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Peter Reynolds

The life and times of Peter Reynolds

Posts Tagged ‘CBD

Review. Cannectar Honey-Infused CBD

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Cannectar Honey CBD Syringe 1000mg

There is now a wealth of different CBD products on the market. All sorts of oils, pastes, capsules, sprays, lozenges, creams. It’s a wonderful ingredient that can be added to almost anything we consume.

I’m fortunate in that I am sent a lot of products to try, so when I decide which to write about, I choose those that I buy for myself.

I was sent a selection of Cannectar products by CBD-UK and I was quite taken with the sugar-free and not-too-sweet sweets (sweetened with Stevia) but it was this honey-infused CBD paste that really caught me.  It is delicious!  If you like CBD in your coffee this is a particularly fine way of adding it.  Squirt out an inch or two and whisk it into an unsweetened espresso.  A gorgeous mix which meant I finished the whole syringe very quickly. So yes, I went to the website and ordered two more right here: https://www.cbd-uk.com/cannectar-honey-cbd-syringe-1000mg

At first, I was hesitant about a syringe as the packaging but it is practical and it dispenses accurately and cleanly which is exactly what is needed.

This is now a regular part of my morning routine. Tea, breakfast then about half a dozen double espressos, two of which I will dose with CBD.  It’s what keeps me going!

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Written by Peter Reynolds

February 5, 2019 at 5:59 pm

Posted in Product Review

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Daily Mail Profits From Illegal Advertising For Cannabis

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On the same day that the Mail publishes yet another inaccurate and misleading article on cannabis and CBD in particular, it is carrying a full page advertisement for CBD which breaches medicines, food and advertising law.

The ad, from Woods Supplements at https://www.woodshealth.com/, claims medicinal benefits for its product for joint pain, migraine, psoriasis, acne, depression, pain and inflammation.

While there is probably a substantial amount of truth in these claims, it is unlawful to make them without the product having a licence or marketing authorisation (MA) from the MHRA.

Why does this matter? I advocate for the medicinal use of cannabis in all its forms, so why would I object to any company making these claims?

Medicines regulation is essential, otherwise we will have people selling bottles of coloured water as a cancer cure.  Most CBD companies are responsible and understand it is unlawful to make medicinal claims, so irresponsible companies like Woods Supplements need to be stopped.  They are stealing business from responsible companies. So Woods Supplements is NOT a reputable company as it claims in its ad.

But despite the MHRA regularly flexing its muscles and talking tough, it does nothing.  There is simply no enforcement going on. Remember in 2016, it threatened to shut the entire CBD industry down over medicinal claims?  Most companies work extremely hard at considerable cost to stay compliant but the MHRA does nothing to support them.

As for the Daily Mail, scourge of truth about cannabis, profiting by illegal advertising, what should be done?  Well as these offences can result in a two year jail term and the publisher and editor of the Daily Mail are clearly complicit in them, when we can expect to see them marched from their desks in handcuffs?

Presumably the directors of Woods Supplements will be waiting at HMP Brixton to welcome them.

Written by Peter Reynolds

January 30, 2019 at 4:53 pm

Another Attack by Bureaucrats on CBD and its Consumers

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Today’s article in the Daily Mail on CBD follows that publication’s usual pattern – there is a kernel of truth but on top of that is piled inaccuracy upon misleading comment upon nonsense.

So let’s deal with the truth and send the nonsense back to the Daily Mail where it belongs.

Within the last few days it has emerged that the UK Food Standards Agency (FSA), has been working surreptitiously with its opposite numbers in four other EU countries to add all products derived from cannabis except hempseeds to the EU Novel Food Catalogue. This step has been taken without any communication or consultation with the CBD industry or the millions of consumers benefiting from the products. It is important to understand that inclusion in this catalogue does not create law.  Suppliers of CBD are entitled to continue marketing their products if they consider they are not ‘novel’.

What does ‘novel’ mean?  The EU novel foods legislation states that any food or ingredient used in foods that was not in widespread use prior to 1997 will be subject to an authorisation process that must demonstrate either evidence of widespread use prior to 1997 and/or that it is safe.

To be clear, the Daily Mail’s claim that this means “experts probe whether it has any real health benefits” is nonsense. It has nothing to do with that at all.

