In the process of receiving dealer’s license for medical cannabis it is important to be efficient and professional in order to succeed in the competitive and dynamic medical cannabis market.
We accompany organizations and companies in complex processes that allow them to become leading players in the medical cannabis industry.
Any action in the cannabis plant or its products, including development of genetic lines and varieties, multiplication, growth, production, extraction, distribution, possession, transfer, laboratory testing, issue or research of the cannabis plant, requires appropriate licenses from the Ministry of Health, in order to create a mechanism for supervision and control of the medical cannabis field and to ensure the quality of the product throughout the supply chain from end to end - to the end consumer.
The licenses are issued by Yakar, the Medicinal Cannabis Department at the Ministry of Health.
It is important to know the field and regulation in order to shorten and streamline the process with the Ministry of Health!
Areas of professionalization we can assist in the processes:
The field of medical cannabis is in its early stages and therefore has great business potential.
In order to obtain the necessary certifications, you must start now to establish and adapt your business professionally, thus you can succeed in the field of medical cannabis.
Good luck!
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.
IMC - G.A.P Standard for growing medical cannabis
The Director General's Directive IMC – G.A.P – Growing Cannabis according to Procedure 51 was issued on May 21, 2017.
The G.A.P Standard – the Standard for Good Agricultural Practice – is based on the international standard for good growing of fruit and vegetables GLOBAL G.A.P.IFA 4.0 (FV), Mar.13
For the Director General's Directive Procedure 51 Growing Cannabis for Medical Purposes, Click Here.
Any practice with the cannabis plant or its products, such as cultivation, production, marketing, possession, distribution, laboratory tests, supply or research, is required the appropriate licenses from the Ministry of Health. The license for growing cannabis plants is issued by the Ministry of Health's Director General or the Director of Yakar, the Medicinal Cannabis Department at the Ministry of Health.
This procedure is intended to create control and supervision of medical cannabis in order to ensure a high quality level supply chain for medical cannabis, including cultivation, production, distribution and supply.
Read the Blog - Medical Cannabis Reform
Read the Blog - Farmers' petition to the court
Procedure for obtaining the G.A.P Standard for Growing Cannabis for Medical Purposes
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-G.A.P 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 G.A.P 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.
Registration of cosmetics is a necessary process for anyone who intends to produce, import and sell cosmetics in Israel.
The registration procedure and receipt of registration is executed at the Ministry of Health. The process requires the collection of numerous documents and compliance with strict registration regulations.
Importers and manufacturers, who wish to enter the local market in the shortest time possible, should perform the process with the assistance of expert professionals in order to save resources.
Click Here to determine whether a particular product / device requires Registration of Medical Devices.
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