MHRA’s New Guidance Points To A ‘Truly Pharmaceutical Path’ For UK Medical Cannabis And Could See End To ‘GACP To GMP Washing’


NOVEMBER 30, 2022; Source:

THE UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last week released new detailed guidelines for medical cannabis companies operating in the UK. 

This new guidance from the MHRA and the Home Office sought, for the first time, to provide a step-by-step plan for companies ‘that do not already hold the necessary authorisations’ to begin producing cannabis-based medicinal products and APIs in the UK. 

Some have called this release ‘the most significant development since 2018’, suggesting it points to a step change in the Government’s attitudes towards the industry. 

Others have argued that the fact it is considered significant shows just how little progress the UK’s industry has made over the past four years. 

Regardless of its overall impact, the release suggests the Government intends to pursue a ‘truly pharmaceutical path’, and may look to relinquish its reliance on expensive ‘specials’ imports in favour of domestic production. 

Key Points 

The main purpose of the newly published guidelines is to provide a clear framework for companies, to overcome a ‘chicken and egg’ conundrum when undergoing the licensing process. 

Specifically, it addresses the needs of ‘an increasing number of companies’ entering the industry with a lack of previous pharmaceutical experience and  licences. 

In order for the MHRA to grant a company authorisation, the latter must be able to demonstrate its ability to consistently and correctly manufacture its product. 

However, in order to be licensed to handle controlled substances, which are needed to manufacture said products ‘consistently and correctly’, companies need a licence from the Home Office. 

But the Home Office will not issue a licence without assurances that the company can meet the requirements of the MHRA licence, leading to companies being bounced back and forth between the two authorities.