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The U.S. Uyghur Forced Labor Prevention Act and Supply Chain Ethics

Posted on by rfxadmin

Signed into law on Dec. 23, 2021, the U.S. Uyghur Forced Labor Prevention Act (UFLPA) prohibits the importation of certain goods into the United States and aims to ensure that businesses are not complicit in human rights abuses. It’s one of many regulations around the world that aim to make supply chains more ethical, transparent, and sustainable.

Let’s see what the act says and examine why supply chain transparency is the key to making such legislation viable and successful. For another example of recent laws, see our blog post about Germany’s Supply Chain Due Diligence Act.

What is the Uyghur Forced Labor Prevention Act?

The Uyghur Forced Labor Prevention Act, or UFLPA, is a response to concerns over forced labor and human rights violations in the Xinjiang Uyghur Autonomous Region in northwest China.

It’s worth quoting the U.S. Customs and Border Patrol website at length for a thorough description. It says the act:

“establishes a rebuttable presumption that the importation of any goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part in the Xinjiang Uyghur Autonomous Region of the People’s Republic of China, or produced by certain entities, is prohibited by Section 307 of the Tariff Act of 1930 and that such goods, wares, articles, and merchandise are not entitled to entry to the United States.

“The presumption applies unless the Commissioner of U.S. Customs and Border Protection (CBP) determines that the importer of record has complied with specified conditions and, by clear and convincing evidence, that the goods, wares, articles, or merchandise were not produced using forced labor.”

Furthermore, the act required the Forced Labor Enforcement Task Force, chaired by the U.S. Department of Homeland Security, to develop a strategy for supporting the legislation. This strategy was published on June, 1, 2021, and includes the UFLPA Entity List, which names “entities in Xinjiang that mine, produce, or manufacture wholly or in part any goods, wares, articles and merchandise with forced labor.”

Key provisions

The Uyghur Forced Labor Prevention Act has provisions to combat forced labor and enhance supply chain transparency, including:

      • Import restrictions: As we noted above, the act bans the importation of goods produced wholly or in part in China’s Xinjiang Uyghur Autonomous Region, unless importers can provide clear and convincing evidence that the goods were not produced with forced labor.
      • Enhanced due diligence: The act places the responsibility on companies to exercise due diligence and conduct comprehensive risk assessments of their supply chains to identify any forced labor risks or links to Xinjiang.
      • Publicly available information: Companies must disclose information on their efforts to ensure their supply chains are free from forced labor, including the specific measures they have implemented and the results of their due diligence assessments.
      • Coordination with government agencies: The act requires collaboration between government agencies, including the Department of Homeland Security, Department of Labor, and Department of State, to ensure effective enforcement and implementation of the legislation.

Implications and challenges for businesses

The act has very real implications for businesses operating in the United States. They must have the means to see into their partners’ operations, as well as into the often opaque landscape of secondary and tertiary suppliers. Other challenges include:

      • Not being able to produce audits that meet Forced Labor Enforcement Task Force credibility requirements
      • Traceability challenges in the supply chain (e.g., aggregated and commingled products with difficult-to-prove provenance)
      • Regulations in other countries that make compliance more difficult/complicated
      • Challenges related to sourcing (i.e., not being able to find a crucial raw material or item outside of China)

The government provides resources for businesses concerning the Uyghur Forced Labor Prevention Act. For example, see the U.S. Customs and Border Protection’s UFLPA Operational Guidance for Importers and its FAQs about the act.

Final thoughts

The Uyghur Forced Labor Prevention Act is part of broader regulatory efforts to eliminate forced labor and human rights abuses in global supply chains. Businesses must be prepared (and willing) to audit and assess their operations, engage with their suppliers (and their suppliers’ suppliers), and establish mechanisms to trace the origin of goods to ensure compliance.

And they should be proactive about it. A first step is contacting us to talk about supply chain transparency. Our transparency solutions enable companies to track and trace their supply chains in real time from virtually anywhere in the world. Our technology makes every product a “digital asset” with a certified, provable, and sharable provenance. We can show you how it works with a short demo.

If you’re interested in learning more about supply chain transparency, check out the articles below. “Transparency” means just about the same thing in every supply chain, so consider these as case studies about how it works, why it’s important, and the business benefits it can bring.

