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Falsified Medicine Directive 2 of 5 – Will the EU Falsified Medicine Directive deadlines be delayed?

Falsified Medicine Directive deadlines are putting pressure on the industry. How to get over the EMVO hurdles and how the member states get over those hurdles?

Big system changes are challenging, especially during the beginning stages. The EMVO is doing a great job of getting their side of the framework. It ultimately comes  down to solution providers like rfxcel and others to help the manufacturer’s do their piece of the bargain. This process is not going to be easy, but it needs to happen for patient safety. The underlying theme of the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA) is patient safety. The end result will enable drug companies keep their product safe by tracing it. All of it is possible. It is just a matter of allocating the right resources and people who will prioritize the effort.

 

The  US has delayed enforcement for a year for DSCSA how does this impact the FMD?

One can never rule out that a delay or postponement will come because it is always possible. However, experts are not convinced there would be an enforcement delay. A deadline is a deadline. Management needs to take action regardless of there being a delay or not.

The reason there is a delay in the US is that Pharmaceutical companies had a difficulty getting the job done in the time available. This indicates to all of the EU that they should not underestimate the difficulty of the project. The real problem here is serialization isn’t just a manufacturing challenge. It is not printing numbers on bottles. It is a business change program across the whole corporation, and supply chain. When companies implement serialization all departments need to get involved in the project. They have to do a lot of work and a lot of internal coordination to get it done.

 

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.