rfxcel Archives - Page 3 of 14

FSMA Traceability: A Comprehensive Guide for Food Industry Compliance

Posted on February 24, 2023December 7, 2023 by rfxadmin

The Food Safety and Modernization Act (FSMA) is the most significant development in food industry traceability. One specific set of requirements in the law, the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is reshaping and modernizing the approach to food safety and food supply chain data.

Whether you’re a grower, processor, distributor, or retailer in the food industry, understanding and implementing FSMA traceability is vital. Let’s walk through FSMA traceability requirements so you can adapt to the FDA’s Food Traceability Final Rule and ensure your compliance.

What Is FSMA Traceability?

FSMA traceability refers to the ability to track every step of a food product’s journey from farm to table, as required by the law. It’s primary goal is to help prevent and mitigate foodborne illnesses

FSMA traceability requirements center around creating, maintaining, and sharing a clear record of where food comes from, where it was, where it is now, where it’s going, and who’s handling it.

Under FSMA, the Food Traceability Final Rule defines additional recordkeeping requirements all those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), which includes cheeses, shellfish, and certain fruits and vegetables. It provides you and your trading partners with clear guidance on what data you must keep and share as your products move across your supply chain.

The FDA’s Role in FSMA Traceability

The Food and Drug Administration plays a pivotal role in FSMA traceability: It sets FSMA traceability requirements, evaluates foods using a risk-ranking model, and holds stakeholders accountable for complying with the act. In addition to setting traceability recordkeeping requirements, the FDA also assesses penalties for non-compliance with the traceability program.

Compliance Requirements for Food Industry Professionals

FSMA 204 and other provisions of FSMA apply to:

Harvesters
Coolers
Packers
Processors
Distributors
Retail food establishments

The specific requirements for your business will vary based on your role in the food supply chain. Many requirements focus on initial packing and labeling; proper packaging and labeling promote FSMA traceability and streamline the flow of goods along the supply chain.

FSMA 204 also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Benefits of FSMA Traceability

Embracing traceability promotes better food safety and protects consumers from foodborne illnesses. If an issue arises with one of your products, you can use traceability data to quickly find where it came from and where it is now. This granular, read-time information expedites recalls and ensures that all affected products are removed from store shelves as quickly as possible.

From a business perspective, FSMA 204 helps you protect your brand image, as you can ensure the quality, integrity, and safety of food products. In addition to enhancing your reputation, you can use FSMA traceability to identify bottlenecks within the supply chain and eliminate waste.

Technology and Tools for FSMA Traceability

FSMA gives the FDA the authority to establish modern, science- and risk-based requirements, including all the traceability requirements in Section 204.

The law dovetails with the Agency’s New Era of Smarter Food Safety, which is “a new approach to food safety, leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.” It will the FDA identify ways to further its modernization goals and help ensure that the regulations evolve with the industry and available technology to reduce foodborne illness.

So, what we’re seeing with FSMA 204 is part of the FDA’s plan to secure the food supply chain using technology. FSMA traceability, anchored by requirements for food companies to record and share Critical Tracking Events (CTEs) and Key Data Elements (KDEs), is attainable with currently available digital supply chain technology.

Other requirements, such as using traceability lot codes and having systems to share electronic sortable spreadsheets with traceability information to the FDA, are also part of a strategic approach to leveraging technology for FSMA compliance.

Food supply chain traceability software is the best road to meeting technological requirements and FSMA compliance. It’s also the best way to ensure you remain compliant and competitive as regulations, food trends, and consumer attitudes evolve.

Common FSMA Traceability Challenges

Challenges to complying with FSMA traceability regulations include the following:

Integrating traceability systems with existing processes: Adding any new tech tool to your established systems/process could disrupt operations, including interactions with trading partners.
Ensuring your partners are preparing: Traceability requires participation from everyone in the supply chain. Talking with your trading partners about FSMA readiness is vital to being ready to comply by the January 2026 deadline.
Training staff: You’ll need to educate and train staff on FSMA 204 compliance and the effect it will have on your business. Training is also necessary to create a culture of food safety in your organization.
Managing data: Complying with FSMA means you will be creating, sharing, accessing, and storing massive amounts of data. Your systems not only have to handle the volume — they must ensure the data is compliant.

Navigating the challenges requires a holistic approach. First and foremost, you need to get your team on board by being transparent about the regulations, how they will affect your daily operations, people’s roles and responsibilities, and what you are doing to prepare.

The Importance of Data Security and Privacy

With so much sensitive data being generated, security and privacy are paramount. You need to make sure that your traceability data is protected from unauthorized access and breaches. This means investing in secure systems and being mindful of privacy laws and regulations.

Additionally, you must ensure that your partners are doing their part to promote data security. Remember, you’ll need to integrate some of your technologies with theirs to expedite the flow of traceability data. You don’t want to inadvertently create a blind spot or weak link in your data infrastructure by partnering with a vendor that does not take data security as seriously as you do.

Anticipating Regulatory Audits

Nobody wants to be audited, but everybody should be prepared. The key to passing an audit is to make food safety and FSMA compliance part of your company culture. If these are only afterthoughts or simply a box to check, the chances of failing an audit are much higher. In contrast, being proactive means an audit will essentially be a formality (and become an opportunity to stand out among competitors).

Final Thoughts: FSMA Traceability with rfxcel

Familiarizing yourself with FSMA traceability requirements will help you achieve and maintain compliance, improve food safety, and preserve your brand image. Prioritize compliance and implement effective traceability practices by partnering with rfxcel. We’ve been a leader in traceability (and compliance) technology for 20 years, and we will work with you to develop a solution suited to your needs.

Book a demo to learn more. We also invite you to explore our other FSMA resources.

For a Leading Berry Producer, Antares Vision Group Digitalizes Billions of Products for Tight Supply Chain Oversight and Direct Consumer Connections

Posted on January 20, 2023January 20, 2023 by rfxadmin

The Group’s Supply Chain Transparency solution serializes packages in the field, enabling the use of unit-level data to help ensure customers are satisfied with product quality.

Travagliato (Brescia), January 17, 2023 – Antares Vision Group (EXM, AV:IM), an Italian multinational and a leading provider of track and trace and quality control systems that ensures the transparency of products and supply chains through integrated data management, has successfully piloted a Supply Chain Transparency solution for a prominent berry company. The project entails the digitalization of over 1.5 billion products, empowering the berry producer to protect, support, and communicate with its customers.

