Information for NMVOs

Insight into the Falsified Medicines Directive and Delegated Regulation

Welcome to Aegate

Aegate is the world leader in the digital authentication of medicines. Patient safety is the reason for our existence and that commitment drives our innovation and service delivery.

Our mission is to protect patients from falsified, counterfeit, recalled or expired medicines. Our secure real-time service verifies the authenticity of medicines.  Operating seamlessly from manufacturer database through to point of dispense in pharmacy, our service fully meets the requirements of the EU Falsified Medicines Directive.

Our Experience

What makes the Aegate authentication service unique is its proven ability to work in the live dispensing environment.

Aegate has many practical operations (they are not trials or tests) across Europe that have demonstrated many benefits:

  • Long term performance measurement of speed of response, accuracy and security. Proving the robust nature of the service.

  • Understanding of the cultural and structural differences and challenges in the individual markets across Europe.

  • Meaning that we understand that when it comes to implementing a successful authentication service, the devil is in the detail.

  • Our service has enabled pharmacists to understand more about this important new patient safety legislation and to prepare their own systems, work flows and staff for the changes ahead

Currently scanning 200,000 packs of medicine an hour, the Aegate authentication service provides the measurable proof of performance that gives buyers the confidence that they can implement and authentication service securely, efficiently and professionally.

The Aegate Experience in Action

Since August 2006, Aegate has processed over 3.5 billion verification requests.

We currently process over 500,000 transactions per hour at peak periods

Our Technology

Aegate has invested 100m€ into building our technology and the skills and expertise of the team who continue to develop system performance and our wider market understanding.

Our authentication service is built on three key pillars of:

  • Exceptional speed of response

  • Efficient service scalability

  • Excellent system security

These pillars enable complete compliance with the requirements of the Falsified Medicines Directive for all stakeholders. They are unmatched by rival systems.

Our unique technology is the only authentication service being used by pharmacies across Europe every day and therefore has proven performance and reliability.

For the latest on FMD issues and talking points download our Acumen Newsletter here
The FMD Clock is Ticking

With the publication of the Delegated Regulation on February 9 2016 the time available to implement the Falsified Medicines Directive reduces every day. That is less time to connect 170,000 pharmacies, less time to test, less time to be ready to scan 10 billion packs every year and less time to protect the 500 million citizens of Europe.

What makes the Aegate service unique?
  • It is already working at a high capacity and to a high performance standard in different European markets – it does not need to be tested, it is already proven.
  • It already meets and exceeds the requirements of the Delegated Regulation
  • It is supported by strong relationships with numerous software providers across Europe
  • We have an ongoing commitment to invest in our technology, the skills and expertise of our team and the performance of our service and overall system
  • We are the only provider who has taken the time and resources to understand the specific requirements of hospital dispensing environments
Our ground breaking work in hospitals

A unique approach is required for these unique dispensing environments.

They are complex settings with numerous potential dispensing points, large scale goods in arrangements, different work flows compared to retail pharmacy plus the use of robots to aid stock control and dispensing.

To provide guidance in this area Aegate has produced the Good Authentication Practice guide or GAP™.

This 12-point guide was developed as the result of an ongoing research project with Oxford NHS Trust.  The points in the Guide have been formulated as a direct result of observations, and research findings and are based on practical application and not abstract thought.