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Indonesia Track and Trace Regulations: What They Mean for the Pharma Industry

Posted on February 13, 2024 by rfxadmin

Indonesia track and trace regulations are designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the supply chain. The goal is to protect consumers and increase patient safety, as well as boost Indonesia’s competitiveness in the pharma global pharma industry.

The National Agency of Drug and Food Control (BPOM) began rolling out regulations in 2018. In 2022, it established provisions and procedures for implementing 2D DataMatrix codes for drug and food products. The country’s digital platform is called the Track and Trace Anti-Counterfeit (TTAC) system.

Key regulations went into effect in 2023; the next big deadlines are set for 2025 and 2027. So let’s take a closer look at Indonesia track and trace regulations and what they mean for the pharma industry.

Indonesia’s Pharma Market in Context

At the time of writing, Indonesia’s population is approaching 279 million — the fourth largest in the world. It’s no surprise, then, that the sprawling archipelago is the largest pharmaceutical market in Southeast Asia.

According to Business Indonesia, sales of medicines in 2020 were valued at about $7.6 billion (110.6 trillion rupiah); this is expected to increase to more than $11 billion (176 trillion rupiah) by 2025. In terms of U.S. dollars, this equates to a compound annual growth rate of 10.7 percent.

Furthermore, the Indonesian government is making significant investments in the country’s healthcare system. The same Business Indonesia article reported that healthcare spending in 2022 accounted for 9.4 percent of the total government budget.

In this context, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

The Framework of Indonesia Track and Trace Regulations

Most of today’s global pharma compliance requirements have a few things in common:

- - Companies must register products with a country’s regulatory body.
  - Companies must send compliance information to a centralized system (e.g., a portal or website like Indonesia’s TTAC).
  - Products must be labeled in a manner that identifies them at the unit level (i.e., serialization) and/or a “higher” level, such as a pallet or case (i.e., aggregation).
  - Regulators prefer GS1 labeling standards [e.g., 2D DataMatrix codes, Global Trade Item Numbers (GTINs), and Serial Shipping Container Codes (SSCCs)]. Read our “Understanding GS1 Barcodes in the Global Supply Chain” article for a comprehensive overview of these standards.

Indonesia track and trace regulations follow this basic framework:

Registration

Imported and locally produced medicines must be registered with the BPOM before they can be distributed. Pharma companies must have a local business agent or partner to register products, and it’s advisable to obtain all permissions before exporting products to Indonesia.

Labeling

The BPOM requires all medicines sold in Indonesia to be labeled for identification, and upcoming regulations will further require products to be labeled for authentication. The BPOM uses GS1 standards.

Identification Barcodes

Starting on December 7, 2023, traditional medicines and over-the-counter drugs — as well as cosmetics, supplements, processed foods, and some raw materials — were required to be labeled with a QR code that identifies the product in the market and verifies that it’s legal. For products that do not have to be serialized, this is the only marking required.

Identification codes must contain a Marketing Authorization Number and an NIE, or Nomor Izin Edar, which can be translated as “distribution permit number,” both issued by the BPOM. Alphanumeric NIEs provide master product data, including where the product was manufactured, and allow verification through a database called Cek Produk BPOM (“Check BPOM Products,” roughly).

Authentication Barcodes

December 7, 2025, is the deadline for serializing and labeling narcotics and psychotropics (e.g., antipsychotics and antidepressants) with a 2D DataMatrix code. By December 7, 2027, all prescription drugs, including biological products, must be serialized and authenticated. Aggregation, following GS1 standards, is also required.

The authentication codes must contain the following information:

- - A GS1 Global Trade Item Number (GTIN)
  - A Marketing Authorization Number from the BPOM
  - A production code or batch number
  - An expiration date
  - A serial number

Companies can obtain codes from the BPOM or from an independent source.

Some products/packs are exempt from the authentication requirement. These include blister packs, strip packs, pre-filled syringes, stick packs, single packaging, and catch covers.

Other Indonesia Track and Trace Regulations: Distribution

The BPOM has other requirements coming into effect between 2024 and 2026:

- - December 7, 2024: Distribution centers with minimum stock keeping units (SKUs) of 1,500 serialized products must submit reports to the BPOM.
  - December 7, 2025: “Second-tier” distribution centers (min. 750 serialized products) must submit reports to BPOM. Note that this coincides with the deadline for serializing and labeling narcotics and psychotropics.
  - December 7, 2026: “Third-tier” distribution centers (min. 400 serialized products) must submit reports to BPOM. This applies to certain categories of pharmacies or clinics.

