The EU Falsified Medicines Directive Regulation Explained
Here’s a deep dive into the details of the European Falsified Medicines Directive regulation and requirements for pharma manufacturers and non-manufacturers.
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Here’s a deep dive into the details of the European Falsified Medicines Directive regulation and requirements for pharma manufacturers and non-manufacturers.
The global cost of counterfeiting and diversion is estimated to be over 1.7 trillion dollars annually. We have compiled all the proven tools and techniques that are essential to combat this supply chain threat.
In an era where sustainability is a driving force for change, Systech empowers companies to make responsible choices, reduce waste and enhance transparency.
With the United States being far and away the largest pharmaceutical market in the world, complying with necessary regulations is critical for the industry.
DSCSA compliance requires that drug manufacturers, dispensers, and distributors (basically all stakeholders in the pharmaceutical supply chain) follow certain federal
Systech announced recently that it joined the National Association of Boards of Pharmacy (NABP) Interoperable Partner Program, Pulse by NABP. This is important news as both Systech and NABP want to ensure that pharmacies and dispensers are ready for DSCSA (Drug Supply Chain Security Act) compliance this November. Though a stabilization period has been granted by the FDA, the November 27, 2023 date is still the legal target for the industry.
This extension is pivotal in addressing evolving challenges and further fortifying the integrity of the pharmaceutical supply chain.
Professional services With resources located in regions across the world, Systech’s teams support local and professional implementations of our proven;
Systech showcases solutions to eliminate supply chain risks at Pack Expo Las Vegas 2023 Share: Experience Systech’s complete L1-L5 solution
August 29, 2023 (Princeton, N.J.) – Systech, part of Markem-Imaje and Dover, and a leading provider of digital identification and
In the realm of taxation and revenue collection, governments face numerous challenges in ensuring compliance, minimizing tax evasion, and combating the illicit trade of goods.
Don’t misconstrue that the DSCSA implementation is being delayed—it isn’t.
“If data and product don’t flow seamlessly across the pharma supply chain, massive rework requirements will boomerang back to manufacturers,
As the DSCSA deadline looms, is your data in order? “All stakeholders in the drug supply chain must adopt robust
Worldwide, medical device fraud runs rampant. Steve Tallant examines this growing threat in a recent Viewpoint column featured in Securing
As part of the FDA’s Drug Quality and Security Act, one key rationale for the Drug Supply Security Act (DSCSA) was to protect US patients from receiving counterfeit or illegitimate medications. Everything the industry is doing to connect manufacturers, wholesalers and dispensers to create an interoperable supply chain is all about patient safety.
Careers Established in 1985, Systech is the leader in providing digital identification and traceability solutions. We are an innovative organization
In the rapidly evolving landscape of pharmaceuticals, maintaining regulatory compliance is paramount for pharmacies. The Drug Supply Chain Security Act (DSCSA) aims to enhance patient safety by establishing a secure supply chain for prescription drugs.
Explore Systech Insight™ to access your line data for greater visibility and improved operations.
Systech boosts capabilities of its intelligence platform Share: Systech boosts capabilities of its intelligence platform Systech Insight™ 2.0 enables Systech
The receiving process for totes at pharmacies from wholesalers hasn’t changed much over the past 25 or more years.… Physical packages reconciled to a printed manifest/order. Quantities checked. Verification that nothing is damaged. Inspection to see if anything is already expired. Data entry into a pharmacy inventory system. Even if there are some issues, the medicines get put into stock.
Even if we do get a Drug Supply Chain Security Act (DSCSA) enforcement delay from the FDA, pharmacies are still on the hook for compliance. And compliance means connections.
Systech receives prestigious certifications Share: ISO 9001 achievement highlights Systech’s commitment to quality and operational excellence and NOM compliance enables
“While the DSCSA has already brought numerous positive changes to the supply chain, even a minor hiccup could throw the
Who we are Established in 1985, Systech is the leader in providing digital identification and traceability solutions. Our offerings establish
New Systech Offering Addresses DSCSA Compliance for Dispensers and Pharmacies Share: To date, much less focus has been placed on
August 29-31, 2023 Location | Washington, D.C. Learn More: https://www.hda.org/events/2023-traceability-seminar/sessions/
September 24-26, 2023 Location | Berlin Learn More: https://www.serialization-conference.com/
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Get insights on how to protect the medical product supply chain and ensure patient safety.
