 |
answer text |
<p>The Medicines and Health products Regulatory Agency (MHRA), the Government body
responsible for the safety and licensing of medicines in the United Kingdom, is not
aware of any legal loopholes for the supply of human unlicensed medicinal products.</p><p>
</p><p>Before a human medicine can be marketed or sold in the UK, a number of licences
are required. The product itself must have a licence called a ‘marketing authorisation’
unless an exemption applies.</p><p> </p><p>UK medicines legislation contains a provision
for the supply of an unlicensed medicine (commonly known as ‘specials’) which is provided
for by way of an exemption from the requirement for a marketing authorisation. In
the interests of public health this exemption is narrowly drawn because these products,
unlike products holding a marketing authorisation, will not have been assessed and
approved against the criteria of safety, quality and efficacy in the UK.</p><p> </p><p>Unlicensed
medicines can be manufactured in the UK under European Union good manufacturing practice
or imported into the UK by the holder of an appropriate licence issued by the MHRA.</p><p>
</p><p>Notifications prior to importation of unlicensed medicines are required and
are assessed by the MHRA and objections may be raised where there are prohibitive
safety or quality concerns. Any person that sells or supplies an unlicensed medicine
is required to keep records and report suspected adverse drug reactions.</p>
|
|
