In late 2016, Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK issued its judgment on the medicinal value of CBD products and mandated businesses to remove their existing stock of CBD products sold for medicinal purposes. It is admissible to mention that before the judgment, the agency updated manufacturers and suppliers of cannabidiol products about the regulatory review of CBD products.
Specifically, MHRA stated that retail CBD contained products used for medical purposes must be licensed accordingly before being legally distributed across the United Kingdom. As a result, the availability of CBD products in the UK dried up appreciably while manufacturers and suppliers strived to obtain the necessary market authorization. It was made clear by the MHRA that continued retail of the products without fulfilling the licensing requirements would result in prosecution. As Vaping360 explain in the section ‘CBD laws around the world” of the linked page, the laws on CBD vary around the world and things are particularly confusing in the UK, as some believe products should be legal whereas others believe the law is to unclear to decide.
As of 2017, MHRA formally recognizes cannabidiol as a medicine. It should be noted that MHRA is accountable for guaranteeing that medical devices and medicine work, are of appropriate quality and do not pose any safety hazard. The MHRA also includes the Clinical Practice Research Datalink (CPRD) and the National Institute for Biological Standards and Control (NIBSC). The regulatory Agency is an executive branch of the Department of Health and primarily operates to protect public health through a functional system of rules and regulations.
The Process of Regulation
Every pharmaceutical manufacturer and distributor operating in the United Kingdom’s marketplace is subject to a system of inspection and licensing. This certifies that the medicinal products abide by the internationally-agreed standards and that those medical drugs are manufactured, warehoused, and distributed in accordance with the required regulatory standards. The MHRA regulates medicines in the UK market in accord with the Human Medicines Regulations 2012.
The MHRA is working tirelessly with individual businesses and trade bodies to make sure that, CBD-contained medical products that are classified as medicines must also conform to the terms of the Human Medicines Regulations 2012. It is pertinent to state that a product is classified as a ‘medicinal product’ in conformity with the description of a medicinal product and is not based on any usage risk to the consumers. Therefore, once a valid application is made the product will be evaluated regarding its quality, safety and effectiveness in the medical claims made.
The manufacturers should never forget that CBD-contained medicines must have a product license (marketing authorization) before being offered commercially unless exempted otherwise.
The exempted CBD-contained medicines are offered as specials by authorized prescribers. A distinguishing aspect of a special is that it may not be advertised. These products are specially manufactured or imported to treat individual patients after being ordered by a doctor, independent nurse prescriber, dentist, pharmacist, supplementary prescriber, or an independent prescriber. Furthermore, the Human Medicines Regulations 2012’s regulation 167 offers an exemption from the need for a product license for a medicinal product that is:
Supplied in reply to an unsolicited order.
Used by a patient for whose treatment that individual is solely accountable to satisfy the unique needs of that patient and meets the terms specified in regulation 167.It is pertinent to mention that in the interest of public health the exemptions are narrowly drawn as these products, unlike accredited medications, are often not assessed by the Licensing Authority against the benchmarks of quality, safety, and efficiency.
.It is pertinent to mention that in the interest of public health the exemptions are narrowly drawn as these products, unlike accredited medications, are often not assessed by the Licensing Authority against the benchmarks of quality, safety, and efficiency.
Therefore, an unlicensed medicinal product should only be supplied as a last resort to meet the distinctive needs of a patient. It is crucial to remember that an unlicensed medicinal product should not be distributed in a region where a comparable licensed medicinal product can fulfil the needs of the concerned patient. Therefore, anyone offering unlicensed medicinal products anywhere in the UK, where a corresponding licensed medicinal product is available should rationalise the existence of a special need for the unlicensed medicinal product.
The MHRA is expecting that in the foreseeable future the documentary evidence of this special need CBD medicines should be obtained by importers, manufacturers, or distributors, and that this proof must be made available on request of the relevant licensing authority. Although, the evidence could be in the form of a prescriber’s letter, a fully documented audit trail via the supply chain that confirms the particular need could be more feasible.
Besides, MHRA does not endorse outside the licensed indications (known as off-label) use of products. Therefore, if a United Kingdom licensed product can meet the medical need then irrespective of it being off-label, it can be utilised instead of an unlicensed product.
Lastly, the responsibility to decide if a patient has special needs that cannot be cured through licensed products is that of a doctor, dentist, pharmacist, supplementary prescriber, independent prescriber, or the person responsible for the patient’s care. The examples of special needs include an allergy or intolerance to a particular ingredient or incapacity to ingest solid oral dosage forms.