Seamless Windsor Framework Compliance with Navitas Life Sciences

Ensuring Compliance with the Windsor Framework

The Windsor Framework is now implemented, transforming the regulatory landscape for pharmaceutical companies operating in the UK. While the framework simplifies processes by enabling a UK-wide licensing system under the Medicines and Healthcare products Regulatory Agency (MHRA), companies that have not yet aligned with the new requirements must act swiftly to maintain market access.

Navitas Life Sciences provides expert guidance to sponsors navigating these regulatory changes, ensuring seamless compliance and uninterrupted operations.

Key Aspects of the Windsor Framework

1. UK Wide Licensing: The MHRA now licenses all medicines for human use across the UK, eliminating the need for separate authorizations for Northern Ireland. This simplifies the regulatory process but requires sponsors to transition from previous EU-aligned procedures.

2. Pharmacovigilance Compliance: Companies must ensure adherence to the updated UK pharmacovigilance framework, including compliance with the Human Medicines Regulation 2012 (as amended). This includes reporting adverse drug reactions and maintaining risk management plans in alignment with MHRA requirements.

3. Labelling and Packaging Updates: The Windsor Framework mandates new labelling requirements, including “UK Only” identifiers on products. Companies must ensure that all packaging aligns with these standards to remain compliant.

4. Parallel Import License Adjustments: Parallel import licenses (PLPIs) now apply across the UK rather than just Great Britain. Products must comply with UK-specific labelling and safety requirements, and Falsified Medicines Directive (FMD) rules no longer apply in Northern Ireland.

Challenges for Non-Compliant Sponsors

For companies that have yet to align with the Windsor Framework, non compliance could lead to regulatory action, including the cancellation of existing licenses and restrictions on market access. Sponsors must urgently address key areas such as:

• Transitioning from previous EU regulatory pathways to MHRA processes
• Updating marketing authorizations and withdrawing duplicate licenses
• Implementing new pharmacovigilance reporting mechanisms
• Revising labelling and packaging strategies

How Navitas Life Sciences Can Help in The Windsor Framework Compliance

Navitas Life Sciences provides tailored regulatory solutions to help sponsors achieve compliance with the Windsor Framework.

Our expertise includes:

• Regulatory Strategy Support : Our experts help pharmaceutical companies transition to the MHRA’s UK-wide regulatory framework, ensuring all licensing requirements are met efficiently.
• Pharmacovigilance & Safety Compliance : We assist in aligning pharmacovigilance operations with UK requirements, including adverse event reporting, risk management plans, and ongoing regulatory compliance.
• Labelling & Packaging Compliance : Our team ensures that all medicinal products meet new labelling and packaging standards, preventing potential regulatory disruptions.
• Regulatory Submissions : With strong expertise in regulatory submissions, we support clients in updating marketing authorizations, managing withdrawals, and ensuring timely communication with the MHRA.

Act Now to Maintain Market Access

If your company is not yet fully compliant with the Windsor Framework, immediate action is required to prevent disruptions in the UK market. Navitas Life Sciences offers comprehensive regulatory support to help sponsors navigate these changes effectively.

Contact us today to ensure full compliance and secure your product’s place in the evolving UK pharmaceutical landscape.

Article

The Windsor Framework: Insights on the regulatory shift for medicines

The Windsor Framework has resulted in critical regulatory changes, particularly in labeling, packaging, and market authorization. Get a comprehensive analysis of the framework’s impact and strategic insights.

Read Now

Authors

Mallikaarjunan R

SVP - Regulatory Services and Technology

Raghunandan Reddy

Lead – Labeling, Regulatory Services

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