Poland buy Cannabis

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Poland buy Cannabis

Cannabis is illegal in Poland for recreational use , but medicinal use is legal. As of November , the use of marijuana for medicinal purposes and treatment was legalized, allowing physicians to prescribe marijuana as a form of treatment for specific medical conditions. THC is defined under the I-N category as having a high probability of abuse in Poland, so it maintains an illegal status for recreational use. Medical marijuana can be obtained in Poland, but the Polish government has specific laws and regulations. Research institutions and pharmaceutical companies can grow cannabis containing more than 0. Importing and selling cannabis is also allowed in Poland if it is used for prescription medications per government guidelines. There is limited information on cannabis possession amounts for medical patients. Each patient is assessed on a case-to-case basis. However, a non-legally binding rule is that patients should not possess more than 90 days of the standard daily treatment amount of high THC-based medical products. Sativex a THC-based spray is commonly prescribed to treat conditions such as multiple sclerosis. However, due to complicated laws surrounding the prescription of cannabis and a lack of education and resources for physicians regarding the health benefits of medical cannabis , many physicians avoid prescribing it to patients with chronic pain. It is unclear whether telemedicine consultations are allowed. However, due to strict rules, it is unlikely that medical cannabis can be prescribed through online communications. Patients would need to see licensed physicians in a face-to-face consultation. There are no reports of employment laws protecting medical cannabis cardholders in Poland. Due to the rigorous procedures required to be a medical cannabis patient in Poland, it is unlikely that there are laws in place to protect medical cannabis cardholders. The cultivation of cannabis that is under 0. Cannabis with less than 0. There is no regulation on how much low-THC cannabis hemp can be grown. Pharmaceutical companies can grow cannabis over 0. To obtain cannabis with higher THC percentages from foreign countries, pharmaceutical companies must obtain authorization from the Office for the Registration of Medical Products. With cannabis being illegal for recreational use in Poland, it is unsafe to purchase it anywhere. It is safe to buy cannabis for medical purposes if medical professionals have approved it. In saying this, it is costly to purchase cannabis for medicinal purposes, as the Polish Ministry of Health MoH has not subsidized the costs of cannabis-based medicines. Although fines and imprisonment can be avoided while possessing small amounts of marijuana in Poland, it is only safe to consume marijuana when it is prescribed for medical purposes. The EMCDDA European Monitoring Center for Drugs and Drug Addiction states that although there are laws in place surrounding the consumption of cannabis, Eastern European countries such as Poland are likely to suspend prison sentences and reduce the consequences associated with recreational marijuana consumption.

