Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
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。
May 18, 2025
Approximately 5 minutes
UK Distance Selling Logo Registration for Online Medicine Sellers
Registering for the Distance Selling Logo in the UK
1. Overview of Distance Selling Logo Requirements
The Distance Selling Logo is a regulatory identifier intended to help members of the public recognise legitimate online sellers of medicines operating in Northern Ireland. Sellers based in Northern Ireland who offer medicines to the public via a website must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and display the logo on every web page offering medicines for sale.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
The logo requirement stems from EU-based rules that continue to apply in Northern Ireland under the Northern Ireland Protocol. Sellers must comply with these obligations even after 1 January 2021, when Great Britain ceased requiring use of the EU common logo for online medicine sales.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
2. When You Must Use the Logo
If you are based in Northern Ireland and sell or supply medicines online to the public in Northern Ireland or in an EEA country, you must:
- Register with the MHRA on the Process Licensing Portal.
- Display the Distance Selling Logo on every page of your website that offers medicines for sale.
- Provide MHRA contact details and a link to the MHRA website on your pages.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
This requirement applies even if you sell through third-party marketplaces; the logo must appear where the medicines are offered for sale.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
3. Registration Process
To register for the Distance Selling Logo:
- Register your company and any relevant websites via the MHRA Process Licensing Portal.
- Only one registration is required per company, though multiple websites can be covered.
- The MHRA will conduct checks and, once approved, send confirmation with a link to download the Distance Selling Logo for use.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
Processing of new applications in Great Britain (England, Wales and Scotland) has ceased, and the MHRA is considering alternatives for Great Britain in the future, though this does not affect requirements that remain in Northern Ireland.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
4. Fees and Updates
Application fees and payment details for Distance Selling Logo registration are provided by the MHRA as part of the process. After registration, any changes to your company details or website should be reported to the MHRA via the Process Licensing Portal.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
If you suspect a website is selling medicines illegally, you can report it to the MHRA for investigation.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
5. Selling Medicines from the UK via the Internet
For sellers in Northern Ireland, you must ensure that all products sold online (including to EEA countries) are authorised for use in the destination country. Packaging and labelling requirements in the product authorisation must be complied with, and sellers must use licensed sources for medicines.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
Conclusion
The Distance Selling Logo aims to enhance public assurance and safety by identifying legitimate online medicine retailers in Northern Ireland. Sellers must register, display the logo correctly, and maintain compliance with MHRA and cross-border sale requirements.
Source: Register for the Distance Selling logo (gov.uk) (gov.uk)
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