Electronic Leaflet Pilot (2023-2025)

A pilot for electronic leaflets (e-leaflets) began in July 2023 and is scheduled to conclude in July 2025. Wanting to transition from a paper-based system, the BPOM plans to develop a dedicated mobile app for scanning a single code (likely the mandated GS1 2D DataMatrix code) that will take users to information online. The pilot is being conducted in three phases:

- - Phase I for vaccines and injections (completed)
  - Phase II for prescription drugs, including vaccines and injections (completed)
  - Phase III for over-the-counter and prescription drugs, including vaccines and injections (in progress)

Final Thoughts About Indonesia Track and Trace Regulations

As we said above, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

This is where we can help. Our solutions for global pharma compliance will help ensure you’re prepared for Indonesia’s requirements for product identification, serialization, and aggregation.

It’s all part of our 20-year commitment to protecting patients, combatting counterfeit drugs, and securing supply chains. Our solutions report into all global government agencies, help ensure you meet your regulatory obligations, and protect products and people everywhere you do business. Contact us today to learn how it works!

EPCIS DSCSA Exceptions Handling: What Is It and Why Is Everyone Talking About It?

Posted on January 4, 2024 by rfxadmin

Just a little over four months into the FDA’s DSCSA extended stabilization period and with the clock ticking down to the November 27, 2024, compliance deadline, EPCIS DSCSA exceptions handling is top-of-mind in the pharma industry.

But why? Let’s take a look at EPCIS DSCSA exceptions handling and how we can deal with it to ensure DSCSA compliance.

EPCIS DSCSA Exceptions Handling Keeps Your Products Flowing

The DSCSA requires the interoperable, electronic exchange of serialized product data. Specifically, trading partners must exchange Transaction Information (TI) and Transaction Statement (TS) data every time a regulated drug changes hands.

Exceptions are errors that may occur when partners exchange this data using EPCIS. If there’s an exception, the product cannot move forward in the supply chain, which means it won’t reach patients and consumers in a timely manner. Furthermore, if exceptions aren’t resolved quickly, a product could be considered suspect or illegitimate.

This is why EPCIS DSCSA exceptions handling is top-of-mind for the pharmaceutical industry.

Given the complex nature of securely exchanging serialized product data, it’s logical to expect exceptions, especially in the early days of enforcement. The Healthcare Distribution Alliance (HDA) has identified six categories of EPCIS DSCSA exceptions:

1. 1. Data Issues
  2. Damaged Products
  3. Product, No Data
  4. Data, No Product
  5. Packaging
  6. Product Hold

Exceptions have been on the HDA’s radar for years. At its Traceability Online Seminar in November 2021, for example, industry leaders discussed establishing standards for dealing with exceptions. They also discussed example scenarios, such as overages as a “Product, No Data” exception. In this scenario, a downstream trading partner might have 16 cases arrive at its facility but receive EPCIS data for only 15 of those cases. How does it notify the manufacturer? How does the manufacturer correct the TI so the case can be removed from quarantine and be on its way?

The message is clear: Trading partners must focus on building a system that quickly communicates and resolves data issues so products can keep moving.

Note: Also remember that the DSCSA requires all partners to be authorized trading partners (ATPs). This isn’t necessarily relevant to our discussion today, but it’s a critical part of compliance.

EPCIS DSCSA Exceptions Handling Solutions: Communication and Collaboration

The most important thing to remember about dealing with exceptions is that trading partners must communicate and collaborate. You are not working in a vacuum, and there is not a “lone wolf” solution for exceptions handling.

Herein lies the challenge. The communication infrastructure in the pharma supply chain — emails, online portals, phone calls, and so on — wasn’t designed with DSCSA compliance in mind, let alone dealing with exceptions handling in an interoperable, electronic data-exchange system.

So, in order for an EPCIS DSCSA exceptions handling solution to be effective, it must be built on a foundation of fast, targeted, and precise communication between/among the right people. In the overages example above, this would mean the trading partner that received the extra case would know exactly who to contact at the manufacturer, what information to share with that person, and how long it would take to fix the data error.