 

 

Spherity and Antares Vision Group further partnership to ensure life sciences customers will comply with upcoming DSCSA regulations

Posted on by rfxadmin

Antares Vision Group, through rfxcel technology, has integrated Spherity’s Credentialing Service into its DSCSA solutions to verify authorized trading partners’ identities and licensing in all regulated interactions.

Reno, Nevada, April 25, 2023 — Spherity, a German leading provider of digital wallet and credentialing solutions, and Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, are continuing a partnership that helps ensure life sciences customers comply with this year’s U.S. Drug Supply Chain Security Act (DSCSA) regulations.

By November 27, 2023, manufacturers, distributors, dispensers, and other actors in the life sciences supply chain must prove that they are legitimate organizations, or authorized trading partners (ATPs), as defined by the DSCSA.

The two companies first partnered in 2021, when Spherity’s Credentialing Solution, CARO, was integrated into the Group’s Verification Router Service (VRS) solution, enabled by rfxcel technologies, to allow life science customers to confirm their ATPs status. The combined solution also allows customers to exchange DSCSA-compliant electronic Product Identifier (PI) messages, trace products, and create an audit trail of their VRS business interactions.

CARO uses Self-Sovereign Identity (SSI) technology to establish a secure, verifiable digital enterprise identity for every ATP. By integrating the service into its VRS solution, rfxcel customers can ensure secure, authenticated data exchange with other ATPs and verify they have the credentials required by the DSCSA, including state licenses and U.S. Food and Drug Administration Entity Identifiers (FEIs).

“We partnered with Spherity to enable our customers to comply with this year’s DSCSA authorized trading partner (ATP) requirements,” said rfxcel Senior Vice President of Product and Strategy Herb Wong. “With Spherity’s CARO, our VRS solution automatically confirms whether a company is an ATP. Now, every customer can add ATP credentialing to our entire product portfolio and secure their VRS interactions.”

“Spherity will ensure that Antares Vision Group’s customers can securely exchange data with previously unknown entities,” said Georg Jürgens, Spherity’s Manager for Industry Solutions. “The concept of exchanging and verifying credentials using Digital Wallets supports company and product compliance use cases that require communication between regulators, existing supply chain partners, and new trading partners.”

Spherity and Antares Vision Group are members of the Open Credentialing Initiative (OCI), and both contribute to the standardization and industry-wide interoperability of credentialing technology.

For more information about the Spherity-Antares Vision Group partnership, their solutions for DSCSA compliance with ATP requirements, and the Open Credentialing Initiative, contact Spherity’s Manager for Industry Solutions Georg Jürgens at georg.juergens@spherity.com and visit caro.vc, and rfxcel Senior Vice President of Product and Strategy Herb Wong at hwong@rfxcel.com.

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 Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223.5 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT SPHERITY

Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated technical sectors. Spherity’s products empower cybersecurity, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

India iVEDA Deadline Delayed for Track and Trace, Reporting

Posted on by rfxadmin

Our team in India just let us know that the iVEDA deadline for track and trace and reporting has been delayed. Here are the details.

As we wrote in early March, the Indian government had stipulated March 31 as the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules were to apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

Today, however, the government extended the iVEDA deadline to August 1, 2023. The announcement was made through Public Notice 3/2023, which was signed by signed by Director General of Foreign Trade Santosh Kumar Sarangi.

As of today, the August deadline for barcoding the Top 300 domestic pharma brands is still valid. This requires eight data points to be incorporated into a bar code or QR code, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates. The codes must be printed on or affixed to the primary packaging.

Final thoughts about the iVEDA deadline and requirements

We will of course continue to monitor these regulations and post news when necessary. Bookmark our blog and check back often to make sure you’re keeping up to date. And contact us today if you have any questions about this delay or compliance in any other country where you do you business.

For a good overview of India’s pharma regulations, read our update from September 2022. If we may say, our “Final thoughts” section in that article was prescient. We wrote that “India’s track and trace requirements are obviously evolving” and the pharma industry should “expect more changes as the deadlines for APIs [active pharmaceutical ingredients], iVEDA reporting, and barcoding get nearer.”

