pharmaceuticals Archives

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

Posted on April 25, 2023April 24, 2023 by rfxadmin

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

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

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

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

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

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

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

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

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

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223.5 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

ABOUT SPHERITY

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

India iVEDA Deadline Delayed for Track and Trace, Reporting

Posted on April 3, 2023April 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, 2023March 7, 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, 2023April 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, 2023March 2, 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.

Uzbekistan Serialization Requirements: March 1 Deadline and More

Posted on February 27, 2023February 28, 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 the March 1 deadline.

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 1 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.

Final thoughts

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

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

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

Published Feb. 27, 2023

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

Posted on September 27, 2022March 17, 2023 by rfxadmin

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

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

India track and trace requirements for 2023

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

Labeling APIs: January 2023 deadline

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

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

The QR codes must contain 11 data points:

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

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

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

Reporting to the iVEDA Portal: March 2023 deadline

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

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

Draft regulations for barcoding pharma products: May 2023 deadline

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

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

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

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

Industry observers have noted concerns with the guidelines, including:

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

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

Final thoughts

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Final thoughts

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

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

We hope to see you in October!

UAE Tatmeen Track and Trace System: Just the Facts

Posted on September 13, 2022March 17, 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.

DSCSA Summary: A Look at the Law as We Count Down to 2023

Posted on September 7, 2022March 17, 2023 by rfxadmin

As the clock continues to tick toward the November 27, 2023, U.S. Drug Supply Chain Security Act (DSCSA) deadline, we thought it was a good time for a recap. Our DSCSA summary will hit the major milestones, changes from the FDA, and compliance requirements.

We’ll also include an updated timeline graphic that first appeared during our three-part DSCSA webinar series last summer, which dealt with authorized trading partners (ATPs), EPCIS, and the Verification Router Service (VRS). We wrote about those topics twice just last week: Check out our FDA DSCSA Guidance Update: EPICS, ATPs, and the Countdown to 2023 and the Q&A with our SVP of Product and Strategy Herb Wong.

Now, on to the DSCSA summary: everything you need to know in 5 minutes.

What is the DSCSA?

The DSCSA is a 10-year plan to transform the U.S. pharmaceutical supply chain. It became law in November 2013, as Title II of the Drug Quality and Security Act (DQSA), and has been rolled out since 2015. Implementation culminates on November 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.

The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”

Furthermore, the DSCSA “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”

Who has to comply?

Manufacturers, wholesalers, dispensers, repackagers, and third-party logistics providers (3PLs) must comply with DSCSA if they want to do business in the United States.

Key requirements

The FDA puts DSCSA requirements into four categories. This is what Herb Wong calls “the four cornerstones” of the law.

1. Product identification (serialization). A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.

2. Product tracing. Stakeholders must provide information about a drug and who handled it each time it’s sold. This includes the following:

- - - Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred. Note: We’ll be writing more about NDCs soon.
    - The transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the DSCSA.
    - Transaction history (TH) is an electronic statement with the TI for every transaction going back to the manufacturer. Note: TH will not be required after the November 2023 deadline.

For the record, the FDA defines “transaction” as the “transfer of product between persons in which a change of ownership occurs.”

3. Verification (VRS). Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables a rapid, secure exchange of data to do this

4. Authorized trading partners (ATPs). The DSCSA also says that if you’re not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs

If you want to know more, read our in-depth explanations of the VRS and ATPs. Or just contact us today to talk to one of our DSCSA experts!

Other requirements

Detection and response + notification. Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.

Licensing. Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.

DSCSA Summary: Timeline

The FDA has delayed the rollout of the DSCSA two times (September 2019 and October 2020). However, an FDA official said in August 2021 that there would be no more delays. November 27, 2023, is a done deal.

Final thoughts

If you have any questions about this DSCSA summary, contact us today. There might be one or two things that surprised you — like the sunsetting of the transaction history (TH) requirement — and we want to make sure you’re sure about what’s happening.

Our extensive writing about the law is a valuable resource, but nothing beats spending 15 minutes with one of our supply chain experts. So schedule a short demo of our DSCSA compliance solution. Our No. 1 priority is to help you understand the regulations and be prepared for the full serialization of the U.S. pharma supply chain next November.

And if you happen to be going to this year’s HDA Traceability Seminar in Washington, D.C., drop us a line here to arrange a meeting and be sure to catch Herb Wong in the “EPCIS Onboarding Across the Supply Chain” panel discussion and his roundtable about industry readiness for November 2023.