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<p>To make a medicinal product available for sale in a pharmacy without a prescription,
the product must be reclassified to pharmacy only status, also known as [P] medicines,
by the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p>This process
is triggered by an application submitted to the MHRA by a company which holds a licence
for the particular product. The MHRA will consider all submitted applications, with
a decision to reclassify a medicine reached following a robust evaluation of the relevant
data, including evidence of the safe use and supply of the product without a prescription.
The company must also demonstrate in their application that the criteria specified
in relevant legislation, such as the Human Medicines Regulations 2012, have been met.</p><p>In
accordance with the Human Medicines Regulations 2012, regulation 62(3), Prescription-Only
Medicine status will apply where: a direct or indirect danger exists to human health,
even when used correctly, if used without medical supervision; there is frequently
incorrect use, which could lead to direct or indirect danger to human health; further
investigation of the activity or side-effects is required; or the product is normally
prescribed for parenteral administration, via injection.</p><p>Currently, United Kingdom
law specifies that all products administered by injection must be subject to a prescription.
The MHRA is therefore unable to reclassify the status of injections, including Vitamin
B12, to [P] medicines, as this would not be consistent with the legislation.</p>
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