What pharmaceutical wholesalers need to know about The Windsor Framework in 2025

pharmacy

Big changes are coming for pharmaceutical wholesalers in 2025, is your business prepared? 

The Windsor Framework, taking full effect in January 2025, will overhaul trade rules between Great Britain and Northern Ireland. To help pharmaceutical businesses prepare, the UK government recently released the Windsor Framework Pharmaceutical Wholesaler Guide

While the framework simplifies some Northern Ireland Protocol issues, it also adds layers of complexity, particularly for the pharmaceutical sector. For wholesalers, understanding these changes is crucial to staying compliant and competitive.

What the Windsor Framework means for medicines

The Windsor Framework reshapes how medicines are regulated, giving the Medicines and Healthcare products Regulatory Agency (MHRA) authority over licensing medicines across the UK, including Northern Ireland. This replaces the old system where EU marketing authorisations applied in Northern Ireland.

Here’s the key change: medicines are now divided into two categories.

  1. Category 1 Medicines: These cover products previously under the EU’s centralised authorisation procedure. From January 2025, they’ll shift to UK national licenses, regulated by the MHRA under UK law.
  2. Category 2 Medicines: These products, outside Category 1, will still follow certain EU rules, particularly for safety reporting. This includes periodic safety updates (PSURs) and post-authorisation safety studies (PASS).

While this system ensures compliance, it also creates challenges for wholesalers managing diverse product lines.

Challenges and complexities

Pharmaceutical wholesalers face hurdles as they adapt to the Windsor Framework. Key challenges include:

  • Two regulatory systems: Products may fall under both UK and EU rules, adding administrative strain.
  • New labelling rules: From January 2025, medicines must carry “UK Only” labels to prevent unintended movement from Northern Ireland to the EU. Existing stock can remain unchanged until expiry, but new packs need updated labels.
  • Regulatory divergence: Future changes between UK and EU rules remain unpredictable, increasing compliance uncertainty.

Flexibilities for transition

To ease the shift, the government has introduced several flexibilities for pharmaceutical businesses:

  • Early labelling: Products marked “UK Only” can hit the Great Britain market before January 2025, giving companies extra time to adjust.
  • Simplified updates: Businesses can use regulatory shortcuts, self-certification, and new processes that delay some requirements by 12 months.
  • Repacking options: Labelling updates can be done at UK-approved repacking sites, avoiding the need to return products to the original manufacturing location.

How pharmaceutical wholesalers can prepare

Preparation is everything. Here’s how wholesalers can stay ahead:

  1. Audit your portfolio: Identify which products fall into Category 1 or 2 and understand their regulatory needs.
  2. Upgrade labelling processes: Ensure your systems can handle the new “UK Only” labelling requirements.
  3. Collaborate with stakeholders: Work closely with suppliers, trade groups, and regulators to address challenges early.
  4. Leverage resources: Use MHRA guidance and industry support to streamline compliance efforts.

Partnering with Orderwise for a smoother transition

At Orderwise, we’re here to make the Windsor Framework transition as seamless as possible. Our integrated warehousing solutions help you manage inventory, update labelling, and track compliance with ease.

We’ve already updated our systems to align with the new rules. Whether you’re handling Category 1 or 2 medicines, our tools are designed to save time, reduce complexity, and keep your operations running smoothly.

Ready for the Windsor Framework?

The Windsor Framework is more than a regulatory hurdle. It’s a chance to refine operations and gain a competitive edge. Looking to learn more? Get in touch to find out how we can support your business through these changes and beyond.