Drug Serialization: What Are We Talking About?
In February 2019, the European Commission made drug serialization mandatory. This measure aims to fight counterfeiting and protect patients. It mainly concerns prescription medicines. All actors in the ecosystem must comply with this obligation, under penalty of sanctions.
Serialization to Fight Drug Counterfeiting in Europe
Drug serialization came into force on February 9, 2019 to comply with a European directive dated June 8, 2011. This system prevents counterfeiting through an authenticity verification system. This concerns medicines subject to mandatory medical prescription (PMO). However, serialization also concerns certain medicines not subject to PMO. These are listed in the annexes of the European Commission’s delegated regulation.
Serialization is an essential means to avoid the introduction of falsified medicines into the European pharmaceutical supply chain. Indeed, the measure contributes to establishing a European system against counterfeiting to protect patients. To ensure the effectiveness of drug serialization, all community pharmacies and hospital pharmacies (PUI) in European Union member countries must participate. Furthermore, securing the distribution chain also involves the participation of other actors, such as pharmaceutical laboratories and distributors.
Drug Serialization: A Unique Identifier for Secure Distribution
Serialization is based on an anti-tampering device applied to all medicines. The manufacturer must place a unique identifier on each box, materialized by a Datamatrix code. This includes four pieces of information:
- the Product Code (CIP);
- the batch number;
- the expiration date;
- and the serial number.
This unique identification allows differentiating each medicine box in the national database. Pharmaceutical laboratories holding Marketing Authorizations (MA) are responsible for issuing this number. In addition, they are required to feed European and French databases by recording the unique identifiers of the boxes they market. Thus, this procedure guarantees the security of the distribution chain.
Pharmaceutical Serialization: The Essential Role of Pharmacists
At the end of the chain, community and hospital pharmacists must proceed with verification of medicines and deactivation of the unique identifier. To do this, they must scan the Datamatrix code. They then check the information in the national database using a connected software. If necessary, pharmacists can consult European databases (EMVS) of other countries involved in distribution.
If community pharmacies and PUIs do not comply with the drug serialization obligation, the European Union threatens to heavily sanction the different countries involved. Indeed, the Commission could initiate proceedings against these countries before the European Court of Justice.
Read also: “Community Pharmacies: Getting Started with Serialization, Where to Begin?”
PharmaliZr Drug Serialization Software
Pharmacies must comply with strict regulations on drug serialization in force since 2019. Therefore, using software like PharmaliZr helps pharmacists effectively manage this mandatory procedure. PharmaliZr is a compliant and easy-to-use application. It was developed in close collaboration with pharmacists.
You can join PharmaliZr on the ELODI market of CAIH or subscribe online on our website.
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