The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations
This is an email from the MHRA to a CBD/Hemp supplier which name is redacted. It clearly sets out the MHRA’s position regarding the Cannabis Trades Association, its ‘Cannabis Products Directive’ proposal and how anyone is able to obtain advice from the MHRA without having to join any trade association. It also explains how medical claims may only be made about a CBD product if it has the required licence known as a marketing authorisation.
This is authoritative guidance from the medicines regulator which is an agency of the Department of Health and Social Care. If you have received alternative guidance or suggestions that you must join a trade association to sell CBD products, this is incorrect.
From: xxxx.xxxx@mhra.gov.uk
Date: October 2018
Subject: CTA and CBD
To: Redacted
Dear xxxx,
Thank you for your email of 22ndSeptember 2018 to the Agency. Please note that we can only comment with regards to our position and advise you to contact appropriate Government Departments with regards to obtaining their views.
The CTA represent a number of companies in the UK who market CBD and they have proposed a framework, which they have termed the ‘Cannabis Products Directive’, that effectively sets out quality requirements for their members.
The Medicines Borderline Section of the MHRA has been clear from the outset that we will work with companies and trade bodies to ensure compliance in respect of CBD products. This is in line with our approach across the borderline and we do not require a company has membership of a trade body to enter into dialogue with us. There are a number of trade bodies, covering a range of product types who are well versed in borderline matters and they are able to advise companies but, if a company does not want to become a member, we can provide them with advice regarding their products. On occasions we may work with trade bodies; as they are able to communicate information on our behalf to their members and we may assist them if they want to come up with guidance on a specific aspect etc. However, ultimately MHRA is responsible the licensing of medicines and for the classification of borderline medicinal products and this cannot be passed to third parties.
We list a large number of trade bodies etc who have an interest in borderline matters in a ‘Useful addresses’ Appendix in our Guidance Note 8 (GN8).
Our current position with regards to CBD is as follows:
MHRA has offered an opinion on the regulatory status of CBD and advised that we are currently evaluating the evidence of pharmacological effect. At present we are providing the following general guidance to enquirers until we determine the status of CBD.
MHRA is of the opinion that products containing CBD, when used for a medical purpose, should be regulated as medicinal products. The MHRA’s opinion has been issued at this stage with the intention of seeking voluntary compliance by companies supplying CBD for medical purposes. This does not preclude MHRA from seeking to use Part 9 of the Human Medicines Regulations to classify any particular product.
A “medicinal product” is defined in Article 1 of Council Directive 2001/83/EEC and included as Regulation 2 of the Human Medicines Regulations. The definition is as follows:
(1) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(2) Any substance or combination of substances which may be used by or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”
In respect of the first limb of the definition, were you to market any product that makes a medicinal claim, this would mean that the product falls within the definition of a medical product. For the avoidance of doubt, you should also be aware that this includes any testimonies, studies, links to articles, historical uses etc that you may wish to include on your website or any other promotional material. Further guidance in relation to medicinal claims can be found in our Guidance Note 8
Insofar as the second limb of the definition of a medical product applies to your products, it is a matter of fact that there have been a number of clinical trials which demonstrate that CBD has a therapeutic effect, particularly in the treatment of severe epilepsy. MHRA’s clinical assessors have reviewed relevant scientific and clinical evidence to support the mode of action of CBD in the treatment of a range of medical conditions. It should also be noted that the European Medicines Agency has given CBD products an orphan designation on four occasions, for three different clinical conditions; graft versus host disease, perinatal asphyxia and Dravet syndrome.
The MHRA is now working with trade bodies in relation to making sure products containing CBD, used for a medical purpose, which can be classified as medicines, satisfy the legal requirements of the Human Medicines Directive as transposed into UK law by the Human Medicines Regulations 2012. This work is ongoing. Given the ongoing evaluation, MHRA can give no assurance that any particular product, including products under development, will not subsequently be classified as a medicinal product.
