IMC- GMP Standard for good manufacturing procedures for medical cannabis

The Director General's Directive IMC-GMP for good manufacturing procedures for medical cannabis according to Procedure 152 was issued on May 10, 2017.

In Israel, any practice or contact with cannabis including manufacturing cannabis for medical purposes, is required the appropriate licenses from the Ministry of Health. The Standard presents the appropriate conditions for the manufacture of medical cannabis products and its purpose is to ensure that the product is of high quality and safe to use.

A manufacturing plant for cannabis products is conducted according to the conditions of good manufacturing procedures and holds an IMC-GMP approval at all times.

The Ministry of Health consider the regulation of medical cannabis of high importance in order to ensure that the quality of the supply chain of medical cannabis will be at the highest level. The Ministry of Health regulations relate to all stages of the supply chain: cultivation, production, distribution and supply of the medical cannabis products.


Procedure for obtaining the GMP Standard for good manufacturing procedures for medical cannabis

Understanding the Organization

Begins with understanding the environment in which the organization operates and the work processes according to which the Standard will be implemented.

Writing procedures and documents

Defining the work methods according to which the organization is operating, in a clear language, suitable for all the organization's employees and as required by the Standard.

Training and Implementation

"Aligning" of work processes that are known to the employees with the quality processes that we will integrate into the organization's activities.

Completion and closing gaps

Final preparations for the certification audit (= license) and a review of the completions and gaps that were defined to conform to the requirements of the Standard.

Audit and receiving the license

The applicant for IMC-GMP submits a request to the certification body for the certification process.

The Certification Institute reviewer will review the organization's quality management system and following the audit's results, the organization will receive a certificate according to the GMP Standard.

Yakar will issue a unique identification number (registration number) to the certification body, on behalf of the applicant, which will identify the applicant and will serve as a unique identification.


Which approvals exist in the medical cannabis industry?

License for growing/cultivating cannabis – Cannabis will only be grown in appropriate greenhouses on cannabis farms that hold a valid license according to the Dangerous Drugs Ordinance. The growing license holder may dispatch cannabis only to a licensed manufacturing plant.

License for a cannabis products manufacturing plant – Cannabis products will only be manufactured in manufacturing plants for cannabis products that hold a valid license according to the Dangerous Drugs Ordinance. Parts of the cannabis plant will be processed into products in manufacturing plants for cannabis products that are conducted in accordance with the appropriate professional standards.

Cannabis Products Trading License – Cannabis products will be transported to cannabis trading companies that hold a valid license according to the Dangerous Drugs Ordinance. The trading companies are conducted in accordance with appropriate professional standards (the existing GDP Standard for Pharmaceutical Trading House adjusted for cannabis trading companies) from which the products will be distributed to the pharmacies.

Pharmacy License to supply cannabis products – Cannabis products will be supplied by pharmacies that submit a request and meet the required conditions. The pharmacies will supply cannabis products to patients that hold a permit to consume medical cannabis and in accordance with the license terms. The pharmacists supply and administration of cannabis products will be carried out according to the instructions of the Ministry of Health.