Love Hemp, CBD market leaders

Anyone who has any knowledge at all about cannabis will understand how ludicrous it is to suggest that it is ‘novel’ in any form.  It is even described as the oldest cultivated plant in the Guinness Book of Records. It is widely recognised to have been cultivated for at least 12,000 years.

So this move by the FSA and its equivalents in France, Germany, Italy and the Netherlands is, demonstrably, bureaucracy for bureaucracy’s sake. Cannabis is the oldest crop cultivated and used by mankind. Asking for evidence of its widespread use before 1997 is no different and as absurd as asking for the same evidence for wheat or barley.

The CBD industry and consumers faced a similar atack from the Medicines and Healthcare products Regulatory Agency (MHRA) in 2016.  Then, as now, it was CLEAR that stepped in and organised the response.  The MHRA quickly backed off, accepted that it had no power to carry out a wholesale shutdown of the industry and the leading CBD companies began a process of self-regulation which has led to the development of a very successful marketplace.  Millions of consumers now gain great benefit from CBD products which help to maintain health and improve wellbeing.

Whichever side of the Brexit debate you are on, it is precisely this sort of overbearing, oppressive bureaucracy at an EU level that led many people to vote leave. There can be no sensible suggestion that CBD is harmful.  In 2017, the World Health Organisation (WHO) published an unequivocal conclusion that CBD “does not cause harm”. It is, therefore, safe and is demonstrated to be so by thousands of years of use.  So why is the EU and the FSA, its agent in the UK, engaged in this spurious and wholly unnecessary attack?  Can it be for any other reason than simply to sustain the bureaucracy and create work for the bureaucrats keeping them in their comfortable jobs?

It remains to be seen whether the FSA will try to explain its actions.  CLEAR’s trade association for CBD businesses, Cannabis Professionals (CannaPro), has been dealing with the FSA for some time and trying, unsuccessfully, to obtain straight answers. We participated in a conference which included the Head of Novel Foods in December 2018 and only yesterday we wrote to him complaining that, if anything, the situation was becoming more confused.  Now, unconfirmed statements from the FSA suggest that it is requesting Trading Standards to work with it on ‘enforcement’ and to remove CBD products from shelves. In our view the FSA and Trading Standards would be exceeding their lawful authority if they took this action as inclusion in the EU Novel Food Catalogue does not represent law.

It’s also important to understand the context in which the FSA bureaucrats are flexing their muscles and trying to talk tough.  For some time, CBD isolate has been in the EU Novel Food Catalogue and it has been genrally accepted by the industry that it is genuinely novel.  All responsible businesses have stopped selling isolate but there are a host of disreputable companies still selling isolate and neither the FSA nor Trading Standards have taken any enforcement action whatsoever.

Similarly, when the MHRA tried to get tough in 2016, it had a legitimate complaint that unlawful claims of medicinal benefit were being made.  All responsible businesses have ceased to make such claims but the marketplace is still full of confidence tricksters and the MHRA has taken no enforcement action whatsoever.  There are full page advertisements appearing in newpapers (including the Daily Mail) making the most outrageous medicinal claims but the MHRA does nothing. And this lack of enforcement severely damages responsible businesses that are working hard to remain compliant.

So, the truth is that even when justified and necessary, no enforcement is taking place.  In austerity Britain, even if you report a burglary or a car theft, the police will do nothing about enforcement.  The FSA’s action may well cause some of the major retailers to step back from the market.  It will certainly cause unnecessary confusion and damage to this burgeoning market but there is zero chance that it will stop people buying and selling CBD products.  Thousands of jobs now depend on the British CBD industry and millions of people find the products helpful and beneficial.

Key Points of Advice and Guidance

Don’t panic.  If you’re using CBD it will continue to be available. You might find it easier to buy it online in future.

Don’t panic.  If you’re a CBD business, the future remains bright, you should be used to a few obstacles in your path!

Don’t panic.  If you are visted by Trading Standards, stay calm and explain that your products contain nothing ‘novel’ and have been in widespread use for hundreds of years.

Don’t panic.  All CannaPro Certified businesses will have support in compiling evidence that your products are not ‘novel’. You are entitled to be given time to submit this.

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A final point that needs to be made on this subject.  When CLEAR organised the successful response to the MHRA’s intervention in 2016, it led directly to the establishment of the Cannabis Trades Assocation UK (CTA).  For reasons concened mainly with the ethical conduct and antecedents of Mike Harlington, who we appointed to run the CTA, we, along with many CBD businesses have disassociated themselves. This is turn led to the formation of Cannabis Professionals.

