Draft decision on the evaluation of operators who will seek licensing for medical cannabis is revealed

The Ministry of Health and Social Protection is in the final stages of drafting a draft decision on the detailed criteria and procedures for evaluating license applications for operators who will cultivate and process cannabis for medical purposes.

So far, no operator requests for licensing have been approved by the Ministry of Health. The approval of the draft decision is expected to pave the way for the licensing of operator requests, a procedure that is expected to begin within this year.

The drafting of the draft decision is within the framework of completing the legal acts necessary for the implementation of Law No. 61/2023 "On the control of the cultivation and processing of the cannabis plant and the production of its by-products for medical and industrial purposes".

The draft aims to guarantee a transparent, objective and equal process for all entities seeking to be licensed for this activity. According to the draft decision, it aims to clearly define the criteria for the required experience in the main activities such as production, cultivation and circulation. The criteria for assessing professional experience and administrative capacities. The procedure for scoring and ranking applicants, as well as the method of resolving cases when applicants result with equal points.

The draft includes a 100-point scoring scheme, which will assess:

-3 years of experience in at least 3 of the main activities: Production, Cultivation, Circulation (import, export, transit, supply, purchase, sale, exchange, storage and warehousing.

-International experience, good production practices, capital, financial performance and organizational capacities of the entity.

This is expected to include meeting criteria such as: the entity or a shareholder thereof, who owns shares in the company, must be engaged in the production of cannabis plant by-products in one of the countries of the Organization for Economic Cooperation and Development for at least 5 years; must be in possession of good manufacturing practices, issued by the European Medicines Agency or the US Food and Drug Administration for at least 3 years; must have a company capital of not less than 100,000,000 (one hundred million) lek; must have shown positive financial performance in the last financial year; must have the administrative, organizational and reliability necessary to successfully engage in the main activities required for licensing.

In cases of equal points, a detailed procedure will be followed to determine the winner, including priority criteria such as international experience or chronological order of application.

The draft decision is expected to be approved in the coming days, to complete the legal framework for the medical cannabis industry in Albania, with the aim of guaranteeing international standards and safety in the sector.

Also at the beginning of May, the decision on the approval of cadastral zones where cultivation will be allowed came into force. According to the decision, the location of 17 permitted cadastral zones will be in the north of the country. 11 of them will be in the administrative unit of Gruemira in Malësia e Madhe, 3 of them in Postribë and 3 in the Shkodra District.

The licensing process has been accompanied by the previous approval of a series of legal and sub-legal acts, including the joint instruction of the Ministry of Health and the Ministry of Finance and Economy "On the procedure for paying the license fee for the production of cannabis for medical purposes and the manner of using this fee".

The fee set is 100,000 lek. This fee is non-refundable. The income obtained from this fee is collected in the treasury revenue account in favor of

National Cannabis Control Agency and are used according to the provisions of the decision of

Council of Ministers No. 646, dated 16.10.2024, “On the procedure and manner of using the revenues of the National Cannabis Control Agency”.

The decision of the Council of Ministers has determined that 70% of the revenues from licensing fees will go to the state budget and 30% to the budget of the National Cannabis Agency.

Meanwhile, the Ministry of Agriculture's instruction "On quality control methods, regarding the content of cannabinoids, as well as physical-chemical and microbiological control, on the method of packaging, form and quantity" published in the Official Gazette has determined the quality control methods, before packaging the material as well as the method of packaging, form and quantity./ Monitor