Are You Ready for EPCIS DSCSA Exceptions Handling?

The FDA’s extended stabilization period has given the pharmaceutical industry an additional year to prepare for the full serialization of the U.S. drug supply chain, including being able to deal with EPCIS DSCSA exceptions handling.

This is good news for everyone. But you have to use this time to ask yourself the tough questions:

- - Do you have systems up and running?
  - Are you testing your systems?
  - Are you communicating and collaborating with all of your trading partners?
  - Are you complying with the DSCSA requirements that are enforceable right now?
  - Are you working with a solution provider that fully understands your role in the supply chain, your product(s), your business, and your DSCSA compliance needs?
  - Are you going to be ready for November 27, 2024?

We are here to help. We have led on the DSCSA since rollout began in 2014. Today, we’re working with the industry to develop a collaborative approach to exceptions handling using GS1-based error correction.

Don’t let bad data disrupt your business. Contact us today to learn more. We’ll ensure you receive compliant data from your trading partners, quickly resolve data quality issues, and keep your products moving.

FDA Postpones Enforcement of Key DSCSA Requirements to November 27, 2024

Posted on August 28, 2023November 10, 2023 by rfxadmin

In a guidance document published on Friday, August 25, the U.S. Food and Drug Administration (FDA) announced that it was delaying by one year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date to November 27, 2024.

The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products. We provide the specifics below.

The key takeaway: Don’t stop preparing for the DSCSA requirements. If you have questions about the DSCSA delay 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.

And if you’re going to the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C., stop by Table-Top 21 to meet our team and talk about the developments in person. Click here to learn more.

Overall FDA rationale for the DSCSA delay

The FDA said extending enforcement will give supply chain stakeholders — particularly manufacturers, wholesale distributors, dispensers, and repackagers — 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.”

Furthermore, the Agency said, “additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

What DSCSA requirements are affected?

Product identifiers

The requirement. Trading partners must include the product identifier at the package level for each package in a transaction into the transaction information. Furthermore, a product’s manufacturer or repackager must incorporate the PI at the package level for each package “introduced in a transaction into commerce.” These requirements are included in section 582(g)(1)(B) of the Food, Drug, and Cosmetics Act (FD&C Act).

Reasoning for DSCSA delay. The FDA said the delay will “accommodate the additional time (beyond November 27, 2023) that may be needed by trading partners to achieve compliance and to help ensure continued access to prescription drugs as trading partners continue to refine processes” to include the PI at the package level. Furthermore, the FDA said “this policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.”

What is a PI? The PI is a standardized graphic that contains, in both human-readable form and on a machine-readable data carrier, four data elements:

1. 1. National Drug Code (NDC)
  2. Serial number
  3. Lot number
  4. Expiration date

Saleable returns

The requirement. Each person accepting a saleable return must have systems and processes in place to allow acceptance of the product. Furthermore, they may accept saleable returns only if they can associate the product with its transaction information — including the PI — and transaction statement. These requirements are included in section 582(g)(1)(F) of the FD&C Act.

Reasoning for DSCSA delay. FDA said delaying enforcement of this requirement until November 27, 2024, will “facilitate the continued use of methods currently being used by wholesale distributors for associating a saleable return product with its applicable transaction information and transaction statement while accommodating the additional time that may be needed for all trading partners to mature the new systems and processes required for acceptance of saleable returns.”

Interoperable, electronic product tracing at the package level

The requirement. Transaction information and transaction statements must be exchanged in a secure, interoperable, electronic manner. This requirement is included in section 582(g)(1)(C) of the FD&C Act; the standards for exchange are established under section 582(h) of the DSCSA.

Furthermore, systems and processes for verifying products at the package level, including the standardized numerical identifier, must meet the standards established in DSCSA section 582(a)(2) and the guidance in DSCSA section 582(h).

Reasoning for DSCSA delay. The FDA these policies will allow trading partners to continue to provide, capture, and maintain data for the data exchange for product tracing and verification while providing additional time that may be needed to “continue to develop and refine systems and processes for electronic data exchange.”

Investigating suspect and illegitimate products

The requirement. In the even of a recall or to help investigate a suspect or illegitimate product, stakeholders must be able to promptly provide product transaction information and transaction statement when requested by the FDA secretary or other appropriate federal or state official. This requirement is included in section 582(g)(1)(D) of the FD&C Act.

