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UAE Tatmeen Track and Trace System: Just the Facts

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

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

What is the UAE Tatmeen track and trace system?

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

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

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

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

How does the UAE Tatmeen track and trace system work?

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

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

Tatmeen timeline, next deadline, and news

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

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

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

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

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

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

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

Final thoughts

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

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

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

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

FDA National Drug Code: Proposed Format Changes & Industry Impact

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

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

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

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

What is the FDA National Drug Code?

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

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

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

The Proposed Changes to the FDA National Drug Code

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

When and how will the change be rolled out?

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

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

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

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

Impact on product labeling

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

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

Industry reaction

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

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

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

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

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

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

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

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

Final thoughts

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

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

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

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

DSCSA Compliance Update with Herb Wong: What’s Happening Right Now?

Posted on August 30, 2022November 10, 2023 by rfxadmin

Herb Wong’s a busy guy. We said that the last time we did a DSCSA compliance update with him, and it’s still true today Just last week, for instance, he participated in two Healthcare Distribution Alliance (HDA) webinars, “DSCSA 2023: How a Service Provider Can Help You Prepare” and “All About the VRS.” These were part of the HDA’s 2022 Traceability Webinar Series, which Antares Vision Group is sponsoring.

That’s why it was such a treat to get some one-on-one time with Herb for a real-time DSCSA compliance update — what’s happening right now with industry readiness.

We asked Herb to talk about what he calls “the four cornerstones” of DSCSA compliance: product identification (EPCIS and serialization), product tracing, authorized trading partners (ATPs), and verification (the Verification Router Service, or VRS). Here’s what he had to say.

DSCSA compliance update #1: product identification (EPCIS and serialization)

All solution providers’ systems are ready to send and receive serialization data in the EPCIS format, but we still need to help the industry get data flowing. To use an analogy, even though the pipes have been laid and connected, we’re just not getting enough water through to test for “leaks” in the system — errors in send/receive processing. Just as important, we need time to “flush the pipes” to ensure that we have “clean water.” By that I mean ensuring that the data is correct.

We’re trying to do everything we can. We’ve actually developed a standard process for onboarding customers and getting data exchanged with other solution partners. We’re going to be piloting this so we can refine the onboarding process. [Herb’s talking about the EPCIS Onboarding Guide Workgroup and its draft “Guide for Accelerated EPCIS Onboarding.”]

What’s the key takeaway, Herb?

The key takeaway is, “Let’s connect, let’s get the serialized data out.” Time is running out. That’s the biggest message. People who think they have time to wait until next year, you really don’t. Because what’s going to happen is similar to what happened when the lot-based laws went live: The people who waited couldn’t find help. All the solution providers were busy; everyone was busy. And everyone who waited was trying to get through the same door to meet the deadline.

So, if you’re a manufacturer, you have to start sending data early. If you’re serializing and not sending data downstream, start now. Don’t wait till the November 2023 deadline. You have to “turn on the switch.” Send your data downstream now.

At this point, we decided to ask Herb about aggregation.

DSCSA doesn’t say anything about aggregation. But wholesalers are asking for aggregation to support their business processes. When you send electronic data, wholesalers need to know what serial numbers are in the cases they just received.

Aggregation is a business requirement for operational efficiency. For example, if you get 10 cases with a hundred items in each case, you don’t want to open the cases and scan every item to see what you received and will ultimately ship. Aggregation makes things faster and more efficient. It’s similar to how VRS had both a legal and a business requirement: The legal requirement mandated a response within 24 hours for saleable returns verification. But given the potential volume of saleable returns, 24 hours was too slow for wholesalers; it would cause the receiving docs to fill up with products pending verification. For this reason, wholesalers mandated a business requirement of sub-second response times.

DSCSA compliance update #2: product tracing

A centralized solution or standard has not been defined for product tracing. A lot of different approaches have been discussed, but there’ve been no specs, no firm requirements, that solution providers can implement at this time.

Right now, we’re supporting the industry’s manual process for product tracing. The HDA, NABP, and PDG have done a really good job of outlining what’s required for tracing. [That’s the Healthcare Distribution Alliance, the National Association of Boards of Pharmacy, and the Partnership for DSCSA Governance.]

They’ve walked through a series of scenarios that can be executed manually and have helped the industry to better understand the complexity and nuances of tracing a product through the system. In parallel to this effort, the PDG is working on a data format to communicate traceability requests and responses. PDG is putting that information into a JSON format to communicate the need. [JSON is the JavaScript Object Notation data interchange format. Its advantages are that it uses human-readable text and is a more compact means of communicating data.]

