The changes in act on counteracting drug addiction came into effect.
On April 6, 2022, the Sejm of the Republic of Poland announced acts amending the act on counteracting drug addiction [1], [2]. The changes concern, among the others, the following areas:
- The regulation enables the cultivation of non-fibrous hemp, carried out in research institutes supervised by the Minister responsible for agriculture, in order to obtain raw material intended for the preparation of magistral preparations. In addition, it regulates the principles of carrying out these crops and harvesting.
- Research institutes wishing to cultivate non-fibrous hemp will have to meet a number of requirements imposed by the said amendment and obtain an appropriate cultivation permit issued by the Main Pharmaceutical Inspectorate.
- The regulation changes the definition of fibrous hemp by increasing the permissible THC and THCA content to 0.3% on a dry weight basis with the THC and THCA content rounded to one decimal place; a similar change has been made for the definition of ‘non-fibrous hemp herb’.
- The regulation introduces the possibility of cultivating fibrous hemp and poppy for own needs – with the cultivation area not exceeding 1 ha per year.
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What has NOT been changed?
Despite the appeals of patients and pharmaceutical companies, pharmaceutical raw materials containing cannabis are still not reimbursed. It is also worth noting that the EMA has issued a new document on the nomenclature of medicinal products containing cannabis “Compilation of terms and definitions for Cannabis-derived medicinal products” [3]. It is worth paying attention to the guideline not only when developing medicinal products, but also pharmaceutical raw materials based on hemp, as it systematizes, among others, nomenclature of hemp extracts. The guideline explains names that are not recommended, such as the confusing term “cannabis oil” used for cannabis extracts and cannabinoid solutions, while the term should apply to oil that is derived from seeds and does not contain cannabinoids.
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[1] Act of March 24, 2022 amending the act on counteracting drug addiction, Journal Of Laws 2022, item 763;
[2] Act of March 24, 2022 amending the act on counteracting drug addiction and some other acts, Journal Of Laws 2022, item 764;
[3] EMA/HMPC/161753/2020 Compilation of terms and definitions for Cannabis-derived medicinal products.
If you have any questions regarding the changes in medical cannabis law, please do not hesitate to contact us.