Systech shortlisted at the SaaS Awards 2023 Share: International SaaS awards program announces initial shortlist Princeton, NJ – July 5,
Key DSCSA takeaways from PDG’s latest publication: Proactive steps to avoid “misalignment exceptions.”
Counterfeiters and diverters of successful medical products have little regard for consumer safety or governmental oversight. They don’t care about the patient. They only care about money.
Our new online training platform can be the perfect complement to the instructor-led experience.
Get details on Good Manufacturing Practices and how to be compliant with the RDC-658 directive.
Systech Delivers Layered Approach for Medical Product Supply Chain Transparency and Safety Share: Systech’s solutions create and capture product identification
Optimized operations – Systech Insight™ Insight is an intelligence platform that leverages the solutions already implemented on your line to
Digital authentication – UniSecure® UniSecure is a revolutionary product authentication solution that works with existing barcodes and packaging to deliver
Integrated traceability – UniTrace® Systech offers an industry leading, one-vendor, cloud-based software solution that provides the ability to track and
Serialization simplified – UniSeries® UniSeries® is the industry-leading packaging execution and serialization software suite. It is a flexible, fast, proven
Packaging verification and vision inspection In today’s dynamic manufacturing environment, you need your product packaging to be rock-solid reliable. Systech’s
How to combat medical product counterfeiting and optimize distribution efficiency.
Smart factories are helping manufacturers ensure product quality across their supply chains.
DSCSA compliance: What it means for pharmacies and dispensers As the global leader in pharma serialization and product tracing, Systech
Learn how pharma companies can optimize packaging operations and leverage their supply chain data.
We discuss the requirements, challenges and guidance for pharmacies as they prep for compliance.
A webinar recap on how to ensure secure data exchange with trusted entities only.
The services will include compliance testing, a readiness GAP review and master organizational validation. Read the full article here.
Training: Maximize your investment We offer a comprehensive, multi-faceted training program—tailored to your particular knowledge level and goals—to ensure every
Prepare your pharmacy to meet DSCSA requirements by November 27, 2023.
“Greater transparency among trading partners opens the door to better communication, better collaboration, and, ultimately, better decision-making,” writes Victoria Kickham
Assigning a unique product identifier or serial number to packaging of products via printed data matrix or 2D barcode to
Assigning a unique product identifier or serial number to packaging of products via printed data matrix or 2D barcode to
Applying protections to packaging and establishing monitoring programs to combat counterfeit or harmul products from entering the supply chain https://www.youtube.com/watch?v=BnQXPa15K-w
Also known as Tax Stamps, they are physical stamps or marks placed on products, such as cigarettes, alcohol, or pharmaceuticals,
The EUFMD is the European Union Falsified Medicines Directive: It lays out the logical and legal justification for taking union-wide
A type of packaging that uses digital technology to enable interaction between the physical product and the consumerhttps://www.youtube.com/watch?v=rn0f-NfroGI
The process of uniquely identifying products with a serial number, and tracking each product in the supply chain as it
Counterfeit goods pose a significant threat to the health, safety, and well-being of consumers, as well as the global economy
Supply chain traceability is the ability to identify, track and trace products as they moves through the supply chain enabling
Supply chain traceability is the ability to identify, track and trace products as they moves through the supply chain enabling
Good automated manufacturing practice (GAMP) is a set of guidelines for manufacturers and other automation users follow to maintain operational
A corporate program that safeguards brand reputation and consumer trust through IP protection through anti-counterfeit and diversion detection plus online
DSCSA compliance requires that drug manufacturers, dispensers, and distributors (basically all stakeholders in the pharmaceutical supply chain) follow certain federal
Assigning a unique product identifier or serial number to packaging of pharmaceauticals via printed data matrix or 2D barcode to
The process of assigning a unique code to the packaging of each drug and printing this code on the packaging.
