- Exploring the impact of the legalisation of cannabis-based medicinal products
- Original news
- The publication by MHRA of guidance on CBD products follows the government's changes to the legal regime in respect of cannabis for medical use. What is the background that led to this change in the law?
- How will the new regulations work in practice? On what basis may CBD products be supplied and what are the limitations to the supply/prescription of CBD products?
- The MHRA has also published a new document: 'The supply of unlicensed cannabis-based products for medicinal use in humans' to provide guidance following the rescheduling of cannabis under the 2018 Regulations. This guidance supplements the MHRA guidance note 14 on specials—what are the products in the scope of this additional guidance and when can these products be prescribed?
- What are the specific guidelines on persons authorised to prescribe unlicensed CBPMs, manufacture and assembly in the UK, importation into the UK, record keeping, distribution, storage requirements, labelling, advertising, and pharmacovigilance and reporting of adverse drug reactions (ADR)?
- Persons authorised to prescribe unlicensed CBPMs
- Manufacture and assembly in the UK
- Importation into the UK
- Record keeping
- Storage requirements
- Pharmacovigilance and reporting of ADR
- What is the impact of the new regulations on guidance issued in the Home Office's Drug licensing factsheet—cannabis, CBD and other cannabinoids?
- What are the background and purpose of the MHRA guidance on CBD products?
- Has the MHRA guidance clarified the regulatory landscape for CBD products? How will CBD be regulated?
- What are the implications of the 2018 Regulations and the MHRA guidance for manufacturers of CBD products?
Life Sciences analysis: Alison McAdams, head of life sciences at DAC Beachcroft LLP and Jonathan Deverill, partner at the same firm, discuss the new legal framework allowing doctors to prescribe cannabis-based medicinal products to patients.
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