Falsified Medicine Directive 1 of 5- What makes rfxcel different?

Falsified Medicine Directive: What makes rfxcel different?

What are the serialization and compliance needs in Europe and how can rfxcel help with Falsified Medicine Directive?

There is a huge need globally for serialization and associated services, particularly for Pharmaceutical companies in Europe. There are several thousands of Pharmaceutical companies in Europe that have to get ready for a tight deadline on February 9, 2019. This deadline is right around the corner and Pharmaceutical companies need professional service providers that will get this job done right and on time.

People in the industry, recognize rfxcel as one of those companies that can get that job done. Pharmaceutical companies need, reliability, dependability and technical excellence to get them ready for their obligations. The Falsified Medicines Directive (FMD), it is different than the Drug Supply Chain Security Act (DSCSA) and it contains a number of wrinkles, bits and pieces, data requirements that people need to get ready for. Pharmaceutical companies need to have a system that can cope with a spectrum of requirements.

 

If a US Manufacturer with a built-in serialization compliance formatted with US DQSA, is it also set to go in in the European Market?

Europe is different in the sense that the overlying data architecture is similar, it is a GS1 based data framework that his being used so global trade out serial numbers, lot numbers, expiry etc. However, the big differences in the FMD are in which the data is captured. In the US it is transaction by transaction and it builds up over time. In Europe, with some exceptions, the manufacturers upload the data when they create serial numbers and the pharmacist verifies that number is true and they dispense the product. The in-between supply chain is not universally checked as it is in the US. In some case it is checked but every transaction like in the United States.

The second major difference; in Europe manufacturers have to make their products tamper evident. The Drugs Supply Chain Security Act (DSCSA) is silent on the physical packaging. However, in Europe the box has to be sealed and ensure it stays closed.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil  for over 13 years. Glenn focuses on building a company with industry leaders and experts  including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years experience bringing solutions to the Pharmaceutical industry.