Unique Device Identification (UDI)
Complying with the US Food and Drug Administration (US FDA)
The Delegated Regulation (EU2016/161) from the European Parliament and Council supplements the Falsified Medicines Directive (FMD) and introduced two mandatory safety features that will allow medicines to be verified and authenticated.
Marketing authorisation holders are required to place safety features on the packaging of all medicines which fall within the remit of this regulation by 9 February 2019.
Whether you’re a pharmaceutical manufacturer, distributer, or pharmacy, there are significant benefits to your business in uniquely identifying product information, and then capturing and sharing this along its pathway – and eventually to the patient.
These benefits go beyond simply meeting regulatory compliance with the Falsified Medicines Directive. There are the benefits and cost savings in operational efficiencies and – ultimately – patient safety. Think about being able to automatically validate expiry dates. Or even track and locate safety recalls right down to the individual batch number and which patient it has been given to.
We can offer you the support and guidance you need in order to meet new regulations and achieve so many more benefits. Find out the benefits GS1 UK can bring to your business.
We offer regular free webinars that explain the background to healthcare regulations and how GS1 standards ensure you comply.
Whether it’s classroom training or one-on-one help for your business, our training provides greater understanding on how you use GS1 standards to identify devices and pharmaceuticals, encode the correct production information, follow barcode best practice and manage your data to ensure compliance with new rules.
We offer one day classroom sessions and bespoke on-site delivery.
Complying with the US Food and Drug Administration (US FDA)
We have developed a range of services to help you implement our standards
See how GS1 standards are delivering benefits in the UK and globally