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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘hemp

The MHRA On CBD/Hemp Products And Its Relationship With Trade Associations

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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.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2014/11/human_orphan_001425.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2016/10/human_orphan_001832.jsp&mid=WC0b01ac058001d12b

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2015/08/human_orphan_001612.jsp&mid=WC0b01ac058001d12b

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)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#application-process-all-procedures

(Licence application forms)

https://www.gov.uk/apply-for-a-licence-to-market-a-medicine-in-the-uk#fees

(Fees)

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/313624/MHRA_fees_definitions.pdf

(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

 

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Written by Peter Reynolds

October 18, 2018 at 12:41 pm

WARNING. CBD Flowers, Buds, Weed, Hash Are NOT Legal In The UK.

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This is an extremely serious warning which people need to take seriously.  Both CLEAR and the Cannabis Trades Association have independently dealt with several people who are being prosecuted for possession. The law treats these products exactly the same as any other cannabis. It makes no difference what the THC level is, it is a class B drug and the penalty for possession is up to five years in jail and an unlimited fine.

The confusion arises because of the misunderstood idea that the legal limit for THC is a maximum of 0.2%.  This is the limit for a low THC cultivation licence for what is defined as industrial hemp – but you still need a licence!  Without the licence the law regards industrial hemp exactly the same as the highest THC cannabis that the tabloids would describe as ‘super strength skunk’.

Products ‘derived from’ industrial hemp such as CBD oil or hemp teas can be ‘exempt products’ but there is yet more confusion here.  The THC limit in these products is not 0.2% because, self-evidently, when you extract oil from a low THC cannabis plant you concentrate the THC.  The limit in these products is 1mg of THC per container.  It doesn’t matter how large or small the container is, the limit is 1mg.  That limit also applies to the other ‘controlled drug’ found in such products, cannabinol (CBN).  ‘Exempt products’ must not contain more than 1mg of THC and/or 1mg of CBN in any single container.  The law that defines this is the Misuse of Drugs Regulations 2001. 2.(1)(c).

There are a number of websites offering these products for sale and, notoriously, one particular shop in Portobello Road.  Whilst these sellers may well misunderstand the law, ignorance is no defence. It is almost inevitable that sooner or later one or more of these sellers will be prosecuted and go to jail.

An email seeking confirmation of the position from the Home Office was replied to as follows:

“Thank you for your email.

I can confirm that the leaves and flowers of the genus Cannabis are controlled and defined as cannabis as outlined in Section 37(1) of the Misuse of Drugs Act 1971

“cannabis” (except in the expression “cannabis resin”) means any plant of the genus cannabis or any part of any such plant (by whatever name designated) except that it does not include cannabis resin or any of the following products after separation from the rest of the plant, namely—
(a)mature stalk of any such plant,
(b)fibre produced from mature stalk of any such plant, and
(c)seed of any such plant;”.

Once the separation of the stalk and seeds from the plant has occurred it will not be defined as cannabis. This also extends to the fibre produced from the stalk.

Regards

Jill Frankham
Senior Compliance Officer
Drugs & Firearms Licensing Unit”

 

 

Written by Peter Reynolds

July 8, 2018 at 4:35 pm

Posted in Consumerism

Tagged with , , , ,

CLEAR and GroGlo Establish First UK Clinical Trials on Cannabis for Chronic Pain.

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groglo banner

CLEAR has formed a partnership with the research arm of GroGlo, a UK-based manufacturer of high power, LED, horticultural grow lighting.

The plan is to grow cannabis under a Home Office licence for the production of cannabis oil, both as a dietary supplement and for the development of medical products.  To begin with, a low-THC crop of industrial hemp will be planted.  We will be using the finola strain, originally developed in Finland and known for its short stature and early flowering. Unlike hemp grown for fibre, finola is usually grown for seed and only reaches a height of 160 – 180 cm but we will be removing male plants before they produce pollen and cultivating the female plants to produce the maximum yield of oil from their flowering tops.

Finola Industrial Hemp

Finola Industrial Hemp

The low-THC oil will be marketed as a dietary supplement, commonly known as CBD oil. There is already a burgeoning market in the UK for CBD products, all of which is currently imported from Europe or the USA.  In the USA, the CBD products market was said to be worth $85 million in 2015 so there is huge potential here at home. Aside from the benefit of being UK grown and processed, we anticipate achieving a CBD concentration of about 40%, which is higher than most products already on the market.

Cultivation will be in glasshouses supplemented with LED lighting.  GroGlo already has an established glasshouse facility in the east of England.  Initial trials will experiment with adjusting the LED technology to provide a changing blend of light wavelengths at different stages of plant growth.  This is GroGlo’s area of expertise -combining LED lighting and plant sciences, including existing relationships with some of Europe’s top universities. Professor Mick Fuller, GroGlo’s director of plant science, will lead this research and development process.

Professor Mick Fuller

Professor Mick Fuller

During the R&D phase, CO2 extraction of oil will be carried out under laboratory conditions at universities in York and Nottingham which already have extensive experience of the process. Each crop will be measured for yield, cannabinoid and terpene content using high pressure liquid chromatography (HPLC).  Safety testing will also look for the presence of heavy metals and other contaminants.  The results of testing will be fed back into cultivation and extraction processes to maximise yield and quality.

It is anticipated that the first batches of low-THC oil will be ready for market in six months.  We are already in discussions with potential distributors and wholesalers. The CBD market in the UK is ripe for an effective marketing campaign which could build a very substantial business for whoever gets it right.

Once we are successfully achieving our production goals with low-THC cannabis, the same testing and development process will begin with high-THC varieties of cannabis.  The aim will be to produce a range of oils extracted from single strains, selectively bred and stabilised for different THC:CBD ratios.

Professor Fuller says that GroGlo lighting products “are in use worldwide to grow a range of crops, but some 60% of sales currently come from overseas users growing cannabis for legitimate medical use.”  He explains that there is an emerging market for all sorts of nutritional and medicinal plant products but cannabis shows particular promise. GW Pharmaceuticals is the only UK company to enter this market and it has become a world leader, despite the current restrictive legislation.  He says:  “Together with CLEAR we believe we can help bring a range of safe, high quality UK-produced cannabis products to market within a matter of two to three years.”

A key issue in the development of a successful medicinal cannabis product is the method of delivery.  Smoking is not an acceptable solution as inhaling the products of combustion is an unhealthy practice but one of the great benefits of cannabis smoked as medicine is very accurate self-titration.  That is the effects of inhaled cannabis are felt almost instantly and so the patient knows when they have taken enough or when they need more to achieve the required analgesic effect.

The oral mucosal spray developed for Sativex is unpopular with patients, many complain of mouth sores from its use and it was developed at least as much with the objective of deterring ‘recreational’ use of the product as with delivering the medicine effectively. It strangles the therapeutic benefits of the cannabis oil of which Sativex is composed in order to comply with the concerns of the medicines regulators about ‘diversion’ of the product into what they would term ‘misuse’.  Absorption of the oil is quicker through the mucous membranes of the inside of the mouth than through the gastrointestinal system but, inevitably, some of the oil is swallowed and the pharmacology of cannabis when processed through the gut and the liver is very different.

We believe the best option is a vapouriser device and our intention is to source a ‘vape pen’ of sufficient quality to operate within clinical standards of consistency and safety. Vapourising cannabis oil avoids inhaling the products of combustion but still enables accurate self-titration of dose.  A vape pen would provide a handy, convenient and very effective method of consuming medicinal cannabis.  However, aside from the technology itself, initial research shows that vapour is more effectively produced when the oil is blended with either vegetable glycerin (VG) or propylene glycol (PG).  Establishing the correct ratio of VG or PG to the oil is another important task.

We anticipate that clinical trials for the use of cannabis oil in treating chronic pain could start within two years.  We want to compare different oils, ranging from high-CBD to equal ratios of THC:CBD and high-THC content. Prior to that we have to overcome the challenges of cultivation, oil extraction, vapouriser development and assemble the necessary research team and gain ethical approval for the trials.  Recruitment for the trials will start in about 18 months time.  If you wish to be considered please email ‘paintrials@clear-uk.org’ with brief details of your condition (no more than 100 words). Do not expect to hear anything for at least 12 months but your details will be passed to the research team as a potential candidate.

Mike Harlington, Managing Director of GroGlo

Mike Harlington, Managing Director of GroGlo

CLEAR is promoting this venture simply because someone needs to do something to make this happen. For all the campaigning and lobbying of MPs and ministers, at the end of the day, the plants have to be grown and the various legislative hoops have to be jumped through. We cannot wait any longer for a radical change in the law. We have to progress through the government’s regulatory regime if we want to bring real therapeutic benfit to patients.

This opportunity arises because of the vision of GroGlo’s managing director, Mike Harlington and the team of experts he has built around him. There is huge demand for legitimate medicinal cannabis products in the UK which is only going to increase with the inevitable progress towards law reform and increasing awareness of the benefits of cannabis. Together, CLEAR and GroGlo are bringing the great hope that medicinal cannabis offers closer to reality than ever before.

 

Drugs Policy Goes To Police Minister.

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Mike Penning, MP. Minister for Policing, Crime and Criminal Justice

Mike Penning MP

The Home Office has confirmed that responsibility for the UK drugs strategy goes to Mike Penning, MP for Hemel Hempstead, the Minister for Policing, Crime and Criminal Justice.

This must be indicative of the attitude that we can expect from the new Conservative government.  It would seem that this is a hardening of drugs policy as being a criminal justice issue rather than something to do with health.

Ironically, Penning is MP for a constituency that takes its name from the long history of cannabis cultivation in the UK.  Hemel Hempstead means Hemel’s cannabis farm.  Cannabis hemp was, of course, one of the most widely grown agricultural crops prior to the 20th century for its tremendous value as fibre for rope and textiles. Its history as a source of medicine has been largely forgotten but it was widely used and as many as half of all medicines in the British pharmacopoeia once contained cannabis. Without doubt cannabis was used as a recreational drug as well but the experiment of prohibition which began in 1928 has obscured all this history.

Penning is on record as a hardliner on drugs policy. In February 2015, he publicly rebuked Mike Barton, chief constable of Durham, saying:

“I do not agree at all with the chief constable of Durham. I have told him so and I will continue to tell him. Drugs are a scourge in our society and we must do everything we can to crack down on them.”

He has also twice submitted written questions asking how many deaths there have been from cannabis.  Of course, on both occasions the answer has been none but it reveals a worrying lack of knowledge and suggests a readiness to listen to or even promote evidence-free scaremongering.  He has also been responsible for the dreadful drug driving legislation, widely criticised by all informed parties and a classic example of bad lawmaking driven by the tabloid press rather than by evidence.

So this is very worrying and depressing news for those interested in drugs policy reform.  CLEAR will be reaching out to Mr Penning through our network of supportive Tory MPs and we will be seeking a meeting as soon as possible to present our case.  Most urgently we will seek his support for allowing the prescription of medicinal cannabis by doctors.

This reinforces my view that CLEAR’s strategy of engagement and persuasion is the correct way forward. Protests and making demands never have worked and never will, particularly with ministers like Penning.

Sometimes it seems that some UK politicians are oblivious to what is happening in the US, Uruguay, Israel and across Europe, not just on access to medicinal cannabis but on wider drugs policy reform.  That will be another objective; to educate and inform him of policies that more enlightened jurisdictions are pursuing and the great benefits for public expenditure savings, new tax revenue, health, crime and Tory values of individual liberty and free enterprise.

Written by Peter Reynolds

May 16, 2015 at 12:25 pm

The Future Of Cannabis In Britain Is CLEAR

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Last Thursday, 24th March 2011, the latest ballot of the membership of the Legalise Cannabis Alliance closed.  By a two-thirds to one-third majority the members voted to adopt a new constitution and to change the party’s name.  From that moment on we are known as Cannabis Law Reform or CLEAR.

We have moved away from the use of the word “legalise” because it is interpreted as meaning a free for all.  It scares people, particularly politicians and the media and we, as a party, now understand that these are the people we need to influence if we are to advance our cause.

We have also refined and sharpened our aims and objectives.  They are now simple, direct and clear:

  1. To end the prohibition of cannabis.
  2. To promote as a matter of urgency and compassion the prescription of medicinal cannabis by doctors.
  3. To introduce a system of regulation for the production and supply of cannabis based on facts and evidence.
  4. To encourage the production and use of industrial hemp.
  5. To educate and inform about the uses and benefits of cannabis.

Medicinal cannabis is our spearhead.  We seek an end to prohibition for everyone but we demand immediate provision for those who need cannabis as medicine.  It is an obscene and evil shame on our nation that so many who suffer are in fear of arrest and prison for using a medicine that transforms their lives.

We will build a new and effective brand and campaign.  We are reasonable, responsible, respectable members of society from all walks of life and professions.  We are discriminated against by an irrational and absurd policy.  Cannabis is a wonderful thing.  It is relatively harmless but it is a psychoactive substance and needs to be respected. It’s medicinal value is unparalleled but it also offers wonderful recreational, spiritual and creative nourishment.  The relatively young science of cannabinoids now explains why cannabis has been treasured and used by mankind since the dawn of time.  Prohibition is a ridiculous policy. The truth about cannabis is clear.

We intend to build a substantial membership. Annual subscriptions have been cut to £5.00 and for concessions £1.00.  We ask everyone to make a payment of £10 towards campaign funding but money will not be an obstacle to anyone joining.  Please show your support for our campaign and join CLEAR.  Within the next few days we will launch a membership drive with the simplest way to sign up being payment by text message.

We will be fielding candidates in council and parliamentary elections all over the UK.  We do not expect to win many seats but we intend our campaign to be given the respect and attention it deserves.  We will seek electoral pacts with other parties who are prepared to sign up to our aims.  If you would like to stand as a candidate,  please get in touch.  We also need voluntary workers all over the country.

We have exciting campaigns on the way that communicate the scientific truth about cannabis and demolish the scare stories and prejudice that is so widespread.  We will never let another ridiculous tabloid story pass without challenging it.  We will not allow our political leaders to get away with untruths and propaganda without calling them to account.

We will campaign for an end to the ludicrous waste of law enforcement resources on cannabis and for a regulated system of production that will exclude organised crime and the evils of violence and human trafficking that prohibition causes.  We will educate users about cannabinoid content, different strains, varieties and methods of use. We will promote regulation to ensure quality, safety and restriction of sales to adults only.

We already have solid data that proves a tax and regulate regime in Britain would produce a net gain to the economy of at least £6 billion per annum, freeing up police to concentrate on real crime and massively reducing the harms caused by prohibition.

Despite the fact that most people in Britain have used cannabis to no ill effect and that between two and ten million people have it as a regular part of their lives, the cannabis campaign has failed to make any real progress.   Now is when that changes.  The future of cannabis in Britain is CLEAR.

We will release more details about our campaign in the near future.

The truth about cannabis is CLEAR.

When We Grow…This Is What We Can Do

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Written by Peter Reynolds

February 23, 2011 at 5:17 pm

The Hemp Revolution

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Written by Peter Reynolds

February 21, 2011 at 8:48 am