What is the Windsor Framework?
The label and packaging requirements for medicinal products intended for human use are changing. The Windsor Framework, a post-Brexit legal agreement between the European Union (EU) and the United Kingdom (UK), came into effect in late 2023. This framework addresses goods crossing the Irish Sea from Great Britain to Northern Ireland, aiming to reduce checks and paperwork on goods, including agreements on medicine control, VAT, and alcohol duty.
Key Changes Under the Windsor Framework
For the distribution of medicines for human consumption, the agreement ensures that medicines can be approved and licensed through the UK by the MHRA. It exempts certain medicines used in Northern Ireland from the EU Falsified Medicines Directive requirements, ensuring they are not distributed within the Republic of Ireland or any other EU country.
When does the Windsor Framework Take Effect?
Starting January 1, 2025, all UK-approved medicines, whether prescription, OTC, or general listing, must have a ‘UK Only’ label positioned on the outer packaging in an easily visible location. This label should not be hidden, obscured, or interrupted by any other information or images. The font must be 7 points or larger and proportionate to the pack size. All labels must meet current MHRA expectations and best practice guidance. The physical ‘UK Only’ label can be used for six months, up to June 2025. After this date, ‘UK Only’ must be printed directly onto the outer packaging.
Why Choose OPM Group for Windsor Framework Compliance?
OPM (Labels & Packaging) Group has extensive experience in producing high-quality labels and flexible packaging for the healthcare and pharmaceutical sectors. We are fully certified to ISO 9001:2015, PS 9000:2016, and BRC Grade AA+, adhering to GMP guidelines.
Our Leeds-based secure site features a Fully Controlled Print and Finishing Environment called Envirozone, where air quality, temperature, and humidity are regulated. We have strict procedures for cleaning and maintenance and monitor microbiological activity.
OPM Group offers peace of mind for your medical print needs. All our printed solutions are fully traceable, from raw material to finished product. We utilise the latest technology, with AVT equipment on all our presses providing 100% inline inspection to check print quality on every job. We are a low ink migration site and have developed automated workflows to ensure control from origination to final production.
Functional Print Solutions by OPM Group
OPM Group provides functional print solutions suitable for all medical applications, including:
- Tamper Evident Security Labels and Seals: Protect patients with visible proof of authenticity and evidence of tampering, ideal for outer packaging.
- Extended Content Labels: Ask our team about MultiDex, our innovative peel & read solution that provides indexed information.
- Stand Up Pouches, Stick Packs & Sachets: Available with or without zippers, perfect for powdered medicines.
- Lidding Film: Our medical-grade lidding film has the correct barrier properties to protect your products.
- Reclosure Labels: Our patented TLC reclosure system, specially developed for the wet wipe market, features an easy-to-use hinged design that creates a hermetic seal to retain moisture.
- Braille: Ensure your labels are accessible with our tactile print.
