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ESP - GS1 Pharma Serialisation Industry Readiness Survey Report

ESP GS1 Pharma Serialisation Readiness ReportA report on the 2016 ESP - GS1 Ireland survey on industry readiness for pharmaceutical serialisation.

Download your copy of the full report here.

Key findings:

  • The majority of respondents (81%) believe that they will meet their regulatory deadlines.
  • Both the EU and US seem to be following the pattern of adoption of more mature Asian markets.
  • 60% of respondents believe it takes between 6 to 12 months to serialise a line, with 27% believing that it takes under 6 months.
  • The GS1 & ESP Serialisation Readiness survey showed that most respondents had up to 10 lines within Ireland, but had between 50 and 100 lines globally.
  • 68% of respondents will be using GS1 standards when storing and exchanging serialisation data.
  • Approximately a third of respondents plan to aggregate on all sites (32%), in excess of regulatory requirements.
  • A variety of GS1 standards are being used in the process of serialisation, showing how GS1 standards can bring even more value when used together.
  • Information gathering about regulation changes has been highlighted as an issue for manufacturers.
  • Changes in global regulations is ranked as one of the most critical resource issues, along with having insufficient time for the scale of the project, and competing projects and priorities.
  • Approaches to serialisation appear to be multi-disciplinary, with serialisation teams drawn from across their respective organisations.
  • The majority of respondents (72%) see value beyond compliance, including stock management, data analysis, supply chain visibility, and anti-counterfeiting. High cost and lack of resources were noted as hurdles in realising that value.

Download your copy of the full report here.

ESP GS1 LogosFor further information and updates

To keep up to date on serialisation matters and regulatory changes follow ESP on Twitter @ESPNewsandJobs and subscribe to the GS1 Ireland Healthcare Newsletter, selecting serialisation as your topic of interest.

You are also invited to contact the two main contributors to this report:

Liam O'Riordan, Serialisation Director and Senior Consultant, Enterprise System Partners (ESP)

GS1 Ireland Healthcare Team

Thank you

Liam O'Brien ESPProducing this Serialisation Industry Readiness Report was an incredible opportunity to communicate directly with those affected most by serialisation in the industry – the manufacturers, wholesalers, solution providers and consultants. We were enthused by the response to the survey – reflecting the high priority serialisation is being given at corporate level now that deadlines are rapidly approaching. It was interesting to note in particular that while 58% of respondents are well underway in their serialisation implementation, the most pressing concern surrounds the potential for further regulatory changes as well as insufficient time based on current deadlines. ESP are delighted to present these findings to you.

Liam O’Brien, Managing Director, Enterprise System Partners

Siobhain Duggan GS1 IrelandI want to thank everyone who took part in our Serialisation Industry Readiness Survey. GS1 standards play an important role in the solutions being utilised by pharmaceutical manufacturers to meet the requirements of the Falsified Medicines Directive (FMD), and other regulatory requirements from across the globe.

Siobhain Duggan, Director of Innovation & Healthcare, GS1 Ireland

Survey Background

This survey was carried out by GS1 Ireland & ESP in conjunction with a joint webinar on global serialisation regulations in May 2016. The aim of the survey was to measure the readiness for serialisation amongst respondents’ companies. This report presents the sumary fndings of that survey.



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