Medicines that you cannot export from the UK or hoard
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Latest change: Updated to add: Cyclophosphamide (strength: 1g/2g/500mg; pharmaceutical form: powder for solution for injection vials).
AI Summary
The Medicines and Healthcare products Regulatory Agency (MHRA) provides clear guidelines regarding the prohibition of exporting or hoarding specific medicines within the United Kingdom. This policy is designed to ensure a consistent supply of essential treatments for domestic patients and applies to all entities holding a wholesale dealer licence. The regulatory framework governing these restrictions is primarily Regulation 43(2) of the Human Medicines Regulations 2012. Compliance with these rules is a mandatory condition for maintaining a licence. Since January 1, 2021, additional restrictions have impacted the export of branded medicines to the European Economic Area (EEA) due to changes in intellectual property exhaustion and parallel trade agreements. The main violations identified include the unauthorized parallel export of restricted drugs and the hoarding of supplies. Such actions are considered serious breaches of licensing conditions. The MHRA warns that contravening these regulations may result in immediate regulatory intervention, including the suspension of the organization's wholesale dealer licence. To remain compliant, wholesalers are required to regularly monitor the updated restricted medicines list and ensure their trading practices align with legal standards. For clarification on specific restrictions, dealers must contact the Department of Health and Social Care (DHSC) via the provided official channels.
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