The process of assigning “children” to a “parent” to establish a packaging hierarchy and track and trace individual products throughout
The process of assigning “children” to a “parent” to establish a packaging hierarchy and track and trace individual products throughout
A system for DSCSA compliance which seamlessly sends product information back and forth between trading partners to allow for serial
Aggregation is a technique used in conjunction with serialization that establishes and records the relationship between a serialized object and
When an unauthorized party sells a product outside of authorized and/or intended distribution channels, leading to a significant loss of
The EUFMD is the European Union Falsified Medicines Directive: It lays out the logical and legal justification for taking union-wide
What is DCSCA? Drug Supply Chain Security Act: As defined by the FDA, outlines steps to achieve interoperable, electronic tracing
Regulatory driven process of assigning a unique identifier to each drug to enable patient safety through traceability and verification
A corporate program that safeguards brand reputation and consumer trust through IP protection through anti-counterfeit and diversion detection plus online
The process of assigning a unique code to the packaging of each drug and printing this code on the packaging.
Regulatory compliance made easy Complying with legal requirements is critical to doing business, but meeting the mandates isn’t simple. With
Fake products… real risks! Don’t let counterfeiters benefit from your hard fought brand promise and endanger your customers. Systech can
Nutraceuticals: Protecting your products across the supply chain You’ve worked hard to earn customer trust and loyalty. Systech helps keep
Medical devices: Tackling the global supply chain threats of counterfeiting and diversion In the fast-paced world of healthcare, ensuring the
Pharmaceuticals: Delivering value to the industry for 35+ years Systech provides proven inspection, serialization, traceability and authentication solutions. The world’s
What is serialization pharmaceutical packaging? Serialization in pharmaceutical packaging refers to the process of assigning a unique code or serial
Packaging line optimization for improved efficiency and performance Systech offers a productized software suite that quickly gives manufacturers complete control
A digital layer of brand protection for your supply chain You’ve worked hard to earn customer trust and loyalty. Systech
Greater supply chain transparency begins with traceability Manufacturers require greater visibility across the supply chain to achieve objectives in compliance,
Pharmaceutical compliance… We understand what it takes Systech offers powerful serialization and traceability functionality to help you meet global pharmaceutical
Your brand matters. Protect it. Together, our solutions offer the strongest, most cutting-edge brand protection for your products as they
H1 – You brand matters. Protect it. H2 – Together, our solutions offer the strongest, most cutting-edge brand protection for
Contact us Systech is here for you. Let us know how we can help. Request information General information General inquiries:
DSCSA enforcement delay – Read more »Systech joins NABP’s Interoperable Partner Program – Learn more »DSCSA compliance for pharmacies – Learn more
Dealing with data matching exceptions efficiently will be critical to keep the pharma supply chain moving.
How to meet DSCSA requirements and ensure secure data exchange with trusted entities.
Systech addresses updated DSCSA requirements for pharmaceutical supply chain Share: Systech’s unique combination of technology and services ensure its customers
Many major wholesalers are leading the charge for receiving aggregated data—requiring that manufacturers be able to digitally send pallet identifiers with corresponding digital details of all shipments sent to them. Without this data being aggregated, wholesale staff would have to open each pallet and manually scan each serialized product.
Systech completes successful 2022 Share: Furthers pharma industry leadership and delivers value across markets Systech, a leading provider of digital
Company’s have an opportunity to look inward towards self-improvement with a focus on brand protection and supply chain “health”.
Protecting brand integrity is a multifaceted discipline which can be complicated by counterfeiting and diversion, as well as meeting high traceability standards.
In today’s pharma supply chain, optimizing the flow of physical products is no longer enough to ensure product safety, regulatory compliance and supply chain optimization.
Brand protection in the ENDS market is not one singular product, but layers of technology and process.
When the DSCSA was established in 2013, the pharmaceutical industry set a course towards creating a data-driven supply chain.
Systech and Vantage discuss what it takes to be compliant by November 2023, the final DSCSA deadline.
There is a comprehensive data collection and integration reality that is required to get drugs through the supply chain and to the patients who need them.
Systech, the global technology leader in connected brand protection and a Markem-Imaje solutions brand, has partnered with Spherity to offer
Crime has no moral code. If you have a high-demand product, people will likely counterfeit it.
Owning your traceability data is the foundation for future-proof supply chains. The time to start is now…
How to improve operational efficiencies, control costs and more… with information from your packaging systems.
Customers face serious challenges in purchasing authentic and safe products in every marketplace, every day.
When testing sites were established around the globe with unprecedented demand, counterfeiting was quick to follow.
Is a deadline an obligation or an opportunity? That’s something many pharma companies, particularly in the US, are considering as they look ahead to November 27, 2023.
Huge demand plus limited supply creates a perfect environment for counterfeiters.
The frontline of defense against counterfeiting is adding a digital layer of product protection.
Expands portfolio of software solutions serving product identification, traceability, authentication, and consumer engagement applications Markem-Imaje, an operating company of Dover
Your packaging lines have data that can improve operational intelligence and productivity. Learn how to access it…
Learn about a holistic and proactive approach to brand protection from an industry expert.
Your brand image is one of your company’s greatest assets. How well is it really protected?
Serialization alone is not an anti-counterfeiting solution. Layers of protection are needed to secure the pharma supply chain.
Understanding the law, resource requirements, and serialization solution capabilities you’ll need to comply with the EU FMD.
How to protect your PPE products and the people who need them.
Learn how to fast-track your serialization project. There’s a faster path to serialization. Are you on it?
PRINCETON, NJ – (September 15, 2020) Systech, a solutions division of Markem-Imaje, was chosen as one of four winners in
Just because major regulatory deadlines are behind us, serialization isn’t “over” in pharma.
PRINCETON, NJ – (July 9, 2020) Systech International, the software solutions division of Markem-Imaje, today announced the latest release of
The fight to protect brands and products is a never-ending battle. And no time is more serious than now, during
We are finally seeing major progress for vaccines to prevent the spread of COVID-19. With general distribution dates anticipated in
Sao Paulo, Brasil – (April 22, 2020) Systech, a division of Markem-Imaje and the global leader in serialization, track and
In this interview from Global Business Reports, Dave DeJean, SVP Product Management and Strategy at Systech, discusses how existing compliance
PRINCETON, NJ – (April 14, 2020) Systech, the leader in digital brand protection, today announced it is providing a complimentary
PRINCETON, NJ – (April 8, 2020) Systech, the leader in digital brand protection, today announced it is providing their anti-counterfeiting
Princeton, NJ – (January 27, 2020) Systech, the global technology leader in brand protection and digital product authentication, announced today
PRINCETON, NJ – (January 24, 2020) Systech, the leader in digital brand protection, today announced that OZNaturals a leader in
Learn how to protect your supply chain and connect with consumers.
PRINCETON, NJ – (January 7, 2020) Systech International (“Systech”) announced today that it has entered into a definitive agreement to
PRINCETON, NJ – (December 6, 2019) Systech announced today that it has been selected as a finalist in this year’s
PRINCETON, NJ – (November 22, 2019) Systech was chosen as winner in The Abbott Connected Health Challenge during the AIPIA
How going digital creates a trifecta of opportunity–protection, traceability and engagement.
Learn how Boehringer Ingelheim deployed serialization at three sites within six months
Systech replaces a CPOs existing L4 track & trace solution for better cost, scalability & compliance
PRINCETON, NJ – (October 15, 2019) Systech, a global technology leader in digital brand protection and product authentication, today announced
How does a pharma leader prevent drug diversion in high risk markets?
LAS VEGAS, NV – (September 23, 2019) Systech, a global technology leader in digital brand protection and authentication, today announced
PRINCETON, NJ – (September 4, 2019) Systech and San Francisco based Chronicled recently completed a successful end-to-end VRS test with
Learn about a large distiller’s counterfeiting challenges in India.
PRINCETON, NJ – (July 15, 2019) Systech was named as a winner in the Mondelēz Challenge during the AIPIA Summit
PRINCETON, NJ – (July 1, 2019) Systech has been selected as a 2019 recipient of an SDCE 100 Award by
Why serialization compliance alone does not prevent global counterfeiting and diversion.
PRINCETON, NJ – (April 24, 2019) Systech, a global leader in supply chain security and brand protection, along with key
Learn about Takeda’s serialization and aggregation journey.