One of the main concerns about Harlington were his false claims of a ‘special relationship’ with the MHRA and FSA. These events should put the final nail in the coffin of those lies.  He and the CTA have had more than two years to establish a successful working relationship with these authorities but this has clearly been an absolute failure.  More than ever, the UK’s legal cannabis, CBD and hemp businesses need proper and effective representation.  Clearly, the CTA is unable to provide that.

While The NHS Is Failing People, Small CBD Companies Are Stepping Up.

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Alfie Brocklebank

Canabidol CBD Oil

 

 

 

 

 

 

 

 

 

 

 

When Sajid Javid introduced the new regulations on cannabis for medical use last year, it brought hope to hundreds of thousands of people.  Now the NHS is routinely letting patients down and refusing to provide the medicinal cannabis they need.  The law no longer stands in the way but many people are in despair at the cruel and ignorant response of the medical establishment and NHS bureaucrats.

Not least the parents of Billy Caldwell and Alfie Dingley, the high profile cases of children with severe epilepsy, whose stories provoked the media outcry that eventually forced a stubborn government to take a proper look at the evidence.

Remarkably, small CBD businesses are stepping up when the NHS is letting people down and offering to provide CBD free-of-charge to those in desperate need.  And these really are small businesses, little more than the internet equivalent of a corner shop. Even the largest of them is tiny compared to the financial turnover of the smallest NHS hospital.  The owners of these small CBD businesses are funding these donations out of their own pockets and not asking for any PR or publicity in return.

Billy Caldwell is now approaching 100 days in exile in Canada

Billy Caldwell is exiled in Canada again because there is not a doctor in the UK who has the courage or the care to prescribe the cannabis oil he needs containing a small amount of THC.  This is mainly due to the inaccurate and, it has to be said, negligent guidelines from the British Paediatric Neurology Association, which has recommended against prescribing even tiny amounts of THC to children.  Its guidance is based on a misguided interpretation of evidence on the harms of adolescents smoking large quantities of high THC cannabis as a recreational drug.

Billy is OK because a consultant neurologist in Canada who understands cannabis as medicine has prescribed an oil with THC which is working perfectly for him.  It’s just that he’s away from his home and his family.  The doctors and NHS bureaucrats at the Belfast NHS Trust don’t care about that.  Their primary concern is sticking by manifestly stupid guidelines to protect their own careers within the establishment structure.

Take note that the media, so keen to publish Billy’s story before, has lost interest.  He’s still being reported as the poster boy for UK medical cannabis reform but the cruel irony is that the reform has failed him.

Another case in point is Alder Hey Children’s Hospital in Liverpool.  There, one consultant neurologist is prepared to follow the evidence, rather than sticking with failed pharmaceutical medicines. He has prescribed medicinal cannabis for at least two children with epilepsy but the hospital management has stepped in and cancelled them, refusing to allow his clinical judgement to prevail over their bureaucratic procedures.

Both children are in severe distress.  Alfie Brocklebank has Tuberous Sclerosis Complex (TSC) which causes him to have many seizures every day, each one of which is life threatening. The medical director at Alder Hey said he did not meet the criteria to be prescribed medical cannabis so his parents started buying CBD at a cost which soon reached £170 per week. Alfie’s mother Ellen is a nurse, so she knew what she was doing.  Alfie’s seizures stopped.

Ellen Brocklebank

But Alder Hey still refused to prescribe Epidiolex, the GW Pharma CBD medicine, and they wouldn’t help with the cost of the over-the-counter Canabidol CBD which was working so well.  The family simply couldn’t afford to keep spending £170 per week on the oil.

See Alfie Brocklebank’s story here as reported by ITV News.

It was Billy’s mother, Charlotte Caldwell, who reached out to CLEAR.  Canabidol CBD is a CannaPro Certified business, endorsed by CLEAR  as an ethical supplier of legal, high quality CBD products. As soon as we spoke to Tom Whettem, CEO of Canabidol, there was no hesitation.  He immediately undertook to provide the oil that Alfie needs at no cost – and there was no question of wanting anything in return.

Alfie’s mother, Ellen, takes up the story:

“Alfie is starting play school next week. Before we started the CBD this would not of been possible as he was just to poorly and having lots of seizures. Alfie going to a main stream play school with his sister is a huge milestone.

