Company: INCR
Filing Date: 2025-05-01
Form Type: 20-F
Source: 0001641172-25-007971
Chunk: 91

Company: Intercure Ltd.
Filing Date: 2025-05-01
Form: 20-F
Item: Item 4
Chunk 91
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 Annual Report, this change has not been implemented yet.
 
The European Union

On February 13, 2019, the Members of the European Parliament adopted a resolution on the use of cannabis for medicinal purposes (“Resolution 2018/2775(RSP)”). Resolution 2018/2775(RSP) called for a legal definition of “medical cannabis” in order to clearly distinguish between cannabis-based medicines approved by the European Medicines Agency or other regulatory agencies and cannabis for recreational or industrial use that is not regulated by the same standards. Resolution 2018/2775(RSP) also called for increased research into the possible uses of THC, CBD and other cannabinoids for medical treatment, including their effects on the human body, and promotion of equal access to cannabis-based medicines by ensuring that health insurance schemes cover effective cannabis-based medication.
 
There is no formal EU definition of “medical cannabis”. Medical cannabis can be described as whole-plant cannabis-derived products (generally cannabis flower or oils) that are licensed by member state health systems for prescription by a physician. As recognized by the European Monitoring Centre for Drugs and Drug Addiction, medical cannabis refers to a wide variety of preparations and products that may contain different active ingredients and use different routes of administration.
 
From a legal and regulatory perspective, there are two categories of medical cannabis products:
 

●                                                                Cannabis-derived                                                            
    medicinal products - Cannabis derived medicinal products are products which have been granted a marketing authorization from a regulatory
        authority (the European Medicines Agency at the EU level or competent national authorities at EU member state level), after going    
       through extensive clinical trials to test the products’ safety and effectiveness. These products are regulated as (cannabis-derived)  
               “medicinal products” in accordance with the harmonized EU regulatory system set forth by EU Directive 2001/83/EC. To          
        date, several cannabinoid-containing medicinal products have been authorized for marketing in the EU and certain EU member states,   
      have authorized for marketing in their states plant-based products including, but not limited to, Sativex® (nabiximols) and Epidyolex® 
                                   (CBD), and synthetic products Marinol® (dronabinol) and Cesamet® (nabilone).                              
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●                                                                  Cannabis                                                              
       preparations for medical use – Cannabis preparations for medical use consist of products that may be authorized through national  
      distribution and use authorizations or licenses in certain EU member states.