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New Law 4523/2018 On The Production Of Finished Pharmaceutical Products Made Of Cannabis

The Article 1 of Law 4523/2018 provides for the granting to individuals and legal entities of the right to produce, accumulate, store, transport and supply cannabis such as Cannabis Sativa L in raw form, with a THC content of up to 0.2%, as well as the right to establish and the operate the enterprise for the manufacture and processing of finished pharmaceutical products from hemp for the sole purpose of selling them either for medical purposes or for export.

In order for an individual or legal entity to legally be engaged in the production, accumulation, storage, transportation and supply of pharmaceutical cannabis, as well as to create an enterprise for the manufacture and processing of finished medicines from it, they need to obtain permits a) to establish and b) to operate enterprises, which are provided via the General Decision of the Ministers of Economy and Development, Health, and Agriculture and Food, after the relevant applications have been submitted to the Office of the issuance of enterprise business licenses, as well as to The Office of the Business Parks under the auspices of the General Secretariat of industrial facilities. It is acceptable to grant each of the above-mentioned permits to persons 21 years of age who are not burdened with criminal obstacles as well as to legal entities whose management consists of individuals 21 years of age without criminal records, after applications for the issuance of a permit, that is, for the establishment and operation, have been submitted, along with a document confirming the payment of the state duty in the amount of EUR 10,000 per issuance of each of the mentioned permits. According to the law, which provides for granting permission both for the establishment of a company and for its use, as well as in accordance with government announcement no. 511483/700 / F.15 / 2018 (government bulletin 1692 / B / 15-5-2018), a number of the most stringent conditions is applied, relating both to the characteristics of the site in the territory of which all activities of the enterprise will be carried out, and to its infrastructural structures, and the intellectual, criminal, tax and debt status of individuals or legal entities, who submit the aforementioned applications, as well as urban characteristics of the area. It is also necessary to obtain a set of permissions, register a number of declarations of responsibility, which are to be provided by applicants so that this kind of enterprises have been established correctly from a legal point of view and operated in accordance with the law.

If the address of registration of a legal entity is located abroad, then the appointment of a tax representative or agent in Greece is imperative. In any case, persons from non-EU countries must reside in Greece on a permanent basis or have a representative office in Greece.

At the same time, the law establishes strict rules for the safety and security of the enterprise, and all production and processing activities must be carried out in a confined space, on the territory of which storage facilities should be located. More specifically, a grid of barbed wire at least 3 meters in length should be located around the space, the site should be lit around the clock, an alarm system is required, and in continuous operation, with external motion sensors with which you can detect any attempts for crossing the spiny fence or climbing through it, the fence should be equipped with a built-in surveillance system 24 hours a day, the perimeter of the cover should not contain blind zones, and security activities should be carried out by uniformed trained representatives of private security agencies.

Органом, отвечающим за контроль за соблюдением условий безопасности, как в инфраструктурных сооружениях предприятий, так и во время транспортировки конечной продукции, является Директорат общественной безопасности штаба полиции Греции. Перевозка готовых продуктов из каннабиса, как на территории Греции, так и во время прохождения таможенного контроля, осуществляется при сопровождении полиции.

Finally, with regard to the quantity of imported seeds, it should not exceed three (3) kilograms per acre of sowing, and should be calculated so as to cover the sowing requirements of the approved crop area. Packaging must have special labeling in accordance with the requirements of the ministerial decision. At the same time, the importing company is obliged to declare the arrival of the cargo at the point of entry into the territory of the Greek state two working days before the seeds arrive at the local Department of Rural Development and Control of the decentralized services of the Ministry of Agriculture and Rural Development (TAAEA).

Thus, the new law now allows individuals and legal entities to legally produce, accumulate, store, transport and supply different types of cannabis in Greece for the sole purpose of making finished pharmaceutical products for medical purposes or for exporting these finished products abroad. Nevertheless, the law also provides for the establishment of a strict procedure for obtaining permission to establish and operate enterprises for the manufacture and processing of pharmaceutical cannabis. In accordance with the explanatory memorandum to the law, the global market for the cultivation and processing of medical cannabis is in early stages of development, with the result that there is a high demand for pharmaceutical cannabis products and, consequently, high demand for the purchase, supply and export of finished products made of it, therefore, legalization of these enterprises in Greece will determine the boom of the state economy.

The International Law Office of Mrs. Kassakina-Kouskou Svetlana with full responsibility, methodical approach and reliability provides services and advice on the legal procedure for obtaining the required permission to establish and operate an enterprise for the production, storage, transportation and supply, including for export, of pharmaceutical cannabis, and finished products from it, which is going to be created on the territory of Greece, in accordance with the requirements of the new law 4523/2018. Our office provides qualified legal support throughout the process of obtaining the appropriate licenses, representing the interests of the client at all stages of the issue


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