Princeton, NJ – (March 25, 2019) Systech, global leader in supply chain security and brand protection solutions, has announced a partnership with
Princeton, NJ – (March 21, 2019) Systech, a global leader in supply chain security and brand protection, and NW Solutions
Princeton, NJ – (March 11, 2019) Systech, a global leader in supply chain security and brand protection, and Excellis Health
Princeton, NJ – (March 6, 2019) Systech, a global leader in supply chain security and brand protection, has announced the appointment
Princeton, NJ – (February 20, 2019) Systech, a global technology leader in supply chain security and brand protection, and Foodmach, a leading
End product diversion with comprehensive supply chain insight. Companies lose billions of dollars annually to product diversion. Fight back with
Anti-counterfeiting for supply chains. Counterfeiters are relentless, and brands keep adding layers of protection to stay one step ahead. Achieve
Sharp improves its defenses against counterfeiting with a non-additive authentication solution.
Learn how a global haircare brand protected a new product line from diversion.
Smart packaging offers benefits to each stakeholder in the pharmaceutical supply chain. It can enhance patient compliance/adherence; confirm authenticity; support
Manufacturing Chemist sat down with CEO Ara Ohanian to discuss Systech’s solution to the counterfeiting and diversion problems running rampant
Blockchain technology witnessed an explosive increase in popularity last year in the food industry due to massive, country-wide recalls causing
Drug repackagers face unique challenges, driven by their distinctive position in the pharmaceutical supply chain.
Princeton, NJ – (December 17, 2018) Systech, a global leader in supply chain security and brand protection, today announced the latest
Counterfeit malaria and tuberculosis medicines have killed more than 700,000 people worldwide. The counterfeit drug epidemic costs pharmaceutical companies over
FDA News interviews Steve Tallant of Systech to learn how manufacturers can leverage their investment in serialization to vastly improve product security.
At the CPhI Pharma Awards this year, Systech led its field to claim the award for Excellence in Supply Chain,
Princeton, NJ – (October 10, 2018) Systech, the global leader in supply chain security and product authentication, won in the
Princeton, NJ – (October 9, 2018) Systech, the global leader in supply chain security and product authentication, introduces Systech360™, a
Business Reporter sat down with senior executives at Systech and Toppan to discuss product counterfeiting, diversion, and how smart packaging
When counterfeiters flood the market with fake medicine, it can mean life or death. Learn how serialization fails to keep
Systech UniSecure® recognized for “Excellence in Pharma Supply Chain, Logistics and Distribution”, short-listed at CPhI Pharma Awards PRINCETON, NJ— (September
PRINCETON, NJ – London, UK Systech, a global technology leader in brand protection and product authentication, and FarmaTrust, a leader
PRINCETON, N.J., Systech, a global technology leader in consumer safety, brand protection, and product authentication, along with representatives from leading
October 17-19 | Washington, D.C. Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply
November 19-20 | Amsterdam, Netherlands Brand protection, augmented reality, mobile commerce, supply chain control, smart labels, consumer engagement. Being a
FRANKFURT, Germany – June 13, 2018 – Inno4Life, an innovator in life science equipment solutions and Systech, the pioneer of
A key requirement of every pharmaceutical serialization project: revalidate the packaging line and process during implementation.
Meet EU pharmaceutical regulations with proven FMD compliance solutions Falsified Medicines Directive (FMD) requires that every prescription drug sold in
Are you DSCSA-ready? To protect consumers from prescription drugs that are counterfeit, contaminated, adulterated or otherwise unfit for U.S. distribution,
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Privacy Policy Last Updated: October 28, 2019 SYSTECH INTERNATIONAL PRIVACY POLICY: This Privacy Policy applies to the Personal Data (as
Maintenance Ongoing maintenance is key to keeping software current and operational for its intended purpose. With our maintenance and support
News and Events Linkedin Twitter Youtube Upcoming events DSCSA 2023 stabilization period—what it means for compliance October 3, 2023 –
Professional services With resources located in regions across the world, Systech’s teams support local and professional implementations of our proven;
Along our journey from a promising tech start-up in 1985 to where we are today—the global leader in serialization, track
Technical Support Designed to address any technical request as fast and efficiently possible our team of experts is available whenever
Systech International Announces Ara Ohanian as CEO The company positions for robust growth PRINCETON, New Jersey – March 20, 2018
Six tasks that you can do right now to jump-start your serialization process.