‘The advice contained within this email relates to the MHRA’s opinion regarding the status of CBD. The Home Office can advise on psychoactive substances and the Misuse of Drugs Act and any products which are subject to these regulations. Your products must comply with the relevant regulations at all times. It is possible that your products may contain residual levels of THC, and/or other controlled substances. We therefore advise that you contact the Home Office first who can advise in respect of psychoactive substances and the Misuse of Drugs Act. The Home Office can also advise with regards to what licences will be required to grow/import/export such products/substances from/into the UK. Please note that we are only providing general information above and this is in no-way, shape or form an approval of any product. We have not seen any information relating to the products in question and therefore, we cannot comment on its acceptability. If you wish to license your products as medicines in the UK then the attached links provide more information about how to obtain a marketing authorisation (MA) in the UK which we hope you will find helpful. Home Office has also published a Factsheet in respect of CBD and you are advised to review this first: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/674713/Factsheet-_Cannabis__CBD_and_Cannabinoids-_January_2018.pdf
The Agency reserves the right to change its view in the event of any information or evidence which has a bearing on the status of the products, including the way in which they are presented and promoted. This also includes any information, which we have not assessed. You should seek independent advice or consult a suitable trade association or the appropriate regulatory authority about the acceptability of any product you are considering selling, supplying or advertising.
The licensing process is by no means easy, especially with little regulatory knowledge. We have included links below which will direct you to the relevant pages on the MHRA website. As an indication of the Legal Basis, you should focus on an 8(3) Full Application, submitted under the complex fee. A National procedure is for authorisation in the UK only.
In order to market the product in the UK, a Marketing Authorisation is required. As there are no step by step guidelines, please see the below links for the submission of new marketing authorisation applications (MAA).
https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk
(Guidance regarding how to apply for a market authorisation in the UK)
http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm
(EU scientific guidelines for medicinal products)
(Licence application forms)
https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees
(Fees)
(MHRA fees definitions)
Furthermore, to obtain marketing authorisations in the UK you must have a registered office or representative either in the UK or another EU member state. GMP (Good Manufacturing Practice) inspections will take place after marketing authorisation applications have been submitted if the site has not been inspected by an EU authority in the last 3 years and does not hold a valid GMP certificate.
Please see the below link with regards to the requirements for having Manufacturers and Wholesale Dealers licences: Importers Licence queries.
https://www.gov.uk/apply-for-manufacturer-or-wholesaler-of-medicines-licences
Statement Concerning The Cannabis Trades Association UK
With regret, I have withdrawn my endorsement of and support for the Hemp Trade Association Ltd (HTA) trading as Cannabis Trades Association UK (CTA).
I created and founded CTA in September 2016. Since November 2016, HTA has traded under the CTA name with my permission and I was appointed to its advisory board. That permission has been withdrawn from 18th October 2018 and I have resigned from the advisory board with immediate effect.
The reasons behind this are complex and great effort has been made to resolve differences and agree a way forward but this has proved impossible to achieve. The reasons include but are not limited to:
Systematic Dishonesty
Over the two years of HTA’s existence many false claims have been made, in particular about HTA’s relationship with the MHRA and FSA, alleged exclusive stakeholder arrangements and HTA’s ‘authority’ to regulate the CBD market. Further claims have been made by the chairman about his links with the security services, other Home Office staff, ‘inside information’ and unlawful use of government computer systems to run DBS and criminal record checks on prospective members. HTA’s reputation and that of its members was severely damaged by the chairman’s recent conduct in relation to the States of Guernsey, which resulted in official government repudiation of his claims, and his personal feud with a major CBD supplier which is not a member.
Misuse of Members’ Funds
Members pay membership fees primarily in order to have their interests effectively represented to government and the authorities. In practice, very little if any of this takes place and instead membership fees are used to finance the chairman’s ambitions to establish the Cannabis Products Directive (CPD) across Europe. While some members are supportive of the CPD initiative, it is not HTA’s purpose, nor is extending HTA’s operations outside UK.
Failure to Represent Members’ Interests
Instead of representing members’ concerns and interests to the authorities, HTA acts as an enforcer for the authorities. The chairman has confirmed in writing that HTA will “never go against” and will always “work with the authorities”. Members who have complained about lack of action against non-compliant CBD suppliers have been told to “stop bitching”. Non-compliant CBD suppliers is the issue of principal concern to members but HTA has failed to take this up effectively. As a result, it is a positive disadvantage to be a member of HTA as members are subject to stricter enforcement and additional costs than non-members.
Maladminstration of HTA, a Company Limited By Guarantee
HTA was fomed as company limited by guarantee deliberately to place control in the hands of its members rather than its directors. Members have not been properly included in decisions. They have been subjected to autocratic rule, prevented from obtaining proxy votes and resolutions at general meetings have been railroaded through without time for proper discussion. Protests by members at such treatment have resulted in them being ejected from discussion groups.
Bullying, Threats and Intimidation
A large number of reports have been received from former and current members detailing instances of such behaviour as coercion to join HTA or to comply with HTA policies.
Chairman’s Antecedents
Evidence has come to light which reveals that the chairman has a string of 28 dissolved companies behind him and a large number of oustanding county court judgements relating to those companies. He is also indebted to the company of another director of HTA in a substantial five figure sum for a period in excess of two years with no effort made to commence repayment. As a result that director has now resigned.
Unlawful Restrictions on Members
Legal advice has been received which confirms that HTA has been exercising unlawful restrictions on members preventing them from trading freely. This supports allegations that have been published accusing HTA of running a ‘protection racket’.
Will I Be Able To Get Cannabis Prescribed On The NHS?
With the publication of new regulations yesterday, it is now clear how cannabis will be available on the NHS starting on 1st November 2018.
Only consultants will be able to prescribe cannabis and it will be entirely up to each consultant to make a decision about individual patients. The definition of cannabis-derived medicinal products is sufficently wide that both oils and herbal cannabis manufactured to GMP (Good Manufacturing Practice) standards will be available.
There is very little explanation included in the regulations but the intention is that prescribing guidance will be developed over time by NICE (National Institute for Health and Care Excellence). The regulations prohibit smoking cannabis for medical use but if your consultant decides it is appropriate for you, they will be able to prescribe herbal cannabis for vaping. Apart from Sativex, all cannabis products are unlicensed medicines described as ‘specials’, so your consultant is supposed to consider licensed medicines first.
There are no restrictions on which conditions cannabis can be prescribed for. Again, it will be up to your consultant to decide.
So this is marvellous news. It is a fundamental breakthrough and its impact will be enormous but it will take time for it to start working effectively.
The law is no longer an obstacle. The biggest problem now is that very few consultants have any knowledge of cannabis at all and most are probably going to be very reluctant to prescribe. For the best part of a century, doctors, just like the rest of society, have been subject to a relentless flow of propaganda and false information about cannabis. Changing this with medical training, helpful prescribing guidelines and overcoming unjustified prejudice and fear are the new challenges we face.
To begin with, a lot of people will be disappointed because their consultant will be unwilling to prescribe. The first thing you can do about this is ask your GP to refer you to a different consultant but it may be some time before understanding develops and consultants are sufficiently informed. Almost certainly there will be more resistance to prescribing herbal cannabis and it will be easier to get oil.
As ever, the best thing to do is gather evidence on the use of cannabis for your condition(s). If you are well informed and prepared then you can help to educate your consultant. There is now an enormous amount of evidence available online. Just be careful to use proper scientific information and avoid the miracle cures and exaggeration that is still widespread.
Whilst not everyone will immediately be able to get the medicine they need, we are now on the correct path. Instead of politicians imposing their ignorant opinions on you, your doctor will now be making the decisions and that is the way it should be. In time the right to prescribe will be extended to GPs. For now the truly wonderful news is that we are no longer engaged in a battle with the law. What it’s about now is patience and education.
Arrival After A 36 Year Journey.
Today I have arrived at the destination I set out for in April 1983 when I first gave evidence on the use of cannabis as medicine to Parliament at the Home Affairs Select Committee Inquiry into ‘Dangerous Drugs’.
Sajid Javid MP, the Home Secretary, has announced that from 1st November 2018, consultants will be able to prescribe cannabis on the NHS. This will include herbal cannabis produced to GMP standards by organisations such as Bedrocan and Tilray.
I am only one of thousands of people who worked on this campaign and I congratulate all those with whom I have shared this journey. In these 36 years there have been more than 22,000 scientific papers published demonstrating the safety and efficacy of cannabis for a wide range of medical conditions. This is how long it’s taken to get policy changed in the UK in accordance with evidence.
It’s appropriate that it should fall to the son of a Pakistani immigrant finally to sweep aside the prejudice and wilful ignorance that has stood in the way.
Nick Hurd MP, The Home Office And Their Massive Broken Promise On Medicinal Cannabis.
On 29th June 2018 in The Times newspaper, Nick Hurd MP, minister of state at the Home Office, published the following promise:
“If medicinal and therapeutic benefits are identified, the intention would be to reschedule cannabis-related medicine as a treatment available through GPs. Whilst recent cases in the media have involved epilepsy this would be open to patients suffering from all illnesses where such treatment is identified to benefit them.”
Source: ‘Out-of-date rules must not come before compassion for those who need medicinal cannabis’
Recently, including in response to a written parliamentary question on 7th September 2018, this promise has been dramatically broken and Mr Hurd’s message is now wholly different:
“The Home Secretary has confirmed that cannabis-derived medicinal products will be rescheduled. This means that senior clinicians will be able to prescribe the medicines to patients with an exceptional clinical need.”
Source: ‘Cannabis: Medical Treatments:Written question – 167359’
So ‘GPs’ has now become ‘senior clinicians’ and ‘open to patients suffering from all illnesses where such treatment is identified to benefit them.’ has become ‘exceptional clinical need’. These are dramatic and far reaching changes which wholly change the nature of the promise made by Nick Hurd and will result in a highly restricted and limited regime making it very difficult for anyone to access cannabis as medicine.
This is a betrayal of the estimated one million people in the UK currently using cannabis to treat medical conditions. It demonstrates how when this issue was in the headlines it provoked what was a sensible, measured and appropriate response. Now that the media storm has passed, in typical Home Office style, a totally different, hardline and repressive policy is being pushed through as quietly as possible. No attempt has been made to explain why there has been such a dramatic change and it is quite clear that the Home Office hopes this will go through without attracting media attention.
CLEAR has submitted an FOI Request seeking a full explanation which can be seen here: ‘Provide full details concerning minister’s broken promise on the use of cannabis as medicine’
Chuka Umunna Wants To Make Britain’s Failed Democracy Even More Dysfunctional.
Those 650 people in the House of Commons who earn fat salaries and enjoy very generous expense accounts have failed us beyond redemption. The huge opportunity that was Brexit, that we chose by referendum in the most fundamental exercise of democracy, has been destroyed by bickering, self-interest and incompetence.
I first walked into the Palace of Westminster in 1983 and since then, particularly in the last seven years, I have met and worked with many MPs from cabinet ministers to renegade backbenchers. Sadly, my conclusion is that with barely a handful of exceptions they are useless, mostly a waste of our time and money and more of an impediment to our peace and prosperity than anything else.
Our two party system, our archaic parliamentary procedures, our hopeless first-past-the-post voting mean that British democracy is not fit for purpose. It doesn’t benefit us, the people, it only serves those who work in the Westminster bubble. Yes, I include the parasite commentators, journalists, lobbyists and civil servants as well, where again I would make precious few exceptions.
Now Chuka Umunna, a politician who I have always disliked for his creepy, pious, virtue signalling personality, is whining about the exercise of true democracy in the Labour Party where unpopular MPs are being deselected by the party membership. He would prefer that the Blairite-dominated Parliamentary Labour Party of a few hundred members should override the half a million party members. He wants to see power placed firmly back in the hands of Labour’s MPs and let’s be clear, Blairite MPs are particularly heinous examples of the corrupt, self-serving waste of our time and money that I complain of.
He even calls party members “dogs” in a display of the most outrageous hypocrisy from a man who has been at the forefront of criticising other people’s language in the fake antisemitism row, the bickering over Brexit and the wildly exaggerated attacks on men and heterosexual culture. He is a pimp who whores out his own media profile for personal gain, irrespective of truth, justice, decency and least of all the electorate which pays his wages.
It is MPs who should more accurately be described as dogs, perhaps wolves, who prey on the electorate solely for their own purposes. The sooner these arrogant, out-of-touch animals from all parties are brought to heel the better. It’s trite to say that Guy Fawkes had the right idea but while I wouldn’t blow them all up (we should preserve the building at least!), I would sack them all tomorrow. I’d make them all stand for re-election under a proportional representation system and I’d ensure that any of them could be forced to stand again at any time at the behest of a significant number of their constituents. No system of democracy could be worse than what we have now. In fact, the British parliamentary system barely deserves the name.
Chuka Umunna, Theresa May, Margaret Hodge, Chris Grayling – yes, these are examples of MPs who I believe have no place at all in our system of government and there at least 600 others who come a very close second. Our Members of Parliament are a disgrace. They have let us all down again and again and the Brexit fiasco should be the final straw.
Review. Hydrology 9 Vaporiser.
The Hydrology 9 has reawakened my enthusiasm for vaporisers. It has its faults but overall this is a great machine and a real advance in vaporiser technology. It also has one nifty little feature that is very simple but makes a huge difference. It’s genius in fact and more of this later.
