MHRA Issues Guidance on Patient Information Leaflets

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance addressing the standards that apply to patient information leaflets — the printed documents routinely included with medicinal products.

Legal Framework

According to the MHRA, the guidance outlines the regulatory requirements governing these leaflets, drawing on both EU-derived legislation and domestic national law. The document is intended to support those involved in producing or reviewing patient-facing medicine documentation, providing clarity on the obligations that apply in this area.

Information Design Principles

Beyond the legal framework, the guidance also addresses best practice in information design. This reflects a broader recognition that the structure and presentation of written materials can affect how readily patients are able to understand the content of a leaflet — a consideration that sits alongside strict regulatory compliance.

The full guidance is available via the MHRA's official publication page.