National Verification Systems

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.

References (Extract)

Austria

Austrian Medicines Verification Organisation commissions Arvato Systems to set up and operate an IT platform for the verification of medicines

France

France MVO and C.I.P. task Arvato Systems with implementation and operation of IT platform for the verification of serialized medications

Germany

securPharm relies on Arvato Systems' IT expertise

Netherlands

The Netherlands implements National Verification System with Arvato Systems

Norway

Norway begins pilot phase for a National Verification System with Arvato Systems

Poland

Poland uses National Verification System from Arvato Systems

Portugal

Portugal relies on Arvato Systems as its Serialization Partner for the Pharmaceutical Industry

Spain

Spain relies on Arvato Systems’ National Verification System

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

Uploading and storage of master and serialization data using the EU Hub

Integration with the EU Hub for exchanging information between the respective systems

Processing of verification / dispensing inquiries for pharmacies, wholesalers and manufacturers of pharmaceutical goods

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.

European Footprint

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.

Your benefits

Proven Solution

Our IT system has proven itself in the real world and is in constant daily use.

Profound expertise

You benefit from our extensive experience in serialization projects.

Strong team

More than 2.600 IT professionals look after our international customer base.

Single-source

We offer consulting, platform & operational services.

Strong partner

As a 100% Bertelsmann subsidiary, we are backed by a strong corporate group.

Secure operation

We operate and manage your solution in our certified, german data centers.

Flexible platform

Our proven solution enables and embraces new functions.

Data security

We are able to protect your data in the highest possible dimension.

Cost transparency

No hidden costs due to commitment to the EMVO model.

Organisation models

We support a wide range of organisation models and can take on NMVO tasks through our comprehensive portfolio.

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Serialization in Drug Production

White Paper: Interesting background information about the development and the hazards of drug forgery, EU legislation as well as worldwide initiatives and their practical implementation process of serialization can be obtained in our White Paper.

Download White Paper