I’ve assessed it over about four weeks and all that remains is to see how well it lasts. This is an expensive machine at around £200.00 and if it packs up after a few months that isn’t going to be any good. I have high hopes though. Like all vaporisers it does need looking after and regular cleaning. The problem with some is that the dismantling and cleaning is what causes them to deteriorate.
The first and golden rule about vaporisers is that they all take practice before you learn to use them properly. Each one is different and until you get the ‘knack’ they can all seem very frustrating. The Hydrology 9 is no exception and it took me a week before it finally started working for me. As usual, I was at the point of giving up and then suddenly everything clicked. Another three weeks on and it’s become a very special friend, I am loving it!
The most dramatic effect of starting to use it regularly is that my consumption of cannabis has plummeted. What I would put in one neat joint fills the Hydrology 9 about six times over, far more than I want to consume in a whole evening. The quality of the high is much better as well, smoother, cleaner, fresher and, well, higher! If you’ve never really appreciated vaping before, the breakthrough comes when you realise that half of the effect from smoking a joint is the carbon monoxide fugging up your brain. I’ll never stop smoking joints because I enjoy them and sometimes nothing else will do but vaporising has to be first choice.
It’s very well made. The water chamber isn’t entirely leak free but not so that it’s a problem as long as you keep it tightly closed at both ends. You load it at the bottom by unscrewing the bottom lid to reveal a small chamber. When you screw the lid back on there’s an outer revolving ring that operates a stirrer inside the chamber. This is the genius feature that I was referring to. It enables you to stir the weed while you’re actually vaping it, ensuring the hot air reaches all the way through and it’s thoroughly consumed. A simple but incredibly effective idea that I’m sure we will soon see on other vaporisers.
My only reservation is that I don’t think the battery is powerful enough. I have settled on using it at its fourth highest out of five heat settings. If it’s freshly charged then it will just about last for three or four fully-loaded chambers – but only just. You have to be careful to give it a rest before each inhalation. Go back on it too quickly and the heat will drop right off. Of course, you do get used to it and learn to adapt the way you operate it but I would definitely prefer a more powerful battery. This raises one other concern about its longevity. How long will the battery last and what will it cost to replace it? My favourite to date handheld vaporiser has been the Puri5 Magnum 2. My best investment with this has been to purchase three spare batteries and a mains charger. It’s very easy to swop an exhausted battery for a new one and I always have one fully charged on standby. This, perhaps with a more powerful battery is the only significant improvement I would like to see in the Hydrology 9.
Overall I rate the Hydrology 9 extremely highly and although I haven’t yet come to a final conclusion, it may well yet take the accolade of being my favourite ever vaporiser.
Sainsbury’s Now Stocking Legal Cannabis Products As UK Policy Looks Increasingly Shambolic.
In another demonstration of how fast attitudes are changing, Love Hemp water containing soluble CBD cannabis extract is now on sale in a number of Sainsbury’s stores.
This is a remarkable achievement by the team at Love Hemp who are remaining tight lipped about the terms of the deal. A store manager told me that the product is on test in about 100 stores.
Cannabis prohibition is crumbling and the Home Office seems increasingly our of touch with reality with its futile attempts to enforce a policy which nobody is taking any notice of. The real effect of the medical reforms should become clear within the next few weeks. The expert panel process has been revealed as little more than a farce. We still have an outstanding FOI Request on the issue but interim responses seem to confirm that not a single member of the panel, so-called ‘experts’ has any knowledge, experience or expertise in the use of cannabis as medicine.
We await the definition of a cannabis-based product which will determine which products will be re-scheduled and also a decision on who may prescribe. Initial overtures from the MHRA to both CLEAR and the CTA to consult on these issues have come to nothing. It seems that little if anything has been achieved over the summer break.
Home Office licensing policy is also looking increasingly ridiculous. It is refusing any licence application for low THC cultivation where any mention of CBD is made, while every other EU country is striding ahead and British CBD suppliers are having to import all their oil, which they do without any difficulty uner EU free movement rules.
A twist which reveals the absurdity of Home Office policy is that Love Hemp water, which is entirely THC free, is not the first cannabis product that Sainsbury’s has stocked. For many years it has been stocking Good Hemp hempseed oil. Recent lab tests have revealed that THC levels in Good Hemp oil exceed the 1mg limit in each bottle, meaning that it cannot be regarded as exempt under the Misuse of Drugs Regulations. In reality then Sainsbury’s is selling a product that is legally classified as a class B drug.