That post also cited some statistics from India’s Department of Pharmaceuticals’ 2020-21 Annual Report. Check those out and compare them with the highlights from the 2021-2022 Annual Report below. India remains one of largest and most important pharma markets in the world — and we can help ensure you stay compliant as its regulations evolve.

India pharma stats, 2021-2022

• India provides generic medicines to more than 200 countries.
• India is home to 8 of the world’s 20 largest manufacturers of generic medicines.
• More than 55 percent of its pharma exports to go to “highly regulated markets.”
• Ninety percent of World Health Organization (WHO) pre-qualified APIs are sourced from India.
• Sixty-five to 70 percent of the WHO’s vaccine requirements are sourced from India.
• As of August 2021, there were 741 U.S. FDA-compliant manufacturing sites in India.
• As of December 2020, Indian companies had secured nearly 4,400 abbreviated new drug application (ANDA) market authorizations.

 

FSMA 204 and Food Safety: Examining Compliance Requirements

Posted on by rfxadmin

The Food Safety Modernization Act (FSMA) is a sweeping set of regulations designed to revolutionize how we approach food safety in the United States. The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule” or “Final Rule”) implements FSMA Section 204. FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

For the food industry, understanding and complying with FSMA 204 is not just a legal requirement: it’s a commitment to public health and safety. It also creates many value-add opportunities through leveraging supply chain traceability.

Let’s dive into the FSMA 204 rule and what it means for your business.

Understanding FSMA 204

FSMA’s overarching goal is to prevent foodborne illnesses; it has seven rules to govern food production and distribution. Section 204 focuses on enhancing the traceability of FTL food, ensuring that businesses can quickly identify and address potential safety issues. The rule emphasizes the need for detailed recordkeeping. It’s like a meticulous logbook of your food product’s journey from farm to table.

Specifically, FSMA 204 requires supply chain actors to maintain records of critical tracking events (CTEs) and associated key data elements (KDEs). Entities that manufacture, process, pack, or hold foods on the FTL (e.g., harvesters, packers, processors, and distributors) must maintain and share these electronic records. So it’s not a stretch to say that the Food Traceability Final Rule will affect almost everyone in the U.S. food supply chain.

Compliance Requirements

If you’re wondering whether FSMA 204 applies to you, consider the scope of your business. The rule primarily targets businesses that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL). Some items on the FTL include:

    • Nut butters
    • Deli salads
    • Leafy greens
    • Melons
    • Shell eggs
    • Tropical tree fruits
    • Crustaceans
    • Cucumbers
    • Finfish
    • Other fresh produce

To comply, you need to register with the FDA, providing detailed information about your business and the specific food products you handle. While there are exemptions, most members of the food supply chain will have to comply with FSMA 204, which also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Compliance Measures

Compliance with FSMA Section 204 might sound daunting, but it’s achievable with the right approach. Start by thoroughly understanding the Final Rule and its requirements. Develop a system for meticulous traceability recordkeeping. Training your staff on food safety practices is also crucial.

The goal is to make food safety part of your company’s DNA; you can’t treat the FDA Food Safety Modernization Act as an afterthought or a box you have to check.

Navigating the Countdown to Compliance

Let’s take a closer look at the FSMA 204 timeline. Traditionally, the FDA has rolled out major regulations using a phased approach. For FSMA 204, however, the Agency has set a single firm compliance date: January 20, 2026.

Although that’s a little more than two years away, the time to start preparing is now. Don’t wait. Start your compliance process early, and use the time to refine and perfect your systems. That way, if you encounter any unexpected hurdles, you’ll have time to sort them out.

The Importance of Traceability

Traceability is at the heart of FSMA 204. By maintaining and sharing CTEs, KDEs, and detailed records of each food item’s journey, businesses can know where every product came from, where it is right now, where it’s going next, and its final destination. With this rich traceability data, they can swiftly address safety concerns, recall affected products, and provide critical information during investigations. Improving traceability can also mitigate brand damage due to recalls and help maintain consumer trust.

