Serialization –introducing safety features on the packaging of medicinal products

The presence of falsified medicinal products has been increasing worldwide in recent years. Purchasing medicinal products on the black market can be very dangerous for patients because in most cases the origin of these products is unknown, their quality is questionable and often they are falsified medicinal products that can seriously endanger the health of patients.

Falsified medicinal products do not undergo stringent requirements for quality, safety and efficacy assessment required by EU procedures for granting marketing authorization. They can be harmful to patients’ health or even cause death.

When we talk about the risk of falsified medicinal products, serialization implies marking each individual medicinal product packaging with a serial number in order to protect consumers from falsified medicinal products that are becoming increasingly threatening along with advances of the Internet and mobile technology.

There are two safety features that should be placed on the packaging of medicinal products:

1. Unique identifier (UI) consisting of a series of numbers or alphanumeric characters which is unique to each packaging and allows for the authentication and identification of a single package of medicinal products.
2. Anti-tampering device (ATD) to check whether the medicinal product packaging has been opened or altered from the moment it has left the manufacturer’s facilities.

The manufacturer places them on the outer packaging of the medicinal product, thereby allowing the identification and authentication of each packaging on which these features are placed.

This technological solution should stop the sale of suspicious medicinal products over the Internet and enable the monitoring of distribution from the manufacturer to the patient, either through hospitals or pharmacies.

The procedure is demanding in a financial and regulatory sense but it will ensure better business protection against loss of profit and, most importantly, a better public health protection by providing only safe medicinal products available to consumers.