From February 2019, a drug authenticity verification system was launched in the countries of the European Union and the European Economic Area.
From that date, entrepreneurs are required to place a unique identifier on packages of medicinal products and to secure the packages against opening which is to prevent the presence of falsified medicinal products in the legal supply chain.
“Safety features”, new safety features of medicinal products are defined, are introduced on the basis of Commission Delegated Regulation (EU) 2016/161 of October 2, 2015 supplementing Directive 2001/83 / EC of the European Parliament and of the Council by specifying detailed rules for on the packaging of medicinal products for human use.
The document specifies that the packages of medicinal products are to be marked with security features that will enable wholesalers and persons authorized to deliver medicinal products to patients, to verify the authenticity of the products and to identify unit packages.
The regulation introduced two types of security – a unique identifier (UI) and an anti-tampering device (ATD). The identifier in the form of a 2D code and accompanying information contains basic data about a given packaging of a medicinal product, such as the batch number of the medicinal product, serial number of a specific packaging, expiry date, product code. Using an appropriate scanner, the 2D code can be read and information on whether the product has been positively verified or comes from a legal source is displayed at the next stages of the distribution chain.
The purpose of the ATD is to verify that the unit packaging of the product has not been tampered with at the next stages of distribution.
The obligation to have security features applies to medicinal products subject to prescription (Rx), with the exception of products on a separate list and some products without medical prescription (OTC).
WHAT DOES THE PACKAGE PROTECTION LOOK LIKE?
Safety features
The unique identifier consists of the following data elements:
PC – product code,
SN – serial number for the packaging,
Lot – lot number,
EXP – expiry date.
Additionally, each package is equipped with an anti-tampering device (ATD) in the form of a security label or permanent closure of the package, e.g. by gluing the side flaps of the carton
What is serialization ?