Common Challenges and Solutions

As you work to implement FSMA 204 into your business model, you could encounter one of these challenges:

    • Data challenges: Existing data-sharing strategies need to be supplemented with traceability data.
    • Trading partners challenges: If your partners don’t send required traceability data, it will affect your ability to maintain and send CTEs and KDEs across your supply chain.
    • Process challenges: Your system must be able to send and receive traceability data quickly and accurately. It must also be able to spot (and fix) errors and communicate effectively with your partners.
    • Technology challenges: Legacy supply chain systems may not be equipped to capture and organize traceability data.

Overcoming these hurdles requires a holistic approach. You must reevaluate your processes to ensure they promote compliance and, critically, collaborate with your partners to ensure you’ll be able to share all the required FSMA 204 data. Most important, you should determine if you need to replace or augment legacy tech with new solutions designed to modernize and simplify traceability.

Benefits of FSMA 204 Compliance

FSMA 204 compliance provides many, many benefits to your business, your trading partners, and the public. When you comply with FSMA 204, you help maximize traceability, food safety, and supply chain visibility. You also avoid penalties for non-compliance.

Implementing traceability technologies will also make your supply chain more efficient. You’ll gather robust item-level data insights about the flow of goods, which will help you to identify bottlenecks and “blind spots,” reduce spoilage, and even fight diversion, theft, and counterfeits. The more you know about your supply chain, the easier it will be to optimize it.

Complying with FSMA 204 requirements is also an opportunity to leverage rich traceability data to enhance your brand reputation, engage with consumers and build trust, and establish yourself as a leader in food safety. These benefits translate into customer loyalty and business growth.

Final Thoughts About FSMA 204 Compliance

The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

A Guide to Traceability Lot Codes and Food Safety

Posted on by rfxadmin

Traceability lot codes are small but mighty tools that help to ensure food safety. Today, we’re going to look at traceability lot codes, including how they promote safety in the food industry and the important role they play in the Food Safety Modernization Act (FMSA) Section 204 compliance and securing public health.

What Is a Lot Code?

A lot code is essentially a passport for food products. It’s a unique identifier, usually a sequence of numbers and letters, that identifies a specific batch of products that were manufactured (or harvested) under the same conditions and in the same location. Lot codes help track products through the entire supply chain and are vital for troubleshooting quality issues and speeding recalls. Lot codes are assigned to products by the manufacturer.

Whether it’s a pallet loaded with cases of olive oil, a box of cereal, or even a raw agricultural commodity (RAC), the lot code tells you where an item came from and when it was made. This is vital for traceability, helping manufacturers and regulators such as the FDA and USDA keep tabs on products as they move from field to factory to consumers.

Using lot codes not only helps food companies comply with traceability and food safety regulations — they also promote supply chain transparency as part of an indelible provenance that tells where a food came from, who handled it (e.g., harvesters, packers, shippers, and receivers), and its expiration date.

How to Read a Lot Code on a Product

Typically, a lot code includes information about the production date, batch number, and sometimes even the manufacturing line. For instance, a lot code reading “20210305” could mean the product was manufactured on March 5, 2021. If it says “2021030515,” it could mean the product’s expiration date is March 15, 2021. Other numbers can indicate a unique product ID or the name of the grower, producer, or manufacturer.

Role of Lot Codes in Traceability

In the journey from farm to fork, lot codes act like breadcrumbs. They enable traceability at every step, from production to first land-based receiving interactions and beyond. If there is a foodborne illness outbreak or other problem, stakeholders can trace goods back to their sources.

And as we said above, they help you comply with food regulations, including the Food Safety Modernization Act (FSMA), which mandates recordkeeping and traceability requirements for certain foods. More on that below.

Ensuring Food Safety Through Lot Codes

Traceability lot code requirements, such as those in FSMA 204, promote better food safety and transparency across the supply chain. One of the biggest benefits of traceability lot codes is that they help companies and investigators quickly pinpoint  the origins of foodborne illnesses.

If an issue occurs with one of your products, you can quickly determine which products have been affected and where they are in your supply chain or, if they’ve reached their final destination, what retail establishment they’re in. With this granular data, you can implement a focused recall strategy that protects consumers and public health while minimizing product loss. Such precision also helps protect your brand: You can communicate with consumers about the status of the recall, affected areas, and how to dispose of the recalled product.

