Poll: Most Companies Have Started EU FMD Compliance Preparations
Whether or not you were among the pharmaceutical representatives to attend our recent European Union Falsified Medicines Directive (FMD) webinar, you have probably begun thinking about your company’s state of readiness for the EU requirements. Results from our webinar polls reveal that most respondents already have a compliance strategy underway.
Our poll results show a strong commitment by companies to meet the EU FMD compliance deadline of February 9, 2019, and awareness that addressing the extensive requirements will take significant up-front time and effort. Respondent feedback suggests that a holistic and early approach is considered paramount to successful implementation.
Here are some key findings:
1. Companies are addressing EU readiness now
Most webinar respondents (78 percent) report that they are actively in the process of researching, building, and deploying their compliance solution. In fact, one-quarter of the companies whose planning
Businesses in the minority—those just starting to learn about FMD regulation (22 percent)—are at risk of falling behind their peers.
Only 16 percent are planning to wait to deploy until 2018.
2. Four out of 5 will deploy by next year
The fact that 84 percent of respondents say they expect to deploy a solution by 2017 suggests that they realize that serialization preparations are complex, and the sooner they have a solution in place, the better positioned they will be to address issues in a timely manner.
3. Companies perceive scalability as the biggest challenge
Respondents believe that finding a solution that can handle the scope of serialization management will have the greatest impact on readiness, with one-third anticipating that their biggest challenge will come from building a flexible and scalable infrastructure.
Another third reported that master data, compliance reporting, or meeting other global regulations were their company’s biggest challenges.
If you are still getting oriented around the EU requirements, watch our on-demand webinar, “Preparing for European Serialization: An Analysis of the EU Falsified Medicines Directive,” to understand:
EU FMD and Delegated Acts
EU Track and Trace Summary and Transaction Model
Serialization and Compliance Reporting Details
Parallel Importer Requirements
Verification Requirements and Other Considerations for Compliance
TraceLink End-to-End Solutions for EU Compliance