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<p> </p><p>The Human Medicines Regulations 2012 as amended contain provisions for
the import of unlicensed medicinal products to meet the special clinical needs of
particular patients. The importer (who must hold a licence for that purpose) must
notify the Medicines and Healthcare products Regulatory Agency (MHRA) that such importation
is taking place. The MHRA may object to the importation if there is a known safety
or quality issue with the product, or if an equivalent United Kingdom-licensed product
is available.</p><p> </p><p><strong> </strong></p><p> </p><p>Such products are used
on the direct personal responsibility of the prescriber, who would retain clinical
responsibility for the patient while prescribing the product in question.</p><p> </p><p>
</p><p> </p><p>In primary care, prescribers are allowed to prescribe any product,
including any unlicensed product, which they consider to be a medicine necessary for
the treatment of their patients under the National Health Service, as long as that
product is not included in Schedules 1 or 2 to the NHS (General Medical Services Contract)
Regulations 2004 and that the prescriber is prepared to justify any challenges to
their prescribing by the relevant commissioning organisation.</p><p> </p><p><strong>
</strong></p><p>When a patient is being treated by a hospital the consultant can arrange
for the supply of any product, even one not normally available on NHS prescription,
provided the relevant commissioning organisation or NHS trust agrees to supply it
at NHS expense.</p>
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