Please note: Where a half fee is applicable, the sum will always need to be rounded up, e.g. if the fee is £599, then the half fee is £300. From 1 April 2023 fees for inspections will continue to be charged at a daily rate as follows:
Type of inspectionDaily rate £ All GMP, GCP and Pharmacovigilance inspections including (this is not an exhaustive list): intermediate biological sites, manufacturers of active pharmaceutical ingredients (API), sterile, non-sterile and assembly sites, non-routine inspections, pharmacovigilance inspection, clinical trials, contract laboratories, homeopathic manufacturers£3,651 Office based evaluation and risk assessments (see notes below)£2,562 GDP (wholesale dealers including homeopathic wholesalers)  Full day rate£2,662 Reduced rate (see notes below)£1,331 Office based risk assessments (see notes below)  Notes:
There is a minimum fee of 1 day (with the exception of the GDP inspections).
The inspection daily rate is calculated against a standard 7 hour working day (excluding lunch breaks). Therefore the number of days spent on site for fees purposes will be calculated by dividing the number of hours on site by 7. Additional part days of less than 3.5 hours will be charged at half the daily rate and part days in excess of 3.5 hours will be charged at the full daily rate.
The daily rate fee includes pre-inspection preparation, reporting of inspections, resolving issues and may include travel time. It also incorporates activities such as evaluation of compliance assessment report and other support functions and directly related overheads.
A reduced rate fee for a wholesale dealer inspection will be payable by wholesale dealers who handle GSL products only and for registered retail pharmacies and small wholesale dealers where wholesaling of licensed products does not exceed £35,000 of total turnover only where an inspector spends less than 3.5 hours on site.
The MHRA Inspectorate charge a daily fee for each accredited inspector that conducts the inspection. If an inspector is undergoing accreditation and is only qualified to perform specific aspects of the inspection, a partial fee will be charged.
The office based inspection evaluation and risk assessment fee will be charged where a risk assessment of documentation not involving an inspection of a site is conducted which is in connection with the monitoring of GMP, GDP, GCP or GPvP. It can also be used in conjunction with or instead of an on-site inspection as notified to the site prior to the start of the inspection.