Kallik minimizes the impact of staying compliant with current and forthcoming pharmaceutical regulations
What is EU FDM?
These new regulations are designed to increase traceability of devices placed on the market. Additional content needs to be included on device packaging and labelling including a Unique Device Identifier (UDI) in the form of a 2D matrix to be scanned at various points across the supply chain, and an anti-tamper device.
How does Kallik help with EU FMD?
Kallik helps medical device manufacturers ensure their products are correctly labelled in accordance with both the EU FMD and global serialization requirements for device identification, manufacturer, safety and re-use requirements.
- Improves transparency and traceability by managing all fixed and variable product and production data within one global platform.
- Establishes a single source of labelling ‘truth’ that all market-facing product information and materials flow from
- Increases vigilance of label layouts and content and ensures messaging is aligned across increasingly diverse product portfolios and distribution channels
Timeline of Updates
July 2011: New Directive Published
The new European Union Directive was introduced to prevent the entry into the legal supply chain of falsified medicinal products by strengthening good manufacturing and distribution processes, improving regulatory supervision across the supply chain and ensure the integrity and authenticity of medicines.
January 2013: New Directive Comes Into Force
The directive required that member states had to start applying its measures with a unique identifier being encoded in a two-dimensional barcode printed on each unit of sale package containing a product code, randomized serial number, expiration date, batch or lot number.
July 2014: New Obligatory Website Logo Introduced
The Directive introduced an obligatory logo that will appear on the websites of legally operating online pharmacies and approved retailers in the EU. The logo will allow patients and consumers to identify authorized online pharmacies and approved retailers providing authentic, authorized medicines.
February 2016: Delegated Act Published
Delegated Regulation to the Falsified Medicines Directive (FMD) 2016/161/EU, published on the 9 February 2016 specifying serialization, reporting, and verification requirements. All new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
February 2019: EU Manufacturers Must Now Comply With the FMD
From 9th February 2019, market authorization holders were required to place two safety features on all new packs of prescription medicines placed on the market in Europe. All products under the FMD now need to have clearly displayed, legible codes that can be read by the human eye and a scanner.
February 2025: Deferred Compliance
Belgium, Italy and Greece are given 6 additional years due to their current implementation of similar serialization requirements. Each of these countries may decide to align to the baseline FMD timeline. Certain non-EU countries such as Norway and Switzerland have highlighted plans to align to FMD requirements due to the extensive trade relationships they maintain with EU member states.
How To Be Compliant
Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails that all market-facing product information and materials flow from to deliver process transparency and simplify proof of compliance.
Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance
Identify opportunities to maximize operational gains across multiple contract manufacturing and supply chain partners by standardizing content and layout for multiple packaging processes and graphic elements across global supply chain partners.
Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise make identification of all impacted labels an almost impossible task.
Be better prepared for further world adoption of serialization and track and trace regulations by implementing a scaleable, robust and transparent solution to secure your supply chain and deliver globally compliant labeling.
Ensure the quality, format and positioning of 2D serialization barcodes contained within multiple types of print and packaging labeling are detectable to the range of optical and scanning devices used throughout the supply chain.