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

Posted on February 28, 2023October 9, 2023 by rfxadmin

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

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

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

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

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

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

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

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

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

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

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

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

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

Brazil ANVISA update, Part 3: Medical device regulations

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

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

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

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

Final thoughts

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

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

Brazil ANVISA Update: Manufacturers, Distributors, and Dispensers Must Meet April 2022 Serialization Deadline

Posted on October 26, 2021August 4, 2023 by rfxadmin

The Brazilian Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100), meaning the April 28, 2022, deadline for meeting serialization, reporting, and traceability requirements is officially set in stone. Let’s take a look at what supply chain stakeholders can expect with Brazil ANVISA when the law goes into effect just six months from now.

Key Brazil ANVISA requirements for April 28, 2022

The pharma industry has been aware of the Brazil ANVISA requirements since December 2016, when the National Medicine Control System (SNCM) was signed into law (Law No. 13.410/2016), establishing serialization requirements and timelines for Brazil’s pharmaceutical supply chain.

There are three key requirements for April 2022:

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.

To meet serialization requirements, all products must have a GS1 2D Data Matrix barcode that houses a 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), and 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:

For their serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Furthermore, manufacturers must submit a serialization plan that includes all steps and actions they will take to become compliant by April 2022.

Final thoughts

What’s the most important takeaway for Brazil ANVISA? The clock is ticking and you have to be prepared. You should be coordinating with your supply chain partners. You should be registering your products with ANVISA. You should have access to the SNCM portal and be uploading the required reporting data.

You should also register for our “SNCM-ANVISA Serialization and Traceability Compliance” webinar on Wednesday, Nov. 17, 8:30 – 9:15 a.m. Eastern Time. Thiago Alegreti, director of our Latin American operations, will discuss the latest SNCM updates and let you know what you need to be doing to be ready for April 2022.

rfxcel has fine-tuned our traceability software to help manufacturers operating in the Brazilian market comply with the SNCM requirements, and we have an experienced team on the ground in Brazil that can help make sure you’re ready for the regulations. Register for the webinar and contact us today if you have any questions or want more information.

Brazil’s SNCM and ANVISA Updates

Posted on December 17, 2019July 25, 2023 by rfxadmin

Brazil is the largest economy in Latin America. In May 2022, it will join Russia, the EU, and many other counties in mandating serialization in its pharma supply chain. Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM), as described in Law No. 13.410.

The SNCM was signed into law by the Brazilian Health Regulatory Agency (ANVISA) on December 28, 2016; it is the first step toward serialization implementation.

Here’s a rundown of the approaching Brazil serialization deadlines, the responsibilities of the Brazilian supply chain, and all the latest updates.

Original Brazil serializations deadlines

Brazil’s serialization requirements are being implemented in three stages. Stage 1 went into effect in September 2017, which marked the beginning of a 1-year pilot phase. Stage 2, lasting from September 2018 through May 2019, included a pilot review and the finalization of technical guidelines. Stage 3 was initially set for May 2019 to May 2022 and included unit-level serialization implementation.

In November 2019, reports stated there would be changes to these deadlines, which we will address later on in this piece.

Supply chain responsibilities

As of May 2022, every supply chain actor importing to or manufacturing in Brazil is responsible for capturing, storing, and exchanging important events electronically. This initiative was put into place to protect Brazil’s 190 million citizens against common problems in the drug supply chain, including counterfeit drugs and cargo theft.

The SNCM requires unit-level serialization, tracking and tracing products, and monitoring environmental conditions as products move through the supply chain. These serialization requirements state that every item must be visible at the unit level, and all products must have a list of the following specifications:

GS1 2D data matrix bar code that houses a Global Trade Item Number (GTIN)
ANVISA Medicine Registry Number
Unique serial number
Expiration date
Lot/batch number

Latest updates to the SNCM

As we reported in another recent blog post, updates to the SNCM were suggested in November (2019), raising concerns about compliance. The proposed changes stipulate that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020 — a full 18 months earlier than the original deadline. (Other deadlines didn’t change: 50 percent by April 2021, 75 percent by September 2021, and 100 percent serialization and reporting by April 2022.)

We’re not sure what the ramifications will be — a 45-day public review is currently underway — but our Latin America team is monitoring the situation.

Final thoughts: rfxcel’s role in Brazil serialization

For 15 years, rfxcel has deployed its experience to help companies from Latin America to Russia increase supply chain visibility. We have fine-tuned our traceability software to help manufacturers operating in the Brazilian market achieve compliance.

We are prioritizing assisting Brazilian companies to prepare for the May 2022 deadline. Vinicius “Vinnie” Bagnarolli, rfxcel’s Director of Commercial Operations in Latin America, warns that even though the deadline is still far in the future, companies should start preparing for the shift now:

“SNCM requires pharma companies to do a lot of new things and adopt new behaviors. This includes implementing unit-level serialization, tracking and tracing products, and monitoring environmental conditions as they move through the supply chain. Companies will also have to submit detailed transaction data to the government. We want companies, distributors, and dispensers to know that we have the technical expertise and experience in Brazil to help them transition to SNCM. We are on the ground in Brazil; we are here to help.”

If you have questions or concerns about the SNCM or any other aspects of the pharma supply chain in Latin America, you can email Vinnie directly at vbagnarolli@rfxcel.com or contact us to set up an appointment. Also, check back for details about a webinar about these and other issues that Vinnie will host in December!