Date lodged: 8 February 2017
To ask the Scottish Government what discussions it has had with the Scottish Medicines Consortium regarding the use of cannabidiol (CBD), in light of the recent statement by the Medicines and Healthcare products Regulatory Agency (MHRA) approving the product's use.
Answered by: Shona Robison 2 March 2017
The Scottish Medicines Consortium (SMC) operate independently of the Scottish Government and provides advice to NHSScotland on newly licensed medicines. The independence of SMC decisions on individual drugs is well established.
Regulation for the licensing, safety and efficacy of medicines is currently reserved to the UK Government and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA) who operate on a UK wide basis. The MHRA have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. MHRA is currently working with individual companies and trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Regulations 2012
Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. If a company obtains such a licence for a product containing CBD then it will be for the manufacturer to make a submission to the SMC to have the medicine considered for routine use in NHSScotland.