What’s the key takeaway, Herb?

Pay attention to the traceability scenarios that are coming out of the HDA, NABP, and PDG. They’re doing a really good job of trying to show how tracing workflows will happen. They’ll be publishing more results and helping the industry understand. Watch for these, because it will enlighten you about what’s coming in 2023.

DSCSA compliance update #3 and #4: ATPs and VRS

From a solution provider standpoint, the ATP and VRS initiatives have become one and the same. Right now, ATPs have only been applied against the VRS, so the timing for us to get that done has become one implementation effort.

When you make a VRS request, you have to prove you’re an ATP. ATP is there to confirm two things: you are who you say you are and you are authorized to transact business. Proof that you are an ATP is especially important in the VRS network since trading partners may not have direct relationships with other VRS participants.

For VRS, there’s a new version 1.3 that will be deployed before the DSCSA 2023 deadline. The current version we have is based on the 1.2 standards interface. The 1.3 version “opens up” VRS beyond what it was intended to do, which is the verification of saleable returns.

What people should know is that VRS 1.3 is not backwards-compatible. This means VRS providers have to upgrade at once. To ensure that the upgrade occurs on time, solution providers have agreed to “decouple” the 1.3 interface from the 1.3 functionality.

What this means is that everyone on the VRS network will remain connected since we will all support the new 1.3 connections. However, solution providers (or customers) who are not ready to upgrade to the new 1.3 functionality can continue to use VRS as needed. That’s going to be important because it allows us to change the interface so we can at least keep talking to each other. We can be interoperable. But not everyone has to support the features of 1.3 at the same time.

As for timing of the update, we’re talking about doing the testing of the interoperability of 1.3 in Q1 [of 2023]. So we’ll have to push this into a production environment after Q1, but we haven’t agreed on a production date.

What’s the key takeaway, Herb?

There is going to be an upgrade required soon and the industry and solution providers are working to make sure it’s easy to implement. We realize that is not as simple as a software upgrade but we need to carefully consider the revalidation requirements of our customers.

Final thoughts

And there you have it: A DSCSA compliance update about what’s happening right now with industry readiness for product identification (EPCIS and serialization), product tracing, and ATPs and VRS. Thanks, Herb!

Contact us if you have questions about what Herb talked about or the DSCSA in general. We can explain the requirements and how our solutions will help ensure you’re ready for November 2023 and the full serialization of the U.S. pharmaceutical supply chain.

If you like, we can probably arrange a meeting with Herb. But remember, he’s busy. In the coming weeks, he’ll travel to the Antares Vision Group global HQ in Italy, visit the Group’s brand-new North America HQ in New Jersey, and join a panel discussion at the HDA Traceability Seminar in Washington, D.C. (Antares Vision Group is also a sponsor of that annual event.) So reach out today and let’s see what we can work out.

Also take a look at our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including the “four cornerstones” Herb talked about in today’s DSCSA compliance update.

Understanding FDA DSCSA Guidance for the Pharmaceutical Industry

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

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

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

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

What Is the DSCSA?

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

Who Must Comply with the DSCSA?

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

Recent DSCSA Guidance Updates

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

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

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

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

Other Noteworthy DSCSA Guidance Updates

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

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

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

DSCSA Guidance in Context, Today

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

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

What DSCSA Requirements Are in Effect Right Now?

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

What Was Enforceable Before Nov. 27, 2023?

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

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

What Went into Effect on Nov. 27, 2023?

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

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

Final Thoughts About DSCSA Guidance

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

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

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

Everything You Need to Know About Kazakhstan Pharma Serialization

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

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

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

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

Pilot

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

Goals

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

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

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

IS MPT Operator

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

As operator, Kazakhtelecom JSC is responsible for the following:

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

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

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

Timeline

Here are the key dates for Kazakhstan pharma serialization:

Planning and pilot

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

Rollout (note upcoming deadlines in October and early 2023)

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

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

Marking requirements

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

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

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

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

Here are some images of the apps:

Other regulated products/industries

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

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

Final thoughts

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

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

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

Kazakhstan Serialization and Traceability Requirements, Part 1

Posted on August 11, 2022August 4, 2023 by rfxadmin

We posted an Uzbekistan pharma serialization update the other day. This got us thinking about Kazakhstan serialization and traceability requirements, as Uzbekistan’s neighbor to the north is working to localize production, digitalize its infrastructure, and incentivize continued growth in key sectors, including pharmaceuticals.

