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UK / EU Cannabis Compliance

Article: Nearly 3,000 products advance in UK’s $800 million CBD sweepstakes

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Hemp Today reports

The UK Food Standards Agency (FSA) has now advanced a total 2,847 CBD products to the second stage of its three-stage approval process for new (or “novel”) foods. In the most recent development, 2,692 CBD isolate products submitted in a joint application from EIHA projects GmbH, a consortium of the European Industrial Hemp Association, were moved to the “validated” category on the FSA’s register.

FSA is sorting out applications for roughly 12,000 individual products as it works to clarify a flourishing gray market that has seen retail outlets flooded with CBD products over the past several years, raising safety concerns.

The EIHA consortium has another 2,205 products in a second application for CBD distillates which remains at the first stage of the FSA’s review, “awaiting evidence.”

A second consortium organized under the UK’s Association for the Cannabinoids Industry (ACI) also had products in a joint application recently “validated” by the FSA. Those applications cover 29 isolate and distillate products but ACI said they could carry the fate of up to 4,000 products.

The validated products now face safety assessment based on reviews for toxicology and other technical benchmarks.

400 products removed

A total of 400 product applications are now in the “removed” category and are no longer in the running to receive market approval. FSA does not disclose the causes for removals, but has said they reflect withdrawal by applicants, or that the products in some way failed to meet the agency’s criteria. Products struck from the list may no longer be offered to consumers under FSA rules.

More than 300 product applications that have been removed were from JM Wholesale Ltd. of the UK. But that company still has more than 400 products that continue in the first stage of the review. British Cannabis, which submitted the most products (1,471) to the FSA review process, has seen 15 products disqualified; and RX Pharmatech, the No. 2 applicant (801), had eight fall off the list but still has nearly 800 in contention.

To get onto the FSA’s public list of CBD products – and therefore remain on the market pending final approval – products already in distribution had to have been on sale before Feb. 13, 2020. Those introduced to the market after that date were not eligible for the agency’s consideration.

FSA’s challenge

FSA was inundated with CBD applications early last year after stakeholders complained about the review process that guides the one-time chance for producers to get their gray-market products legal. The agency eventually reopened the application window by one full year, which eventually brought a flood of products to the list, nearly quadrupling the original number under review from roughly 3,500 to more than 12,000.

FSA said it expects the first CBD products to be fully authorized during the latter half of 2023 if the evidence necessary for safety assessments is complete. The authorization process can take more time if additional studies are required, according to the agency.

ACI has estimated the domestic CBD market at roughly £690 million ($830 million/€785 million).

Source:  https://hemptoday.net/nearly-3000-products-advance-in-uks-800-million-cbd-sweepstakes/



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UK / EU Cannabis Compliance

Denmark Announces Plans for Cannabis Permanent Legal Framework

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Business of Cannabis

Denmark’s six-year medical cannabis pilot scheme could soon be expanded into a fully legalised market, following a surprise announcement from the government last week.

The Danish pilot scheme has been running since 2018, and has continued to expand in both scope and patient numbers over the past six years, with four different access schemes now operating.

Following the publication of a comprehensive analysis of these programmes, Minister of the Interior and Health Sophie Løhde last week met with the parties behind the trial scheme to discuss plans to ‘make the scheme permanent’.

Danish medical cannabis oil producer Stenocare tells Business of Cannabis that while the structure of the new framework is not yet clear, it’s likely to see a significant expansion in the market.

“It is going to grow the market. Medicinal products are primarily prescribed by specialists, while the pilot programme allows medical cannabis to be prescribed by GPs, so their’s a larger pool of prescribers out there… I think we’ll see an increase in treatment,” its CEO Thomas Skovlund Schnegelsberg said.

Read the full report

https://businessofcannabis.com/new-era-for-medical-cannabis-in-denmark-as-government-announces-plans-for-permanent-legal-framework/?utm_content=330050794&utm_medium=social&utm_source=linkedin&hss_channel=lcp-42296127



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UK / EU Cannabis Compliance

UK: Celeb Big Narstie To Open Medical Cannabis Office In Essex

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High & Polite write

Big Narstie to medical cannabis office in Essex 

Hold onto your spliffs, folks—because Big Narstie is making serious moves in the medical cannabis game!

The grime legend, comedian, and all-around UK icon is turning an old Barclay’s bank in South Woodham Ferrers into his very own medical cannabis office.

Yep, you read that right—Big Narstie Medical is officially open for business, ready to deliver “high-quality medicinal cannabis” to UK patients in need.

Now, we know what some of you might be thinking—“Big Narstie? Medical cannabis?”

But let’s be real, who better to bridge the gap between everyday people and the life-changing potential of medicinal cannabis?

Since the UK legalised medical cannabis in 2018, patients suffering from severe epilepsy, chemo-induced nausea, and MS have found relief through legal weed.

Narstie’s move isn’t just about the clout (though let’s be honest, a medical cannabis office is pretty cool).

He’s shining a much-needed spotlight on the benefits of medical cannabis, especially for those who don’ realise it can be legally prescribed.

So, whether you’re a fan or not, this is one groundbreaking move worth keeping an eye on.

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UK / EU Cannabis Compliance

German Medical Cannabis Associations Call For Wider Regulatory Reform

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In July 2023, Germany’s federal government commissioned the Federal Joint Committee (G-BA) – the body responsible for determining which medical treatments are covered by the country’s statutory health insurance – to amend the current regulations around medical cannabis prescriptions.

The G-BA is in the process of deciding four specialist areas for which the current approval requirement should no longer apply, making it easier to obtain insurance coverage for the medicine.

However, the country’s medical cannabis associations say this does not go far enough and have called for the approval requirement to be removed for all conditions in which cannabis has shown medical efficacy.

Medical cannabis has been legal in Germany since 2017 and can be prescribed by any doctor for patients with serious medical conditions. It is one of the few countries globally where the treatment can be covered under the public health insurance system in certain cases.

But currently, for patients with statutory health insurance, the costs of medical cannabis are only covered if previously approved by the insurance company.

This application process is said to be ‘daunting, lengthy and bureaucratic’ for doctors and patients, with 30-40% of applications being rejected.

https://businessofcannabis.com/german-medical-cannabis-associations-call-for-wider-regulatory-reform/



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