GLP/GMP

Dear Enquirer,

Thank you for your enquiry to the Information Centre at the MHRA.

Please accept this automated response as acknowledgement that your
enquiry has been received and will be dealt with as quickly as
possible.

Your enquiry will be dealt with as follows; straightforward requests
should expect a reply within a few days, those requiring a more detailed
response or contribution from a specialist are likely to take longer.
We endeavour to provide a response to all enquiries as quickly as
possible, and within the Department of Health's target response time of
20 working days. For further information about the service and
timeframes provided by the CEP, please view the information published at
the 'Contact Us' section of our website at the following link:

[1]http://www.mhra.gov.uk/Contactus/index.htm

If you have not heard from us after that time then please contact us on
020 7084 2000.

Kind regards

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
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This email and any files transmitted with it are confidential. If you are
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If you are not the intended recipient, please notify the sender
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Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

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1. http://www.mhra.gov.uk/Contactus/index.htm

Our Ref: FOI 09/293

Dear Mr Casey,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 3rd August 2009.

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.

Yours Sincerely

Central Enquiry Point
Information Centre
MHRA
Market Towers
London SW8 5NQ

Tel: +44 (0)207084 2000
FAX: +44 (0)207084 2353

show quoted sections

Dear Enquirer,

Thank you for your enquiry to the Information Centre at the MHRA.

Please accept this automated response as acknowledgement that your
enquiry has been received and will be dealt with as quickly as
possible.

Your enquiry will be dealt with as follows; straightforward requests
should expect a reply within a few days, those requiring a more detailed
response or contribution from a specialist are likely to take longer.
We endeavour to provide a response to all enquiries as quickly as
possible, and within the Department of Health's target response time of
20 working days. For further information about the service and
timeframes provided by the CEP, please view the information published at
the 'Contact Us' section of our website at the following link:

[1]http://www.mhra.gov.uk/Contactus/index.htm

If you have not heard from us after that time then please contact us on
020 7084 2000.

If you have any urgent enquiries during our closed periods, please
contact the Department of Health on 020 7210 3000.

Kind regards

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/index.htm

Dear Kieran Casey,

REF: FOI 09/293

Apologies for the delay with our response.

Please find enclosed the relevant information that you requested under the
Freedom of Information Act.

GLP

1. There are currently 117 test facilities within the UK GLP
Compliance Monitoring Programme

2. These facilities are inspected at intervals determined by a risk
assessment process, usually every 12 or 24 months.

3. Since January 2008 one facility was deemed to be out of compliance
and was removed from the Compliance Programme. Two new applicants failed
to meet the GLP requirements and were refused admission to the Compliance
Programme.

GMP

1. We have 865 sites on the GMP UK plan

2. These facilities are inspected at intervals determined by
a risk assessment process - up to 30 months

3. As this information is not readily available it would be
necessary to locate and consider a large number of detailed inspection
reports to compile such a comprehensive list of the information requested.
The resource required to complete this work will exceed the

relevant limit in the FOIA of £600, calculated at £25 per
hour and would in fact be in excess of 24 hours. I do not consider, in
this case, that there is an overriding public interest in undertaking this
work.

If you have a query about this letter, please do not hesitate to contact
us at [MHRA request email]

If you are unhappy with our decision, you may ask for it to be reviewed.
That review will be undertaken by a senior member of the Agency who has
not previously been involved in your request. If you wish to peruse that
option please write to the Communications Directorate, 10th Floor,
Medicines and Healthcare products Regulatory Agency, at the above address
quoting the above reference.

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

The 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 withholding information from you.

Yours Sincerely

Central Enquiry Point
Information Centre
MHRA
Market Towers
London SW8 5NQ

Tel: +44 (0)207 084 2000
Fax: +44 (0)207 084 2353

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Information Centre

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/CrownCopyright/in...
2. mailto:[MHRA request email]