Extractions of flowers
The omission from the pharmaceutical framework of raw cannabis flowers is another key element. This is a choice that has been controversial for some, but is increasingly popular in emerging markets, such as Spain.
Although technically allowed, flower can only be used in sealed cartridges that are intended for single use and CE-approved medical equipment.
In a strictly medical market, it makes sense to use this method, as the pharmaceutical industry requires precise, controlled dosing.
It is clear that this will be a plus to regulators in the future, as they can now protect the market and prevent accusations such as the ones made against a pseudo recreational market, which has been seen by Germany, Australia, and the UK. However, the new market also brings with it a number of challenges and possibilities.
When the market is eventually rolled out across France, Péribère believes these inherent barriers to flower will see extracts and oils dominate ‘in the beginning’.
“The future in France is really focused on quick assimilation methods from an extract, full extract, not isolate… They don’t want patients to grind their products, manipulate them. “They don’t want this in the distribution chain.”
The question is also raised as to whether CE-marked medical devices can be readily rolled out in large quantities across the entire market, which would present a huge opportunity to any manufacturer who could meet this need.
When we check the registration number, they don’t appear. “Are they CE-marked?”
Slow and sustainable
While Péribère concedes France’s unique framework presents some significant barriers for businesses hoping to break into the market, the EU’s second most populous country presents a major opportunity for those that do.
The French actor is candid: “I’m not sure that I think we will be able to find many in France” This field will be severely limited by the pharmaceutical file requirements and the requirement for an existing license to exploit pharmaceuticals or partnership with licensed entities.
The laboratory must be a part of a comprehensive pharmaceutical organization. Companies from outside France, without an existing French pharmaceutical company, must work with licensed manufacturers or importers who can handle the regulatory burden.
As such, Péribère notes that companies who’ve already invested heavily in the pilot, including Aurora Cannabis, Tilray, Little Green Pharma, and Panaxia, should have first-mover advantage.
They didn’t invest in this to run away. “They are motivated and have good starting positions.”
Overseed is part of this group. As soon as we receive the published version, we can ask to have this document evaluated,” says he, highlighting the readiness of the company to begin operations from the very first moment.
Estimates from Augur Associate and Prohibition Partners suggest that the market will initially be small. They estimate around 10,000 new patients within the first 12 months, then gradually expand. With 300,000 to 800,000 potentially eligible patients across France’s five approved indications, and a projected annual turnover of €806m by 2035, the long-term opportunity is clear.
But Péribère emphasises that regulatory approval is only the beginning. Prescriber adoption will be the real challenge.
The question in every country is how well we are able to educate the doctors and provide the best information. The availability of the medicines will be greatly affected.
France is currently able to boast a group of between 2,000 and 3,000 trained healthcare professionals, which gives it an advantage that most other markets do not have. To expand the program beyond early adopters requires sustained educational efforts.
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where Péribère and other industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where Péribère and other industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.
Extractions of flowers
A key aspect of the focus on pharmaceuticals is the exclusion of raw marijuana flower. Although this is controversial, it is a common practice in developing markets like Spain, where the new framework is being implemented.
Although technically allowed, flower can only be used in sealed cartridges that are intended for single use and CE-approved medical equipment.
In a strictly medical market, it makes sense to use this method, as the pharmaceutical industry requires that dosing be controlled, repeated, and metered.
It is clear that this will be a plus to regulators in the future, as they can now protect the market and prevent accusations such as the ones made against a pseudo recreational market, which has been seen by Germany, Australia and UK. However, the new market also brings with it a number of challenges and possibilities.
When the market is eventually rolled out across France, Péribère believes these inherent barriers to flower will see extracts and oils dominate ‘in the beginning’.
“The future in France is really focused on quick assimilation methods from an extract, full extract, not isolate… They don’t want patients to grind their products, manipulate them. “They don’t want this in the distribution chain.”
The question is also raised as to whether CE-marked medical devices can be readily rolled out in large quantities across the entire market, which would present a huge opportunity to any manufacturer who could meet this need.
When we check the registration number, they don’t appear. “Are they CE-marked?”
Slow and sustainable
While Péribère concedes France’s unique framework presents some significant barriers for businesses hoping to break into the market, the EU’s second most populous country presents a major opportunity for those that do.
The French actor is candid: “I’m not sure that I think we will be able to find many in France.” This field will be severely limited by the pharmaceutical file requirements and the requirement for an existing license to exploit pharmaceuticals or partnership with licensed entities.
The laboratory must be a part of a comprehensive pharmaceutical organization. Companies from outside France, without an existing French pharmaceutical company, must work with licensed manufacturers or importers who can handle the regulatory burden.
As such, Péribère notes that companies who’ve already invested heavily in the pilot, including Aurora Cannabis, Tilray, Little Green Pharma, and Panaxia, should have first-mover advantage.
They didn’t invest in this to run away. “They are motivated and have good starting positions.”
Overseed is part of this group. He says that the company is ready to start from the first day of publication.
According to Augur Associates’ and Prohibition Partners’ estimates, the market is expected to start off small. It will likely be around 10,000 patients for the first year before slowly expanding. With 300,000 to 800,000 potentially eligible patients across France’s five approved indications, and a projected annual turnover of €806m by 2035, the long-term opportunity is clear.
But Péribère emphasises that regulatory approval is only the beginning. Prescriber adoption will be the real challenge.
The question in every country is how well we are able to educate the doctors and provide the best information. The availability of the medicines will be greatly affected.
France is currently a market that has an advantage, as it already has between 2,000 and 3,000 trained healthcare professionals. But to go beyond those early adopters requires sustained educational efforts.
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where Péribère and other industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.
These challenges and opportunities will be central topics at Cannabis Europa Paris on February 19, where Péribère and other industry leaders will examine whether France’s unique approach justifies the countless delays in the eyes of patients.
Cannabis Law Resources for Poland
Browse essential legal pages on cannabis sales and cultivation in Poland. You can use these resources to learn about the requirements for certification, permissions and compliance.
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Polish News Registration and Interests of Cannabis Businesses
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Permissions for Cannabis Sales in Poland
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Authorization for Importing or Manufacturing Medical Products
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Permission for Manufacturing or Importing Medical Products
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Certificate of Good Manufacturing Practices (GMP)
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Registration of Medical Products in Poland