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15.01.2019

Cannabis – licensing and production in Republic of Macedonia

Kiril Kolemisevski Managing Partner, Investment Mergers & Acquisitions, Banking & Finance

In the past two years, after the amendments in the Law on Control of Narcotic Drugs and Psychotropic Substances and the Law on Medicinal Products and Medical Devices, which allowed cultivation and production of cannabis for medical purposes, as well as refining, extracting and production of hemp seed and cannabis oil, this Macedonian market has been showing serious growth potential which attracted local and foreign investors. Competition in terms of medical cannabis production in Macedonia is rapidly increasing as new companies are showing an interest in being a part of the high-potential market. And we are not just talking about local companies. Even foreign-owned cannabis companies want to join in. Since this sector has been regulated and controlled by several governmental bodies, in this article I will briefly go through the necessary steps that lead to a turn-key business on production of cannabis oil.

The first step of the process is that the interested party needs to have a registered legal entity in the Republic of Macedonia (usually it is a LLC), which will perform as an applicant through out the whole process. In order to submit a request for growing (cultivating) license, the applicant is obliged to meet the conditions that are prescribed by law, such as:  having adequate space, surfaces or land for cultivation, drying and storage, equipped accordingly to the production etc. The license for the cultivation of cannabis is issued by the Ministry of Health within 30 days from the date of obtaining the consent from the Government of the Republic of Macedonia. Upon submission of the application for approval for cultivation to the Ministry of Health, this Ministry ex officio refers to the Government of the Republic of Macedonia in order to obtain prior consent for issuing the respective approval.

Upon receipt of the authorization for cannabis cultivation, the applicant must, prior to sowing / planting, submit a request to the Ministry of Agriculture, Forestry and Water Economy for obtaining approval for sowing / planting cannabis.

The final stage of licensing is that the applicant which produces cannabis should fulfill the conditions for manufacturing of medicinal products in accordance with the regulations on medicinal products and to have obtained a manufacturing authorization by the Agency for Medicinal Products and Medical Devices.

The manufacturing authorization includes a license for the production and sale of manufactured cannabis from the wholesaler itself.

The applicant must comply with certain conditions and requirements prescribed by law, such as land property, adequate space, laboratory, storage, packaging and quarantine area, equipment and employees etc. in order to be licensed accordingly.

 The whole process of licensing is time consuming and it requires a lot of preparation of documentation. Our law firm and our partners that are experts in preparation of an elaborate for cultivation of cannabis, preparation of information on the necessary documents for obtaining GACP for growing of cannabis, preparation of information on the necessary documents for obtaining GMP for extraction, as well as preparation of business plan and marketing plan, can help you and your company in every stage of the licensing process.