Medical cannabis, procedures for paying licensing and packaging fees come into effect

Applications are expected to open this year for licensing operators who will be allowed to cultivate and process cannabis in the country for medical purposes.

The responsible ministries continued to approve procedures for making payments for the license fee for operators, as well as rules for quality control and product packaging.

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" has been approved in the Official Gazette.

The fee set out in Article 14, point 9, 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” is 100,000 lek. This fee is non-refundable.

The instruction stipulates that the fee will be paid by the entity requesting the license according to the collection invoice, referring to the model approved by order no. 35, dated 11.11.2009, of the Minister of Finance, “On the approval of the collection invoice”.

To proceed with the payment, the entity must download the collection invoice from the Agency's website. The "Cash Receipt" is then presented by the entity to the second-tier bank to make the payment.

The second-tier bank will accept the fee only upon presentation of the invoice completed with the data according to the attached model. The document issued by the bank, confirming the payment, is submitted to the National Cannabis Control Agency together with the necessary documentation for the application.

The income obtained from this fee is collected in the treasury revenue account in favor of the National Cannabis Control Agency and is used according to the provisions of the Council of Ministers' decision no. 646, dated 16.10.2024, "On the procedure and manner of using the income 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.

Also, according to Article 15 of the law on the cultivation of cannabis for medical purposes, it was determined that after the third year, operators will pay an annual fee equal to 1.5% of annual turnover, but, in any case, not less than 10,000,000 lek.

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

The instruction states that the methods to be followed for analysis will be in accordance with the criteria of the importing countries. While the packaging in any case must meet the requirements according to Appendix No. 2 attached and integral part of this instruction, including criteria such as the label must not contain product advertising and data that cause misinformation to the consumer, as well as the packaging must be safe for transport./ Monitor.al