The Drug Supply Chain Security Act (DSCSA) contains a series of escalating mandates for companies in the pharmaceutical supply chain. Each deadline falls on the anniversary date of the law’s adoption on November 27, 2013. For 2019, one of the new requirements is for wholesale distributors to begin verifying saleable returns using the Standardized Numerical Identifier (SNI) before they can redistribute them.
***For an UPDATE to the deadlines below please see this new post on Russian Deadlines***
The deadlines for the pharma labeling system (cryptographic serialization and tracing system) MDLP, in the Russian Federation are fast approaching. Companies marketing drugs in the Russia Federation targeting seven named nosologies must register with CRPT, the governments service provider, by July 8, 2019. Then on October 1, 2019, packages of drugs targeting those seven named nosologies...
This the second and last part of the Serialization and Beyond webinar wrap-up. You can find the first part here.
There used to be a time when one could discern a fake cosmetic product from an authentic one by just examining the package. Certain external characteristics—or flaws—like a misspelled word or a flimsy material would give it away. Now, printing and imaging technology has evolved and become so inexpensive that counterfeiters can easily obtain it to create packaging that fools even the savviest consumer. Third-party sellers online like Amazon, Jet.com and other smaller e-retailers have made it...
On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...
Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.
No country is immune from the ravages of drug addiction, abuse and overdose. Last month, news broke of the rising number of deaths in Northern Ireland and the entire UK in general due to counterfeit Xanax which is indicative of this global epidemic. It doesn’t matter if a drug is legalized, prescription-only or not even for sale in a country. If there is a demand for it, it will be available by some channel. No software company, Systech included, is going to stop counterfeiters from...
In partnership with SafeProof.
Bootlegging alcohol didn’t get left behind in the Prohibition Era. In fact, according to a 2014 report by the World Health Organization, unregulated alcohol makes up 25% of all consumption worldwide. But what are the implications of fake alcohol? Why should everyone from consumers to manufacturers to government entities care? Let’s take a look at the facts.
First, allow me to set the stage with some facts:
First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings to...
