MHRA UK Restricted Medicines Export List: Compliance & Licence Suspension

• The MHRA maintains a regularly updated list of medicines that cannot be exported or hoarded from the UK to ensure patient supply.
• Breaching this list constitutes a contravention of a wholesale dealer licence and regulation 43(2) of the Human Medicines Regulations 2012.
• Such non-compliance can lead to regulatory action by the MHRA, including immediate suspension of the wholesale dealer licence.
• The list is dynamic, with frequent additions and removals of various pharmaceutical products.
• Separate guidance exists regarding the export of branded medicines to the EEA as of January 1, 2021, related to intellectual property rights and parallel trade.

Any act of hoarding or exporting a medicine featured on the restricted list constitutes a direct breach of regulation 43(2) of the Human Medicines Regulations 2012.

The Medicines and Healthcare products Regulatory Agency (MHRA) maintains a critical list of medicines that are prohibited from export or hoarding within the United Kingdom. This MHRA UK restricted medicines export list is designed to safeguard the availability of essential pharmaceutical products for patients across the UK. The government has also issued comprehensive guidance detailing these restrictions on both export and hoarding activities.

This vital document is subject to regular revisions to reflect changing supply needs and patient requirements, underscoring the dynamic nature of medicine supply chain management in the UK.

Non-compliance with these prohibitions carries significant legal ramifications for wholesale dealers. Any act of hoarding or exporting a medicine featured on the restricted list constitutes a direct breach of regulation 43(2) of the Human Medicines Regulations 2012. Furthermore, such actions are considered a contravention of the wholesale dealer licence itself.

The Medicines and Healthcare products Regulatory Agency (MHRA) is empowered to take robust regulatory action in response to such breaches, which can include the immediate suspension of the wholesale dealer licence. In October 2019, a specific communication was dispatched to all holders of wholesale dealer licences, underscoring the importance of adhering to UK parallel export restrictions medicines and the potential for wholesale dealer licence suspension UK.

The fluidity of the MHRA's restricted list necessitates continuous monitoring by pharmaceutical stakeholders. Recent updates illustrate this dynamic nature, with various products being added or removed based on ongoing supply assessments. For instance, drugs such as Raltitrexed, Ramipril, Cyclophosphamide, Rivastigmine, Dinoprostone, Co-codamol, Aspirin, Ifosfamide, and Baloxavir have been added to the list, often encompassing all strengths and pharmaceutical forms.

Conversely, several medicines have been removed, including Glucagon, Terbutaline, Cefalexin, Clarithromycin, insulin isophane human, Pyrazinamide, Sitagliptin, Atracurium, Cisatracurium, Diazepam, Erythromycin, Folinic acid, Human corticotrophin releasing hormone, Iodixanol, Iohexol, Peginterferon alfa-2a, and Potassium Chloride. These frequent changes highlight the ongoing efforts to manage UK medicine hoarding regulations and ensure patient access, making regular consultation of the MHRA's guidance imperative.

Beyond the specific restricted list, broader considerations for parallel trade also impact pharmaceutical exports from the UK. Since January 1, 2021, the ability to export branded medicines originally placed on the UK market to countries within the European Economic Area (EEA) may be curtailed. This particular restriction is linked to guidance concerning the exhaustion of intellectual property rights and parallel trade.

Wholesale dealers and compliance officers must therefore consult not only the MHRA UK restricted medicines export list but also relevant guidance on intellectual property and parallel trade to ensure full adherence to all regulatory requirements and mitigate the risk of a Human Medicines Regulations 2012 breach. For specific inquiries regarding these complex restrictions, an official email contact is provided at restrictedmedicines@dhsc.gov.uk, offering a direct channel for clarification on Medicines and Healthcare products Regulatory Agency guidance.

Lawyers and compliance officers advising pharmaceutical wholesalers or parallel traders in the UK must regularly consult this MHRA list to ensure client adherence to export and hoarding restrictions, thereby mitigating the risk of regulatory action and potential licence suspension under the Human Medicines Regulations 2012.

Source: Original reporting via GOV.UK