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:
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:
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.