June 2019 - rfxcel.com

Understanding 5 Pharmaceutical Regulations in Russia: Compliance and Safety

Whether you manufacture medical products in Russia or plan on importing them into the country, you need to understand the regulations for pharma compliance that will go into effect in January 2020. Here are the five most important aspects to consider.

1. Deadlines for Product Serialization

Under the new regulations, the deadline for serialization for products manufactured in Russia or imported into the country is December 31, 2019. Other regulations that came into effect at the end of 2018 called for serialization of products on the Essential Drugs List and “Seven Nosologies,” a state program that helps patients access high-cost treatments for orphan diseases (i.e., rare diseases).

2. Tracking and Reporting Compliance Events

Russian pharma compliance stipulates that all foreign pharmaceutical manufacturers and distributors must track and report up to 36 compliance events. This is a much higher standard than other regulations, including the EU’s Falsified Medicines Directive (FMD), which requires seven compliance events, and the Drug Supply Chain Security Act (DSCSA) in the United States.

Foreign manufacturers and distributors must track a wide range of product transactions and movements, as well as packaging changes, and report to Russia’s Federal State Information System for Monitoring Drug Circulation via XML uploads with electronic signatures. These reports must be submitted within five business days.

3. Reporting Requirements

The new reporting requirements differ depending on the business type and model. The business use case dictates the type of compliance events to track and report, as well as different sequences of those events.

4. Prescription and OTC Products Requirements

The new regulations dictate the tracking and tracing of both prescription drugs and over-the-counter (OTC) products. This is unlike EU and U.S. regulations, which cover only prescription drugs and high-value medicines.

This is a challenge for EU and U.S. pharma companies that are either in the process of storing their product master data or that have already finished compiling it. If these companies want to distribute in Russia, they now also have to source their product master data for OTC products.

Furthermore, pharma companies in the EU or United States that want to do business in Russia have to make sure they serialize their products to meet the pharma compliance deadlines. All their manufacturing lines must include OTC product serialization.

5. Aggregation Requirements

FMD and DSCSA compliance regulations do not have aggregation requirements. Russian pharma compliance, however, will require documenting and reporting aggregation. In other words, all aggregation and disaggregation operations are considered compliance factors. Furthermore, every serial number for medicines in Russia must contain a unique identifier. This is an extra layer of security against counterfeit drugs entering the supply chain.

Final Thoughts

These are the most notable facets of the Russian compliance regulations that foreign companies must keep in mind as 2020 approaches. rfxcel’s Traceability Platform (rTS) can help you properly keep track of all the products in your supply chain. If you want to ensure you’ll be fully compliant with the new Russian regulations, contact us for more information. Our supply chain experts, including staff in Russia, are ready to help!

Get access to Serialization Requirements in Russia Webinar


Track and Trace and the Importance of Order Fulfillment in Pharma

The health care supply chain and the pharmaceutical industry have realized great benefits from track and trace, product serialization, and related requirements in the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA). For example, manufacturers, repackagers, and wholesale distributors can now verify all the products they sell and receive, and guarantee there are no counterfeit drugs on the market.

But what makes that possible? How can they track and trace all the products in the pharmaceutical supply chain?

What Does Track and Trace Mean in Pharma?

Track and trace enables pharmaceutical manufacturers, repackagers, and wholesale distributors to follow products through the entire supply chain. Using traceability platforms, they can track their products at the individual unit level, enabling them to verify every product and instantly identify problems, such as a potential counterfeit drug or environmental excursions. This revolutionary solution will significantly improve order fulfillment and transform the entire health care supply chain.

Serialization is the key to track and trace. Serialization is the process of assigning unique two-dimensional (2D) bar codes to each product (i.e., at the unit level). Today, it’s common for companies to store the codes in a secure cloud. Blockchain, a distributed-ledger technology, has garnered some interest but has yet to be widely adopted in pharma supply chain operations.

Why Is Order Fulfillment So Important?

