Today’s blog will help you navigate registrations for Active Pharmaceutical Ingredients (API), sometimes referred to as the ‘Drug Substance’. If you manufacture, import or distribute API(s) and you are based in the UK you must register with the Medicines and Healthcare Products Regulatory Agency (MHRA).
A flow chart is available to help you decide which registration you require: flowchart on the registration requirements.
Note: This includes virtual operations where no physical handling of the API takes place.
The application process and timeline
- Apply using the MHRA Process Licencing Portal
- New Applications take 60 working days to process, excluding time taken to provide further information or data required
- If an inspection is needed it will take 90 days
Once registered, manufacturers, importers and distributors of APIs must complete an annual compliance report which is due every year on 30th April. The report should be submitted to MHRA using the MHRA Process Licencing Portal.
What are the fees?
Active substance manufacturers:
- New application £5,006 (Additional fee if an inspection is required £792)
Active substance importers and distributors:
- New application £3157 (Additional fee if an inspection is required £582)
There are also fees for updates (variations) to the approved details and assessment of the annual compliance report.
Fusion Pharma can apply on your behalf through our approved access to the MHRA’s Process Licensing Portal. If you would like to discuss how Fusion Pharma can support you, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.