We are also slowly coming off Alfie’s conventional anti-epilepsy drugs as well. I’m nearly 100% sure we wouldn’t be able to do this if Alfie wasn’t on the whole plant extract CBD. The neurologist actually told me in his opinion Canabidol CBD is most likely to be more effective than the Epidiolex.”

A number of other CBD companies have now stepped forward and offered to supply oil to people in need who have been turned down for an NHS prescription. As a result, CLEAR, through its trade association Cannabis Professionals, is launching the CannaPro CBD Compassionate Access Programme.

CannaPro CBD Compassionate Access Programme

Applications should set out details of the patient’s condition, any experience with CBD so far and an explanation of the refusal to prescribe on the NHS.  Please email applications to cbdaccess@cannapro-uk.org. All applications will be confidential and considered by a small sub committee of the CLEAR Executive Committee.  Where we are able to recommend that a patient join the programme we will inform the applicant and introduce them to a donor company.  Donor companies will be allocated in strict rotation according to the date they first offered to participate.

 

 

 

 

Cannabis Professionals. The Trade Association for the UK’s Cannabis, CBD and Hemp Businesses

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Cannabis Professionals (CannaPro) is the trade association for the UK’s cannabis, CBD and hemp businesses.

CannaPro will represent this fast-growing sector to the authorities, standing up to the Home Office, MHRA, FSA and Trading Standards, advocating for members’ interests, not acting as a government enforcer but as our members’ champion and to promote the development of the legal cannabis sector.

CannaPro will offer guidance and support to all businesses, helping them to navigate through law and regulations on drugs, medicines, food and cosmetics.

CannaPro will also launch a social media campaign, aiming to inform and educate the public about the benefits of CBD and the pitfalls.  The market is full of scammers, fake claims and snake oil salesmen.  Because of the historic stigma and fear around cannabis, government authorities are doing nothing, many people are misinformed and misunderstand.  CannaPro will explain the facts clearly and direct consumers to certified businesses which they can rely on.

Membership of CannaPro is without charge. All guidance will be published openly for everyone to benefit from. Free-of-charge support and answers to individual questions will be available online.

Businesses wishing to be certified by CannaPro will be reviewed for their products, trading standards, marketing and conduct. Certified companies will be entitled to display the CannaPro badge as a mark of quality, ethics and reliability.

Backed by CLEAR, the UK’s longest-established cannabis group with a network exceeding all other UK drugs policy groups combined, CannaPro members will benefit from CLEAR’s wide reach and influence with UK consumers.

Website: https://cannapro-uk.org

Facebook Group: https://www.facebook.com/groups/cannapro/

Written by Peter Reynolds

November 20, 2018 at 4:52 pm

Review. Flower Power CBD Infused Coffee

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My name is Peter and I am a coffee addict.

I am hopelessly dependent, both physically and psychologically. Even more serious for the long term is that I really like my thick, sweet, very strong espresso and I have neither the desire nor any intention to give up!

Compared to coffee, my relationships with cannabis and alcohol, my other daily habits, are free and easy.  I can do without even if I’d rather not.  Once I walk away from my keyboard in the early evening then a beer and firing up my vaporiser are my cues to switch off and relax.  But I can go without. Not without the thick black stuff though.  I cannot get to lunchtime caffeine-free.

So the opportunity to combine coffee with CBD is right up my street.  I’ve tried it before and I’ve also tried a wider spectrum of cannabinoids in coffee.  It’s a marriage made in heaven. A caffeine kick mellowed with a cannabis cuddle, or a cwtch as we say in Wales.

From the Flower Power coffee range, I chose Morning Glory.  It promises strength and South American stimulation.  I wasn’t disappointed.  It is truly delicious, blending excellent coffee with the earthy taste of CBD extract in a way that really works.  It’s very easy to get this wrong.  Some of the hemp coffee I’ve tried has been truly disgusting, managing to capture the very worst flavour of the nastiest, most bitter CBD oil you’ve ever tried.  Flower Power have got this right, it’s gorgeous. As they used to say about that other black stuff, it tastes good and it does you good!

To order or for further information go to the website: http://flowerpowercoffeeco.uk/ or contact Scott Hardacre, National Sales Director at: info@flowerpowercoffeeco.uk

 

Written by Peter Reynolds

November 1, 2018 at 1:32 pm

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

 

Written by Peter Reynolds

October 18, 2018 at 12:41 pm