⚠️ 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]

On dear that sounds ominous for the next few months as in delays and possible additional costs with implementing the changes.

 

[JR52]

Would they be allowed to leave people with no medication
Surely they will give people time to make the changes

 

[Muiredach]

This has all been the case over the past month or so already, it's just taken this long to fully understand what the MHRA's new requirements and interpretation of law/guidelines are in the full.

 

[Ibo007]

When is this taking action ?

 

[Muiredach]

Already in-place, when current batches are exhausted - new batches will have to meet the above criteria.

 

[Rimmerworld]

What exactly is wrong with Hindu Kush? Its where the plant is from places names should have exceptions. At least the strain info is on the tub. My lemon skunk says LSK but on the foil says lemon skunk.

I dont rate the CQC DMRC MHRA at all to be honest. Whats wrong as well with emailing the producer? I send emails all the time giving me feedback they never reply but at least they know if its dry or overpriced. Keep emailing them folks! When i emailed Aurora® about the £350 LA Confidential a month later it dropped to £240! £350 was just stupid.

 

[Muiredach]

This post has been reinstated, further remarks below:



We'll be posting further information on our best understanding of what changes are being enforced.

 

[AutisticStoner]

Seems like they’ll want Everything to go like the new Noidecs stuff where the name says nothing about what it is and they hide the lineage so you don’t have a clue what you’re buying. They add more regulations and none of it is for the patients none of it is to address the quality issues none of it is to make any of it any better for patients. The day I don’t know what strain I’m buying is the day I quit medical

 

[GrownHealth]

Seems like they’ll want Everything to go like the new Noidecs stuff where the name says nothing about what it is and they hide the lineage so you don’t have a clue what you’re buying. They add more regulations and none of it is for the patients none of it is to address the quality issues none of it is to make any of it any better for patients. The day I don’t know what strain I’m buying is the day I quit medical

Welcome to the forum @AutisticStoner and glad you joined us and the Noidecs issue is a bad sign as they feel comfy even trying this stuff.
It'll be good to see COA's on everything I reckon is a plus.
With each change and if they all come at once will cause problems for us as patients most probably and costs will be passed on no doubt.

 

[AutisticStoner]

Thanks for the welcome. All it’ll take is MHRA to like the approach Noidecs is taking and then enforce it on all and then we’ll see another massive rebrand of every strain causing massive delays and a totally undesirable medical market which is what they seem to want .

 

[GrownHealth]

Thanks for the welcome. All it’ll take is MHRA to like the approach Noidecs is taking and then enforce it on all and then we’ll see another massive rebrand of every strain causing massive delays and a totally undesirable medical market which is what they seem to want .

No problem .
I look at other countries with hope and think that's got to be where were heading GYO and eventually decriminalisation but then we see stuff like you mention above and it doesn't fit at all ,hopefully patient awareness of this stunt deters other prospectors from trying it but I fear patients at clinics that encourage these products will suffer as they promote these noname products especially new patients who are non the wiser to these stunts.

 

[AutisticStoner]

I look at other countries and get hope and 4C Labs reduced weights made me think we are starting to do things that make sense but they get rejected. I see quality go up then Aurora® the one I considered most reliable starts pumping out a load of dead flower. I’ve already seen the Noidecs get recommended and them asking what strain it is which obviously nobody can answer I can’t stand the attitude of you don’t deserve to know what medication we are giving you it’s infantilising. You wouldnt accept a doctor giving you a generic prescription for pain pills then you ask what they are giving you they say we are the doctors you don’t need to know.

 

[Martybones]

Do I agree with it? No. Can I see why, yes...It will look like a pack of Amoxicillin, but considering I jar everything anyway, I'm not too fussed as long as I can see and read the strain on the side and know what it is. I can see why they're trying to avoid the commercial side of the market and let's face it, who's bought some BM before because of the name and/or packet ?
If anything I hope it means people are looking more at terpenes for their medicinal reasons and choosing the right strain, the first time rather than wasting a fortune because it has cookies in its name.

