Supply unlicensed medicinal products (specials)

AI Summary

This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) establishes the framework for the manufacture, importation, and supply of unlicensed medicinal products, categorized as 'specials.' This framework includes Cannabis-Based Products for Medicinal use (CBPMs), which are specifically prepared to meet the individual clinical needs of patients when licensed alternatives are unavailable. While this document is general guidance rather than a report on a specific company inspection or violation, it outlines strict compliance standards for all entities involved in the supply chain. The regulatory framework requires that specials be ordered only by authorized healthcare professionals, such as doctors, dentists, and independent prescribers. For CBPMs specifically, procurement is limited to doctors on the GMC Specialist Register and organizations holding specific Home Office and MHRA licenses. Required actions for suppliers include verifying the credentials of the prescriber and ensuring all necessary domestic and import licenses are active. Licensed wholesale dealers and registered pharmacies must maintain rigorous documentation to demonstrate that these high-risk products are handled according to law. Failure to follow these procurement pathways risks legal action and jeopardizes patient safety by bypassing essential quality controls designed for unlicensed medications. Organizations must ensure their internal protocols align with these MHRA standards to remain compliant with UK medicinal law.