Serialization in the Pharmaceutical Sector
Arvato CSDB serializes - securely & legally compliant
Serialization for Protection Against Drug Counterfeiting
According to the WHO, the trade-in of counterfeit medicines affects all countries worldwide and is increasing massively. At best, counterfeits are ineffective for end consumers - and in the worst case, they are life-threatening. The worst case affects nearly one million people a year worldwide, where the toxic side effects of counterfeit drug products lead to death.
In order to effectively protect consumers, markets, and manufacturers from counterfeits, a legally binding framework for tracing prescription-only medicines was created, for example, with the EU Falsified Medicines Directive (FMD) of 2011 and the Delegated Regulation (EU) 2016/161. Serialization uses, among other things, Datamatrix codes, database matching with national verification systems and solutions for detecting the integrity of product packaging (Tamper Evident sealing).
Secure Serialization With Arvato CSDB
For pharmaceutical companies, digitization is a key element in the fight against counterfeit drugs. The Arvato CSDB is used as a proven serialization solution by over 80 pharmaceutical companies and ensures both a smooth serialization process and the seamless implementation of legal requirements. Today, our serialisation experts support pharmaceutical manufacturers and retailers worldwide in making medicines counterfeit-proof with IT consulting/process consulting and our own software solution Arvato CSDB.
Our expertise in the healthcare segment covers the entire serialisation process chain end-to-end, from the product to the end customer. Other in-house developments, such as the platbricks Healthcare Suite, offer additional opportunities to optimize processes and expand existing systems.
17 European countries have entrusted us with the operation of their National Verification Systems. The associated regulatory know-how ensures that our customers always have up-to-date processes/systems and thus investment and action security in a complex market.
Good Reasons for Serialization with Arvato Systems
Arvato CSDB - Core Functions of the Serialization
Drug serialisation is much more than a code on the package. Nationally as well as internationally, manufacturers and distributors have to meet the legal requirements regarding counterfeit protection.
The serialisation solution must integrate production lines, partners, customers & suppliers - this means comprehensive integration, adaptation of processes and high security measures. Whether at the intersections between ERP software and production and packaging machines, to the systems of external service providers or to national verification systems: The serialisation of medicines requires technical expertise, process know-how and the software solution Arvato CSDB, which reliably controls the entire serialisation process.
Solutions & Consulting Expertise for Serialization in the Pharmaceutical Industry
Importance of the topic of serialisation for market participants such as pharmaceutical producers, contract manufacturers, marketing authorisation holders or wholesalers.
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Frequently Asked Questions About Serialization in the Pharmaceutical Sector
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