Imperfect order fulfillment leads to lost revenue — even damage to a brand’s reputation — because delayed or incomplete orders negatively affect customer experience.

Suppliers with delayed orders can even face hefty fines from the retailers who distribute their products. If you don’t want to incur penalties or risk losing customers, you need to make sure you always fulfill your orders accurately and on time.

Track and trace solutions have an advantage here because they provide end-to-end visibility of the entire pharmaceutical supply chain. In other words, every single product can be traced. Retailers can proactively monitor goods in real time (e.g., locations of their orders and how they are being processed) and make sure there are no discrepancies or failed transactions.

Such proactive monitoring enables predictive visibility, which helps satisfy all customers. It makes the ordering process much smoother, shortens order-to-delivery cycles, reduces out-of-stock rates, and helps increase revenue.

The conclusion is that track and trace, teamed with product serialization, drives business value. And not only in pharma, but virtually any industry that operates a supply chain. By increasing  visibility and enabling real-time monitoring, it helps optimize inventory, fulfill orders, speed and simplify returns and recalls, increase revenues, and improve brand loyalty.

If you are seeking a superior track and trace solution, contact the rfxcel team. The most tenured track and trace company in the life sciences, rfxcel will help you optimize your operations no matter the circumstances (We even have a solution that enables you to connect to any blockchain.) From meeting all DSCSA compliance requirements and eliminating counterfeit drugs to building your brand reputation and increasing revenues, rfxcel has you covered.

Serialization & DSCSA Compliance

Several years ago, more than 500 manufacturers, distributors, and consultants met to discuss the issues in the US healthcare supply chain. This meeting would tackle the issue of counterfeit drugs in the supply chain and how to reduce their number.

This meeting introduced the idea of product serialization and discussed the need to enhance traceability in the healthcare supply chain. Here’s what all of this means.

What Is Product Serialization?

Product serialization is the unique identification of products, which goes down to the level of individual items, rather than only at the batch level. Serialization pharma is the identification of individual packs of medications, that is, assigning them a globally unique two-dimensional code, and marking it on the packaging.

With the implementation of product serialization, a proper system for tracking and tracing products in the entire supply chain must be integrated. That kind of a comprehensive system will enable US wholesalers to verify the products, as well as exchange data with other wholesalers in the supply chain.

This initiative is called DSCSA compliance, and every pharmaceutical manufacturer, re-packager, wholesale distributor and dispenser in the US must adhere to the regulatory requirements. The mandated deadline for pharmaceutical manufacturer and re-packager was November 27, 2018.

What Is DSCSA Compliance?

DSCSA (Drug Supply Chain Security Act) compliance is the U.S. initiative to prevent the introduction and distribution of counterfeit drugs.

The main goal of this compliance is to enable pharmaceutical manufacturers, re-packagers, wholesale distributors, pharmacies, and third-party logistics to exchange information about every single medication package and see exactly where it has been in the supply chain.

This will help them verify the products, identify illegitimate products anywhere in the supply chain, and make recalls of drug products more efficient.

All of this is made possible with the introduction of serialization and traceability technology. All of the product data will be stored in a secured cloud-based repository.

How to Be DSCSA Compliant?

To be DSCSA compliant, every pharma business affected by the DSCSA compliance laws must capture transaction information (TI), transaction history (TH), and transaction statement (TS) from the previous owner, and provide it to the subsequent owner of each product.

They must maintain their TI, TH, and TS for every transaction for six years. They must only ship legitimate products, and they can never change the transaction history in any way.

Pharmaceutical serialization and traceability will modernize the pharma industry. The initiative will revolutionize the industry and, hopefully, eliminate all the counterfeit drugs from the supply chain.

If you need a reliable solution for tracking and tracing products in the healthcare supply chain, rfxcel is here for you. We can help you meet all the needs of product serialization and become DSCSA compliant in no time. Contact us today to find out more about how we can be of help.