So, welcome to the first of our two-part series about Kazakhstan serialization and traceability requirements. As we did in our series about the Africa supply chain, we’re going to start with context — information about the efforts mentioned above and a snapshot of what’s happening with the pharma industry. Part 2 will get into the specifics of Kazakhstan serialization and traceability requirements in pharma and other sectors.

Kazakhstan serialization and traceability requirements in context

To understand Kazakhstan serialization and traceability requirements, we must first understand what the country is doing to foster economic growth, including modernizing its infrastructure, developing its business enabling environment, and improving the lives of its citizens. Here’s a rundown of what’s been happening.

The Economy of Simple Things

Launched in March 2019, the Economy of Simple Things program is designed to increase domestic production of mostly low-tech, everyday consumer goods and services. The government also hopes to simultaneously boost demand for these goods, decrease reliance on imports, and increase “Made in Kazakhstan” exports.

The program was funded with 1 trillion tenge (almost $2.4 billion in 2019), of which 400 billion tenge (approximately $953 million) was earmarked for manufacturing and services. It was originally slated to end in July 2022 but was extended until the end of 2023.

When Prime Minister Alikhan Smailov announced the continuation, he said the Economy of Simple Things had subsidized more than 1,100 projects valued at almost $2.1 billion, had helped increase production output and payment of taxes by 33 percent and 80 percent, respectively, and had retained and created 67 jobs.

Digital Kazakhstan

Digital Kazakhstan aims to utilize digital technologies to “allow the economy, business, and citizens to enter a fundamentally new development trajectory.” It began in 2018; barring an extension, it will end this year.

The “new development trajectory” means Kazakhstan will work to transition to a digital economy that will improve people’s quality of life. The initiative focuses on five areas, each with publicly stated goals for “What will change/be changed by 2022”:

1. 1. Digitization of the economy: reorganization of the economy using technology to increase productivity and growth; focused on businesses of all sizes. Example of “what will change by 2022”: Labor productivity will increase to the level of “TOP-30 world countries.”

1. 1. Transition to the digital state: transformation of infrastructure to provide services for and anticipate the demands of people and business; calls for “open, transparent, and convenient opportunities” that can be accessed online 24/7. Example of “what will be changed by 2022”: Government services available in electronic format will increase by 80 percent.

1. 1. Implementation of the digital Silk Way: development of a high-speed, secure infrastructure for data transfer, storage, and processing (i.e., internet access and high-quality mobile communications coverage). Example of “what will change by 2022”: ICT development will reach the level of “TOP-30 countries.”

1. 1. Evolution of the human capital assets: transformational changes to enable a creative society and the “transition to the new realities”; calls for a knowledge-based economy and digital literacy through innovations in education. Example of “what will be changed by 2022”: Digital literacy will increase to 83 percent.

1. 1. Innovative ecosystem formation: foster a supportive environment for technological entrepreneurship and industry innovation characterized by stable relations between business, academic institutions, and government. Example of “what will be changed by 2022”: The Astana Hub will become an “international park of IT start-ups.”

Promoting pharma independence

According to the United Nations Comtrade database, a repository of official international trade statistics and relevant analytical tables, Kazakhstan’s pharma imports were valued at $1.56 billion in 2020.

The country’s efforts to attain pharma independence date to at least the mid-2010s. In 2014, for example, the now-discontinued State Program of Accelerated Industrial-Innovative Development (SPAIID) aimed to increase the share of domestically produced medicines to 40-50 percent of the overall market.

How far have they come toward that goal? In October 2020, The Asana Times reported that “the share of domestic manufacturers in the procurement of medicines and medical devices has grown to 30 percent and continues to grow steadily.” It also reported the following:

- - In the first eight months of 2020, production volume increased 34.1 percent, reaching 81.5 billion tenge ($190.28 million).
  - Investments into the industry reached 5.2 percent and 4.1 billion tenge ($9.57 million).

For a little more context, consider these stats from an analysis published in early 2021:

- - In 2018, Kazakh pharma manufacturers produced products valued at 42 billion tenge (about $88 million at current exchange rates).
  - In the first 9 months of 2019, the market for finished pharmaceutical products had grown to 460 billion tenge (about $966 million today), a 22-percent year-on-year increase.

