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。
August 15, 2025
Approximately 5 minutes
Medicines: Register to Manufacture, Import or Distribute Active Substances in the UK
Medicines: Register to Manufacture, Import or Distribute Active Substances in the UK
Overview
Active substances (often called active pharmaceutical ingredients – APIs) are the components that give medicinal products their therapeutic effect. If you manufacture, import or distribute active substances and your activities are based in the UK, you must register with the Medicines and Healthcare products Regulatory Agency (MHRA). You can complete this registration via the MHRA Process Licensing (PCL) Portal.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
You must also comply with good manufacturing and distribution practice (GMDP) when undertaking these activities.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
The Registration Process
- Submit an application via the MHRA PCL Portal for registration as a manufacturer, importer or distributor.
- New applications are normally processed within 60 working days, excluding time taken to request additional information.
- Variations that do not require an inspection take about 30 working days to process.
- If an inspection is required, the MHRA will arrange a site visit before issuing the registration document.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
Change Your Registration
You must notify the MHRA via the MHRA PCL Portal if the details in your original registration change (for example, changes to your site information or activities). Some changes may require a new inspection and fees.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
Annual Compliance Reports
Registered active substance manufacturers, importers and distributors must complete an annual compliance report. This report is due every year by 30 April and should be submitted via the MHRA PCL Portal.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
Terminate Your Registration
To terminate your registration, you should complete the Termination Form provided on the MHRA guidance page and email it to pcl@mhra.gov.uk. There is no fee for termination, but to avoid paying the next annual fee, the request must be made before 31 December of the preceding year.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
Fees and Payment
The fee payable for registration varies depending on the number of sites included in your application. Detailed fees are available in the MHRA fee schedule linked from the guidance page.
Source: Medicines: register to manufacture, import or distribute active substances - GOV.UK
Have a Question?
Ask our experts about this topic. We'll do our best to respond to your question.