Pharma Serialisation and the EU Falsified Medicines Directive

In a recently published shared vision for product identification, the European Federation of Pharmaceutical Industries and Associations (EFPIA) supports the use of GS1 standards for the identification of products.

In the vision paper, a GS1 DataMatrix is selected as the data carrier of choice. The 2D barcode should be encoded with a product identifier, serial number, batch number and expiry date using the appropriate GS1 Application Identifiers (AI).

The choice of GS1 Standards for pharmaceutical product identification and marking has been driven by a broad number of factors including:

• Patient safety - globally unique codes for certainty of product identification
• Interoperability - ability for the solution to work across markets, stakeholders and sectors
• Complexity reduction - one solution which can be leveraged for all levels of packaging with the ability to choose the appropriate symbology
• Technical suitability - robustness of the data carrier and the ability to print in-line
• Cost effectiveness of solutions - appropriate for the needs of users
• Flexible and future compatibility - part of an on-going standard which will not be superseded
• Proven solution - used in the retail and other sectors worldwide.

The GS1 product identifier is called a GTIN or Global Trade Item Number and can be used across countries without any restrictions. This means that no trade barriers are created, which would otherwise potentially impact patient care and safety when products cannot be identified. There are many other benefits of a global approach to identification, such as the possibility to enable traceability within the EU as well as interoperability within and across other sectors.

The GTIN is used today by many industries to uniquely identify all levels of packaging for a given product from pallet, shipper, carton, and retail pack to single unit. It guarantees uniqueness of numbers across all markets, sectors, companies and products. Companies worldwide have used the GTIN for many years in barcodes on retail packs for product identification at point of sale as well as for moving products through the supply chain.

GS1 Healthcare has recently started a global work effort to develop GS1 Standards for item identification at unit dose level. Product identification must ensure that an item, e.g. a product pack, can be globally identified through a unique identifier. This is to avoid different products having the same identifier which would ultimately lead to patient harm and increased costs for healthcare providers.

GS1 has successfully managed communities of users from various sectors for over 30 years. Through the global Healthcare User Group (HUG), GS1 has provided a neutral, user-driven forum for the last six years for all Healthcare supply chain stakeholders to meet and develop the necessary standards. The GS1 system of standards enables all stakeholders to efficiently and effectively meet the requirements for the Falsified Medicines and UDI regulations.

GS1 has published a position paper on the pending EU Directives for both Falsified Medicines (shared vision with EFPIA) and Unique Device Identification (UDI) Implementation which is available