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Russia Chestny ZNAK and the Dairy Industry

A pilot for dairy products began in July 2019 and is scheduled to end on December 31, 2020. Dairy will be unique because Chestny ZNAK plans to share track and trace duties with another government system. Mandatory labeling for some items will begin in January 2021.

This short white paper provides details about the dairy category, such as:

2D Data Matrix Codes for Dairy Products

  • Product packaging must have a blank field up to 15×15 mm to accommodate the code.
  • For products in PET bottles, caps must be prepared properly to accommodate either printing or marking with a laser.
  • If a manufacturer has concerns about marking any of its packaging — an unusually shaped carton or bottle, for example — it can submit a sample of the packaging for testing to determine if the codes will adhere to it and if the form factor affects the accuracy/reliability of scanning.
  • Aggregation is required, and the parent-child relationship must be maintained between the aggregation and the individual units within it.

The white paper also has an easy-to-understand overview of the Russian regulations, including its origins, basic labeling requirements, and other aspects relevant to any company that wants to do business in Russia.

rfxcel is the leader in Russian supply chain compliance, and we’ve been prepared for the Chestny ZNAK regulations since 2018. Our powerful rfxcel Traceability System (rTS) platform ensures companies in any industry will remain compliant. Furthermore:

  • We are an official software and integration partner of the Center for Research in Perspective Technologies (CRPT).
  • We are one of only a few providers with in-country implementations.
  • We’ve tripled our workforce in Russia over the last year.
  • Our team in Moscow provides our clients, which include global consumer goods and pharma companies, the quickest time to market while automating their compliance reporting.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.

Russia Chestny ZNAK and the Bottled Drinking Water Industry

Russia Chestny ZNAK and the Bottled Drinking Water Industry: How to achieve track and trace compliance in Russia + serialization and aggregation for global players

Russia’s National Track and Trace Digital System, Chestny ZNAK, covers a wide range of products and industries. The regulations have strict standards for serializing and tracing all products manufactured in or imported into Russia. For example, products must be labeled with unique cryptographic (“crypto”) codes.

To prepare your products for the Russian market, you must understand the Chestny ZNAK regulations and choose a solution that will fulfill your specific application requirements. This short white paper looks at the principles and approaches for the process of marking and tracing bottled drinking water. It will help you understand Chestny ZNAK’s critical implementation and technological aspects for the bottled drinking water industry.

rfxcel is an official integration, software, and tested solution partner with the Center for Research in Perspective Technologies (CRPT), which manages Chestny ZNAK. Today, companies are using rfxcel’s track and trace solutions to achieve and maintain compliance. rfxcel transforms business value with a digital supply chain and by helping companies accelerate the process for meeting Russia’s regulatory requirements. As your partner, we’ll safeguard your products while ensuring you remain compliant with Chestny ZNAK.

Bottled Drinking Water Pilot Milestones and Goals

  • Economic agents order 2D Data Matrix codes and apply them to finished products.
  • All information transferred electronically to Chestny ZNAK.
  • Aggregation of products in shipping packages and aggregation of codes for each unit in the aggregation.
  • Marked products enter circulation.
  • Track and trace of products in the supply chain and Universal Transfer Documents (UTDs) to record the transfer of codes between stakeholders.
  • Goods withdrawn from circulation at the time of purchase via communication with point-of-sale cash registers and scanning devices.

Dispensers, the DSCSA, and the “3Ts”

The next DSCSA deadline for dispensers is just months away. Our white paper gets into the specifics of what dispensers will have to do to verify and authenticate drugs this November and what they’ve had to do in previous years. rfxcel has committed itself to creating educational materials about dispensers’ responsibilities under the DSCSA, including Web pages, flyers, webinars, and this white paper. If you want more information about your specific needs, please contact us today.

Russia Serialization for Footwear

This white paper uses footwear as a case study to examine the complex Russian serialization regulations for the consumer goods industry. Starting July 1, 2019, manufacturers, importers, distributors, wholesalers, and retailers had to begin labeling their products with 2D Data Matrix codes. By February 1, 2020, footwear supply chain actors were expected to have obtained all necessary equipment (e.g., barcode scanners, printers, cash registers) and mastered the new system. Beginning March 1, 2020, production, import, and wholesale and retail sale of unmarked footwear is prohibited. Learn what you need to know to be compliant now — and always.

Russia Serialization for Pharma

This Russia serialization guide and white paper look at the massive changes coming to Russia’s supply chain, due to be completed by 2024. The transformation, designed to keep fake and substandard products out of the market, will have a huge impact on the pharmaceutical industry. For example, manufacturers and distributors must connect and comply with the National Track and Trace Digital System, Chestny ZNAK. All medications, including OTC medications, must be serialized, and there are special requirements regarding aggregation and separate serialization requirements for batches. Access this concise, easy-to-understand resource about the Russian pharma regulations.

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Quick Guide to Brazil’s National Medicine Control System (SNCM)

Quick Guide to Brazil’s National Medicine Control System (SNCM)

Since 2009, the Brazilian Health Regulatory Agency (ANVISA) has been discussing how control over the circulation of medicines can improve society, either by inhibiting counterfeiting or by reducing theft. According to the World Health Organization, 10% of all drugs sold worldwide are falsified, accounting for approximately $200 billion in lost revenue every year.