Systech International Expands Brand Protection, Track and Trace Solutions to Meet Global Demand and Opens New Training Center Facility Princeton,
Companies today are looking at “connecting” their products and packaging to the data-driven world.
Systech Europe™ Announces Rapid Expansion of Customer Base and Pharmaceutical Serialisation Partners Ready to Meet the FMD Regulation Brussels, Belgium
Systech International announces record third quarter performance. Robert DeJean to retire as CEO Princeton, NJ – (December 7, 2017) Systech International,
Systech International and NKP Pharma Expand Presence in India to Deliver Pharmaceutical Serialization and Traceability Solutions Princeton, NJ – (November
Princeton, NJ – (October 27, 2017) Systech International (Systech), a global technology leader in brand protection, authentication and product safety today
Systech International and Toppan Printing Co., Ltd. Partner to Deliver Brand Protection Solutions through Systech UniSecure™ Princeton, NJ – (October 9,
Systech International and Inno4Life Launch Faster, Fully-Integrated Pharmaceutical Serialization Solution to help meet the European Falsified Medicines Directive (FMD) PRINCETON,
Systech International Showcases Innovative Serialization and Authentication Solutions at Institute of Packaging Professionals (IOPP) – Puerto Rico Chapter Conference Pharmaceutical
Systech Publishes Comprehensive Resources Guide to DSCSA Industry Leader Combines Tools and Information for Rapid Compliance PRINCETON, NJ – (June
Systech Expands Operations to Shanghai, China Local Presence Supports Company’s Industry-Leading Authentication Solution PRINCETON, NJ and SHANGHAI, CHINA – (June
Systech To Feature Brand Protection Expert at June 6 Webcast Branding Authority Mark Davison Speaks on Digital Technology to Protect
Systech International Readies EU Pharmaceutical Companies for FMD Regulatory Deadlines Global Leader in Serialisation Provides Best Practices and Practical Solutions Brussels,
Systech International Global Serialization and Traceability Solutions Featured at Interpack 2017 in Düsseldorf, Germany Systech Showcased at Partner Booths with
When implementing serialization, drug manufacturers and contract packagers need to be mindful of the complete costs.
Systech Serialization, Traceability and Authentication Solutions Featured at LogiPharma Global Supply Chain Conference Full Suite of Technology Solutions Showcased in
Systech Anti-Counterfeiting Technology Solution Protects Brand Integrity and Consumers Allows Brand Owners to Gain Visibility Throughout the Supply Chain via
Systech Participates in Exclusive Seminar Series Organized by U.S. Consulates in India Topics Include Risk Mitigation in the Indian Pharmaceutical
Discussion to include additional measures for brand protection that can be taken through global inspectors, overt and covert packaging modifications,
Systech and INVIXO Consulting Group to Partner on Delivery of Serialization and Track & Trace Solutions to Pharmaceutical Industry in
Originally appeared in Pharmabiz.com Systech International, a global leader in serialization, traceability, and brand protection, will exclusively participate in a
Systech Sponsors Annual Pharma Packaging and Labeling Expo Innovative Solutions Help Brand Owners Verify Product Authenticity and Fight Counterfeiting PRINCETON,
Systech International, a global leader in product verification and brand protection, is pleased to announce its participation at the Arab
Systech Announces 90-Day Rapid Compliance Program for Pharmaceutical Companies Enables U.S. Pharmaceutical Companies that Distribute Prescription Drugs Within the U.S.
Systech International, a global leader in serialization and brand protection technologies, organised ‘UNIQUITY India conference’ – one day global conference
Framework discussion on domestic drug anti-counterfeiting plan Mumbai, India & Princeton, NJ – India’s Joint Secretary, Ministry of Health &
Originally Published In Pharma Tech Although they receive less press than illegal drug trafficking, pharmaceutical diversion and counterfeiting remain huge,
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