Aegate Welcomes Adoption of EU Falsified Medicines Directive Delegated Act

LONDON, October 7, 2015 /PRNewswire/ --

Aegate has today welcomed the adoption of the Delegated Act on safety features appearing on the packaging of medicinal products for human use, supporting the implementation of the Falsified Medicines Directive (FMD).

The FMD provides a real opportunity to protect patients in Europe from the damage which falsified medicines can cause, and the Delegated Act on safety features will play an integral role in its success. The draft was published in August of this year and the Act has now been adopted by the European Commission.

Commenting, Aegate Chief Executive Mark De Simone said:  

'We are delighted that the Delegated Act has now been adopted. This is an important day in the battle to stop falsified medicines, out-of-date medicines and recalled products from falling into the hands of patients across Europe. Publication is expected to follow quickly, so stakeholders should use this time to accelerate their decisions.'

'The steps taken by pharmaceutical manufacturers and related organisations over the next few months are now vital to the success of the FMD. When the Delegated Act is published in the Official Journal of the European Union, we will have a short three year window to get every Member State FMD ready - time is of the essence.'      

'Much attention is being placed on the implementation of the serialisation and new 2D barcodes, which dramatically affect the manufacturing process, but the real complexity is the testing of the new codes within the authentication system. With thousands of manufacturers in each country, a phased approach will be necessary and therefore three years is by no means a long period of time. Without the authentication systems in place to verify the products, the falsified medicines directive cannot be met. Our primary concern must be to ensure effective, efficient and timely implementation, while minimising the impact on pharmaceutical manufacturers, hospitals, pharmacies and, most importantly, the patients themselves.'  

'Aegate is the market leader in medicine authentication systems. We are the only company specialising solely in authentication technology with operational experience and a fully functioning system already in place, across nine Member States to date. Our expertise is unique and we are well placed to help stakeholders leverage our extensive practical experience.'

'I am convinced that our service not only meets but, in many areas, exceeds the standards called for by the Act. We will continue to do everything we can to work with stakeholders to ensure that pharmacies and other dispensing agencies across the European Union are FMD ready.'  

Aegate is the leading expert in medicines authentication and its best-in-class authentication technology is already in place in pharmacies across nine European countries. (Belgium, Italy, Greece, Ireland, Cyprus, Poland, Netherlands, Romania & UK)

About Aegate  

With a documented history of over 3.6 billion medicines scanned to date with an average rate of 200,000 transactions per hour across 21,000 dispensing points, Aegate is the principal active market leader in medicines verification. Aegate's Reach, Assure and Protect services meets the needs of all stakeholders. Supported internationally by manufacturers and pharmacists alike, Aegate is a European company with offices in Belgium, Italy, Switzerland, Spain and the UK. Our mission is to protect patients from falsified, recalled or expired medicines.

Aegate operates a highly secure real-time system to verify the authenticity of medicines. This operates seamlessly from manufacturer to pharmacy, and fully meets the requirements of European legislation for falsified medicines. The Aegate network also supports messaging services that provide additional information for the pharmacist at the point of dispense, such as regulatory or drug safety advice and patient education or adherence information.

For more information on Aegate, please visit http://www.aegate.com