Testing of Labelling on Homeopathy Products

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
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Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency

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Dear Matt Jones,

Thank you for your recent enquiry to the MHRA.

Patient information leaflets for homeopathic products authorised under
the National Rules Scheme are subject to the same user testing
requirements that are applied to leaflets for products granted full
marketing authorisations, to ensure that the information provided is
legible, clear and easy to use. Applicants for homeopathic National
Rules authorisations are required to submit a user test which is
assessed to ascertain all aspects of the user test have been addressed
and that the success criteria, which is 90% of participants can locate
the information, of which 90% understand the information, has been met.

Details and results of specific user tests submitted may be supplied
following a Freedom of Information request (link below):
http://www.mhra.gov.uk/Aboutus/Freedomof...
edomofinformation/index.htm

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

Kind Regards,

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

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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.

Please Note:
The CEP will be closed on Thursday 24th, Friday 25th and Monday 28th
December and also on Friday 1st January.
We will be open for business on all other days.

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