Are You Prepared For The EU's Falsified Medicines Directive?

By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory

European Union (EU) officials have finalized the safety elements for the Falsified Medicines Directive (FMD), so the clock is now ticking for manufacturers, packagers, re-packagers, wholesalers, and pharmacies to apply the rules, which are aimed at preventing counterfeiting, tampering, and diversion of medications.  The complexity of the new requirements, which go into effect February 9, 2019, leaves little time to waste.

Delegated Regulation EU 2016/161 was published earlier this year and provides guidance for safety features, their verification, the supporting repository systems, and certain exceptions.   The requirements include placement of unique identifier codes on individual packs of medications, as well as anti-tampering devices to enhance product safety and security, and will influence everything from data collection throughout the supply chain to how drugs are packaged.  Additionally, manufacturers will need to provide product master and serialized data to the European Medicines Verification System (EMVS).

Leveraging U.S. Serialization Learnings

U.S. serialization requirements go into effect next year under the Drug Supply Chain Security Act (DSCSA), and some of the preparations for complying with that law can be applied to the EU’s requirements, since both require serialization of medications and establish global standards for encoding of the product identifier, serial number, batch number, and expiration date. The implications of both the EU and U.S. rules span areas such as master data discovery and control, packaging features and design, IT solution architecture, and collaboration across the supply chain with suppliers, service providers, and trading partners.

Those who must comply with the application of safety features at the saleable package level face packaging challenges, such as the secondary carton containing the product, which may be in a vial or blister card. The required safety features include both encoding of a serialized Data Matrix code incorporating as many as five data elements, as well as an anti-tampering feature, such as carton seal, adhesive, or mechanical device.  Packagers of these medicines will need to evaluate their carton design and artwork to implement the safety requirements.  Additional factors influenced by the rule include:

• Manufacturers and other supply chain members need to confirm that each national market will accept a common value for the Global Trade Item Number (GTIN) to identify the product. 
• Member states may require their National Healthcare Reimbursement Number (NHRM) to be included in the serialized code, complicating the packaging.
• Allowed/acceptable values for legend title text (e.g. LOT, EXP) for each market — and whether the legend titles will be preprinted as part of the artwork, printed online, or printed using a hybrid approach — must be determined.

4 Steps to Prepare For The EU Requirements

In support of marketing authorization holders’ efforts to develop a comprehensive plan for implementing the required safety features across the product portfolio, the following actions are recommended:

1. Confirm product scope:  This is not always as straightforward as it may appear, depending on the manufacturer’s product portfolio and markets served.  The regulatory affairs team is critical for defining and managing scope by reviewing all marketed products approved for each country, confirming OTC vs. Rx classification, and referring to the white list for Rx exemptions and black list for OTC inclusions for any adjustments.  Collaboration with supply chain and product teams to manage planned product launches and discontinuations is necessary to support this effort.
2. Assess market-specific requirements and supply chain models: Some products may need new market-specific SKUs to meet unique national requirements.  Additional assessment of product supply chain participants, including logistics providers and distributors, should also be conducted to understand how processes such as risk-based verifications and status changes of serialized packs are affected.
3. Select an anti-tampering device (ATD) for the product: Manufacturers, packagers, and distributors need to consider packaging that resists tampering, the equipment used, how the products are encoded, and cost management.
4. Define process, technology, and organizational ownership for data:  With the amount of product-level master data and batch-level serialization data involved, clear definition of the data requirements, organizational roles and responsibilities for discovery and maintenance, and  the technology used for integration with the verification system are key to complying with the EU’s rules.

These actions will not only define the strategy and approach, but will also be used to develop detailed project plans.  Such plans will define the specific tasks and activities for managing changes to carton design and artwork layout, equipping packaging lines with the necessary technology, and integrating IT solutions at all packaging facilities with a centralized solution that will be used for uploading data to the EU hub.

Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s standards immediately, leveraging previous efforts for compliance with other market regulations.

About The Authors

Dave Colombo is a director within KPMG’s Life Sciences Advisory Practice with over 25 years of experience supporting supply chain execution processes at a large global pharmaceutical company. Prior to joining KPMG, he spent six years dedicated to product coding, serialization, and traceability implementing solutions in Turkey, China, Spain, and the U.S.

Dawn Wang is a manager within KPMG’s Life Sciences Advisory Practice currently working with clients to comply with various global compliance requirements, with a focus on pharmaceutical serialization regulations. Prior to joining KPMG, Dawn held various roles in operations, supply chain, quality, and compliance at a global pharmaceutical and medical device company.

This article represents the views of the author(s) only, and does not necessarily represent the views or professional or legal advice of KPMG LLP.