To fuel growth, the government in September 2020 adopted the “Comprehensive Plan for the Development of the Pharmaceutical Industry” through 2025. As reported in the Asana Times, the plan includes the following benchmarks:

- - Thirty new large pharmaceutical operations valued at 77.8 billion tenge ($163.4 million in 2020 dollars)
  - Double medicine production to 230 billion tenge ($537.55 million)
  - Triple exports to 75 billion tenge ($175.10 million)
  - Train more than 2,000 specialists and create permanent jobs for them
  - Increase domestic pharmaceutical production to 50 percent in physical terms

Furthermore, then-Prime Minister Askar Mamin directed the government to scale up support for the domestic pharma industry, especially by stimulating clinical and preclinical trials. He also tasked the Ministries of Industry and Infrastructure Development, Healthcare, and Foreign Affairs to incentivize blue-chip pharma companies to set up shop in Kazakhstan.

One last note for further context: Striving for pharma self-sufficiency isn’t a new idea. For example, earlier this year we wrote about Egypt’s Gypto Pharma City. The Egyptian government envisions this “medicine city” as a regional hub for the international pharmaceutical and vaccine industries, calling it “one of the most important national projects … with the aim of possessing the modern technological and industrial capacity in this vital field.”

Final thoughts

On August 8, the Kazakh Trade and Integration Ministry reported that the country boosted its exports to $34.2 billion between January and May 2022, a 37.2 percent increase over the same period last year.

It seems, then, that the Economy of Simple Things, Digital Kazakhstan, and the Comprehensive Plan for the Development of the Pharmaceutical Industry are reaping dividends. They’re promoting the economic vitality that will help propel the implementation of Kazakhstan serialization and traceability requirements across diverse industries, from pharmaceuticals to footwear.

We’ll talk about those requirements next week in in Part 2. In the meantime, take a look at our solutions for Kazakhstan and the other countries in the Eurasian Economic Union (EAEU). You can also contact us to schedule a short demo of our technologies — rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business.

Uzbekistan Pharma Serialization Update: September 1 Deadline & More

Posted on August 10, 2022August 4, 2023 by rfxadmin

We’ve been following the Uzbekistan pharma serialization rollout as part of our ongoing survey of global pharmaceutical regulations and compliance.

As we wrote in mid-February 2022, the country’s State Tax Committee “extend[ed] the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products. That announcement, however, didn’t stipulate a new deadline.

So, what’s the latest with Uzbekistan pharma serialization? Let’s take a look.

Uzbekistan pharma serialization and Resolution No. 149

On April 2 of this year, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.” This established the following labeling deadlines for medicinal products and medical devices:

- - September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
  - November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
  - March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
  - March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
  - February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health

Additionally, there seems to be a grace period for the 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.

More about the labeling requirements

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

The regulations currently apply to five product categories other than medicines and medical devices: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.

Products in every regulated industry 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

To learn more about Uzbekistan pharma serialization, how ASL BELGISI works, and labeling requirements, read our “Uzbekistan Traceability Update” from earlier this year. Keep in mind that we wrote this before the first deadline delay and adoption of Resolution No. 149.

Final thoughts

The Uzbekistan pharma serialization deadlines are upon us — about three weeks away. Since its inception, ASL BELGISI has been a hot topic in the industry, especially in key pharma-producing countries.

India, for example, has taken a keen interest in the requirements. One recent article reported that Indian pharma companies are “looking for more clarity over regulations and technical standards … and looking for a transition period to migrate to digital labeling.” The same article noted several other interesting points:

- - India’s pharma exports to Uzbekistan more than doubled in fiscal year 2020-21.
  - India’s export of pharma products to Uzbekistan totaled $137 million in 2021.
  - Uzbekistan’s pharma market is valued at $1.5 billion.
  - There are opportunities for investment and exports in Uzbekistan’s oncology and dermatology sectors.

The good news is that we can help you navigate Uzbekistan pharma serialization requirements no matter where you’re based — India, Asia, the EU, the UK, Latin America, the United States. We have experts in all of these markets, and rfxcel and Antares Vision Group are committed to ensuring you’re compliant everywhere you do business. Contact us today and schedule a short demo of our award-winning Traceability System and our Compliance Management solution.

Antares Vision Group Will Be at GS1 Connect 2022 in San Diego Next Month!

Posted on May 23, 2022August 4, 2023 by rfxadmin

We’re getting excited for GS1 Connect, June 7-9 at the Marriott Marquis San Diego Marina! Not only are we a Premier Sponsor — we’ll be speaking about supply chain traceability and smart hospital systems.

We’ll also be at Booth 115 with our award-winning Traceability System, demonstrating solutions for the food and beverage, pharmaceuticals, and cosmetics industries.

