Tackling Regulations at Fast-Moving Consumer Goods Companies- Part One

handshake and regulations icons

This is the first part of a three-part series examining how past, present, and future regulations affect various fast-moving consumer goods (FMCG) companies. We will focus on the areas of pharmaceuticals, medical devices, hazardous ingredients, water and beer serialization, food allergens, tobacco, and cosmetics. This blog will discuss regulations around manufacturing pharmaceuticals and how machine vision can help companies comply with the various global regulations. 

Producers of fast-moving consumer goods (FMCG) such as perishables, packaged foods and confectionery, beverages, toiletries, cosmetics, over-the-counter pharmaceuticals, and other consumables, must comply with many local, national, and multi-national regulations if they wish to sell their products in specific countries and regions. The European Union (EU), Russia, and the United States (US) have considerable impact on the regulatory environment, but the influence of other countries, particularly China, is expected to grow.

Many regulations related to FMCG require specific information on labels and packaging and often involve marking labels or packaging with unique alphanumeric codes or barcodes to enable product authentication and traceability, deter counterfeiting and diversion, and support the collection of taxes and customs duties. Codes also are used to alert consumers, poison centers, and medical professionals about hazardous ingredients in products like laundry detergent. For food products, labels or packaging must carry alerts about the presence of allergens.

Any company that wishes to sell products into these regulated markets must comply with their coding and labeling requirements. In many regions, regulations have been put in place for pharmaceuticals, medical devices, food, beverages, tobacco, cosmetics, and other products. Effective dates vary, but some requirements are already in place, others with deadlines looming.

Compliance with regulations involves a substantial investment in planning and implementation time as well as in hardware, software, systems integration, and training. One of the first steps is to redesign packaging and labels to include requisite information and space for alphanumeric codes, barcodes, and/or product-identifying icons. Icons often are preprinted, but codes, especially unique item-level codes, typically are inkjet- printed, thermal-printed, or laser-marked on the packaging line. This necessitates equipping the packaging line with code-printing systems, the connectivity to transmit code data to and from the line, and vision sensors or systems to perform verification, inspection, and data collection.

white containers being scanned on a factory line

Machine vision systems, AI-based technology, and image-based barcode readers can:

  • Confirm each code is readable and correct
  • Collect data
  • Identify inadequate print quality, trends, and errors
  • Automate the aggregation process that links unit-level codes to carton-level codes to case-level codes and, ultimately, to pallet-level codes
  • Validate tax stamps
  • Provide alerts when coding equipment needs maintenance, thereby preventing scrap (waste) and rework
  • Check for the presence and readability of date, lot code, and allergen information

For full end-to-end traceability, vision systems or barcode readers also must be installed at each point in the supply chain to collect the data needed to authenticate the product and track it from manufacturer to consumer. These coding and machine vision systems are needed on packaging lines to meet existing and future coding requirements for many products including pharmaceuticals, foods and beverages, medical devices, and tobacco.


A stack of white pharmaceutical boxes next to an orange pill bottle 

The Falsified Medicines Directive (FMD) requires each level of packaging for most prescription and a few non-prescription pharmaceutical products sold in the EU to carry a serialized barcode and text. EU member states also may impose additional requirements. The goal is to keep counterfeit medicines out of the marketplace by making it possible to track and authenticate the drug product as it travels through the supply chain.

Failure to comply with the coding requirements will prevent companies from selling their products in the EU. Quality control personnel in pharmaceutical companies must ensure products meet the coding requirements of the EU and the destination country as well as satisfy Good Manufacturing Practices (GMPs) and electronic signature regulations. Regulators at the EU and member state level carry out audits for compliance.

Russia, which is not part of the EU, has established its own coding system for pharmaceutical products. It relies on a Crypto Code, which consists of a human-readable serialized code plus a DataMatrix code with added features and has already taken effect for pharmaceuticals and some other products.1 The Russian Federation’s Center for Research in Perspective Technologies oversees the implementation of the Chestny ZNAK unified national track-and-trace system including Crypto Code assignment, maintenance of a digital database, recording of goods movement, and product authentication.

The serialized Crypto Code helps prevent diversion to the black market and ensures Russia can collect taxes on incoming goods such as pharmaceuticals, shoes, perfume, bicycles, and tires. With the coding requirements, products destined for the Russian market must be marked with the proper serialized code. Failure to comply will prevent sale of the product in Russia.

The US has similar requirements for prescription drugs under the Drug Supply Chain Security Act (DSCSA). On-pack coding deadlines have passed, but the deadline for transaction data transmission between trading partners via GS1’s Electronic Product Code Information Services (EPCIS) is upcoming. However, few stakeholders were prepared to meet the November 27, 2023, deadline. According to a survey by the Healthcare Distribution Alliance’s HDA Research Foundation, 40 percent of manufacturers are currently sending or planned to send at least some serialized data to their wholesale distributor customers upon shipment, 43 percent plan to do so by November 2023. Another 16 percent were unsure of when they plan to exchange data with wholesale distributors for all products. Part of the lack of readiness is that many manufacturers have delayed implementation of aggregation, a prerequisite for transmitting serialized data.

Meeting the requirement for sharing serialized data between supply chain partners is likely to require installation of vision systems to automate the code scanning processes and minimize the additional head count needed to capture the data from each package passing through a facility.

Failure to meet DSCSA deadlines can lead to fines, license suspension, imprisonment, or civil penalties. Currently, FDA has suspended prosecution for noncompliance. However, once the suspension period ends, defaulters can be punished.

Many other countries are working to implement various levels of serialization. Some pending deadlines are shown in the table below.

Pharma Serialization Deadlines & Requirements


Serialization Requirement

Compliance Deadline


Manufacturers must aggregate product

May 2022

In-country agents/distributors must comply with serialization, aggregation, and reporting requirements

June 2022


Products must be serialized and tracked through the supply chain

April 1, 2025


Product must carry a 2D DataMatrix barcode for authentication



Aggregation and serial number reporting

Jan 1, 2023

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