Powered by technology from rfxcel, which is part of Antares Vision Group, the Supply Chain Transparency solution package enables data concerning harvested berries to be collected and integrated into a platform that fully controls product safety and quality.

Using Antares Vision Group’s advanced serialization and mobile traceability technologies, the producer scans each individual clamshell to associate berry type, farm, and growing conditions, giving each package a unique digital identity with detailed product information. Consumers can scan an on-package QR Code to take a survey, giving the producer valuable insight into its customers’ impressions of specific berries grown at specific locations. This allows the company to focus on the types of berries consumers like best, and to ensure product quality is maintained at high standards from field to end user.

Glenn Abood, CEO of rfxcel, said the project showcases the technology’s impact and scalability. “We’re really expanding boundaries with this project,” he said. “Our coordination with the berry producer has been greatly rewarding; together, we’ve designed a system that reliably manages billions of products in the first and last mile of the supply chain. It performs these tasks day in and day out, with sub-second scanning times and exacting accuracy.”

Abood added that Antares Vision Group and the producer had discussed other applications for the wide-scale serialization of products, such as using digitalized unit-level data for consumer engagement activities and risk-mitigation strategies.

Abood continued: “Our serialization technologies are opening up entirely new avenues for brand value and benefits, connecting safety, quality, efficiency, and trust. The brand owners have actionable and granular information about consumer preferences, opening new dialogue channels and highly targeted customer interactions. Recall management is another benefit: It’s not necessary to recall every package, only a single clamshell. These advantages are available only with serialized products, which unlock opportunities with the power of unit-level data.”

For further information

Herb Wong, Senior Vice President, Product and Strategy: +1 925 791 3235 / hwong@rfxcel.com

Alessandro Baj Badino, Head of Investor Relations: +39 030 72 83 500 / investors@antaresvision.com

Davide Antonioli, Investor Relator: +39 030 7283500 / investors@antaresvision.com

Federica Menichino, Axelcomm (Press Contact): +39 3496976982 / federica.menichino@axel-comm.it

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA), Antares Vision Group recorded a turnover of €179 million in 2021, operates in 60 countries, employs more than 1,000 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

India Track and Trace Requirements Update: APIs, iVEDA, and Barcoding

Posted on September 27, 2022August 4, 2023 by rfxadmin

It’s been a busy year with India track and trace requirements. The Ministry of Health has extended a deadline, announced a new deadline, and released new draft rules concerning key areas of the country’s pharmaceutical regulations.

There are deadlines coming up in the next 6 months, so let’s take a look at what’s happening with these India track and trace requirements..

India track and trace requirements for 2023

The upcoming India track and trace requirements affect three areas of manufacturing: labeling active pharmaceutical ingredients (APIs), reporting, and product labeling for the Top 300 brands. We’ll go in chronological order:

Labeling APIs: January 2023 deadline

Starting January 1, 2023, all imported and domestically manufactured APIs must be labeled with QR codes “at each level packaging that store data or information.” The government says this will help combat falsified drugs.

This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points:

1. 1. Unique product identification code
  2. Name of the API
  3. Brand name (if any)
  4. Name and address of the manufacturer
  5. Batch number
  6. Batch size
  7. Date of manufacturing
  8. Date of expiry or retesting
  9. Serial shipping container code
  10. Manufacturing license number or import license number
  11. Special storage conditions required (if any)

QR codes will also link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

Companies are required to get a GS1 Company Prefix, a unique number that identifies a company as the owner a barcode and the product to which it’s affixed, and a GS1 Global Location Number. GS1 Global Trade Item Numbers will serve as the “unique identification code.”

Reporting to the iVEDA Portal: March 2023 deadline

On April 4, 2022, the Directorate General of Foreign Trade (DGFT) released a public notice that extended to March 31, 2023, the deadline for export reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The change applies to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

The deadline for this requirement has been postponed at least four times, starting in 2018, when India track and trace requirements centered around another reporting portal, the Drugs Authentication and Verification Application (DAVA). As we reported when iVEDA was launched, the deadline was changed from April 1, 2020, to October 1, 2020. It was changed again in April 2021 and, as we’re discussing now, in April 2022.

Draft regulations for barcoding pharma products: May 2023 deadline

On September 5, the Ministry of Health and Family Welfare published draft guidelines for barcoding the Top 300 brands in the country, all of which are named in “Schedule H2” of the announcement. The rules will come into force on May 1, 2023.

The goal of these India track and trace requirements — like so many other regulations around the world — is to combat counterfeiting, diversion, and unauthorized sales. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging:

- - Unique product identification code (e.g., GTIN)
  - Proper and generic drug name
  - Brand name
  - Batch number
  - Expire date
  - Manufacturer name and address
  - Manufacture date
  - Manufacturing license number

If there is “inadequate space in primary package label,” the codes must be placed on the secondary packaging.

Industry observers have noted concerns with the guidelines, including:

- - QR codes may not be practical for data-dense pharmaceutical labeling.
  - The guidelines may not actually help fight counterfeits, diversion, and unauthorized sales.
  - In order for the eight mandated data points to be readable, labels would have to be unrealistically large — too big to fit on most packages.
  - It’s not clear if 2D DataMatrix codes would meet the requirements for a “Bar Code” in the guidelines.
  - GS1 standards are not required; in fact, they’re not mentioned at all.

To this last point, the initial response seems to point toward a call for GS1 standards: DataMatrix for barcoding, GTINs to identify products, use of two-digit Authentication Identifiers.

Final thoughts

India track and trace requirements are obviously evolving. Expect more changes as the deadlines for APIs, iVEDA reporting, and barcoding get nearer.

But one thing won’t change: India will continue to cultivate its position in the global pharmaceutical industry. Consider these statistics from its Department of Pharmaceuticals 2020-21 Annual Report:

- - The Indian pharmaceutical industry is the world’s third largest by volume and 14th largest in terms of value.
  - It has the second-most FDA-approved plants for generic drug manufacturing outside the United States.
  - It accounts for 60% of global vaccine production.
  - It is the world’s third-largest API market (8% share of global API industry, 500+ APIs manufactured in India, and it contributes 57% of APIs on the World Health Organization’s Prequalified List of APIs).

Our team has worked in the India pharma market for many years and understand its complexities, challenges, and benefits. We have offices and experienced staff in the country. And our signature Traceability System and Compliance Management solution have helped our customers keep up with India track and trace requirements and remain competitive.

Contact us today to lean more about the India track and trace requirements and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can maximize your impact in India.

