15/16 November 2023
An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Several companies have therefore contacted the MHRA regarding the process of granting the required licences for these products. Now, the agency posted a summary of answers on the MHRA Inspectorate blog (for unlicensed medical Cannabis-based Products (unlicensed CBPMs), please see also the news MHRA Guidance for the Supply of Medical Cannabis Products).
An MHRA issued manufacturing licence (or API registration) is required to manufacture CBPMs. This requires a GMP inspection of the site to confirm it has an appropriate facility, staff and Pharmaceutical Quality System (PQS) and has carried out the required activities (including process and analytical validation). Only when the appropriate authorizations have been granted by both the MHRA (GMP licence) and the Home Office (Controlled Drugs licence) medicines can be supplied. At the point of application, all necessary systems, equipment, and procedures should be in place ("GMP-Readiness"). All qualification and validation of the facility and equipment should be complete up to the point of at least operational qualification (OQ). However, it is accepted that no process validation runs can be completed at the point of application as it will not be possible to handle the controlled materials at that time, and that some PQ activities may also be incomplete.
Where a site has an existing MHRA manufacturing licence, the PQS in place will already have been assessed. Consequently, if the company wishes to handle cannabis-based materials, the Home Office may be able to process the application for a new, or revised, CD licence. This will depend on how much the activities differ to those already authorized. An MHRA inspection may be triggered when the variation to the site’s licence, or registration, is submitted, and this will be assessed on a case-by-case basis.
If only the growing of the cannabis plant, harvesting and selling it as an unprocessed crop is performed, GMP isn’t applicable. Then Good Agricultural and Collection Practice (GACP) applies, which is an unlicensed activity. If any further GMP processing steps are carried out (including drying and trimming) the agency needs to know what is happening where. This also includes steps selling the product, because the subsequent activities carried out can change what type of licence is needed.
More information is available in the post, "MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use" published on the MHRA Inspectorate blog.