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IT budget and systems

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Dear Medicines and Healthcare products Regulatory Agency,

Can you please give me an indication of your current IT budget and which IT systems you use to support and manage inspections? Also can you please confirm the number of inspectors and the number of inspections a year?

Yours faithfully,

Monika Wisniewska

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 17/113

Dear Ms Monika Wisniewska,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 16 March 2017.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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IE&SFOI, Medicines and Healthcare Products Regulatory Agency

Dear Monika,

Many thanks for your below request, submitted under the Freedom of Information (FOI) Act

From our preliminary assessment, it is clear that we will not be able to answer your request without further clarification. Please can you clarify what you mean by please confirm the number of inspectors and the number of inspections a year?
Once you have clarified your request, we will be able to process this request.

Yours sincerely

I,E&S Foi team

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Dear IE&SFOI,

I understand that you are an inspectorate, hence my question about your mobile workforce of inspectors visiting sites and conducting inspections?

Yours sincerely,

Monika

IE&SFOI, Medicines and Healthcare Products Regulatory Agency

Dear Monika,

Thank you for your email.

We would be grateful if you could clarify which types of inspectors and inspections you are interested in, for example, GMP, GDP, PV, GCP or all.

Kind regards,

I,E&S Foi team

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Dear IE&SFOI,

Can you please provide me with number of all inspections on average per year and inspectors who conduct them?

Yours sincerely,

Monika

IE&SFOI, Medicines and Healthcare Products Regulatory Agency

12th April 2017

Monika Wisniewska

[1][FOI #395507 email]

 

Dear Monika Wisniewska

 

REF:  FOI 17/113

 

Thank you for your communication to the MHRA in relation to our
inspections. Below is the answer to your questions,

 

1) Can you please give me an indication of your current IT budget and
which IT systems you use to support and manage inspections?

 

Our IT budget is around £30 million in total. We do not divide this by
function.  We use Sentinel and Empirica Inspections to support and manage
inspections

 

2) Can you please confirm the number of inspectors and the number of
inspections a year?

 

Our inspectors numbers are as follows:

 

GMP:  25

GDP:   19

GPvP:   8

GCP:     7

GLP:      8

 

 

 

The request for the number of inspections a year is exempt under Section
21 of the Freedom of Information Act (FOIA), because the information is
accessible to you, as it is already in the public domain.  The number of
inspections carried out annually can be found at  [2]www.gov.uk under the
Publications section (Publication type:  Corporate reports - Department:
Medicines and Healthcare products Regulatory Agency) link as below.

 

[3]https://www.gov.uk/government/publicatio...

 

If you have a query about this letter, please do not hesitate to contact
me at [4]IE&[email address]

 

If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date of receipt of the response to your
original letter and should be addressed to: Communications Directorate,
Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace
Road, London, SW1W 9SZ. Please remember to quote the reference number
above in any future communications.

 

After that, if you remain dissatisfied, you may write to the Information
Commissioner at;

 

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

 

Yours sincerely,

 

I,E&S

 

MHRA

Inspection, Enforcement and Standards

 

cc         Policy Manager

 

 

 

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