Join Antares Vision Group at the HDA 2022 Traceability Seminar in October

Posted on September 27, 2022September 26, 2022 by rfxadmin

Antares Vision Group will be at the HDA 2022 Traceability Seminar October 12-14 at the Marriott Marquis in Washington, D.C. We’re an official sponsor, and our team will be there with our latest technologies and solutions. Stop by to meet us!

The HDA 2022 Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the DSCSA as distributors, manufacturers, and dispensers implement serialization and traceability technologies.

Attendees also discuss innovative approaches and lessons learned from the first 9 years of the DSCSA rollout and what to expect during the “last mile” of implementation until the November 2023 deadline.

Get the latest DSCSA intel from our experts at the HDA 2022 Traceability Seminar

If you’re reading this, chances are you know that we’ve been leading on the DSCSA since Day 1 and have collaborated with the pharma industry to test key systems, work out kinks, and help all stakeholders prepare. Here are just a few examples:

And it should come as no surprise that Herb Wong, our SVP of product and strategy, will be at the Seminar. He’ll be at our booth, of course, but he’s also doing the “EPCIS Onboarding Across the Supply Chain” panel discussion on Thursday, Oct. 13, from 1:30 to 2:30 p.m.

Herb will also host a Friday morning roundtable about DSCSA readiness. Antares Vision Group is sponsoring the day’s Roundtable Discussions (9:35-10:50 a.m.), where you can discuss operational issues associated with traceability implementation. Choose a topic that interests you and rotate through the tables with your peers. Highlights from the discussions will be shared at the end of the session.

With this experience and knowledge, our team wants to answer your questions and show you our solutions while you’re at the Seminar. No matter how far along you are in your DSCSA preparations, time with our team will be time well spent — informative, interesting, and maybe even game-changing.

Final thoughts

We’re just a year away from the final DSCSA deadline and the full serialization of the U.S. pharmaceutical supply chain. The HDA 2022 Traceability Seminar is really the place to be when it comes to the “right now” of the DSCSA for product identification, product tracing, product verification, and requirements for authorized trading partners.

So bring your DSCSA questions for our team and let us know how things are going. Visit our booth. Sit in on Herb’s Thursday EPCIS panel discussion and his Friday roundtable. If you have 3 minutes, take our DSCSA Readiness Survey. You can also check out our DSCSA Compliance Library for all of our resources about the law.

We hope to see you in October!

UAE Tatmeen Track and Trace System: Just the Facts

Posted on September 13, 2022August 4, 2023 by rfxadmin

There’s a deadline coming up for the UAE Tatmeen track and trace system, so we figured it was a good time to take another look at the platform that will, as the government says, “safeguard the entire supply chain.” We’re going to focus on just the facts today. For a more comprehensive look, check out the article we wrote earlier this year.

What is the UAE Tatmeen track and trace system?

“Tatmeen” means “assurance” in Arabic. The Ministry of Health and Prevention (MOHAP) introduced the system in June 2021 “to ensure protection of public health and improve the security of healthcare at all stages.” It will do this by tracking and tracing all pharmaceutical products and medical devices that enter the country.

In addition to MOHAP, three UAE-based organizations are involved in the Tatmeen system:

- - The Dubai Health Authority (DHA) oversees the “complete health sector” in Dubai and promotes engagement with the private sector. Tatmeen will integrate with the DHA’s electronic medical record system and utilize its paperless drug and medical supplies management system.
  - The Department of Health—Abu Dhabi is the regulative body of the healthcare sector in the Emirate of Abu Dhabi. It “shapes the regulatory framework for the health system, inspects against regulations, [and] enforce[s] standards.”
  - EVOTEQ is a “digital transformation catalyst” that promotes innovation, including digitalization, particularly in public-private partnerships.

GS1 UAE is also involved, as the UAE Tatmeen track and trace system is based on GS1 standards. This includes using GS1’s BrandSync platform as a central reporting repository.

How does the UAE Tatmeen track and trace system work?

Tatmeen is structured around GS1 barcodes and scanning products as they enter the country and move through the supply chain. Explained simply, the process looks like this:

1. 1. Manufacturers put a GS1 barcode on every product. Manufacturers are responsible for aggregation. They must obtain a license from MOHAP to import “conventional, biological or other human pharmaceutical products.” As in other countries, this is a multi-step process. See the MOHAP website for more information.
  2. Customs officials scan products to get detailed information and verify they are legitimate before allowing them into the country.
  3. Distributors and logistics providers scan to keep track of inventory, provide another layer of protection, and help ensure products are delivered to the right place in a timely manner.
  4. Healthcare providers at hospitals, clinics, and other facilities scan to verify a product’s legitimacy and expiration date prior to dispensation.
  5. Patients and consumers can also scan to check the safety and authenticity of products.

Tatmeen timeline, next deadline, and news

As we noted above, MOHAP introduced the UAE Tatmeen track and trace system last June. The first deadline was Dec. 13, 2021, when manufacturers and marketing authorization holders had to be registered with the BrandSync platform and begin using 2D DataMatrix codes.

Truth be told, it’s been pretty quiet since then, with industry getting ready for the next deadline — Dec. 13, 2022 — which concerns serial number reporting, aggregation, and Global Location Numbers (GLNs). See our previous article for those details.

Several updated technical documents have been posted on the Tatmeen website this year:

- - Technical Guide for Dispensers (v2.0, March 21, 2022)
  - Technical Guide for Logistics (v3.0, May 30, 2022)
  - Technical Guide for Manufacturers (v4.0, July 6, 2022)

The Tatmeen Serialization Implementation User Guide, “GS1 Barcoding of Conventional Medicines: An Introduction and Reference Guide,” is still in v1.0, dated Aug. 10, 2021.

One notable event was a 4-day Tatmeen workshop held this past June. Co-hosted by MOHAP and EVOTEQ, it gathered representatives from the DHA, the Department of Health–Abu Dhabi, the Emirates Health Services (EHS), and Federal Authority for Identity, Citizenship, Customs and Ports Security to discuss progress made, attracting manufacturers, and connecting stakeholders in the platform.

Speaking at the workshop, Ahmad Ali Al Dashti, assistant undersecretary for the support services sector at MOHAP, and Ali Al Ajmi, director of MOHAP’s Digital Health Department, said the UAE Tatmeen track and trace system is leveraging technology to transform the health sector and continue the country’s position as a role model for assuring the safety of pharma products, including by fighting counterfeits.

Final thoughts

The UAE Tatmeen track and trace system is the perfect example of how the global push for pharmaceutical traceability and serialization is not slowing down. Quite the opposite, in fact.

Sure, some regulations and big deadlines get more attention than others — the U.S. Drug Supply Chain Security Act leaps to mind — but rest assured other countries are hard at work to modernize and digitalize their supply chains. A few examples that we’ve covered recently include Kazakhstan, Uzbekistan, Egypt, and The African Medicines Agency.

We’re here to help you understand the global regulatory landscape, answer your questions, and help ensure you’re able to do business everywhere you supply chain goes. In terms of the Middle East specifically, we have people on the ground implementing traceability hubs in Lebanon and the Kingdom of Bahrain; we have the know-how to make your supply chain safe, secure, and compliant while optimizing your operations and growing your business.

Contact us today to learn more. In about 15 minutes, we can show you how our automated, intuitive technologies actually make it easy to meet regulations and improve your supply chain.

FDA National Drug Code: Proposed Format Changes & Industry Impact

Posted on September 12, 2022August 4, 2023 by rfxadmin

If you follow our blog (and we know you do), you know that pharma stakeholders will have to verify all products at the individual package level when the Drug Supply Chain Security Act (DSCSA) goes into full effect about 1 year from now. The FDA National Drug Code, or NDC, is integral to this requirement.

At some point, however, the FDA realized that it was “running out of” National Drug Codes. One reason was the pandemic, which the Agency said “significantly increased the rate at which NDC codes were issued.” In response, on July 25 it published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.”

What does this mean? How will a new FDA National Drug Code format affect the pharma industry? Let’s take a look.

What is the FDA National Drug Code?

The FDA National Drug Code is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Today, National Drug Codes comprise 10 digits in three segments:

1. 1. Labeler code (4 or 5 digits), which identifies the labeler. The FDA defines a labeler as “any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.” The FDA assigns labeler codes.
  2. Product code (3 or 4 digits), which identifies strength, dosage form, and formulation for a particular firm. Firms assign product codes.
  3. Packaging code (1 or 2 digits), which identifies the package size and type. Firms assign packaging codes.

National Drug Code formats are commonly referred to as “5-4-1,” “5-4-2” (HIPAA standard), “5-3-2,” or “4-4-2” depending on how many digits each segment has. The illustration below is adapted from an FDA graphic depicting the current format.

The Proposed Changes to the FDA National Drug Code

The proposed FDA National Drug Code would have a “uniform” 12-digit, “6-4-2” format, as illustrated below. The Agency says this “would facilitate the adoption of a single NDC format by all stakeholders [and] eliminate the need to convert NDCs from one of FDA’s prescribed formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).”

When and how will the change be rolled out?

The FDA proposes an effective date 5 years after the final rule is published “to allow stakeholders time to develop and implement changes to their systems.” Pharma stakeholders that use FDA-assigned codes will need to have systems in place to handle the new format by the effective date.

The Agency would begin assigning new 12-digit National Drug Codes in the 6-4-2 format on the effective date. Drug listing files submitted on or after the effective date would also have to use the new 6-4-2 format.

However, “to reduce the burden on registrants,” the FDA says it won’t require companies to resubmit all of their existing drug listing files; instead, the Agency itself would convert the existing codes “by adding leading zeros to the appropriate segments.” For example:

And though the Agency’s proposing a 3-year labeling transition period from the effective date, it’s encouraging manufacturers and distributors to start using the new National Drug Codes as early as possible. Still, during this 3-year period the FDA “does not intend to object to the continued use of 10-digit NDCs on the labeling of products that were assigned a 10-digit NDC prior to the effective date.”

Impact on product labeling

Product labeling will have to be updated with the uniform 12-digit FDA National Drug Code. To make this easier for stakeholders, the Agency proposes revising requirements to allow linear or nonlinear barcodes — as long as they meet mandated standards.

The FDA says it’s also looking into revising 21 CFR 201.25(c), “Bar code label requirements,” to “accommodate potential advances in technologies and standards development by allowing the use of unspecified automatic identification and data capture (AIDC) formats other than linear or non-linear barcodes … without the need to revise the regulation again.”

Industry reaction

These proposed changes to the FDA National Drug Code would affect manufacturers of human and animal drugs, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the National Drug Code, state and local governments, and other supply chain stakeholders that use FDA National Drug Codes.

The pharma industry has known for at least 4 years that the FDA was concerned about running out of codes and was thinking about proposing changes. The Agency held a public hearing on Nov. 5, 2018, “to receive input from stakeholders on how to maximize the benefit and minimize this impact well in advance of any forthcoming change.” Four options were presented at this hearing:

- - Option A: Use 5-digit labeler codes until they run out, then adopt a 6-digit labeler code
  - Option B: Start using 6-digit labeler codes on a designated date
  - Option C: Change to an 11-digit format, then a 12-digit format, when the 5 -digit label codes are gone
  - Option D: Adopt the 12-digit format before the 5-digit labeler codes are gone.

Most comments from industry supported Option D. “Comments were in favor of FDA’s adoption of a single standardized format that could be used by all stakeholders,” the Agency reported. “The majority of the commenters were in favor of FDA establishing a certain date when stakeholders would be required to have systems capable of handling the new format.”

However, industry leaders raised concerns in their public comments. The Healthcare Distribution Alliance (HDA) noted its “agreement with those speaking at the public meeting that … Options, A, B and C, are infeasible. Some of them, for example, would negatively impact bar code technology and interoperability, and others would perpetuate, or even exacerbate the confusion created by the current multiple formats, by adding even more formats. These three Options could also result in creating duplicate NDCs.”

GS1, with input from its New NDC Format Workgroup, advocated for Option D, including implementing “a standards-based format for NDC” (i.e., using a Global Trade Item Number, or GTIN; see below). It also noted concerns, saying this option had “cons,” including its impact on standardized numerical identifiers (SNIs). Let’s examine this a bit further.

FDA National Drug Codes will play a significant role when the DSCSA goes into full effect on Nov. 27, 2023. At that time, drug package labels must include a product identifier. A product identifier is a standardized graphic that contains the product’s SNI, a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number.

With this in mind, GS1 commented that the “SNI Guidance will need modification in advance of and as preparation for Option D implementation. The SNI guidance defined SNI as NDC + serial number. However … this does not support unique identification at every level of the packaging hierarchy, and therefore is not sufficient to support traceability. GS1 members had been able to overcome this challenge by embedding the NDC in a GTIN. However, with Option D, members will no longer have this technical mechanism.”