What I'd like to see for people less savvy or aware of MedBud.wiki etc, is more education for patients by clinics. Where to find further info on terpenes, and what it good for their conditions etc. Patients can then make informed decisions with no favouritism by commercial interest of the clinic. how many times have you had a repeat appointment lasting 2-3 minutes for your £50? They can do better and it should be their responsibility if they are to give people free choice of bud in most clinics - again which I have access to and agree with.

 

[GrownHealth]

Patients can then make informed decisions with no favouritism by commercial interest of the clinic

That is the aim for me
On the terpenes even by displaying the amounts it would spike peoples curiosity to learn but we struggle to get that info half the time and definitely not displayed on the pots this should be standard by now .
Agreed on the names but absolutely need to now what it is and it's lineage so the abbreviating them as suggested is no biggy for me

 

[AutisticStoner]

Do I agree with it? No. Can I see why, yes...It will look like a pack of Amoxicillin, but considering I jar everything anyway, I'm not too fussed as long as I can see and read the strain on the side and know what it is. I can see why they're trying to avoid the commercial side of the market and let's face it, who's bought some BM before because of the name and/or packet ?
If anything I hope it means people are looking more at terpenes for their medicinal reasons and choosing the right strain, the first time rather than wasting a fortune because it has cookies in its name.

What I'd like to see for people less savvy or aware of MedBud.wiki etc, is more education for patients by clinics. Where to find further info onterpenes, and what it good for their conditions etc. Patients then make informed decisions with interest of the clinic. how many times have you had a repeat appointment lasting 2-3 minutes for your £50? They can do better and it should be their responsibility if they are to give people free choice of bud in most clinics - again which I have access to and agree with.

I’m not so bothered about them not putting names like Cat piss as there brand name I’m okay them renaming aslong as they have the real name somewhere and the lineage but if they start saying it’s like red 1 and blue 3 and hide the lineage so you can’t make a informed decision then it becomes unacceptable to me. I wouldn’t let a NHS doctor prescribe me medication if they refused to tell me what there prescribing.Main reason I left Bm is cause it’s hard to know what ur getting and now that could potentially become even worse on MC the fact Noidecs are even allowed to do it I find insulting I hope this is corrected and lineage becomes a requirement. My

 

[Martybones]

I’m not so bothered about them not putting names like Cat piss as there brand name I’m okay them renaming aslong as they have the real name somewhere and the lineage but if they start saying it’s like red 1 and blue 3 and hide the lineage so you can’t make a informed decision then it becomes unacceptable to me. I wouldn’t let a NHS doctor prescribe me medication if they refused to tell me what there prescribing.Main reason I left Bm is cause it’s hard to know what ur getting and now that could potentially become even worse on MC the fact Noidecs are even allowed to do it I find insulting I hope this is corrected and lineage becomes a requirement. My

Couldn't agree more with this! Information is power.

 

[AutisticStoner]

Couldn't agree more with this! Information is power.

MedBud has been amazing with how much information I’ve gained from it I can choose my strains with like a 90% success rate cause of how useful the information is it’s made my experience far easier and to know they could end up handicapped by companies withholding information just disappoints me.

 

[GrownHealth]

MedBud has been amazing with how much information I’ve gained from it I can choose my strains with like a 90% success rate cause of how useful the information is it’s made my experience far easier and to know they could end up handicapped by companies withholding information just disappoints me.

Totally agree on getting info from MedBud and it made my Medical Journey better informed and now as I'm changing clinics its here again with the info I need .
in fact if it was left to my clinic for strain info I would get a strain name THC content and price to choose from and then spend hours searching for info on them on the net .

 

[AutisticStoner]

Totally agree on getting info from MedBud and it made my Medical Journey better informed and now as I'm changing clinics its here again with the info I need .
in fact if it was left to my clinic for strain info I would get a strain name THC content and price to choose from and then spend hours searching for info on them on the net .

I highly rate my clinic and it still totally lacks information it doesn’t differentiate between beta and gamma it just says irradiated doesn’t give any terp info I got excited for a second seeing pink cookies on Montu then saw it’s Gamma on here and now it’s a swerve another win for MedBud Good luck on your move