Some important updates on how the MHRA is processing new product registrations, including the new registration name requirements for CBPM products:
- Must not reference a person, a place or a thing.
- Cannot be named after any conditions, or any symptoms (ie. 'sleep'.)
- Abbreviations are allowed, but what that abbreviation/acronym stands for will be questioned. This can be an abbreviated cultivar name.
- Company/brands names can be used, and abbreviated, but only if that specific company is EU-GMP/MS licensed.
- The registration title can be no longer than 16 characters in total.
- Within the 16 characters THC/CBD percentages (active ingredients) must be included, including any minor cannabinoids over 1% by weight (CBG etc.)
- The registration title must match the designation on product packaging, on bulk import packaging, on all paperwork et cetera.
- Full cultivar names can still be included in the small print on packaging.
- No use of images or colours to represent a person, place or thing - or to make packaging appear more enticing. Product labelling needs to be as plain as possible.
- No branding of any kind, unless the branding is a trademarked part of a company name - and the company itself is EU-GMP/MS licensed.
- If a cultivator is not GMP licensed, and is only GACP (for example Celadon, Glass Pharms) - they cannot be mentioned on packaging.
- Terpenes can be included on packaging in the ingredients panel, with specific allowances for it in the QRD, but are also subject to an allowed -/+ 10% variation.
- Patient Information Leaflets can be linked to via QR code compliantly, this must be a separate page which does not link to any other part of the website which must be inaccessible.
- Companies can compliantly include a full COA on the PIL. This must be a final packaging COA, and not representative bulk COAs. The COA must be updated with each new batch imported.
- Labels must be UK specific and cannot be the same as used in other European countries, and must be in English.
A further note on 'letters of clinical need' used to evidence imports: companies cannot solicit CN letters from doctors, whom must approach a company independently if they feel an upcoming product could be suitable for their patients - upcoming products can however be shared with doctors if part of a general price list update or otherwise. This may be audited in the future, and could invalidate an import application and make it unlawful if a company is found to have solicited clinical need letters.
Another important note made for producers/cultivators:
In regards to industry/patient online Q&As and such:
In general over the coming months, as current stock runs out, expect to see many changes to product names, and packaging.
Fortunately we have more flower in the country available for prescription than ever before, and hopefully it's enough of a reserve to deal with what's expected to be multi-week delays to restocking various medications. Aside from the head of unlicensed medication, there's just two part-time staff dealing with all applications.
These changes do not reflect any change in law, but the correct application of other policies and procedures for specials/unlicensed medicine in general, which previously were not being strictly applied.
In short, medical cannabis is now being brought in-line with the same stipulations as all other unlicensed medications - and there will be delays to most new medication and batches becoming available.
This information was sourced from the UK Cannabis Industry Council which MedBud is a member of - due to working group rules we cannot attribute the information provided to any specific person nor company, but all information provided is accurate to the best of our understanding.
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not had a useable flower with them I expected them to be my fave.
told myself this year to wait till a few reviews from patients or youtubers come in first before buying, still the odd one will make me override common sense