Final thoughts

That’s a lot to think about. The comment period for the FDA National Drug Code proposed rule ends Nov. 22, 2022, and industry stakeholders are sure to once again share their opinions in the docket. Some of the issues that could be raised include the following:

- - Companies’ serialization systems and ancillary systems could be affected because they contain and use FDA National Drug Codes.
  - Systems will have to accept and store both the current and new formats.
  - Stakeholders will have to know which format to send and when.
  - Systems may have to carry both formats simultaneously for current medicines.

The biggest takeaway, though, is that companies should be thinking about the change and preparing now. This is a DSCSA mantra, right? Prepare for the Verification Router Service (VRS). Prepare for ATPs. Prepare for product identification, serialization, and EPCIS.

If you have questions, contact us today to speak to one of our DSCSA and supply chain experts. We’re participating on the GS1 New NDC Format Workgroup and have been actively involved in discussions about how the changes will affect pharma companies. With only a little more than a year to go before rollout of the DCSCA is complete, now is the time to connect with us and make sure you’re going to be ready for the full serialization of the U.S. pharma supply chain.

Sustainability in the Cosmetics Supply Chain: Tracking and Tracing for a Greener Future

Posted on August 30, 2022August 4, 2023 by rfxadmin

The health and beauty industry is under increasing pressure from regulatory bodies and consumers to maintain and demonstrate due diligence in their supply chains. Forward-thinking companies are responding by making cosmetics supply chain sustainability an integral part of their mission statements and consumer engagement activities.

For example, “The Big 3” are prioritizing cosmetics supply chain sustainability. L’Oréal puts environmental and social performance at the heart of its business to drive value. Estée Lauder’s mission is “to bring the best to everyone we touch and to support the environment in which we live.” And Unilever reports thoroughly on environmental and ethical statistics, including water, energy, greenhouse gases, waste and plastic packaging, sustainable sourcing, and community investment.

So let’s take a look at sustainability in the cosmetics supply chain. The industry faces a slew of challenges with sustainability, such as environmental and human rights issues, counterfeiting, an evolving regulatory landscape, changes in consumer behavior, and utilizing new technologies, and all affect their decisions and processes.

What is “sustainability”?

Before we get into cosmetics supply chain sustainability, let’s take a step back for a moment and talk about sustainability generally.

Sustainability might seem to be a relatively new concept, but it has been around since the 19th century, when some industries sought to improve working environments and create less pollution. In the 1960s, new laws and organizational bodies were introduced to address pollution in the United States and Europe.

The U.S. Food and Drug Administration (FDA) “is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all major agency actions to determine if they will have a significant impact on the human environment.” Federal agencies implement NEPA and evaluate the possibility for environmental impacts by condcuting categorical exclusions, environmental assessments, and environmental impact statements.

The European Commission says it “aims to ensure coherence between industrial, environmental, climate and energy policy to create an optimal business environment for sustainable growth, job creation and innovation.”

In 2015, the Association of Southeast Asian Nations (ASEAN) adopted the ASEAN Socio-Cultural Community Blueprint 2025, which “promotes and ensures balanced social development and sustainable environment that meet the needs of the peoples at all times.”

If you read our Global Cosmetics Market white paper, you’ll know why we used the United States, Europe, and Asia as examples: They’re the world’s top cosmetics markets — and their regulators are concerned about sustainability.

What is cosmetics supply chain sustainability?

Cosmetics supply chain sustainability addresses the environmental and human impact of products, from the sourcing and production of raw materials, through to manufacturing, packaging, distribution to the final customer, and post-consumer activities.

Increasingly, there are calls for cosmetics supply chain sustainability standards to be made mandatory. The European Parliament in March passed a resolution to tackle environmental and human rights in EU supply chains. This new Supply Chain Act will require organizations to integrate sustainability into corporate governance and management systems, and frame business decisions in terms of human rights, climate, and environmental impact.

The United States is yet to follow suit, but consumer groups are letting the government know they want tighter standards for the raw materials used in cosmetics.

Even without government mandates, organizations that want to burnish their environmental credentials would do well start with their supply chains. In a January 2021 report called Net Zero Challenge: The Supply Chain Opportunity, the World Economic Forum states that companies wanting to improve their environmental and social performance can look to their supply chains to make cost-effective improvements.

Environmentally responsible production: the rise of “Clean Beauty”

Much of the drive toward sustainability is coming from consumers, who want to know that ingredients are pure (or at the very least safe) and have been ethically sourced. For example, 62 percent of Generation Z consumers (born in the late 1990s) prefer to buy from sustainable brands, and 73 percent will pay more for sustainable products.

In the United States, where the Food and Drug Administration (FDA) from being used in cosmetics, there is mounting pressure for stricter regulations. For example, environmental and consumer advocate groups such as the Environmental Working Group (EWG) believe more chemicals should banned, like in the EU, where 1,300+ substances are prohibited from being used in cosmetics.

This is part of larger “Clean Beauty” movement that advocates for safe, clean ingredients and transparency in product labeling. According to a

Clean Beauty is also concerned with ethical sourcing of ingredients. Consumers want reassurance that their cosmetics are not linked to issues such as deforestation, pollution, and animal or child cruelty. The primary problem here is that a wide variety of cosmetic products use a few “core” ingredients, many of which pose unique challenges for achieving sustainability in the cosmetics supply chain. They are difficult to obtain sustainably and ethically, and child labor, poor working conditions, and illegal mining are common.

For example, a 2016 report from the Amsterdam-based nonprofit Centre for Research on Multinational Corporations (SOMO) found that more than 20,000 children are forced to work in mica mines while their families live in severe poverty. Similarly, palm oil, the global market for which is expected to reach $57.2 billion by 2026, has a history of human rights problems. Palm oil is used for moisturizing or texture effects.

As more companies stake their reputations on being sustainable and consumers become more aware and demanding, it’s certain that the call for cosmetics supply chain sustainability will only get stronger.

How can we achieve cosmetics supply chain sustainability?

As we’ve seen, cosmetics companies operate in a challenging environment where many groups — including consumers, perhaps their most important audience — are calling for them to achieve sustainability in their supply chains.

To be successful, they must be able to adapt to changes in the market as technology, product development, and consumer sentiment shape the industry. Whether it’s faster production methods, demand for new products, or desire for ethical and sustainable options, companies must be able to change with the market if they want to survive and succeed.

