Export and hoarding of restricted medicines

AI Summary

This guidance from the UK Department of Health and Social Care (DHSC) and the MHRA outlines restrictions for wholesale dealers regarding the export and hoarding of medicines. To ensure UK patients have access to critical treatments, the government prohibits exporting or withholding medicines that are in short supply or at risk of shortage. The regulatory framework is governed by the Human Medicines Regulations 2012, specifically Regulation 43(2), which mandates that wholesalers must prioritize the UK market. Violations, such as unauthorized exporting or hoarding of restricted products, can result in the immediate suspension of a wholesale dealer’s license or the imposition of restrictions on export activities. Repeated non-compliance is considered a criminal offense. Wholesalers are required to regularly check the official restricted medicines list before conducting trade. Certain exemptions apply, such as for marketing authorization holders, clinical trials, and supplies for the armed forces or humanitarian aid. Companies must ensure their stock management processes do not lead to hoarding, while the DHSC commits to reviewing and updating the restricted list to remain transparent and proportionate. This measure is a response to supply chain pressures to safeguard public health.