Regarding the Windsor Framework’s Packaging and Labelling Requirements, as of January 1st, 2025, all PLUK licensed medicines must bear the ‘UK only’ label on their packaging.
Recently, I had the privilege of attending a client meeting with their stakeholders. While I appreciate their diligent focus on implementing this change to comply with regulations and expedite product release, there’s more to the story.
Allow me to refrain from singing my own praises, but I must say they were fortunate to have me at that meeting. Why, you ask? Well, it’s because I posed the following thought-provoking questions:
- Have you assessed the impact on the export market?
- How many licenses do you hold outside the EU that rely on UK licenses?
- How many international markets receive your UK-packaged products?
- Are customers in those countries comfortable receiving packaging that reads ‘UK only’?
- Should you transition from UK packaging for exports, how will it affect production?
- Will this necessitate the creation of a new SKU?
- What is the projected cost of this change?
- How do you plan to manage potential write-offs?
- What’s your cost-effective regulatory strategy to implement these changes with minimal disruptions to the supply chain?
- Who is spearheading this change as the project manager?
- How will you garner support from other stakeholders?
- What’s your strategy for handling data management?
- Who within the company will serve as the sponsor, supporting the project manager and wielding influence when necessary?
Now, not everyone has someone as inquisitive as me in their meetings, but fear not—these questions are now at your disposal. I urge you to consider the broader impact before rushing into compliance without fully assessing how it will affect your business.
Here’s a little secret for you: we revamped our client’s entire regulatory strategy to implement this change, saving them a tidy sum of nearly £300K. It was easy to add ‘UK only’ to their mock-ups and get regulatory approval, and it caused minimal disruptions to their export operations.
If you’re keen on saving costs and ensuring a smooth journey for your UK and international business, I strongly encourage you to book a 1-to-1 call with me.
“Accelerated Regulatory Action Call.”
Best regards,
Aziz