So take 20 seconds (really) to sign up to meet us. We have a limited number of discount codes for 10 percent off your registration fee. And while you’re at Booth 115, take our short survey and you could win a $500 DoorDash gift card.

More about GS1 Connect and our speakers

The theme of this year’s conference is “Adapt.” The focus is on how businesses have used GS1 Standards to overcome challenges to thrive in uncertain times. There will be 40+ live sessions (including ours!), 50+ exhibitors (including us!), trading partner roundtables, and other events centered on user stories and leadership insights for supply chain optimization.

As GS1 says, the event is a place to “network with the greatest supply chain minds and learn how to leverage GS1 Standards to optimize your business.” Indeed.

In “Supply Chain Traceability: Can Your Business Survive Without It?” Herb Wong, our vice president of product and strategy, will discuss why traceability is foundational to business success in a rapidly evolving landscape of digitalization, ever-changing consumer expectations and power dynamics, tougher regulations, and supply chain uncertainty. He’ll be speaking on Thursday, June 9, at 1:45 p.m.

In on-demand session 509, “Smarter and Safer Hospitals: When Innovative Technologies Meet Patient Safety,” our Digital Healthcare Department Director Adriano Fusco and Dr. Alberto Sanna, director of the Research Center for Advanced Technologies for Health and Well-Being of the IRCCS San Raffaele Hospital in Milan, Italy, will discuss how traceability and GS1 Standards enable end-to-end visibility of medications from arrival at the hospital to dispensation and optimized resources to focus on patient safety.

Final thoughts

We’ve always valued GS1 Standards, and we’ve always ensured our customers can adhere to them and take full advantage of them to maximize efficiency and create value across their operations everywhere they do business.

And who took the time to note the 50th anniversary of the venerable Global Trade Item Number (GTIN)? We did, with a blog post devoted to GS1 barcodes.

As we said in that article, “Where would we be without standards?” We’d love to see you at GS1 Connect and talk about those standards and how they fuel traceability. We hope you’ll take those few seconds to sign up to meet us at Booth 115, get 10 percent off your registration, and enter to win a nice prize when you take our survey.

In the meantime, drop us a line if you have any questions or want to know more about our traceability solutions for pharma, food and beverage, cosmetics, and other industries. We never pass on an opportunity to talk about what makes us your best partner for end-to-end supply chain solutions, from L1 all the way to L5!

See you in San Diego June 7-9!

Brazil ANVISA Deadline Is Just Two Weeks Away. Here’s What You Need to Know.

Posted on April 14, 2022August 4, 2023 by rfxadmin

The Brazil ANVISA deadline is just two weeks away. On April 28, 2022, pharmaceutical companies must comply with the serialization, reporting, and traceability requirements set out in the National Medicine Control System (SNCM), which the Brazilian Health Regulatory Agency — ANVISA — signed into law a little more than five years ago.

If you follow our blog (and we know you do), you know we’ve covered ANVISA and the SNCM since Day 1. You could also probably guess that we weren’t going to miss this opportunity to share more update about what to expect as the Brazil ANVISA deadline countdown enters its final days. Let’s take one last look.

Brazil ANVISA deadline and the SNCM: A recap

The Brazil ANVISA deadline has been on the industry’s radar since the SNCM was passed on December 28, 2016 (as Law No. 13.410/2016). It regulations will help Brazil protect its almost 213 million citizens against common problems in the drug supply chain, such as counterfeits and theft.

The SNCM requires every pharma supply chain actor to capture, store, and exchange data electronically. All products must have a GS1 2D Data Matrix barcode with five data points:

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

The ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number make up the Unique Medicine Identifier (Identificador Único de Medicamentos), or IUM, which must be printed on every product. Compliant labeling might look something like this:

Overall, there are three key requirements for the April 28 Brazil ANVISA deadline:

All prescription medicines must be serialized.
All manufacturers and importers must have a “serialization plan” in the SNCM portal.
All supply chain stakeholders must submit product event reports to the SNCM.

For serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Manufacturers were also required to submit a serialization plan that includes all steps and actions they would take to become compliant by the deadline.

Final thoughts

As we said above, this is our last look at the Brazil ANVISA deadline and SNCM requirements before April 28. However, it is most definitely not the last you’ll hear from us about Brazil’s pharma market and how it’s being regulated. We will continue monitoring the situation, posting updates, and answering your questions — always.

