February 2023 - rfxcel.com
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Month: February 2023

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

Posted on by rfxadmin

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

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

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

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

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

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

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

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

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

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

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

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

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

Brazil ANVISA update, Part 3: Medical device regulations

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

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

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

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

Final thoughts

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

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

Understanding Uzbekistan Serialization Requirements: Ensuring Compliance and Efficiency

Posted on by rfxadmin

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

What are the Uzbekistan serialization requirements?

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

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

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

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

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

Key dates in 2022

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

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

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

March and May 2023 Uzbekistan serialization requirements

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

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

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

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

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

Final thoughts

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

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

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

Published Feb. 27, 2023

FSMA Traceability: What the Food Industry Needs to Know Today

Posted on by rfxadmin

U.S. regulators want a more robust, technology-driven approach to traceability and safety in the food supply chain. Their strategy has several components, but the FSMA traceability requirements published in November 2022 should be top-of-mind for the food industry in the United States and elsewhere.

Let’s take a look at the Food Safety Modernization Act (FSMA) and FSMA traceability requirements. Even though the compliance deadline is about three years away, now is the time to start planning your strategy.

FSMA implementation and goals

The Food and Drug Administration (FDA) is the primary implementing regulatory agency of FSMA, a law that seeks to transform the United States’ food safety system “by shifting the focus from responding to foodborne illness to preventing it.” It focuses on five areas:

    1. Preventive controls
    2. Inspection and compliance
    3. Imported food safety
    4. Response (i.e., recalls)
    5. Enhanced partnerships

In terms of FSMA traceability, the regulations address the “need for rapid and effective tracking and tracing of foods.”

FSMA Section 204 and the three pillars of FSMA traceability

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

    1. Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
    2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
    3. Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

Today, we’re going to focus on Nos. 2 and 3, which concern the FDA’s Food Traceability List and the Final Rule on Requirements for Additional Traceability Records for Certain Foods (“Final Rule”).

The Food Traceability List and the Final Rule

The Food Traceability List (FTL) was developed with input from a 2014 Request for Comments and for Scientific Data and Information in the Federal Register, members of the FDA and the Centers for Disease Control and Prevention, and external subject matter experts. It includes “high-risk foods” such as leafy greens, shell eggs, crustaceans (e.g., shrimp, crab, lobster), and finfish (e.g., cod, tuna, salmon).

In September 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods.” Known as the “Food Traceability Proposed Rule” or “Proposed Rule,” it defined additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FTL.

After making modifications and holding a period for public comments, The FDA in November 2022 announced the Final Rule on Requirements for Additional Traceability Records for Certain Foods.

The gist of the Final Rule and FSMA traceability is that businesses are responsible for establishing and maintaining records of critical tracking events (CTEs) and associated key data elements (KDEs).

CTEs are typically events that occur during growing and processing (e.g., harvesting, initial packing, and shipping). KDEs provide the granular details for FSMA traceability, such as time, location, unit measurements, and a company’s contact information.

The information companies must keep and share with their partners depends on the type of supply chain activities they perform with respect to food(s) on the FTL. The activities encompass the entire food supply chain, from harvesting or production, to processing, distribution, and receipt at a retail location or other point of service.

The FDA says this “framework forms the foundation for effective and efficient tracing and clearly communicates the information that FDA needs to perform such tracing.”

Final thoughts

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

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

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

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

Read more about FSMA:

 

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