The key takeaway is that cosmetics supply chain sustainability is not a pipe dream. Technology and solutions exist right now to help companies evaluate their operations and identify strengths, weaknesses, and pain points and take corrective action. These include supply chain digitalization, cloud-based data systems, and real-time monitoring. For instance, a 2021 report by Gartner said that digitalization is a key enabler of agility because it supports a more transparent, automated, intelligent, and orchestrated end-to-end supply chain.

Final thoughts

Sustainability. Consumers want it. More and more regulators are demanding it. It’s good for the planet. It’s good for people. It’s a business best practice.

Is it difficult to attain sustainability? Yes and no. It is a process. It has a lot of moving parts that may require tough decisions. But if a company has the will to be sustainable, it can develop strategies, chart a course, and get to work … and reap the benefits.

Technology is essential for sustainability. rfxcel and Antares Vision Group are committed to helping companies meet their sustainability goals and empowering them to protect product, profit, people, and planet.

Our Traceability System enables you to see and follow everything in your supply chain in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, sharable provenance that proves to consumers and regulators that your sustainability initiatives are real and working as intended. Its intuitive, scalable solutions can be used individually or as a complete platform to shepherd sustainability initiatives to completion and create end-to-end traceability, transparency, and visibility.

Contact us today to see how it works. And be sure to check out our other resources about the cosmetics industry, sustainability, and traceability:

Cosmetics Supply Chain Transparency for Business Value and Opportunity

Posted on August 29, 2022August 4, 2023 by rfxadmin

Today, we’re looking at what cosmetics supply chain transparency means, why it matters, and how cosmetic companies can achieve it through the use of technology and gain much more than just a healthier bottom line.

Cosmetics supply chain transparency vs. traceability

Cosmetics supply chain transparency means the whole supply chain is visible, from raw materials, production, and packaging to delivery to retailers and, ultimately, consumers. A lack of transparency in complex supply chains that move billions of products can cause significant risks to both consumer and product owner.

Transparency results from creating a full, shareable, fact-based profile of every aspect of the supply chain. It is a means for companies to support its claims (e.g., product provenance, sustainability, ethical sourcing) and tell the world, “We are what we say we are.” In this way, transparency is a strategic concept — one more and more cosmetic companies are adopting because of its significant benefits for operational efficiency, consumer engagement, brand protection, and profitability.

Traceability most often concerns individual products and aggregations (e.g., boxes, cartons, pallets) and observing/monitoring them as they make their way through the supply chain. It is a means to identify, follow, and verify what’s in your supply chain, as well as comply with regulations that mandate traceability through serialization and digitalization.

Cosmetics supply chain transparency for business value

It’s the global cosmetics market will grow from $287.94 billion in 2021 to $415.29 billion in 2028. Indeed, there are signs the market is booming. For example, L’Oréal, the world’s largest beauty brand, reported record profits last year, with CEO Nicolas Hieronimus, recently commenting, “2021 was a historic year for L’Oréal … Over two years, the Group achieved growth of +11.3 percent like-for-like, spectacularly outperforming a market that had returned almost to 2019 levels.”

The other leading cosmetics brands also did well in 2021. Unilever reported just over $24 billion in beauty and personal care sales, and Estée Lauder had $16.2 billion in sales, an increase of 13 percent over last year.

The “Big 3” of the cosmetics industry have something in common other than strong market performance: Each is committed to transparency and puts it front and center in their business strategy and mission. For example, L’Oréal held a virtual “Transparency Summit” last year, Unilever equates transparency with “integrity,” and Estée Lauder has a dedicated supply chain transparency page on its website.

Transparency and risk management

Despite the opportunity for growth, however, global supply chain challenges can threaten a company’s ability to satisfy growing consumer demand. We all know about the supply chain weaknesses revealed during the pandemic, including overreliance on manufacturing hubs and shipping bottlenecks, not to mention changes in consumer expectations and the way they want to buy and interact with cosmetics.

In a rapidly evolving landscape of tougher regulations, ongoing supply chain uncertainty, increased consumer expectations, and brand risk, transparency has become foundational for success.

Regulatory compliance. Cosmetics regulations vary around the world. For instance, laws in the EU are much broader than in the United States. Generally, however, companies are responsible for making sure their cosmetics are safe, properly labeled, and comply with the regulations that apply to them.

Furthermore, more and more regulatory bodies are calling for modernization via the adoption of digital technologies to ensure products are safe and that companies are able to remain compliant as regulations evolve. Cosmetics supply chain transparency (and traceability) is crucial to compliance. Read our “Global Cosmetics Market” white paper to learn more about regulations in key markets and how technology is driving the industry.

Counterfeits and fakes. And as we’ve written before, counterfeiting is a big problem for the cosmetics industry. Fake products endanger consumers’ health. They can contain toxic substances such bacteria, animal waste, and carcinogenic substances (e.g., lead).

Counterfeits and fakes also damage profits. In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Brand reputations are also jeopardized by counterfeits. One bad (or very bad) experience can send customers to your competitors and tarnish your image, especially as consumers broadcast their opinions online. Our brand protection series talks more about counterfeits. It’s a real problem that every industry must contend with.

Diversion, theft, and gray markets. The complexity of global supply chains makes it possible for products to end up in markets where they shouldn’t be. Unauthorized or unofficial distribution channels shepherd expired, damaged, or otherwise compromised goods to unauthorized third-party sellers that consumers may think are legitimate. A product bound for Asia winds up in the United Kingdom.

Transparency is not a singular solution for these problems, but it is an indispensable facet of a coordinated, integrated supply chain management strategy to mitigate risk and create real business value.

Mainstreaming sustainability and ESG reporting

As we’ve noted, consumers are demanding more information about the products they purchase; they want to know that ingredients have been ethically sourced and are safe. They want a trust-based relationship with their brands — and if they don’t get it, they’ll happily take their business elsewhere.

This means cosmetics companies must be vigilant and forthcoming about everything in their operations, from their labor standards and how they source raw materials to packaging and other fundamentals of their supply chains. In response, environmental, social, and governance (ESG) reporting has become more prevalent.

ESG reporting measures a company’s social and environmental performance through its supply chain and operations. Cosmetics companies are under pressure, not least from consumers, to reduce their environmental and social impact, set up monitoring systems, use sustainable materials, and publish their social credentials. In this way, ESG reporting is part of cosmetics supply chain transparency.

Or, more accurately, cosmetics supply chain transparency enables effective, accurate ESG reporting.

