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 2014 fees for inspections will continue to be charged at a daily rate as follows: 

Type of inspection
Daily 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
2,655 
 
 
Office based risk assessments (see notes below)

1,863

GDP (wholesale dealers including homeopathic wholesalers):
Full day rate
1,936
Reduced rate (see notes below)

 941

Office based risk assessments (see notes below)

1,354

Please also see the following fees pages:

Fees for inspections for blood banks and blood establishments

Fees for inspections for brokers

Fees for registration of active pharmaceutical ingredients manufacturers, importers and distributors

Notes:

  • There is a minimum fee of one 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, travelling time, reporting of inspections and resolving issues. 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 15% or £35,000 of total turnover ONLY where an inspector spends less than 3.5 hours on site.
  • For inspections where two (or more) fully qualified inspectors undertake the inspection, the time on site for fees purposes will be the aggregated time for both inspectors.
  • All accredited inspectors attending an inspection will be charged for, but inspectors in training will not. The status of the inspectors should be made clear to the company at the start of the inspection.
  • The office based inspection risk assessment fee will be charged where a risk assessment is conducted which does not lead to an inspection.


Page last modified: 09 April 2014