Background of CBD in the UK

Cannabidiol (CBD) is a non-psychoactive compound found in cannabis plants, distinct from tetrahydrocannabinol (THC), which is responsible for the psychoactive effects associated with cannabis use. CBD has garnered significant interest for its potential therapeutic benefits, particularly in the treatment of conditions such as severe epilepsy and chronic pain.

In the UK, the legal and regulatory landscape surrounding CBD has evolved considerably. Historically, cannabis was classified as a Schedule 1 drug under the Misuse of Drugs Regulations 2001, meaning it was considered to have no medicinal value. However, following a review by the Home Office and recommendations from key medical authorities, certain cannabis-based products for medicinal use were rescheduled to Schedule 2, allowing them to be prescribed under specific conditions.

Regulatory Framework for CBD and CBPMs

The regulatory framework for CBD and cannabis-based products for medicinal use (CBPMs) in the UK is comprehensive and involves multiple layers of oversight:

1. Schedule 2 Classification: As of November 1, 2018, CBPMs are classified under Schedule 2 of the Misuse of Drugs Regulations 2001, enabling their prescription by specialist doctors under controlled conditions​.
2. NICE Guidance: The National Institute for Health and Care Excellence (NICE) has issued guidelines to support the prescription of CBPMs, mainly focusing on conditions with evidence of benefit, such as severe epilepsy​ (GOV.UK)​.
3. BPNA Recommendations: The British Paediatric Neurology Association (BPNA) recommends the use of pure CBD products, like Epidiolex®, for pediatric patients with certain forms of severe epilepsy while advising against the use of other non-licensed cannabis-derived products​ (GOV.UK)​.
4. FSA Novel Food Status: In January 2019, the Food Standards Agency (FSA) adopted the European Commission’s decision that CBD is a novel food, requiring companies to obtain authorisation before placing CBD food products on the market. This involves demonstrating safety through comprehensive scientific data. Post-Brexit, the FSA was able to deviate from the EU Novel Food regulatory framework and establish its own unique mechanism for manufacturers to follow whilst at the same time allowing CBD ingestibles to remain on the British market as long as an active novel food submission was being processed.(GOV.UK)​.

Making Submissions and Compliance

For companies looking to market CBD products in the UK, several regulatory submissions and compliance steps are essential:

1. Novel Food Authorisation: CBD products intended for consumption must be submitted for authorisation through the FSA's regulated product application service. This process requires detailed safety assessments and evidence of the product’s composition​ (GOV.UK)​.
2. MHRA Guidance: Products claiming medicinal benefits must also comply with the Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines. This ensures that the products meet the necessary standards for medicinal use​ (GOV.UK)​.
3. Home Office Licensing: Activities involving the production, possession, supply, or import/export of controlled cannabinoids, including CBD products with any THC content, require a Home Office controlled drug licence​ (GOV.UK)​.

How Global Regulatory Services (GRS) Can Help

Global Regulatory Services (GRS) offers comprehensive support to CBD and Medicinal Cannabis companies navigating the complex regulatory landscape in the UK:

1. Regulatory Compliance Support: GRS assists in ensuring that all CBD products comply with the latest FSA and MHRA regulations, helping companies prepare and submit the necessary documentation for novel food authorisation and medicinal product approval, including Good Agricultural and Collection Practice (GACP) and Good Manufacturing Practice (GMP).
2. FSA Submissions: From ‘field’ to the final submission and beyond. Our experts guide companies through the FSA novel food application process, from initial safety assessments to the final submission. We ensure that all required data is robust and meets the stringent criteria set by the FSA.
3. Home Office Licensing Assistance: GRS provides support in obtaining the necessary Home Office licences for the production and distribution of CBD products, ensuring compliance with all legal requirements.
4. Ongoing Regulatory Advice: We offer continuous regulatory advice to help companies stay updated with legislative changes and maintain compliance as they bring new CBD products to market.

With our deep expertise and proactive approach, GRS ensures that CBD companies can focus on innovation and growth while meeting all regulatory standards. Connect with our experts by visiting https://globalregulatoryservices.com/global-regulatory-services-contact-details or drop us an email – grs@globalregulatoryservices.com