CAMBRIDGE, England, May 24, 2015 /PRNewswire/ --
EU Falsified Medicines Directive – When benchmarking for expertise and experience in operating a Medicine Verification Service, look for EU Member States who have a fully operational system in place, not a pilot. Pick an Aegate country: for example BELGIUM
The Falsified Medicines Directive (FMD) is a new EU-wide legislation being introduced to protect patients from counterfeit medicines. The FMD requires all 28 Member States to have a system in place to detect falsified medicines: uniquely serialised medicine packs, tamper-proof seals and their authenticity verified before being dispensed to patients.
The scale of the challenge is considerable and will be mandated by law. Over 6,000 pharmaceutical manufacturers must serialise and add tamper proofing to roughly 10 billion packs of prescription medicines that are dispensed every year across Europe.
On top of this, some 175,000 retail pharmacies and thousands of other dispensing points in all 28 Member States must have a system to verify the authenticity of medicines. Wholesalers must also have a system in place to check medicines on a risk-based approach.
The system has to be in local languages, and fully operational by the end of 2018.
Stakeholders in each Member State will have an important decision to make on who to appoint as their local service provider.
A leading example is the Aegate system, which has been in operation in Belgium, Greece and Italy scanning serialised codes since 2007, as well as The Netherlands and the UK in 2015 - it is now operational in over 18,000 dispensing points. In this time, the system has scanned over 3.3 billion medicine packs from branded and generics manufacturers, and flagged up over 2.4 million potential issues to safeguard patients.
A comparison between the existing operational Aegate National System for stakeholders in Europe, and the securPharm pilot in Germany, shows the difference in scale and capability to which the system provider needs to be prepared to support individual countries at a local level:
German Aegate National SecurPharm Benchmark Criteria Stakeholder System Pilot Operational Countries 3 1 pilot Medicine verifications requests 3.3 Billion 15.2 Million Pharmaceutical products 2,754 179 Pharmaceutical manufacturers represented 92 25 Participating pharmacies 15,595 387 At least 500 ms: made up of 230 ms verification 180 ms total round and 270 ms Message delivery time [Belgium] trip time delivery
An experienced, trusted service provider is needed in every country - Aegate are ready now for deployment throughout Europe.
With a documented history of some 3.3 billion medicines scanned to date with an average rate of 200,000 transactions per hour across 18,000 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 throughout Europe. Our mission is to protect patients from falsified, recalled or expired medicines.
We operate 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
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