhibition is taking place at the RAI Amsterdam.

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