Furthermore, Section 582(g)(1)(E) of the FD&C Act requires stakeholders to “produce the transaction information for each transaction going back to the manufacturer” in certain situations, including a recall or investigating a suspect product or an illegitimate product.

Reasoning for DSCSA delay. FDA believes these compliance policies will facilitate the continued use of methods currently being used by trading partners to respond to the type of requests for information described above while accommodating the additional time that may be needed for trading partners to mature the new systems and processes required for such activities under section 582(g)(1)(D) and (E) of the FD&C Act.

Compliance Management: Key Challenges and How to Overcome Them

Posted on June 12, 2023August 4, 2023 by rfxadmin

Effective compliance management takes time and effort, but it’s much better to be prepared and prevent problems before they occur. Violating the regulations that govern your industry means you risk losing customers, damaging your reputation, and hurting your bottom line. Fortunately, taking a proactive approach means you can address many of the compliance challenges that companies face. Let’s take a closer look at compliance management systems and their benefits.

What Is Compliance Management?

Companies in any sector must understand and follow the local, state, federal, or international regulations that affect how they do business. Compliance management is the set of tools and procedures that a business uses to ensure they follow the laws that govern its industry. Regulatory requirements may be established by:

Government entities
Labor unions
Trade associations or other industry organizations

For example, pharmaceutical companies have to comply with the U.S. Drug Supply Chain Security Act (DSCSA), whose requirements include product serialization and electronic, interoperable data exchange. Similarly, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) has specific requirements for traceability and data-sharing.

Why Is Compliance Management Important?

Compliance requirements are often in place to ensure ethical behavior toward customers or competitors. Clear, enforceable regulations set standards for businesses, governments, and civil society organizations.

Failure to adhere to applicable laws or regulations could result in fines, fees, suspension of business operations, revocation of licenses or certifications, or other compliance issues. Thus, many businesses create and establish governance, risk management, and compliance (GRC) programs to minimize their risk.

Three Approaches to Compliance Management

A compliance management solution can vary from simple to complex and must be uniquely tailored to suit an organization’s structure and industry. Three common methods of compliance management are:

Strict, Top-Down Approach

This is the most rigid approach to compliance management. Internal policies are created and implemented by the person or team at the top of the organizational chart. There is no room for flexibility or interpretation. A top-down model is usually needed when the health, safety, and welfare of employees or the people they serve are paramount. For example, a daycare operator must follow all the state and local regulations created to keep minors safe.

Hands-Off Approach

In contrast, a hands-off approach is the most flexible type of compliance management. In this model, leadership may establish compliance standards, but the implementation of day-to-day business processes is handed off to middle managers or other employees.

This approach can work in certain situations. For example, a franchisor that has retail food establishments in different states may be subject to health department inspections in each state. Recognizing that each franchisee is subject to a different set of regulations, they may leave it up to each site manager to implement training or an inspection checklist at their respective franchise.

Shared or Distributed Model

In this approach, compliance activities are shared by employees across the organization. Instead of receiving strict guidelines from a central authority, departments or teams may share the responsibility of creating and implementing compliance activities. Or, the organization may issue a central policy and solicit feedback from employees on what to change or improve. A distributed model can work especially well when companies are implementing newly issued regulations and need feedback from staff on the front lines of their industry.

Compliance Management Challenges

Thoughtful, proactive implementation of compliance measures helps save time and money down the line. But compliance management is not without its challenges, which can include:

Evolving regulatory landscape: Whether you’re a startup or a multinational corporation, keeping up with new and changing regulations can be difficult. In an increasingly complex corporate environment, it makes sense that organizations may struggle to stay up to date.

Changing working environments: In recent years, more and more businesses have embraced a hybrid work model. While letting employees work from anywhere can help organizations stay nimble, it also exposes them to a new set of cybersecurity risks and HR challenges.

Vendor management: You can’t be an expert in everything. Understandably, businesses often partner with third-party vendors for certain services, whether it’s benefits management, IT support, or legal services. Improper vetting or insufficient due diligence can mean that you end up working with vendors that are out of compliance with your industry requirements.