Common Questions About Traceability Lot Codes

Let’s consider a few common questions about traceability lot codes.

Can a Lot Code Tell You Whether a Product Is Organic or Not?

Lot codes don’t directly convey this information; however, they can be used alongside other product details to let consumers know if a product is organic.

How Can Consumers Use Lot Codes?

Consumers can use lot codes to make informed decisions about the food they buy. They can check the lot code to determine whether their product is part of a recall. It’s also a handy way to gauge a product’s freshness.

Why Are Lot Codes Important for Food Safety?

Lot codes make tracking and tracing products faster, easier, and more accurate. If there’s a problem with a food item, such as a contamination issue, the codes help quickly identify which products are affected.

Consumer Awareness and Lot Codes

If you want to establish your brand as transparent and customer-centric, you should educate consumers about traceability lot codes. Teaching consumers how to read codes and learn what information they provide will empower them to make informed choices regarding the food products they buy.

The FSMA Traceability Lot Code

The Food and Drug Administration’s (FDA) Food Safety and Modernization Act (FSMA) is the primary set of regulatory requirements governing the use of a lot code on food products. FSMA rules outline when to put a lot code on food products, what traceability data you must retain, and more.

The FDA Food Safety Modernization Act requires you to track key data elements (KDEs) and critical tracking events (CTEs) for certain foods like shell eggs, butter, tree-borne fruits, and more. The final rule’s requirements have a compliance date of January 20, 2026. However, some aspects are already being enforced.

What is the FSMA Traceability Lot Code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

      • Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
      • Performing the first land-based receiving of a food obtained from a fishing vessel
      • Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

FSMA Traceability Lot Codes in Action: CTEs and KDEs

To fully understand FSMA traceability lot codes, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

      • CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
      • KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
      • Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do You Have to Comply? Are You Exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final Thoughts About Traceability Lot Codes

This is a lot of information to digest, especially the FSMA requirements. The best option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.

Read More About FSMA:

 

Antares Vision Group, Through rfxcel, Begins Partnership with Renown Health Network for DSCSA-Compliant Pharmaceutical Tracking

Posted on by rfxadmin

rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.

Reno, Nevada, March 8, 2023 — Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, today announced that rfxcel, which is part of the Group, has begun a partnership with Renown Health Foundation to implement compliance software so the network can track and trace pharmaceuticals in compliance with the Drug Supply Chain Security Act (DSCSA).

With rfxcel’s DSCSA compliance solutions, Renown Health’s medical groups and pharmacies will achieve real-time electronic tracing of drug products at the package level to identify and trace prescription drugs as they are distributed throughout the health system. This will enhance Renown’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

“Reno has been our home since 2018 and many of our employees live and work in the northern Nevada region,” said rfxcel CEO Glenn Abood. “Renown is one of the leading not-for-profit healthcare organizations here and is the perfect partner to team with to give back to our community. We are excited about the opportunity to work with them and to help improve the health and well-being of our friends and neighbors.”

“Ensuring our patient’s medications are safe and legitimate is of the upmost importance to us,” said Renown’s Vice President of Pharmacy Services Adam Porath. “When members of our community get involved in our work, it brings us all closer together. We are thankful that Antares Vision Group and rfxcel are partnering with us on our healing mission. They are making it possible for us to keep our patients safe, comply with the demanding DSCSA requirements, and respond quickly to changing supply chain requirements.”

For further information, write us at news@rfxcel.com.

 

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.

ABOUT RENOWN HEALTH

Renown Health is Nevada’s largest, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California. With a diverse workforce of more than 9,000 employees, Renown has fostered a longstanding culture of excellence, determination, and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in a community-based genetic population health study, the Healthy Nevada Project®.

India Track and Trace Regulations: March 31 Deadline for Exports & More

Posted on by rfxadmin

India iVEDA deadline extension link

This year will be a busy one for pharmaceutical compliance as governments around the world continue to roll out their serialization and traceability plans. India track and trace regulations are no exception: There was a deadline in January, there’s one at the end of this month, and another is coming in August.

Let’s take a look at the India track and trace regulations and what the pharma industry has to do to be ready.

