Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure the (a) quality and (b) safety of imported cannabis-based products for medicinal use; if he will make a statement.

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.

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.

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.