Company: INCR
Filing Date: 2025-05-01
Form Type: 20-F
Source: 0001641172-25-007971
Chunk: 90

Company: Intercure Ltd.
Filing Date: 2025-05-01
Form: 20-F
Item: Item 4
Chunk 90
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 general practitioner, family physician, internal physician and pediatrician) to write prescriptions for medical cannabis for patients under the supervision of health care providers (widely known as Kupat Holim), without requiring a usage license from the Ministry of Health.
 

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The main changes in the Regulations Amendment are: (i) any specialized doctor can issue permits without the need for specialized training; (ii) the permits for the use of cannabis will be in the form of prescriptions for a number of indications, and not in the form of licenses from the MOH as the current framework requires; and (iii) The regulations Amendment significantly simplifies operational processes for cultivation and manufacturing sites by transferring greater responsibility to these entities. This includes a reduction in the frequency of mandatory audits and required tests for companies that demonstrate compliance with a robust quality management system. Additionally, the amendment liberalizes the production chain, allowing for more flexible licensing options: entities can obtain licenses for cultivation without the need for postharvest facilities, or for manufacturing facilities that include postharvest activities. These changes reflect a significant shift in the IMCA’s oversight approach, emphasizing the delegation of regulatory responsibilities to the companies themselves. (v) The amendment enhances support for innovation and R&D by making the research approval process more transparent. It introduces a structured research license applicable to cultivation or manufacturing facilities. This enables researchers to prescribe medical cannabis to study participants, establishing a transparent protocol to assess the safety and efficacy of new medical cannabis administration methods through clinical trials. (vi) The amendment also streamlines the export process, allowing exports to be conducted based on a declaration, without the necessity for on-site inspections. This facilitates the movement of raw materials or products between companies for export purposes and allows EU-GMP certification by the Institute for Audit and Standardization or another entity authorized by the Director General of the Ministry of Health, for manufacturing facilities that meet the stipulated criteria. (vii) The new regulation includes a new product category table in that aligns with the EU pharmacopeia and a new packaging design standards. (viii) The definition of a dangerous drug is refined, particularly concerning CBD. Following the recommendations of the Shemer Committee and the assessments of the follow-up team led by Dr. Boaz Lev, the Ombudsman for Medical Professions, the amendment considers limiting the classification of cannabis as a dangerous drug solely to variants containing psychoactive THC concentrations of less than 0.3%. This change is proposed to take effect from February 2024. As of the date of this