January 1: Labeling APIs

As of January 1, 2023, all imported and domestically manufactured active pharmaceutical ingredients (APIs) must be labeled with QR codes “at each level packaging that store data or information.” 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, including a unique product identification code, the name of the API, and the manufacturing and expiry dates. The QR codes must link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

March 31: Full track and trace and reporting to the iVEDA Portal for exported drugs

For all exported drugs, March 31 is the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs. The iVEDA portal is used for only registering and reporting exported drugs.

August 1: Barcoding for the Top 300 domestic pharma brands

These rules were originally scheduled to come into force on May 1, but that was pushed back to August 1. 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, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates.

Final thoughts about the India track and trace regulations

We talked about these regulations in more detail last year. See that article here. As we said then, our team has worked in the India pharma market for many years and understands its complexities, challenges, and benefits. We have offices and experienced staff in the country. Contact us today to learn more about the India track and trace regulations and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can help ensure you comply while maximizing your impact in this huge market.

 

Brazil ANVISA Update: SNCM Status, Medical Device Regulations & More

Posted on by rfxadmin

We thought it was time for a Brazil ANVISA update. News has been sporadic since last September, when the Brazilian Health Regulatory Agency — ANVISA — permanently suspended its contract with DataPrev to develop and manage the country’s National Medicine Control System (SNCM).

Let’s catch up with what’s been happening.

Brazil ANVISA update, Part 1: What happened in 2022?

We’ve been following Brazil’s pharma regulations regularly since the SNCM was established in 2016. There were several delays in the rollout, but as we wrote early last year, the industry was anticipating an April 28, 2022, deadline to comply with the SNCM’s serialization, reporting, and traceability requirements.

However, just before that date, the SNCM was put on hold. Events start to cascade from there:

      • May 12: Law No. 14,338/2022 was enacted. This mandated that manufacturers had to provide digital versions of the printed inserts included in drug packaging. The inserts had to have a QR code linked to a digital version maintained in a database authorized by ANVISA. The law also confirmed that ANVISA intended to have a drug traceability system, but did not stipulate a timeline for implementing it.
      • May 23: ANVISA suspended its contract with SNCM developer DataPrev for 120 days.
      • September 12: ANVISA dissolves its contract with DataPrev, and test and production environments were not accessible. The SNCM is effectively suspended.

In case you need a refresher, the SNCM was going to require every pharma supply chain actor to capture, store, and exchange data electronically. All products were to be labeled with a GS1 2D Data Matrix barcode with five data points:

      1. Global Trade Item Number (GTIN)
      2. A 13-digit ANVISA Medicine Registry Number
      3. A unique 13-digit serial number
      4. An expiration date (in the MM/YY format for human-readable form)
      5. A lot/batch number (up to 20 alphanumeric characters)

For the April 28, 2022, deadline specifically, all prescription medicines had to be serialized; all manufacturers and importers had to have a “serialization plan” in the SNCM portal; and all supply chain stakeholders had to submit product event reports to the SNCM.

Brazil ANVISA update, Part 2: Will the SNCM resume in 2023?

On February 14, 2023, a Brazilian publication called JOTA, which monitors Brazil’s government and whose stated mission “is to make Brazilian institutions more predictable,” published an interview with ANVISA Director-President Antonio Barra Torres.

Torres said “the merits of traceability are still alive,” adding the time was right to resume the discussion about the SNCM. Other key takeaways from the interview included the following:

      • Torres said ANVISA was ready, technologically, to support the SNCM; resumption should be able to occur quickly.
      • He believes big manufacturers and most smaller ones are ready to comply.
      • He expects the World Health Organization (WHO) will inspect the SNCM in 2024; the Pan American Health Organization (PAHO) has also offered to inspect the system.
      • He said traceability data wouldn’t solve drug shortages, but could contribute to mitigation strategies.
      • ANVISA is currently short-staffed and needs to fill about 1,110 positions.

