Are You Ready for the New Windsor Framework Regulations?

Are You Ready for the New Windsor Framework Regulations?

BY: BOB TILLING / DATE: 16/05/2024 / TOPICS: DISPOSITIFS MÉDICAUX, PHARMACEUTIQUE, LABEL DESIGN

In the wake of Brexit, the regulations on medicinal products are undergoing significant changes. It is crucial for companies involved in the manufacturing and distribution of these products to the UK to keep well-informed in order to ensure compliance and avoid potentially expensive recalls and penalties.

When it comes to the pharmaceutical and medical device industries, compliance can be life or death for patients using the products. And with regulations changing constantly at the moment, it’s important to be using a labeling and artwork management system that’s futureproof and can easily make mass changes with minimal stress and hassle.

The recent announcement of the new labeling and packaging requirements under the Windsor Framework Agreement means organizations will now have to make mass changes to their product packaging in order to stay compliant. To help you understand these regulations and their implications, we've compiled a comprehensive guide. 

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Here's a brief overview of the guide, 2024 Windsor Framework Regulations & Labeling: What You Need to Know.

Part 1: Understanding the New Windsor Framework Regulations, Who They’ll Affect, and What Steps to Take

The Windsor Framework, born out of post-Brexit negotiations between the UK and EU, mandates labeling changes for goods intended for sale in Northern Ireland and Great Britain. Notably, from January 1, 2025, all UK medicinal products must bear a "UK Only" label, impacting various stakeholders, including pharmaceutical companies and retailers. Failure to comply could lead to goods being halted at the border, causing significant delays and potential financial penalties.

Part 2: How End-to-End Labeling and Artwork Management Software Can Help

In the face of these regulatory changes, leveraging modern technology becomes imperative. Enter Veraciti™, an innovative software solution offered by Kallik, designed to streamline labeling and artwork management processes. Through features like Where Used and Automated Artwork Generation, Veraciti™ empowers companies to make mass changes efficiently while ensuring compliance and accuracy. Additionally, Veraciti™'s label templates and Cascade feature significantly reduce errors and streamline the approval process, ultimately enhancing speed-to-market and reducing costs.

Stay Informed, Stay Compliant, and Stay Ahead

With the deadline for compliance looming, proactive action is essential. By understanding the Windsor Framework Regulations and leveraging tools like Veraciti™, companies can navigate these changes with confidence. Ensuring compliance not only mitigates risks but also safeguards consumer safety and maintains market competitiveness. Don't wait until it's too late. Take steps now to adapt and thrive in this evolving regulatory landscape.

To delve deeper into these topics, download the full guide. To learn more about Veraciti™ and how it can benefit your organization, request a demo.

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TEKLYNX is Kallik's strategic integration partner of choice to help power Veraciti™ labeling and artwork management solution. TEKLYNX and Kallik present unparalleled expertise in offering a cloud-based solution for end-to-end labeling and artwork management in highly regulated industries, including pharmaceutical and medical device.