Help, we’ve been counterfeited !
We hope your products remain safe, or at least that you have proactive brand protection and a strategy for when things go wrong. Unfortunately, experience tells us that some of you are “winging it”.
Just because you haven’t found fakes yet doesn’t mean they aren’t there. It is much safer (for patients as well as your career) to plan for the possibility of counterfeiting than to do nothing and react only if and when it happens.
Ignorance is no excuse
The “do nothing” strategy is about to get even more dangerous, as regulators’ reporting expectations increase. Hidden deep in the EU Falsified Medicines Directive (Article 18, actually) is the phrase:
“Where a manufacturer has reason to believe that the … product may not be authentic [he] shall immediately inform the relevant competent authorities”
In the US Drug Supply Chain Security Act there are several requirements to file reports on suspect products within one business day – whether the trigger is a request from authorities or an incident identified by the stakeholder.
Don’t use Excel and duct tape
Collating, approving and filing something so business critical within 24 hours is a demanding task. It requires a software system, not crossed fingers and a spreadsheet. Serialisation software won’t solve this problem either, because those systems are designed to handle numbers, not case reports and the other disparate elements of counterfeit surveillance and incident management. If you believe your “suspect product reporting” process is not fit for purpose, we can help. Our Knowledge Capture™ software was developed by our technology partner Integritie and optimised for pharma with our help. It provides litigation-grade tools to support your brand protection function. You may not have a large team but you can have a wide reach with Knowledge Capture. Contact us today to arrange a demonstration.
Tags: consultancy, European Union, serialization, software, USA