Undoubtedly, we’ve established ourselves as a leader in solutions for Brazil ANVISA and the SNCM. We’ve fine-tuned our software to help manufacturers and other pharma stakeholders achieve SNCM compliance, and we’ve prioritized assisting companies to be 100 percent compliant throughout the long rollout of the regulations. We’ve also built a dedicated São Paulo-based team that’s been extraordinarily active and involved every step of the way.

So, if you hear this or that provider saying they’re the only company offering a comprehensive solution, platform, or framework for SNCM compliance — or any other compliance requirements — be skeptical. Then contact us to get the straight talk about what you need to do and how our compliance and supply chain traceability solutions will get you where you need to be quickly and efficiently, no matter where you do business.

Keep an eye on the April 28 Brazil ANVISA deadline and drop us a line if you have questions!

DSCSA EPCIS Update: 3 Questions for rfxcel SVP of Product and Strategy Herb Wong

Posted on March 24, 2022August 4, 2023 by rfxadmin

Herb Wong’s a busy guy. As senior vice president of product and strategy at rfxcel, he’s always on the go, advising and conferring with customers, talking and brainstorming with industry leaders, dashing off to speak at conferences, and thinking of new ways to improve … everything. So we were happy that he found time to talk with us about what’s happening with DSCSA EPCIS.

Our chat comes as Herb is fresh off an appearance at the Healthcare Distribution Alliance (HDA) Distribution Management Conference in Austin, Texas, where he participated in the “EPCIS Standards and Implementation Process” panel discussion. HDA also recently published a DSCSA EPCIS Implementation Benchmarking Survey about the progress of adoption and trading partner plans for sending data.

Here’s the scoop:

Herb, what has the EPCIS Center of Excellence learned about industry readiness for the DSCSA EPCIS requirements?

Well, the EPCIS COE, which we introduced at the HDA Quarterly Update in September last year, has discovered a number of things through our studies and meetings. Here are takeaways in the key areas of education, consistency, and standards.

As we get closer to the November 2023 deadline, new participants are less knowledgeable about EPCIS and DSCSA. Their integrations take more time and they have more questions and need more education. This was a recurring theme we started hearing during our EPCIS COE interviews. Because of this, the HDA and GS1 are looking to see how they can offer/repackage training to get the industry up to speed.

In terms of consistency, we are looking into developing a common, consistent process for all solution providers to begin an EPCIS exchange. This can improve the efficiency across all supply chain partners.

And for standards, we have been discussing a process or tool to have all participants verify that their EPCIS data is formatted correctly before they begin exchanging it with others. GS1 developed an offering for this and everyone agrees that it’s a good idea; but determining who pays for this testing has been challenging.

How has the industry reacted to the EPCIS COE’s efforts?

Overall, everyone has been receptive. But this is a huge undertaking. It reminds me of the question, “How do you eat an elephant?” Answer: “One spoonful at a time.” Accelerating EPCIS data exchange is like that. It’s so big that people don’t know exactly where to start.

The answer is to just start somewhere and then learn and improve. The hardest part is getting started. Once we decide on a few areas where we can make an impact, momentum will keep us moving forward. We are in the process of agreeing on what we can do, so stay tuned!

What are your thoughts about industry readiness?

A number of supply chain partners asked me this question at the HDA Distribution Management Conference in Austin earlier this month. The industry is becoming more focused on the deadline. Everyone is realizing that the time for open-ended discussion is coming to a close and decisions must be made. We have 19 months to be ready for DSCSA 2023 and a lot of different efforts must be aligned.

Final thoughts

Herb Wong, everyone!

We hope Herb’s answers were helpful and shed light on the industry’s efforts to be ready for the DSCSA EPCIS requirements. As he said, it’s an elephant-sized undertaking with a lot of moving parts that need coordination and consensus. The EPCIS COE is “the spoon” that’s helping the pharmaceutical industry digest the requirements, address the challenges, and get everyone compliant by November 27, 2023.

If you still have questions, your first step should be to contact us. One of our supply chain experts can explain the requirements and how our solutions will get your house in order. If you like, we can probably arrange a meeting with Herb. So reach out today and let’s talk.

We also encourage you to browse our DSCSA Compliance Library. It’s a clearinghouse of information with links to our blog posts, white papers, webinars — everything — about the law, including EPCIS requirements.

Last, we want to let you know that in June Herb will head to San Diego to speak at the GS1 Connect 2022 conference. On Thursday, June 9, he’ll present “Supply Chain Traceability: Can Your Business Survive Without It?” Herb will discuss why traceability is foundational to business success and how companies in any industry can leverage traceability in a digital supply chain to ensure they comply with regulations and much more. Check back for updates as we get closer to June!