The Windsor Framework, effective from 1 January 2025, introduces substantial changes to the regulation, packaging, and labelling of medicinal products across the UK. These changes aim to ensure consistency, transparency, and trust in the UK’s pharmaceutical supply chain, with the notable requirement for 'UK Only' labelling on licensed medicines to prevent unauthorised distribution within the EU or European Economic Area (EEA). However, for unlicensed medicinal products, commonly known as "specials", there has been ambiguity regarding their compliance requirements under this framework.
Seeking Clarity on ‘Specials’ and the Windsor Framework
In light of the uncertainty surrounding whether the Windsor Framework applies to specials, we contacted the Medicines and Healthcare products Regulatory Agency (MHRA) to seek clarification. The query aimed to determine whether unlicensed medicines would need to adhere to the 'UK Only' labelling requirements and where relevant guidance could be found.
The MHRA’s response confirmed that the Windsor Framework’s labelling requirements do not apply to specials, which explains the lack of specific guidance addressing them. This clarification reassures stakeholders in the specials market that they are not subject to the same labelling mandates as licensed products under the new framework.
MHRA Guidance for Labelling Cannabis-Based Products for Medicinal Use (CBPMs)
Although the Windsor Framework does not extend to specials, the MHRA provided detailed advice on the labelling of Cannabis-Based Products for Medicinal Use (CBPMs), which are a subset of unlicensed medicines. This guidance highlights essential labelling elements to ensure clarity and compliance:
Product Name, Strength, Pharmaceutical Form, and Pack Size
These must be prominently displayed in the same font and size for easy identification.
Naming Conventions
Fanciful or branded names are prohibited, as these products are classified as medicines.
Simplistic Design
Labels should remain unbranded and professional, avoiding unnecessary design elements.
Company Logo
If included, the logo should be small and unobtrusive.
Prominence of Product Description
The product’s name, strength, and pharmaceutical form should dominate the label design.
Accurate THC/CBD Content
Exact amounts of THC and CBD must be specified; approximations are not allowed.
Cultivar Names
These may be included in small font within the ingredient list.
Batch Number and Expiry Date
Both must be clearly displayed for safety and traceability.
Compliance with British Pharmacopoeia Monograph
The label must adhere to standards set out in the British Pharmacopoeia for unlicensed medicines.
Positioning of Label Elements
For optimal clarity, refer to the QRD Annotated Template and the MHRA’s Best Practice Guide on Labelling Medicines.
Practical Implications for Stakeholders
The MHRA’s guidance highlights the need for high labelling standards even for unlicensed medicines. Businesses involved in the manufacture, importation, or distribution of specials should focus on:
- Ensuring clear, professional labelling that prioritises essential product information.
- Avoiding branding and promotional elements on labels.
- Maintaining compliance with British Pharmacopoeia standards and MHRA’s best practices.
While the Windsor Framework simplifies and harmonises regulations for licensed medicines, the bespoke requirements for specials demand meticulous attention to detail. Stakeholders must ensure their products meet the MHRA’s expectations to avoid regulatory issues and guarantee patient safety.
The Windsor Framework marks a pivotal step in enhancing the UK’s medicinal product regulations, providing clarity and uniformity for licensed medicines. Although its labelling requirements do not extend to specials, the MHRA’s detailed guidance on unlicensed medicines ensures that these critical products adhere to the same high standards of safety and professionalism. For businesses navigating these changes, proactive compliance will foster trust and uphold the integrity of the UK’s healthcare system.
Published: 8th January 2025
