⚠️ Important Updates on MHRA Handling: Delays Expected, Multiple Changes

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.

Notes on packaging/labelling:

• 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.

These changes apply to all future imports, meaning new batches for existing medications are likely to be delayed while they're re-registered in full compliance with the above requirements. From a regulatory perspective, any re-registered products will infact be new products.

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:

If a patient contacts you, you should not be communicating with them - they should be communicating with their clinician, or their pharmacist. A producer can have no role in the discussion with the patient, under law.

In regards to industry/patient online Q&As and such:

You can always talk in general about cannabis, but you can never talk to a patient, or a patient group, about the use of specific products for treatment.

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.

 

[GrownHealth]

Thanks ,as for your clinic I didn't know much about them until recently and from members feedback alone yourself included it's all been positive so fair play to them they must be doing something right
As for the Gamma and Beta irradiation it seems another way/scheme to get imperfect Canna to us but I'm guilty as charged of ordering it
On the other hand they say my mrs has to have beta and gamma which does my head in because there the products that are probably least medically beneficial.

 

[AutisticStoner]

Thanks ,as for your clinic I didn't know much about them until recently and from members feedback alone yourself included it's all been positive so fair play to them they must be doing something right
As for the Gamma and Beta irradiation it seems another way/scheme to get imperfect Canna to us but I'm guilty as charged of ordering it
On the other hand they say my mrs has to have beta and gamma which does my head in because there the products that are probably least medically beneficial.

There very patient lead and they seem to do the best they can whilst still making a decent profit which is fair. I refuse to touch Gamma I feel like it turns a strain that’ll last 3-4 hours into something that lasts half an hour like the Hindu Kush I’ve had this Bm good effects on MC it’s closeish but the effects don’t last at all. Beta I feel mixed about I don’t know enough to say too much I just feel like some are better irradiated than others I feel like some have just been thrown in the microwave. I have loads of ideas about the irradiation but 90% of them are probably wrong I just know the less irradiated it is the better it’s been for me. I defo feel like we will soon see a article saying that irradiation speeds up the decay rate of terpenes or something on them lines it’s not a coincidence all my fave strains are the non irradiated ones. They restrict some people to irradiated products over immune system issues which I get if the data actually proves it’s needed which it’s a problem solved before it even existed so who knows not seen anyone with any issues have you. Oh god I just saw how much I’ve been writing I must be high

 

[GrownHealth]

I have seen a few pictures lately of some gamma bud and it didn't look to shabby ,either Kush Cookies or Cookies Kush but what you mention about reducing the amount of time you'll feel the effects from gamma products makes a lot of sense really and sort of makes them not cost efficient at the same time as a patient would need more to do the same as a non gamma product.
I've gone past high now ,I'm like an ancient ruins ,crumbled

 

[R3d4]

I have seen a few pictures lately of some gamma bud and it didn't look to shabby ,either Kush Cookies or Cookies Kush but what you mention about reducing the amount of time you'll feel the effects from gamma products makes a lot of sense really and sort of makes them not cost efficient at the same time as a patient would need more to do the same as a non gamma product.
I've gone past high now ,I'm like an ancient ruins ,crumbled

So how do you think these changes will alter what MedBud is able to , ie will clinics importers growers be less likely to engage with you? For fear of falling foul of regulations? It sounds like that is already the case with the council

 

[GrownHealth]

So how do you think these changes will alter what MedBud is able to , ie will clinics importers growers be less likely to engage with you? For fear of falling foul of regulations? It sounds like that is already the case with the council

Personally I'm not qualified to answer that as I'm pretty new around here ,but I'm sure @Muiredach will when he's about next
I will say that less interaction with MedBud would be bad for patients in my view as even before the forum for me this source was vital from day one one of my MC journey and I imagine is a first stop for a lot of patients to do with their MC journey.

 

[R3d4]

Personally I'm not qualified to answer that as I'm pretty new around here ,but I'm sure @Muiredach will when he's about next
I will say that less interaction with MedBud would be bad for patients in my view as even before the forum for me this source was vital from day one one of my MC journey and I imagine is a first stop for a lot of patients to do with their MC journey.

