A guide to the MHRA's requirements for new entrants
Breaking into the UK's medical cannabis sector can seem like a daunting task, especially for new businesses. The industry is tightly regulated, and the requirements set by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Home Office can appear overwhelming.
Understanding the landscape, the competition, and the legal, financial, and practical aspects of operating in this sector is critical for success. But, help is at hand. Maple Tree is here to guide you every step of the way. With our tailored approach, industry expertise, and strategic relationships, we can help you to navigate the obstacles and take advantage of the potential for growth in this sector. Let's take a closer look at what it takes to become a Licensed Producer of cannabis-based products
Becoming a Licensed Producer in the UK
Applying to manufacture cannabis-based products for medicinal use in the UK - to become a Licensed Producer - involves several steps, as set out by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Home Office.
Companies aiming to manufacture cannabis-based medicinal products or active pharmaceutical ingredients (APIs) must obtain authorisation from both the MHRA and the Home Office.
Controlled Drugs Licence: The Home Office issues this licence, which is required for the cultivation, production, supply, and possession of cannabis. To ensure adequate safety measures are in place, the Home Office must inspect the facility and the organisation's procedures.
Manufacturing Site Authorisations: The MHRA issues a manufacturing licence or API registration. This entails an inspection to verify the facility, staff, and pharmaceutical Quality Management System, including process and analytical validation.
Challenges for New Entrants
Companies new to the sector wishing to manufacture cannabis-based products will need to meet the requirements of both the MHRA and the Home Office.
This presents a dilemma because the MHRA requires evidence of competent manufacturing, whereas the Home Office requires assurance that MHRA's requirements can be met before a controlled drugs licence can be issued.
For businesses, this means that the supply of cannabis-based medicinal products can only begin once the necessary authorisations have been granted by both the MHRA and the Home Office.
The Government, in recognition of this dilemma, the government has produced an outline to be followed, available online and summarised below:
Step 1: Site Applies to the MHRA for the Appropriate Licence or Registration
The site must be ready for inspection, and an operational Pharmaceutical Quality Management System (QMS) must be in place. The facility should be suitable and qualified with all equipment installed and certified to at least an Operational Qualification level, and staffing should be adequate to meet the requirements of the EU Good Manufacturing Practice (GMP).
Step 2: MHRA Carry Out a Remote (Desk-based) Inspection
The MHRA conducts a remote review to assess the company's preparedness for manufacturing medicinal products. This involves evaluating the QMS and reviewing standard operating procedures. The layout of the facility and the equipment used are also assessed for their suitability. Upon a successful inspection, the MHRA informs the Home Office but does not issue a GMP/GDP certificate at this stage.
Step 3: Site Apply to the Home Office for Controlled Drug Licence
Following a successful remote inspection by the MHRA, the company may apply to the Home Office for a Controlled Drugs Licence. The Home Office then carries out an on-site inspection to verify the facility's preparedness and the robustness of procedures for handling cannabis-based materials. If the inspection is successful, a Controlled Drugs Licence is issued.
Step 4: Site Completes Outstanding Validation Activities
Once the Controlled Drugs Licence is granted, the company is allowed to handle cannabis materials, enabling it to complete the required validation activities, including process and analytical validation. Once these tasks are completed and reported, the company notifies the MHRA that they are ready for the final inspection.
Step 5: MHRA Carries Out On-Site Inspection
In the final step, the MHRA carries out an on-site inspection to review validation and other aspects not covered in the initial remote inspection. If the inspection is successful, the MHRA issues the appropriate authorisations along with GMP/GDP certificates. If the inspection is not successful, the Home Office is informed.
Get support from the UK's leading medical cannabis consultancy
As we've discussed, navigating the journey of establishing and operating a successful cannabis-based medicinal product business in the UK can be a challenging and complex process. But, you don't have to do it alone.
Maple Tree Consultants is the leading expert in the UK's medical cannabis sector, ready to guide you through every step of the MHRA and Home Office's requirements. From applying for the right licences and completing necessary validations to preparing for inspections, Maple Tree can guide you to success through our deep understanding of the market and its regulations and with strong strategic relationships across the sector.
Whether you're a new business considering entering the market, or an existing player looking to further develop your cannabis operations, we can provide you with the tailored advice and support you need to thrive. Take advantage of the emerging opportunities in this rapidly growing market.
Don't hesitate; partner with Maple Tree Consultants today and let us help you grow your medical cannabis business to its full potential.