Serialisation Readiness Survey shows companies focus on compliance as deadline draws closerAug 22, 2017,
by Kevin O'Brien & Liam O'Riordan - Category: Pharma Serialisation
Preliminary results from GS1/ESP Serialisation Industry Readiness Survey
In less than 18 months, the EU FMD serialisation deadline will be upon us. Those manufacturers supplying the EU market will have to adhere to the stringent serialisation requirements or face exclusion from the market. As manufacturers grapple with the implementation of serialisation they are faced with not only challenges but with many opportunities. GS1 Ireland and Enterprise System Partners (ESP) have teamed up once again to create an industry benchmark to highlight these issues as part of our partnership to share industry knowledge and promote best practice. The result was our Serialisation Industry Readiness Survey, which returned in 2017 for its second year.
The survey was conducted earlier this summer by GS1 Ireland and ESP. Respondents were drawn from a pool of over 3,000 industry stakeholders in the serialisation process including manufacturers, virtual pharma companies, CMOs, wholesale distributor repackagers and third party logistics (3PLs). These respondents represented a variety of companies, from small scale to large, and from across the globe.
There was an enthusiastic response to the survey, which allowed us to get a snapshot of how the industry is positioned over a year before the legislation comes into force. We believe that the resulting report will serve as a weather-vane to the industry in this critically important area.
The initial evaluation of the data has shown some interesting results.
More than half of companies surveyed are including aggregation capability as part of their EU strategy despite the fact that it is not explicitly required by the legislation. This is consistent with the findings of our 2016 survey.
One in every five companies surveyed are resource constrained in terms of their serialisation implementation. This tallies with general concerns in the industry regarding the ongoing shortage of experienced and trained personnel.
One notable change between the 2016 and 2017 surveys is the number of respondents who said their implementation is purely focused on compliance. This figure has risen significantly from 28% to 53% of respondents. Liam O'Riordan, Director of Serialisation at ESP, posits that with the 2019 deadline fast approaching, the increase is indicative of companies exerting far more focus on the even more imminent and pressing objective of regulatory compliance.
If you would like to read the finished report, you can register your interest by clicking here. We will email you the 2017 report once it has been finalised. The 2016 report can be accessed by clicking here.Tags: Serialisation, EU FMD, GS1 ESP Serialisation Industry Readiness Report 2017,