The Oakley ERP Blog

Is the Pharmaceutical industry ready for the new FMD and GS1 regulations?
Wednesday March 15, 2017

The new NHS Procurement Strategy mandates the use of GS1 standards and states that every supplier of every pharmaceutical product (and all other products and services that supply goods to the NHS) must comply.

What is GS1?

GS1 is an international not-for-profit organisation (previously known as European Article Numbering-Uniform Code Council). GS1 created a standardisation barcoding system that is increasingly being used across the globe. This standardising enables a product (in this case pharmaceuticals) to be identified throughout the entire supply chain including full product details and national numbers.

Does every pharma company need to comply?

There will be some UK companies that will only have to comply with one or two of the new regulations, however, others will need to comply with them all. For those supplying pharmaceuticals into the US there is an additional law called the Drug Quality and Security Act (DQSA) that is road mapped to be fully integrated in the next eight years.

How does this regulation differ from what pharma companies currently do?

In Europe, the current system tracks the point of entry and the point of exit, this strategy does not trace individual items through each stage of the supply chain – Only at the point of packaging and production (entry) and the point of dispensing (exit). The new GS1 regulations will bring Europe more in line with the US style Pedigree system (this system provides a complete chain of custody record, known as ‘pedigree’ for each product in the healthcare supply chain).

This change does come with challenges, for many pharma companies this change will require planning and preparation to ensure these new regulations are met. Lack of time, specialist skills and knowledge can be the biggest barrier towards compliance, not having the right software in place to manage the vast amounts of data and tracking process for each product is likely to cause delays and possible problems if, and when an audit is undertaken.

Oakley ERP understand the new GS1 regulations and can offer pharma companies an ERP Software solution that meets their needs. With Sage 300, products can be tracked throughout the entire supply chain using the GS1 coding system and ensure compliance across the board.

Talk to us today to find out more about how Oakley ERP can support you through the changes to regulations before the 2018 deadline.

Written by Oakley ERP at 14:10