Hemp Today reports on Italy’s updating of its rules on CBD and how that affects a range of products.

They write…

CBD has been classified as a narcotic in Italy, with officials simultaneously banning the compound from the Italian market.

Under a recent decree issued by the Ministry of Health, CBD was officially added to the country’s list of medicines; a separate order from Italy’s Customs and Monopoly Agency, which quickly followed, warned retailers “not to hold and sell . . . inflorescences (flowers), oils and resins or other products containing substances derived from hemp sativa.”

Published in Italy’s Official Gazette, the decree adds CBD to the country’s table of medicines as “compositions for oral administration of cannabidiol (CBD) obtained from cannabis extracts.”

THE DECREE

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Authorization required

“This decree specifies that CBD for oral use extracted from cannabis is in the drug table and can only be produced with the authorization of AIFA (the Italian Medicines Agency),” Giacomo Bulleri, a lawyer who analyzes the Italian cannabis sector and serves as a board member at Federcanapa, an Italian hemp trade group, told the website Fanpage.it. “Therefore the oils on the market for undefined use are illegal,” Bulleri said.

The moves set up an apparent conflict in Italy following a separate recent decree from the Agriculture Ministry that listed hemp flowers for “extraction uses” as an agricultural product, and not a drug.

Epidiolex poised to enter market

Observers have noted that the decree establishing narcotic status for CBD is, in part, preparation for the introduction of Epidiolex, a CBD-based drug whose manufacturer, UK-headquartered GW Pharmaceuticals, has requested authorization to begin selling that product on the Italian market. GW is slowly expanding its distribution of Epidiolex in Europe, with rollouts also afoot in the U.K., Germany, Spain and France.

Epidiolex has been found to be effective in patients who suffer Dravet Syndrome and Lennox-Gastaut Syndrome, two debilitating forms of epilepsy. GW made cannabis history in 2018 when it earned approval from the U.S. Food & Drug Administration (FDA) for Epidiolex, making it the first cannabis-derived prescription drug to gain federal approval in the United States.

What about smokable hemp?

It remains to be seen what will happen in Italy with smokable hemp, which is based on hemp flowers (“inflorescences”) and therefore not extracted, under the Customs and Monopoly Agency’s stop-sell order. Sold as pre-rolled cigarettes and loose in pouches, smokable hemp has rapidly grown in popularity in Italy and Switzerland over the past couple years.

Hemp inflorescences can also contain hemp seeds, which are technically legal in Italy, raising still further potential confusion. Roughly 80% of Italian hemp production is in food seed, according to a report published earlier this year by the Foreign Agricultural Service of the U.S. Department of Agriculture.

Clouds on Europe’s CBD horizon

The situation in Italy comes amid recent ominous signals in the European Union regarding CBD and other hemp extracts; the European Commission earlier this year issued a “preliminary conclusion” that hemp extracts, including CBD, are to be considered narcotics. While European stakeholders – who were blindsided by the EC decision last July – are known to be pushing back against the Commission’s conclusion, there’s been little indication so far that they’re having any success.

European hemp interests have said if the EC does not change its position on extracts, it could have a drastic negative effect on the CBD sector, and the hemp industry overall.

 

FANPAGE IT ARTICLE 16 OCT 2020

CBD oil is now a drug added to the drug table

A decree of the Ministry of Health inserts “compositions for oral administration of cannabidiol obtained from cannabis extracts” in the single text of drugs in the table of medicines.

CBD oil , the active ingredient of cannabis universally recognized by medicine and the WHO as non-psychotropic, has been classified as a narcotic in Italy and included in the table of medicines. A decree of the Ministry of Health  published in the Official Gazette puts it in black and white : “In the table of medicines, section B, of the decree of the President of the Republic 9 October 1990, n. 309, and subsequent amendments, the following category of substances is inserted in alphabetical order: compositions for oral administration of cannabidiol obtained from cannabis extracts “.

One of the reasons that led to this decision is that after being approved in recent months, Epidiolex , a CBD-based drug , is about to be marketed., manufactured by GW Pharmaceuticals. In fact, in the premises of the decree it is explained that: “A request for authorization to start the marketing of a medicine, in an oral solution containing cannabidiol, which has already received the ‘centralized marketing authorization by the European Medicines Agency (EMA) and that the same medicine is controlled through a compassionate use program, notified to AIFA, for patients treated with Dravet syndrome and Lennox syndrome -Gastaut “. Another reason indicated is that: “Medicines based on narcotic active substances are indicated in the table of medicines, including active substances for pharmaceutical use”.

If CBD oils, as written in the decree, are included in the consolidated text on narcotics in the table of medicines, they will no longer be able to be sold freely in stores: it remains to be seen what will happen to cannabis light , inflorescences and therefore not extracted, which contain CBD.

Not only that, because yesterday the general director of the Customs and Monopoly Agency , Marcello Minenna issued a ban on the sale of inflorescences, oils and products derived from hemp sativa. Representatives of neighborhood businesses, pharmacies and parapharmacies are asked “to undertake not to hold and sell, within the business, leaves, inflorescences, oils and resins or other products containing substances derived from hemp sativa”. The determination was necessary “to avoid that, in the shops authorized by ADM for the sale of inhalation liquids, these products are also marketed, in violation of the legislation on drugs pursuant to Presidential Decree no. 309 “. And without self-certificationof the commitment not to sell these products, it will no longer be possible to obtain the release of the necessary authorizations and any renewals.

“This decree specifies that CBD for oral use extracted from cannabis is in the drug table and can only be produced with the authorization of AIFA. And therefore the oils on the market for undefined use are illegal” explains the lawyer Giacomo Bulleri , an expert in the sector who, on the other hand, underlines on cannabis light: “It is a product that, after the sentence of the Supreme Court, is not in the legal destinations of industrial hemp but remains tolerated in some areas where the concept of doping efficacy below 0 is applied. , 5%. But it is discretionary on a case by case basis, in some courts it has been found illegal regardless of the THC limit “.

It must be clearly emphasized that the WHO had recommended just the opposite. In the cannabis reform recommended by the international body, in addition to recognizing the medical properties of cannabis, it was noted that CBD products should not be included in any table . The ratification of these decisions should have taken place in December.

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