Published on: 11/1/16
Today has seen the unexpected announcement by the Medical Healthcare Regulatory Agency (MHRA) extending the grace period given to UK CBD manufacturers to comply with their criteria for the regulation of substances classed as medicine.
In a statement today they say:
“Our primary concern is patient safety. In order to ensure that products remain available until individuals have the opportunity to discuss their treatment with their doctor, companies now have until 31 December 2016 to voluntarily operate within the law, by withdrawing their existing products from the market, or working with MHRA to satisfy the legal requirements of the Human Medicines Regulations 2012”.
Previously the MHRA had given CBD companies 28 days to act, which had caused an outcry from both UK producers and the thousands of CBD consumers who use CBD to treat conditions such as chronic pain, epilepsy, MS and autoimmune diseases. After the 28 days had passed, they would no longer have been able to legally buy CBD, potentially putting their health at risk.
The MHRA has written to 18 UK CBD companies with their decision. In order to legally sell CBD after 31st December a marketing authorisation costing £103,000 will be required, plus full scale clinical trials proving safety and efficacy.
Peter Reynolds, president of CLEAR Cannabis Law Reform, commented:
“This is very welcome news in accordance with common sense and the MHRA’s mission to “improve health”. Its previous statement clearly endangered the health of tens of thousands of people”.
CLEAR Cannabis Law Reform is one of a number of parties from the UK medical cannabis lobby to form the ‘UK Cannabis Trade Association’ and will be meeting with the MHRA to discuss what happens next.
Reynolds says, “we now have legal advice that the MHRA broke its own rules in its original statement, failed to consult with stakeholders, caused financial damage to many CBD suppliers and, in any case, is unable to apply any such blanket ban. It has to assess products on an individual basis.”
It remains to be seen how this UK CBD regulatory change plays out. But if the situation remains as it is, from 1st January 2017, CBD will no longer be available from UK suppliers for the foreseeable future.
Disclaimer: Views expressed here do not necessarily reflect those of Endoca and its staff. This article is not intended to provide medical advice, diagnosis, treatment or cure. Endoca CBD products have not been approved by the US Food and Drug Administration (FDA).