Clinical trials for medicines: labelling

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines mandatory labelling requirements for Investigational Medicinal Products (IMPs) and Non-Investigational Medicinal Products (NIMPs). Effective as of April 28, 2026, the guidance supports the Medicines for Human Use (Clinical Trials) Regulations 2004 and its 2025 amendments. The framework ensures that all trial-related medications are clearly identified and safely handled to maintain regulatory compliance and participant safety. Key issues addressed include the necessity of specific labelling for unauthorised products, which must include the phrase 'for clinical trial use only,' child-safety warnings, and comprehensive contact details for sponsors and investigators. For blinded trials, the guidance highlights the importance of consistent label appearance to prevent accidental disclosure of treatment assignments. Specialized rules are also provided for small primary containers, decentralised manufacturing, and products authorised within the UK, EU, or ICH regions. Required actions for sponsors include submitting detailed descriptions of label content during the initial trial application. While standard pharmacy labelling may suffice for certain authorised products, any deviations or modifications require explicit approval. Furthermore, any significant changes to label text during an active trial must be processed as a 'Route A' substantial modification. Sponsors and investigators are ultimately responsible for ensuring that all delegated labelling activities adhere to Good Manufacturing Practice (GMP) principles to avoid compliance violations.