The law 4801/2021, recently voted from the Greek parliament, with title “Production, export and distribution of final cannabis products of the type Cannabis Sativa L, with a tetrahydrocannabinol (THC) content of more than 0.2%” accelerates the implementation of investments in Medical Cannabis.
The bill allows the producer company in Greece to export with the necessary license to another country, dried flowers and any other pharmaceutical form of products.
This facilitates the implementation of investments from companies that have received installation license to establish medical cannabis production facilities as they are allowed to start the production of medical cannabis products intended for export, even if they have not marketing license approval in Greece. A basic condition, of course, is that a relevant permit has been issued in the country of destination.
The main points of the law of the Greek Ministry of Development are the following:
- From now on, all the activities of the facilities for the processing and production of finished cannabis medicinal products will be approved in two stages, instead of the current one. The first stage is the installation and the second the operation.
- A new installation approval and modification of the operating approval is required at any change in the activity of the processing units of Pharmaceutical Cannabis.
EOF (National Organization for Medicines), by way of derogation from any provision to the contrary, shall approve and authorize the production of finished cannabis products of the Cannabis Sativa L content with a THC content of more than 0,2%, regardless of form, which are intended exclusively for export for medical purposes.
- The issuance of a production license for products exclusively for export requires, among other things, the submission of a license or other document by the competent authorities of the country of destination and the description of the product, while EOF is obliged to grant the license within 90 days from the submission of the complete dossier.
- The interested companies will pay a reciprocal fee in favor of the EOF of 2,500 euros plus 400 euros per form and content. The exports of these products will be made by the 3rd Custom office of Piraeus and the 1st Customs office of Thessaloniki.
- The production of finished cannabis medicinal products in the form of dried flower packaging up to 30 grams is allowed for the sole purpose of exporting them for medical purposes only, whether or not they are intended to be used as a final or intermediate product or raw material for medical and pharmaceutical purposes in the importing country.
- The production license exclusively for the export of finished cannabis medicinal products in the form of dried flower is granted in case that the production facility has at the same time submitted an application for product distribution approval of the final product in Greece in a product form which is different from that of dried flower.
- Stricter safety requirements are required in the production facilities when they also produce products in the form of dried flower. In particular, additional internal fencing will be required for the perimeter protection of the facility, an enclosed neutral control zone for incoming and outgoing vehicles, as well as reinforced masonry and security doors at the storage points of active raw materials and dried cannabis products in the form of cannabis.
Cannabis Sativa L cannabis propagating material with a THC content of more than 0.2% may be exported under conditions.
- From now on, the establishment of the activity of cultivation and production of finished medicinal cannabis products in areas of high productivity is prohibited.
Those companies that have already received licenses, or are in the process of receiving a license, will be excluded from the restrictions of the establishment of production units in high productivity land.
- An extension of the exemption is also planned, with approximate duration of three to five months, as there are several interested parties who, either have made pre-agreements or have not yet applied, but have bought high-productivity land for a medical cannabis investment.
- Installation approval decisions issued until the new legal framework enters into force will remain in force.
Additionally, investments in medical cannabis facilities in Greece are supported by the Greek Development Law and may be partially funded either through a subsidy or through tax exemptions or a combination. The funding rate (subsidy and/or tax exemption) amounts up to 55% of the investment (maximum amount of aid: up to €10mil.).
Concluding, the new law will boost the domestic growth, enhance export activity of Greek medical cannabis companies, which will be able to distribute dried flower products and ready-made cannabis medicines, effectively laying a solid foundation for the emergence of a robust industry amid a dynamically growing global Medical Cannabis market.
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