Brazil ANVISA update, Part 3: Medical device regulations

New medical device regulations were supposed to go into effect this month but were put on hold. Here’s the context:

Law RDC 751/2022 was passed September 21, 2022. It included rules for medical device classification and regulatory regimes and replaced two previous laws, RDC 185/2001 and RDC 40/2015. Here are some of the requirements in simple terms:

      • Risk classification of medical devices is consolidated into four levels (low, medium, high, maximum). The classifications rules and medical device definitions generally follow the European Medical Device Regulation (MDR).
      • There are specific classification rules for new technologies, including software as a medical device (SaMD) and nanomaterials.
      • Manufacturers must upload medical device instructions for use to an ANVISA portal.
      • Instructions for use, labels, and ANVISA documentation must be in Portuguese; other documents can be in English.
      • The law includes requirements for Brazilian Good Manufacturing Practices.
      • The law does not apply to vitro diagnostic devices, refurbished devices, and personal medical devices.

At the time we’re writing this, it seems the proposed timeline to comply with the new classification rules will begin next year and end in 2028.

Final thoughts

We’ll continue monitoring what’s happening with ANVISA and the SNCM — the entire global regulatory landscape — so bookmark our blog and check back often.

If you have questions about the regulations, contact us today. Our team in Brazil can walk you through what to expect for 2023 and beyond and demonstrate how our pre-configured and pre-validated solutions take the guesswork out of SNCM compliance. We’ve been ready to go since 2016 and we’re ready to go today.

Understanding Uzbekistan Serialization Requirements: Ensuring Compliance and Efficiency

Posted on by rfxadmin

The rollout of Uzbekistan serialization requirements will continue on schedule as spring 2023 approaches. Let’s take a look at the requirements, what happened last year, and what to expect for this year’s deadlines in March and May.

What are the Uzbekistan serialization requirements?

Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of the Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

Today, the Uzbekistan serialization requirements apply to seven product categories: medicines; medical devices; tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks. Regulated products must be labeled with DataMatrix codes that include four data points:

      • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
      • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
      • A four-character verification key generated by CRPT Turon
      • A 44-character verification code (i.e., crypto code) generated by CRPT Turon

Product packaging must also have the following human-readable information:

      • GTIN
      • Serial number
      • Expiration date in YY/MM/DD format
      • Batch number or lot number

Key dates in 2022

It’s been a little more than a year since Uzbekistan’s State Tax Committee extended the schedule for the “phased introduction of mandatory digital markings” of pharmaceutical products.

We’re also approaching the 1-year anniversary (April 2) of Resolution No. 149, which established the labeling deadlines for four groups of medicinal products and medical devices. There were two deadlines in 2022:

      • September 1: Products produced with secondary (external) packaging (except for orphan drugs)
      • November 1: Products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)

March and May 2023 Uzbekistan serialization requirements

Resolution No. 149 stipulates two labeling deadlines for March 1:

      • Products and medical products to treat orphan diseases as designated by the Ministry of Health
      • Drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan

As with the 2022 deadlines, it seems that Resolution No. 149 established a grace period for mandatory labeling in two circumstances:

      • Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
      • Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.

And on May 1, the law requires full track and trace and aggregation with Serial Shipping Container Codes (SSCCs) on tertiary packaging. A customs aggregation code (AIC) for imported products and aggregation code for locally manufactured products is already required. The AIC has 25 digits: a 14-digit tax identification number (TIN) for businesses or personal identification number (PINFL) for individuals; the date the AIC was generated by ASL BELGISI (6 digits in DDMMYY format); and a random 5-digit security code generated by ASL BELGISI.

Final thoughts

The Uzbekistan serialization requirements mean that pharma companies that want to do business in the country have a long list of items to check off their compliance to-do list, including generating and managing serial numbers, obtaining crypto codes from CRPT Turon, and monitoring packing lines to ensure compliance with the requirements.

The good news is that we can help you navigate the requirements. Contact us today and schedule a short demo of our compliance management solution, which takes the guesswork out of compliance by automatically sending reports to regulators, adapting to changes in laws, and updating your partners. Our digital supply chain experts will help you evaluate your needs and work directly with you to design a solution customized for your business.

And sure to bookmark our blog and check back for more updates about Uzbekistan serialization requirements and requirements in other Commonwealth of Independent States nations and members of the Eurasian Economic Union.

Published Feb. 27, 2023

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

Posted on 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. 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.

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