Leading cosmetics companies are now using ESG reporting, or some form of it, as a strategic tool to monitor their success in sustainability. For example, in 2021, L’Oréal implemented “L’Oréal for the Future,” its sustainability program for 2030. Without mincing words, it prioritizes transparency in product manufacturing, transport, the sourcing and quality of ingredients, sustainability, and more:

“Our commitments towards 2030 mark the beginning of a more radical transformation and embody our view as to what a company’s vision, purpose and responsibilities should be to meet the challenges facing the world.”

Ironically, ESG has enabled some bad players to essentially fake their declarations of transparency and sustainability. It’s called “greenwashing,” when “a company purports to be environmentally conscious for marketing purposes but actually isn’t making any notable sustainability efforts.” Greenwashing is the antithesis of transparency. It’s unethical, and companies that engage in it never intend to meet or quantify their stated transparency, sustainability, and ESG claims.

We’ll be talking more about cosmetics supply chain sustainability tomorrow. Be sure to visit our blog for that.

Final thoughts

Cosmetics supply chain transparency benefits consumers and brand owners alike. For consumers, it means products are safe and legitimate, comply with regulations, and demonstrably rise to the company’s sustainability and ESG goals. For brand owners, transparency offers greater operational efficiencies, mitigates common supply chain risks, and creates opportunities to burnish their reputations, engage with consumers, and tell them with certainty that your products and processes are what you say they are.

Is it difficult to attain transparency? No. Our Traceability System enables companies to follow everything in their supply chains in real time from virtually anywhere in the world. It makes every product a “digital asset” with a certified, provable, and sharable provenance. Its intuitive, scalable solutions can be used individually or as a complete platform to create transparency and end-to-end supply chain traceability and visibility. rfxcel and Antares Vision Group are committed to bringing transparency to all supply chains. We can show you how we do it in about 15 minutes, so contact us to schedule a demo.

And if you’re interested in a transparency case study of sorts, read our global seafood “Transparency Trilogy.” What’s true for seafood is true for cosmetics: Its supply chain reaches into remote areas and involves vulnerable populations and threatened resources.

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

Posted on August 18, 2022December 19, 2023 by rfxadmin

The Drug Supply Chain Security Act (DSCSA) was passed 10 years ago in November 2013. Congress created the legislation to secure the U.S. pharmaceutical supply chain through unit-level product identification (serialization) and electronic exchange of product information.

Over the years, the FDA has issued updates and revised DSCSA guidance for manufacturers, dispensers, wholesale distributors, and other pharma stakeholders. If your products and/or operations are regulated by the law, it is vital to remain aware of requirements, changes, and deadlines.

Let’s explore the DSCSA guidance and requirements and what the FDA has done in recent years.

What Is the DSCSA?

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

Who Must Comply with the DSCSA?

Manufacturers, wholesale distributors, repackagers, dispensers (i.e., pharmacies, healthcare systems), and third-party logistics providers (3PLs) all have requirements with which they must comply.

Recent DSCSA Guidance Updates

Recently, the most notable action from the FDA was its announcement in August 2023 that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

This DSCSA guidance primarily affects manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers (PIs) at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products.

Though this gives the industry more time to comply, the Agency has made it clear that the postponement doesn’t amount to a grace period. It said the stabilization period was “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.”

You can read the FDA’s official document about the stabilization period here.

Other Noteworthy DSCSA Guidance Updates

July 25, 2022: The FDA published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The National Drug Code, or NDC, is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Read more about the NDC and what the FDA said here.

October 23, 2021: In a policy document, the FDA announced it was delaying enforcement of key requirements to verify saleable returns. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The timeline below provides an at-a-glance view of DSCSA guidance as the law has been rolled out over the last decade.

DSCSA Guidance in Context, Today

The stabilization period announced in August 2023 did not, in fact, change the original compliance deadline of November 27, 2023; it is up to individual states to decide if they’re going to enforce the requirements before November 2024.

However, the FDA said extending enforcement will give supply chain stakeholders the extra time that may be necessary “to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”

What DSCSA Requirements Are in Effect Right Now?

It follows from what we just said that there is DSCSA guidance in effect right now. Some digressions are prohibited per the FD&C Act and can be enforced — with consequences ranging from product seizure to fines to imprisonment. Both federal and state authorities may take action against DSCSA violations.

What Was Enforceable Before Nov. 27, 2023?

Here are a few regulations that can be enforced now. For a full list, see the National Association of Boards of Pharmacy’s (NABP’s) excellent article here. (And also be sure to read about how we were the first DSCSA solution provider to join NABP’s Pulse Interoperable Partner Program. Learn more here!)

All trading partners must be authorized trading partners (ATPs) and can only buy, sell, or trade with other ATPs.
ATPs must be able to identify and manage suspect and illegitimate products.
A product identifier (PI) must be placed on all regulated drug packages and homogenous cases — except for grandfathered products or products with an FDA waiver, exception, or exemption.
ATPs must provide certain information about a drug and who handled it each time it’s sold: transaction information (TI), transaction statement (TS), and transaction history (TH).

What Went into Effect on Nov. 27, 2023?

The November 2023 deadline was when enhanced security requirements went into effect. We’ve written extensively about this for years (in our recently updated DSCSA white paper, for example), but here’s a summary of what companies must do to comply:

Exchange TI and TS securely, electronically, and interoperably. TI must include each package’s unique identifier.
Verify PIs at the package level.
Respond to appropriate tracing requests and trace products at the package level (serialization).
Associate saleable returns with the TI and TS associated with its initial sale.

Final Thoughts About DSCSA Guidance

So what’s the upshot of all this information? It’s simple: Don’t stop preparing.

Use your extra time during the stabilization period to evaluate your systems, communicate and coordinate with your trading partners, and — importantly — ensure you’re working with a solution provider that knows the DSCSA guidance inside and out.

If you have questions about the DSCSA or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We are committed to meeting DSCSA compliance for all our customers in a timely manner.

Everything You Need to Know About Kazakhstan Pharma Serialization

Posted on August 15, 2022August 4, 2023 by rfxadmin

Welcome to Part 2 of our series about Kazakhstan serialization and traceability requirements. Part 1 detailed the country context, including government efforts to achieve pharma independence. October 1, 2022, is the next deadline in the rollout of Kazakhstan pharma serialization, so today we’ll get into the specifics of the regulations, as well as regulations for other key industries. Let’s get started.

