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<p>Cannabis based products for medicinal use in humans (CBPMs) is a term that usually
designates medicinal products that are not licensed in the United Kingdom. Most CBPMs
in use in the UK are unlicensed medicines imported into the Country. Regulation 167
of the Human Medicine Regulations 2012, as amended, allows for medicines without a
marketing authorisation, also referred to as a licence, to be supplied under certain
circumstances. In the interest of public health, the exemption is narrowly drawn because
unlicensed medicines or specials, unlike licensed medicinal products, have not been
assessed by the Licensing Authority against the criteria of safety, quality and efficacy.</p><p>An
unlicensed medicine may be supplied following a bona fide unsolicited order and is
formulated in accordance with the specific requirements of the prescriber. This means
that the quality, safety and efficacy of unlicensed medicines is the direct responsibility
of the prescribers responsible for the care of individual patients as they are the
ones that determine if these are fit for purpose.</p><p>The Medicines and Healthcare
products Regulatory Agency (MHRA) ensures that any importer of an unlicensed medicinal
product into the UK must be suitably licensed to import unlicensed medicines and prior
to the importation taking place the importer must notify of their intent to import
the unlicensed medicine and provide a set of supportive documentation, which the MHRA
will assess to ensure the medicine’s quality and safety. This typically includes the
requirement that a medicine has been produced in facilities meeting Good Manufacturing
Practice or equivalent recognised quality standards for medicines.</p>
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