Pharmaceutical, Food and Beverage, and Cosmetics

Companies in the pharmaceutical, food, and beverage, and cosmetics industries face unique challenges when it comes to compliance management. Consumers need to know that the food they eat, the medicine they take, and the personal care products they use are safe.

Pharmaceutical compliance regulations such as the U.S. DSCSA and the EU Falsified Medicines Directive (EU FMD) are in place to improve patient safety, ensure product integrity, and keep counterfeit drugs out of the supply chain. For the food industry, the Food Safety Modernization Act (FSMA) and guidelines like the Global Food Safety Initiative (GFSI), are in place to make the food supply safer and reduce rates of foodborne illness. Regulations for cosmetics vary widely from country to country, but generally, companies must take steps to ensure their products are safe, have complete ingredient labels, and they can verify their labeling claims.

Throughout all these industries, regulatory bodies are increasingly looking to improve supply chain transparency and traceability.

Compliance Management Best Practices

Companies can support regulatory compliance through best practices such as:

Thorough documentation: When in doubt, document everything, even if it’s not mandated by law. A central document repository makes it easy for employees across the organization to find the information they need and prevent non-compliance.

Set data standards: Be sure that you’re meeting the industry standards for high-quality data across all business operations. Inaccurate or incomplete data means you’ll be less prepared for accurate compliance reporting.

Education and engagement: Know your industry inside and out. Staying connected with industry associations, participating in continuing education, and attending events and conferences helps the organization stay up to date on industry changes and trends.

How to Create a Compliance Management Program

Whether you’re implementing compliance management at a new business or overhauling an existing compliance program, these steps are critical:

Conduct a Thorough Risk Assessment

Start by assessing internal and external risks that could affect regulatory compliance. Review each department to identify and document potential issues and to collect qualitative and quantitative data that you can compare against regulatory standards.

Establish Corporate Policies and Procedures

Look to industry guidance to help you create an initial draft of your compliance policy. You’ll likely need input from stakeholders across the organization, including IT, HR, legal, financial, and risk management leaders. If you don’t already have a compliance officer in place, you’ll need to appoint (or hire) one.

Communicate the Plan and Provide Training

Once your organization has a final compliance policy, it must be communicated to all staff and board officers. Set aside time for dedicated training on the policy, how to use a compliance checklist, and how to conduct an internal audit. Make sure all staff is familiar with any regulatory changes or new rules for recordkeeping and reporting.

Account for Routine Maintenance

Schedule regular reviews of your organization’s compliance policy to ensure it reflects changes in your industry or business operations. Budget the resources to help your compliance team stay abreast of changes in the industry and new regulations.

Conduct Periodic Compliance Audits

Routine internal audits can help identify potential issues before they snowball. Plus, periodic audits ensure your company is better prepared to respond to inquiries from government or regulatory bodies. If violations or vulnerabilities are discovered through an internal audit, take remediation steps immediately and review existing policies to see if there’s a way to prevent similar problems in the future.

Compliance Management Solutions

In addition to a set of internal procedures, a compliance management solution should include:

Auditing tools
Ongoing compliance training and education for staff
Board and management oversight

Additionally, workflow tools and apps can help organize compliance processes and automate certain tasks, like data analysis.

Compliance Management Systems

Today, many organizations rely on digital tools to streamline their compliance efforts. A well-designed compliance management system (CMS) can:

Improve data quality and business analytics
Ensure consistency across multiple business locations or branches
Make tracking, traceability, and reporting easier
Automate routine tasks so employees can focus on other business priorities
Minimize an organization’s overall risk exposure

Compliance Management Software

Compliance management software offers a central platform for communicating, overseeing, and documenting compliance activities across an enterprise. We’re committed to improving compliance management through supply chain transparency. With our tailored industry solutions, you can track your supply chain in real-time, no matter where your business is located. rfxcel serves businesses in the pharmaceutical, food and beverage, and consumer goods industries around the world. To learn more about our compliance software solutions or schedule a demo, contact us today.

India iVEDA Deadline Delayed for Track and Trace, Reporting

Posted on April 3, 2023August 4, 2023 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.

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

Posted on March 8, 2023November 10, 2023 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 March 2, 2023August 4, 2023 by rfxadmin

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 February 28, 2023October 9, 2023 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. 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 February 27, 2023August 4, 2023 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

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!