FOI release

Freedom of Information request on income related to EMA and PLPI applications (FOI 21/1161)

Published 26 May 2022

FOI 21/1161

10th November 2021

Dear,

Thank you for your email.

With regards to your questions please find attached a spreadsheet with this information, we have additionally provided some information for each of your enquiries below

  • We have provided income related to EMA however we are unable to provide income related to services to other European regulatory institutes as this is not recorded separately.
  • We have provided income for PLPI applications and PLPI variations on the spreadsheet but we do not distinguish inspection income according to PLPI categories and we also do not have the split of PLPI service fee income received in the years. We have put the total income relating to these areas on the spreadsheet.
  • We have broken down the PLPI costs into staff and other costs. Please note accommodation and IT costs are not included as these are held centrally and are not charged to the unit.

If you have a query about the information provided, please reply to this email

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU