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Pharmaceutical Compliance: A Global Overview

rfxcel continually monitors the regulatory landscape in order to improve our products and customer service and maintain our position as the leader in pharmaceutical compliance. We strive to bring you the most accurate and complete information about news, trends, and other developments at all levels of the pharmaceutical supply chain — local, national, regional, and global.

Updated periodically, our “Worldwide Pharmaceutical Compliance Requirements” publication summarizes regulations in key markets, from Australia to United Arab Emirates. It provides at-a-glance details about pharmaceutical compliance fundamentals, including deadlines, milestones, barcoding requirements, aggregation, and traceability. We also share links to other helpful information about global pharmaceutical compliance, such as official government agencies and their supply chain regulations and announcements.

Furthermore, we’ve taken the opportunity to include a comprehensive bibliography of our own pharmaceutical compliance resources. We share our white papers, webinars, blog posts, articles in industry publications written by our supply chain experts, and press releases about rfxcel’s accomplishments in pharmaceutical compliance. These resources cover everything from specific regulations (e.g., the EU Falsified Medicines Directive, the U.S. Drug Supply Chain Security Act, and Russia Chestny ZNAK) to more general information about the pharmaceutical supply chain and how to keep it safe and secure.

Russia Serialization Deadlines: Overview of Russian track and trace requirements

Russia has the strictest supply chain regulations in the world. Are you ready to comply?

Some Russia serialization deadlines have come and gone; others are scheduled for 2021 and 2022. The fact is that the Russian supply chain is undergoing massive change. The transformation is due to be complete by 2024 and will affect virtually every industry, from pharmaceuticals and footwear to tires and tobacco.

The regulations are complex, but the gist is that companies must connect and comply with Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Requirements and Russia serialization deadlines vary by industry, but hallmarks include DataMatrix codes, serialization, aggregation, crypto codes, and electronic reporting and records management.

The paper begins with an overview of Chestny ZNAK, the regulations and Russia serialization deadlines, and considerations for stakeholders (manufacturers, importers, wholesale distributors, and retailers). It then addresses each industry, including labeling requirements and detailed lists of products that must be serialized.

It provides a comprehensive examination Russia serialization deadlines and the requirements for every industry that currently must comply with Chestny ZNAK:

  • Bicycles
  • Dairy
  • Footwear
  • Fur
  • Light industry
  • Medications
  • Perfumes
  • Photo cameras and flashbulbs
  • Tires
  • Tobacco

It also dives into Russia serialization deadlines and requirements for ongoing or scheduled “experiments” (i.e., pilots):

  • Bottled drinking water
  • Wheelchairs
  • Biologically active food additives
  • Brewing products and low-alcohol drinks

rfxcel is the leader in Russian supply chain compliance, and we’ve been prepared for the Chestny ZNAK regulations and Russia serialization deadlines 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 accredited as an IT Company by the Ministry of Digital Development, Communications, and Mass Media.
  • 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.

 

Blockchain Based Supply Chain Traceability

Blockchain Based Supply Chain Traceability:

Blockchain is here to stay, and companies in diverse industries are either investigating how they might benefit from its strengths or have already invested in using the technology in their operations.

As you probably know, a key appeal of blockchain is its ability to maintain immutable records in a decentralized fashion. For supply chain traceability, blockchain allows the provenance of any product to be easily demonstrated with and supported by immutable, tamper-proof data. This not only improves product safety, expedites regulatory compliance, and helps prevent counterfeiting, fraud, and waste — it enhances transparency and visibility, and creates new possibilities to engage consumers with compelling, verifiable product stories.

This white paper provides an overview of the origins of blockchain, from its earliest applications in cryptocurrency and recordkeeping, and discusses how it has transitioned into other industries, including supply chain management. In so doing, we hope to demystify blockchain, which despite its growth and the “buzz” surrounding it, remains opaque to many.

We also examine rfxcel’s Blockchain solutions, our proprietary, platform-agnostic solution that helps customers and their partners ensure that they can interface with blockchain applications. You’ll see how our solutions improve end-to-end supply chain traceability, visibility, and transparency, and learn how it can work in the pharmaceutical, food and beverage/agribusiness, consumer goods, and government industries.

Our trust in the items we consume, from prescription drugs and organic foods to name-brand designer goods, depends on the reliability of supply chains. For almost 20 years, rfxcel has committed itself to making supply chains safer, faster, and more traceable and transparent. We recognize the potential of blockchain and will work with you when you’re ready to see how it might benefit your operations.

 

Russia Chestny ZNAK and the Dairy Industry

A pilot for dairy products began in July 2019 and ended on December 31, 2020. Mandatory labeling for cheese and ice cream is scheduled to begin June 1, 2021. Labeling for products with specific shelf lives is to begin on September 1 and December 1, 2021. Dairy will be unique because Chestny ZNAK plans to share track and trace duties with another government system.

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, including bottled drinking water. The pilot for bottled drinking water began on April 1, 2020, and is scheduled to end on June 1, 2021.

Russia’s 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. We’re also accredited as IT Company by Russia’s Ministry of Digital Development, Communications, and Mass Media. Today, companies are using our 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

Our Russia serialization white paper looks 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 over-the-counter (OTC) medications, must be serialized, and there are special requirements for aggregation and separate serialization requirements for batches. Download this concise, easy-to-understand resource about the Russian pharma regulations.

For other questions, please reach out to our local experts:

Russia
Victoria Kozlova
Director of Operations
Send Mail
P: +7 985 7504284

USA
Nigel Taylor
VP of Sales
Send Mail
P: +1 650 576 7235

Europe
Simon Manley
Commercial Director
Send Mail
P: +44 1223 926923

Latin America
Vinicius Bagnarolli
Commercial Director
Send Mail
P: +55 11 97148 7826

India
Arun Rao
Head of Business Development
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P: +91 982 063 9476

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