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<p>The drug Lanosterol is not licensed for human use in the United Kingdom.</p><p>
</p><p>The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible
for the licensing of medicinal products according to legislation set out in European
Directive 2001/83 EC. The MHRA's primary aim is the protection of public health, for
which an important objective is assessing the safety, quality and efficacy of medicines,
and authorising their sale or supply in the UK for human use.</p><p> </p><p>A medicine
can only become licenced if an application is made to the MHRA for a licence, usually
by the manufacturer, demonstrating that the product meets the required standards of
safety, quality and efficacy. In their role as a regulator, the MHRA is not in a position
to hold product licences or to solicit for new product licence applications.</p><p>
</p><p>There has been no evidence submitted to MHRA to support the use of Lanosterol
in humans at present. There have been no applications for UK clinical trials or marketing
authorisations for this product.</p><p> </p><p>Under their terms of service, general
practitioners and hospital doctors are allowed to prescribe any medicinal product,
including any unlicensed medicinal product, which they consider necessary for the
treatment of their patients and under their clinical responsibility. They should always
satisfy themselves that the medicinal products or other substances they consider appropriate
for their patients can be safely prescribed, that patients are adequately monitored
and that, where necessary, expert hospital supervision is available. We would expect
clinicians to also seek informed consent from their patients on the basis that there
are risks associated with using an unlicensed medicine as well as potential therapeutic
benefit(s). Patients should also be informed that the licensing assessment of the
medicine for unlicensed use will not have taken place.</p><p> </p>
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