National Verification Systems
Legally compliant verification procedures in the pharma supply chain
European Security in the Pharmaceutical Industry
The topic of drug safety is increasingly becoming an area of focus in politics. EU Directive 2011/62/EU (anti-forgery guidelines) and the further technical refinement provided by Delegated Regulation 2016/161/EU of the European Commission lay the foundations for combating counterfeit drugs in the legal supply chain.
Big changes started on February 9, 2019: The EU Falsified Medicines Directive states that from this date forward prescription drugs may only be put into circulation if their packaging carries an individual serial number. Using this serial number, the identity and authenticity of a drug can be checked, thus preventing counterfeit drugs from entering the legal supply chain.
Our Solution: EMVO-Certified Blueprint Provider
Proven system ready for international rollout
Arvato Systems has been officially named as National Blueprint Service Provider by the European Medicines Verification Organization (EMVO).
In addition, as part of its comprehensive supplier evaluation, the EMVO has confirmed Arvato Systems' quality standards. All member states of the European Union are obliged to provide a nationwide IT system that allows for an end-to-end handling and tracking process within the pharmaceutical distribution and supply chain.
Components of our National Medicines Verification System
securPharm: Protection against counterfeiting in Germany
From 09 February 2019 on, the pharmaceutical industry must ensure that all prescription drugs are equipped with a data matrix code. The code, which will be printed on the packaging, will contain mandatory information such as
- the product code,
- the individual serial number,
- the batch number,
- the expiration date as well as
- additional information
Before the product reaches the market, the manufacturer reports the information to the pharmaceutical companies' (PC) database.
Every package of medicine is then scanned by the pharmacist in the pharmacy before it is dispensed to the customer. Using the data matrix code and the item's individual identifier, the authenticity of the product can be instantly verified. Only once the status of the medicine has been verified is the pharmacist allowed to give the item to the customer. The status of the individual serial number is changed on the securPharm platform as soon as it is dispensed; it is then listed as "used" and cannot be dispensed again. The pharmaceutical wholesaler is also required to carry out risk-based audits.
securPharm complies with all requirements of the EMVO. All of the blueprint processes have been implemented and have proven successful in daily use.
Why Arvato Systems?
High data volumes, short reaction times and demanding safety regulations present securPharm with organizational and technical challenges. This is why participating trade associations in the industry turned to us early on for support and assistance. From its first hour of operation, we have run the securPharm platform from our own data center, supported ongoing test phases, and taken the lead in further developing and expanding the system – and that includes anticipating upcoming legal requirements.
Our roots are in Europe and this is also where we feel most at home: At some 150 locations in 22 countries, we support local projects with local resources so that we can be there, right by the customer's side.
Our IT system has proven itself in the real world and is in constant daily use.
You benefit from our extensive experience in serialization projects.
More than 2.600 IT professionals look after our international customer base.
We offer consulting, platform & operational services.
As a 100% Bertelsmann subsidiary, we are backed by a strong corporate group.
We operate and manage your solution in our certified, german data centers.
Our proven solution enables and embraces new functions.
We are able to protect your data in the highest possible dimension.
No hidden costs due to commitment to the EMVO model.
We support a wide range of organisation models and can take on NMVO tasks through our comprehensive portfolio.