Why serialize?

While this may seem unlikely in France, where we buy our medicines in pharmacies, counterfeit drugs are manufactured and sold all over the world. The World Health Organization even estimates that 700,000 deaths a year are due to the sale of counterfeit medicines worldwide. And it was to combat the rise in counterfeiting that the pharmaceutical industry decided to introduce drug traceability, starting with serialization.

What does it mean to serialize a drug?

Most of the products we use every day carry a unique serial number (vehicles, computers, industrial equipment, household appliances, etc.), enabling us to authenticate their origin and track them throughout their life.

For medicines, serialization consists in printing a unique serial number on each box of medicine, whatever its galenic form (dry, liquid or paste). It therefore concerns the medicine’s secondary packaging, also known as the case.

Each serial number must be legible and encoded in a Datamatrix on each case.

Which drugs are concerned?

It’s prescription-only medicines that need to be serialized.

Serialization of medicines in Europe

The serialization of medicines within the European Union officially came into force on February 9, 2019 following European Directive 2011/62/EU, passed by the European Parliament in 2016.

Serialization, the first step towards drug traceability

Serialization is the first step towards a complete drug traceability system. In order to trace each box of medication from the manufacturer right through to delivery to the patient in the pharmacy, each case and pallet in which each serialized box is packed needs to be identified.

This new stage, also known as aggregation, is one of the major challenges facing pharmaceutical companies in the years ahead.