ANVISA’s National Medicine Control System (SNCM), slated to go into effect in May 2022, will help companies reduce financial losses, lessen the impact of criminal activities, and help ensure that citizens have access to medicines that did not originate in parallel markets.

rfxcel has prepared a Quick Guide to foster and accelerate understanding of SNCM, including:

  • Its key requirements
  • Complexities facing the industry
  • How to prepare to meet the May 2022 deadline

Download the Quick Guide to learn more.

Guia Rápido para o Sistema Nacional de Controle de Medicamentos – SNCM

Desde 2009 vem se discutindo sobre as melhorias que o controle sobre a circulação de medicamentos pode trazer para a sociedade – seja por inibir a falsificação quanto para reduzir o desvio de cargas. Segundo a Organização Mundial da Saúde (OMS), de todos os medicamentos vendidos mundialmente, 10% são falsos, o que representa aproximadamente 200 bilhões de dólares em receita por ano.

O Sistema Nacional de Controle de Medicamentos – SNCM da ANVISA vem para ajudar as empresas a diminuírem seus prejuízos e impactos de atividades criminosas, e também para auxiliar e garantir que a sociedade terá acesso aos medicamentos não provenientes de mercados paralelos.

Visando acelerar o entendimento destes requerimentos, a rfxcel desenvolveu este Guia Rápido para o SNCM. Nele você entenderá:

  • Principais requerimentos para o SNCM
  • Complexidades que a indústria enfrentará
  • Preparação necessária para cumprir o prazo de implementação

 

rfxcel VRS Pilot Program and Industry Update

rfxcel’s Verification Router Service (VRS) pilot began in mid-2018. rfxcel is the first solution provider in the United States to implement and pilot the Drug Supply Chain Security Act (DSCSA) verification solution for wholesale distributors and manufacturers. We now have test results and success to help trading partners meet the DSCSA requirements for 2019.

With a single 2D barcode scan, the rfxcel Verification Router Service (rVRS) solution verifies serialized products in 1 second. rfxcel follows the GS1 Verification Messaging standards. By following this messaging framework, which asks verification questions and receives actionable information, the requesting party is immediately able to determine whether to accept, reject, or quarantine a product instance. rVRS will ensure wholesale distributors and manufacturers meet the November 27, 2019, deadline for the DSCSA Saleable Returns Requirement.

This rfxcel webinar presents a full industry overview as of February 2019. If you would like to receive access to the webinar recording, please email us at rfxwebinar@rfxcel.com.

The webinar covers the following:

  1. Insight into the VRS
  2. Timeline/Updates on the VRS pilot
  3. Findings of rfxcel’s VRS pilot
  4. Industry Updates: What’s next for VRS?

About rfxcel: 

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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DSCSA VERIFICATION ROUTER SERVICE (VRS) BASICS | rfxcel

DSCSA VERIFICATION: Starting in November 2020, the FDA will require wholesale distributors to verify the product identifier before re-distributing saleable returned products. By using the Verification Router Service (VRS), distributors will be able to rout the serialization data to manufacturers. In this case, when a saleable return is received, the distributor sends the product data to the third-party routing service, which then routes the information to the manufacturer.

Initiated by the Healthcare Distribution Alliance (HDA) with feedback from the pharma industry, the VRS is an interoperable solution used to manage the acceptance, formatting, and delivery of requests and responses to support DSCSA verification requirements and other business requirements as defined between trading partners.

In this webinar presentation document, you’ll learn about the VRS activities listed below. To get copy of the webinar recording, please email us rfxwebinar@rfxcel.com.

  • Accept information from an authorized requestor via an interface or manual entry using a VRS portal. This information is a called product identifier (PI).
  • The requester will provide the Global Company Prefix (GCP) or Global Trade Item Number (GTIN).
  • With the GCP or GTIN, you determine the routing location to where the verification will be submitted.
  • The verification request is sent to the responder’s master database/system directly or to a VRS used by the responder.
  • After the response is obtained, the requestor will be able to view the data and view an electronic record.

The idea is that when a return occurs, a distributor would scan the Data Matrix code, format, and send the verification request to the VRS provider. By the use of master data, which is called a Lookup Directory (LD), the request is routed to the right source. The verification request goes to the manufacturer to check if the PI is present, If it is present, the  request is verified; if it isn’t, then both parties need to investigate where the issue might be.

rfxcel is the industry thought leader in VRS. We extended the testing of VRS and implemented a pilot program for the U.S. Food and Drug Administration. Applying our expertise in supply chain track and trace, serialization, and compliance solutions, we are helping the pharma industry prepare for the November DSCSA Saleable Returns Verification deadline.

Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive

Winning the numbers game: Countdown to complying with the serialisation requirements of the Falsified Medicines Directive

The Falsified Medicines Directive’s (FMD) February 2019 deadline is fast approaching. Those who don’t serialize by this deadline will be unable to sell their products in Europe.

The regulations set forth by the FMD state that every Marketing Authorization Holder (MAH) must upload serialization codes to the European Medicines Verification Organization.

But serialization isn’t a straightforward numbers game, and not all solutions are created equal. rfxcel has provided this document to help you determine how you need to serialize and what you need out of your serialization partner.

Serialization is a daunting, frustrating journey, but having the right solution and the right partner can make a world of difference.

This document aims to help you:

  1. Understand the regulation
  2. Identify the right partner for a serialisation solution
  3. Take these actions