I agree with you, feelings are mixed about the changes but it would be a step towards GP prescribed MC I guess

 

[GrownHealth]

I agree with you, feelings are mixed about the changes but it would be a step towards GP prescribed MC I guess

Just read that and thought about NHS GP prescribed MC and a warmth spread over me as the costs with two patients in my household are severe and any step in this direction as long as followed by action would be welcome from a financial point of view ,more regards vape carts and oils as my understanding is it will be extremely hard for flower to be prescribed on the NHS because of consistency issues is my understanding but I would love this to change.

 

[R3d4]

I guess ultimately legalisation if the government can make enough from taxation

 

[GrownHealth]

I guess ultimately legalisation if the government can make enough from taxation

That would be the enticement for recreational for government I reckon as I'm not sure how much medical is taxed?
I know our invoices show no added tax but understand there are a lot more chances to put tax on it before it hits our invoices.
Maybe we could see one follow the other in quick succession as recreational taxes from coffeeshops and flower etc would help fund the NHS costs of MC although this would save the NHS a lot of money in the long run anyway in my opinion.

 

[R3d4]

Im suprised this hasn't generated more discussion

 

[GrownHealth]

Im suprised this hasn't generated more discussion

It's probably as much because many members haven't been around since the post was reinstated yesterday and I am going to give it a thorough read again myself now but I'm sure others will want to discuss when they come across it.

 

[GrownHealth]

Im suprised this hasn't generated more discussion

Just had a look and can't find a fixed date for these changes and reading the MedBud Tweet it suggests these changes have been happening and will continue to happen over the next months and I reckon it's the possible disruption that may or may not ensue that would be the main problem as the branding and such is neither here nor there for me but also I would like to know what other members feel about this as it was briefly discussed in September but I imagine a few of the changes are very close to being in place after months of preparation .
As regards possible preparation for NHS prescribing personally

 

[GrownHealth]

I would say this will be ok for labelling

 

[AutisticStoner]

I would say this will be ok for labelling
View attachment 1654

On packaging I think that’s good I prefer how Miracle Valley Canada do it but 100% acceptable honouring the original cultivar which means you can know what to expect without having names they don’t like. I would of liked them to enforce that some information is included rather than leaving it optional

 

[GrownHealth]

I take it you mean terpene profiles and now I think about each batch has to have a new COA on it going forward so I'd expect bigger batches as they wouldn't want to pay for 5 COA's to cover 5x3kg batches they would and I imagine will get one COA done on 15kg and maybe as its one batch that would need testing for terpene profile to cover a more significant size batch we may have more chance of brands doing this and if not why not

 

[AutisticStoner]

I take it you mean terpene profiles and now I think about each batch has to have a new COA on it going forward so I'd expect bigger batches as they wouldn't want to pay for 5 COA's to cover 5x3kg batches they would and I imagine will get one COA done on 15kg and maybe as its one batch that would need testing for terpene profile to cover a more significant size batch we may have more chance of brands doing this and if not why not

I love how basic it is whilst also telling you everything you need to know. Can tell I’m a big fan of Miracle Valley Canada they don’t hide anything cause there confident in there product. I don’t like any company that try’s to infantilise there patients or mislead them. The bigger batches may happen but that’ll definitely take time and you could see bigger inconsistency from what one person gets in a batch and another but we will see how these companies react

 

[GrownHealth]

Had to check then as I new there's a new Miracle Valley Canada product coming up the Detroit Runtz so that'll be interesting .

MVC MAC-4+ T21 Detroit Runtz

MedBud is a 100% independent organisation tracking theUK medical cannabis industry with impartiality.

MedBud.wiki

 

[AutisticStoner]

Had to check then as I new there's a new Miracle Valley Canada product coming up the Detroit Runtz so that'll be interesting .

MVC MAC-4+ T21 Detroit Runtz

MedBud is a 100% independent organisation tracking theUK medical cannabis industry with impartiality.

MedBud.wiki

Yh I noticed that awhile back this is one I’m most keen to try it might be our first good runtz it’ll be £10 a g but I’ll be buying it

 

[GrownHealth]

I actually liked the Green Karat one but not worth £10/g and the OHT Runtz felt good for only a few days then pretty dull ,Hopefully this'll be the best of the bunch an I had an idea you might of seen it already

 

[AutisticStoner]

I’ve had terrible experience with Green Karat not had a useable flower with them I expected them to be my fave.