Dear Sir or Madam,

Please could you forward me(or direct me)too any publications that
are relevant to the above authorities assessment for OTC
applications regarding current POM for Obesity. I noticed that
Orlistat (a current POM in UK) is available as an OTC in the states
and want to know if there has been consultation or application for
a similar arrangement in UK.

Yours faithfully,

Ajay Mann

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:
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 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

Dear Ajay Mann,

Thank you for your recent enquiry to the MHRA. The product called
'Orlistat' is licensed by the European Medicines Agency (EMEA), and we
advise you contact them. Please note 'Orlistat' is mentioned in the
Press Release "European Medicines Agency recommend first switch from
Prescription-only to non-prescription for a centrally authorised
medicine" under the section Latest Press Releases at the following link
below:

www.emea.europa.eu

EMEA
7 Westferry Circus
Canary Wharf
London
E14 4HB

Tel: 020 7418 8400

[email address]

Please contact us again if you need further assistance with this, or any
other queries.

Kind Regards,

Peter
On behalf of the Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

show quoted sections

Dear MHRA Information Centre,

Has the MHRA evaluated this as a potential OTC therapy already, and
if so what was the outcome of the evaluation process? If the MHRA
have yet to evaluate this as an OTC therapy would they be bound to
a decision by the European commission or EMEA approval?

Yours sincerely,

Ajay Mann

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:
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 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

Our Ref: FOI 08/382

Dear Ajay Mann,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 29th October 2008.

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 Ajay Mann

Thank you for your Freedom of Information Act (FOIA) request of 29
October 2008. This has been passed to me as FOIA Coordinator for
Vigilance and Risk Management of Medicines Division.

The MHRA as the UK competent authority has been involved in the
assessment of Orlistat in accordance with the usual regulatory procedure
for a centralised product.

As this is a centralised product, the UK will be bound by any decision
taken by the European Commission based on the Committee on Human
Medicinal Products (CHMP's) opinion.

When a final European decision has been made the outcome will be
published in an E-PAR (European Public Assessment Report) on the EMEA
website.

Yours sincerely

Stephen Fawbert

Information for Public Health Group
Vigilance and Risk Management of Medicines (VRMM)
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 2788

www.yellowcard.gov.uk

www.mhra.gov.uk

show quoted sections