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Registrar Corp
維吉尼亞州漢普頓 (總部), 中國深圳, 英國倫敦, 法國巴黎, 西班牙馬德里, 印度海得拉巴, 馬來西亞吉隆坡, 以色列特拉維夫, 瓜地馬拉瓜地馬拉市, 南非開普敦
000 家企業處理 FDA 註冊、美國代理人要求、標籤合規及扣留協助等事務。我們提供包含 FDA 合規監控器 (Compliance Monitor) 和不良事件管理軟體在內的技術解決方案,協助食品、飲料、醫療器材、藥品和化妝品行業的企業應對複雜的法規環境。
MedEnvoy Global
荷蘭海牙, 英國倫敦, 美國, 瑞士, 澳洲
一家全球法規合規合作夥伴,專注於為醫療器材和 IVD 製造商提供在地代表(EC Rep、UKRP、CH Rep、美國代理人)和獨立進口商服務。我們協助企業應對歐洲、英國、瑞士和美國的複雜法規,同時保持供應鏈的靈活性。
KoBridge Co Ltd
韓國首爾, 瑞士洛桑
我們為需要應對日益複雜的全球法規的醫療器材製造商提供快速、有效和靈活的解決方案。他們的核心能力涵蓋 CE 標誌、FDA 510(k)/PMA、MDSAP,尤其是韓國 MFDS 註冊和 KGMP 合規性。他們處理主動、非主動、組合和動物源性設備,提供從策略規劃和文件準備到品質系統實施 (ISO 13485) 和稽核的服務。
IMed Consultancy Ltd
英國, 愛爾蘭
幫助醫療器械和體外診斷公司進行 CE 標記、品質管理系統、審計和全球註冊。
January 15, 2026
Approximately 5 minutes
UK Controls on Parallel Export and Hoarding of Restricted Medicines
UK Controls on Parallel Export and Hoarding of Restricted Medicines
Overview of the Policy
The UK government has introduced restrictions on the export and hoarding of certain medicines that have been placed on the UK market and where there is evidence the medicine is in critical shortage or at risk of critical shortage. This measure aims to prevent worsening medicine shortages and ensure that medicines are available to meet the needs of UK patients.
Source: Parallel export and hoarding of restricted medicines (gov.uk)
“Hoarding” refers to a situation in which wholesale dealers withhold a medicine from supply when it is in short supply, which could jeopardise access for patients.
Source: Parallel export and hoarding … (gov.uk)
Export and Hoarding Restrictions
Under the guidance, wholesalers and licence holders may be prohibited from exporting or hoarding medicines on the restricted medicines list. This list is reviewed and updated regularly, and it is the responsibility of the trader to check it prior to export.
Source: Parallel export and hoarding … (gov.uk)
Restrictions apply to exports both within and outside the European Economic Area (EEA) for products that have been placed on the UK market for UK patients.
Source: Parallel export and hoarding … (gov.uk)
Decision Criteria for Restrictions
The Department of Health and Social Care (DHSC) regularly reviews which medicines should be subject to export restrictions. A medicine may be restricted if it meets all of the following conditions:
- The medicine is required to meet the needs of UK patients.
- The medicine is currently in critical shortage or at risk of critical shortage.
- Exporting that medicine would worsen or contribute to the shortage in the UK.
Source: Parallel export and hoarding … (gov.uk)
The UK has committed to removing medicines from the restricted list when they no longer meet the criteria, in line with its obligations under the World Trade Organisation (WTO).
Source: Parallel export and hoarding … (gov.uk)
Examples and Updates
As of late 2025, the restricted medicines list contains a variety of products such as Atomoxetine, Baloxavir, Cefalexin, and others that cannot be exported or hoarded due to ongoing supply concerns. The list is updated periodically to reflect the current market situation and supply risks.
Source: List of medicines that cannot be exported … (gov.uk)
Export Limitations for Branded Medicines
Since 1 January 2021, branded medicines placed on the UK market may no longer be exported to countries in the EEA where such exports could negatively impact UK supply. Traders should also be mindful of guidance on the exhaustion of intellectual property rights and parallel trade.
Source: Medicines that you cannot export or hoard (gov.uk)
Regulatory Consequences
Attempting to export or hoard a restricted medicine may be considered a breach of the Human Medicines Regulations 2012 (regulation 43(2)) and a contravention of a wholesale dealer licence. Regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA) could include suspension of the wholesale dealer licence.
Source: Medicines that you cannot export … (gov.uk)
Importance for UK Supply Chains
These restrictions form part of the UK’s broader strategy to maintain medicine availability and supply chain resilience. Limiting exports and hoarding in times of strain helps protect public health by ensuring that critical medicines remain available domestically rather than being diverted elsewhere.
Source: Parallel export and hoarding … (gov.uk)
Conclusion
The UK’s controls on parallel export and hoarding of restricted medicines are designed to safeguard the supply of essential medicines for UK patients, especially during periods of shortage. By enforcing export limits, maintaining an up-to-date restricted list, and ensuring compliance with regulatory obligations, the UK targets balanced and transparent management of medicine supplies.
Source: Parallel export and hoarding of restricted medicines (gov.uk)
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