Kazakhstan pharma serialization: pilot, goals, operator, timeline, marking requirements

The transformation of Kazakhstan’s pharmaceutical supply chain began almost seven years ago, when the government in September 2015 issued guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal. In November of the same year, the Ministry of Health tapped GS1 Kazakhstan to conduct a pilot for the traceability system, which is called the Special Information System for Marking and Traceability of Goods (IS MPT).

Pilot

The pilot ran from Sept. 9, 2019, to July 31, 2021. It was led by Kazakhstan’s state-run distributor, SK Pharmacy, which labeled 100,000 packages of 30 different drugs and traced them all the way through the supply chain to hospitals and pharmacies. Four domestic manufacturers, 1 importer, 2 distributors, 5 pharmacies, and 8 medical institutions also participated.

Goals

The goals of Kazakhstan pharma serialization — and labeling of other product categories — are essentially the same as regulatory goals in other countries:

- - Communicating product information to consumers
  - Combating counterfeit and falsified products
  - Eliminating gray markets (“Shadow market” seems to be the preferred term in Kazakhstan.)
  - Protecting consumers
  - Protecting legal businesses
  - Identifying entities that violate tax laws

The Kazakh government has also said that digital labeling will help businesses increase productivity, improve logistics, increase market share, ultimately leading to increased revenue.

IS MPT Operator

Kazakhtelecom JSC, the country’s largest telecommunications company, operates the IS MPT. Sometimes referred to as “the Single Operator,” it’s the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT) and Uzbekistan’s CRPT Turon. Its main offices are in Nur-Sultan (formally Astana) and Almaty.

As operator, Kazakhtelecom JSC is responsible for the following:

- - Generating marking codes
  - Providing traceability to the state
  - Interacting with the integrated system of the Eurasian Economic Commission (EEC) and operators in other Eurasian Economic Union (EAEU) states
  - Providing a digital passport of goods for market participants
  - Developing a free mobile application (NAQTY SAUDA) to accept and withdraw marked goods from circulation (primarily for participants who are unable to purchase scanners)
  - Developing a free mobile application (NAQTY ÓNIM) for the public to participate in the system
  - Creating a 24/7 IS MPT contact center

In official government reporting dated Nov. 17, 2020, Kazakhtelecom JSC’s Chair of the Board Kuanyshbek Yessekeyev talked about the benefits of the IS MT. “Among its main advantages,” he said, “one can single out a decrease in the shadow market by 50 percent until 2025, which will lead to additional budget revenues by 2025 in the amount of 58.4 billion tenge [$122.5 million], according to our calculations.”

Yessekeyev also concluded that additional legal business revenues would reach 336.5 billion tenge [$706.5 million] by 2025.

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

- - September 2015: The government issues guidelines on labeling, marking, and requirements for accessing and uploading data to a central portal.
  - November 2015: The Ministry of Health taps GS1 Kazakhstan to conduct a pilot for IS MT.
  - 2018–2019: GS1 Kazakhstan conducts testing for the pilot.
  - Sept. 9, 2019: The pilot begins.
  - July 31, 2021: The pilot ends and the government issues serialization guidelines.
  - August 8, 2021: The Ministry of Health identifies 93 products — about 1% of all drugs in the country — for the first phase of serialization.

Rollout (note upcoming deadlines in October and early 2023)

- - June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
  - August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
  - October 1, 2022: Mandatory serialization for 20% of drugs scheduled to begin.
  - January 1, 2023: Mandatory serialization for 60% of drugs and mandatory data reporting for 20% of drugs scheduled to begin.
  - April 1, 2023: Mandatory serialization of at least 80% of drugs scheduled to begin.
  - July 1, 2023: Mandatory serialization of 100% of drugs scheduled to begin

Note: At present, Kazakhstan pharma serialization regulations do not require aggregation.

Marking requirements

As in other EAEU and Commonwealth of Independent States (CIS) countries (e.g., Russia and Uzbekistan, respectively), products must be labeled with a DataMatrix code with four data points:

1. 1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
  2. A 13-character randomized serial number (21)
  3. A four-character verification key (91)
  4. A 44-character verification code (92)

The maximum cost of one code will be 2.68 tenge ($0.0056) without VAT. Every code goes through the same five steps during its “lifetime”:

1. 1. The manufacturer applies a code to every package and sends them to a distributor.
  2. The distributor receives and scans the products, then sends them to the retailer (e.g., a store or supermarket).
  3. The retailer receives the new (legal) batch of goods, scans the codes, and sells the products.
  4. At checkout, the cashier scans each code (either with a scanner or using the NAQTY SAUDA app) and it’s withdrawn from circulation.
  5. Consumers can use the NAQTY ÓNIM app to learn more about the product.

Here are some images of the apps:

Other regulated products/industries

In 2019, Kazakhstan ratified an agreement for labeling of goods within the territory of the EAEU. In doing so, it agreed to the EEC’s decisions concerning labeling of fur products, shoes, perfumes, tires, and other products. Here is the latest information from IS MPT:

- - Tobacco products: Mandatory labeling of cigarettes began Oct. 1, 2020; April 1, 2021, for cigars, cigarillos, and other categories.
  - Fur products: Mandatory labeling began March 1, 2019.
  - Footwear: Production and import of unmarked shoes have been prohibited since Nov. 1, 2021; sale of unmarked shoes has been prohibited since April 1, 2022.
  - Alcohol: Mandatory labeling began April 1, 2021.
  - Light industry (primarily clothing and linens): A pilot ran from Dec. 15, 2020, to Dec. 31, 2021.
  - Dairy products: A pilot began on Oct. 1, 2020, and was extended in November 2021.
  - Soft drinks: A pilot ran from July 1, 2020, to Jan. 31, 2022
  - Jewelry: A pilot began in March 2022 and is scheduled to end on Oct. 31, 2022.

Final thoughts

That’s a lot to think about. We’ve provided the granular details of Kazakhstan pharma serialization requirements, but let’s boil them down to what you have to be ready for in just a few weeks: Mandatory serialization for 20 percent of drugs starts on October 1.

If this affects you, are you ready? The good news is that complying with Kazakhstan pharma serialization requirements doesn’t have to be difficult. The fastest way to ensure you’re ready for the October deadline — and all the 2023 deadlines — is to contact us and walk through our solutions with one of our supply chain experts.

We offer a holistic, fully validated, preconfigured, automated platform for compliance and L1-L5 connectivity. With rfxcel and Antares Vision Group, you’ll be prepared for regulations in the EAEU and everywhere else your supply chain goes.