Medical Cannabis & Cannabinoid Regulation 2024

Poland buy Cannabis

It assists pharmaceutical and manufacturers of medical device. The firm has three senior lawyers who provide daily support in commercial and regulatory areas. It assesses permitted relationships with HCPs, advises on or audits marketing studies and activities. It counsels in regulatory matters, pharmaceutical advertising, clinical trials and reimbursement. The firm also advises on distribution and manufacturing of medicines and medical devices, including drafting relevant contracts. There are a number of laws in Poland that govern the production, distribution and use of medical cannabis and cannabinoids. The most popular cannabinoids are tetrahydrocannabinol THC and cannabidiol CBD ; therefore, this article will focus on regulations concerning these two. It should be noted that the cannabis species referred to as medical cannabis contains higher doses of THC, while CBD comes first from hemp. Medical cannabis and hemp are different strains of the same species, which is cannabis sativa. The LPNA addresses numerous aspects concerning medical cannabis and hemp, including their classification, holding and permitted use, placing on the market, cultivation and harvest. It also imposes the obligation to obtain various authorisations or permits before engaging in any of these activities. These terms are used throughout Polish regulations applicable to cannabis. Non-fibrous cannabis is, in practice, equivalent to medical cannabis; other strains are considered hemp. Fibrous cannabis hemp is defined in the LPNA as a plant belonging to the cannabis species cannabis sativa L , in which the content of the deltatetrahydrocannabinol and tetrahydrocannabinolic acid deltaTHCcarboxylic acid in flowering or fruiting tops of the plant from which the resin has not been removed does not exceed 0. In contrast, any other cannabis containing higher content than the above THC combination will be considered non-fibrous cannabis. All herbs and extracts, pharmaceutical tinctures and all other extracts of non-fibrous cannabis that is, containing THC of over 0. Manufacturing, use and distribution of such narcotic drugs is either prohibited or strictly limited, while the same activities regarding hemp are considerably less regulated. According to the LPNA, possession of any narcotic drugs is authorised only for entities or individuals who are allowed to possess them under binding statutory provisions. The police or customs authorities may seize and secure any possessed narcotic drugs in the absence of such entitlement. Medicinal products containing narcotic drugs such as those defined above regarding derivatives of medical cannabis for individuals are available in pharmacies, on special medical prescription. For details, please see 1. According to the LPNA, all narcotic drugs I-N and II-N — including, therefore, herbs and extracts, pharmaceutical tinctures and all other extracts of medical cannabis, as well as cannabis resin, as defined in the LPNA — may be used only for medical, industrial or research purposes upon meeting other applicable requirements. For medical purposes, such derivatives and resin may be considered pharmaceutical raw materials that might serve for the preparation of pharmaceutical materials in pharmacies, and which are available on medical prescription and subject to special marketing authorisation. It should be noted that recreational use of medical cannabis is currently not allowed in Poland and is subject to criminal liability please see above, under Possession. Use of products including only CBD is not regulated under the LPNA; however, limitations on such use may result from other legal regulations, in particular those concerning novel food for details, please see under Other Regulations below, and see also 3. Most of the terms applicable for marketing medical cannabis are included in the LPNA. Marketing medical cannabis requires a special marketing authorisation, designed specifically for medical cannabis that is, herbs of non-fibrous cannabis and cannabis resin — please see the definitions discussed above , and referred to in the LPNA and a corresponding MoH Regulation. This concerns the application form for the marketing authorisation of pharmaceutical raw material for the preparation of prescription medicines in the form of non-fibrous cannabis herbs and extracts, pharmaceutical tinctures, and other extracts of non-fibrous cannabis and resin, as well as a detailed range of data and a list of documents covered by this application. Also provided are details of specific proceedings, in which the marketing authorisation specifically for medical cannabis is issued, such as concerning the content of the application and the required documents including, in particular, the manufacturing authorisation. The marketing authorisation, in the case of medical cannabis, is issued for a pharmaceutical raw material and not a medicinal product ; specifically, no summary of product characteristics is issued. Other general requirements on marketing authorisations that would also apply to medical cannabis are included in the Pharmaceutical Law see below under The Pharmaceutical Law ; and the LPNA refers to a number of specific provisions regarding renewals, fees and refusals to grant. The LPNA regulates two basic stages of manufacturing of medicines, including narcotic substances, such as the derivatives from medical cannabis. The first stage consists of manufacturing the active pharmaceutical ingredient for the further manufacturing of a pharmaceutical raw material containing medical cannabis, and, as is explicitly defined in the LPNA, of grinding dried parts of plants and carrying out physicochemical operations as a result of which the substance is produced including extraction, and packaging in bulk packaging. The requirements of Good Manufacturing Practice for active pharmaceutical ingredients, included in the Pharmaceutical Law and in the corresponding MoH Regulation concerning the requirements of Good Manufacturing Practice, apply to such operations. One such requirement is the obligation for the manufacturer to be registered in the register of manufacturers of active substances. The second stage is manufacturing the pharmaceutical raw material, and consists of repackaging from bulk into packaging in which the raw material will be delivered to pharmacies. These operations should observe the requirements of the manufacturing of medicinal products, contained in the Pharmaceutical Law and in the corresponding MoH Regulation on Good Manufacturing Practice. The key requirement is holding a regular manufacturing authorisation. The LPNA also requires a separate specific authorisation for the manufacturing, processing, importation and distribution of narcotic drugs, including medical cannabis. Cultivation of hemp fibrous cannabis is allowed only for explicitly listed purposes; however, their scope is quite large and covers numerous industrial purposes. Both cultivation and buying hemp from its manufacturer require prior registration in a special register run by the National Support Centre for Agriculture. The LPNA provides for numerous requirements applicable to manufacturers and buyers of hemp, and determines the required content of applications and the documents that should be submitted with them in order to be registered. It also provides for the right to inspect manufacturers and buyers to ensure they are compliant with applicable requirements. Cultivation of medical cannabis non-fibrous cannabis is strictly regulated. Until , it was only permitted to cultivate strains of cannabis other than hemp for research purposes, by very limited categories of research institutions, upon special authorisation issued by the Chief Pharmaceutical Inspector. Since May , in Poland it is permitted to cultivate non-fibrous cannabis medical cannabis , as well as to harvest herbs and resin from it, for the purpose of the manufacturing of pharmaceutical raw material, with a special permit issued by the Chief Pharmaceutical Inspector. Such permit may be issued only to research institutions, supervised by the Minister of Agriculture. Wholesale of medical cannabis is also strictly regulated by the LPNA and requires special authorisation for details, please see 1. The second major legal act applying to medical cannabis only is the Pharmaceutical Law Ustawa prawo farmaceutyczne , which establishes legal requirements for the manufacturing, importation, wholesale and retail distribution of medicinal products in general. The following provisions of the Pharmaceutical Law apply to medicinal products containing derivatives of medical cannabis:. In Poland, medicinal products containing medical cannabis are not currently reimbursed; therefore, a person wishing to buy such product and holding a medical prescription will have to bear its entire cost. Various products other than medicinal products containing cannabinoids especially CBD are available on the Polish market. These products may be divided into the following categories among others :. It should be noted that food and cosmetics laws and regulations are often EU-wide and, therefore, are directly applicable throughout the entire EU. However, it must be emphasised that in Poland there are no regulations dedicated specifically to non-controlled cannabinoids especially CBD. There is a wide variety of such products on the market, in terms of both their ingredients and their quality. The President of the ORMP is responsible for issuing marketing authorisations for human and veterinary medicines. The President of the ORMP issues marketing authorisations specifically concerning medicinal cannabis coming from a determined supplier , as a pharmaceutical raw material from which a medicine available in pharmacies can be manufactured. Such marketing authorisation is issued for five years, in special proceedings regulated by the LPNA, an MoH Regulation and the Pharmaceutical Law for details, please see 1. The ChPhI is the governmental authority for supervision of manufacturing, importation, wholesale distribution and advertising of medicinal products, and is a major governmental agency dealing with medical cannabis, whose determined derivatives please see the definition in 1. The various authorisations and permits issued by this authority are listed below. The ChPhI issues regular manufacturing authorisation required to manufacture any medicinal product, including medical cannabis, as the raw pharmaceutical material. Also, importation of medical cannabis ie, from countries outside the EEA and its testing and distribution would require an import authorisation issued by the ChPhI. The ChPhI is also responsible for issuing specific authorisation required to manufacture, process, import or distribute narcotic drugs, such as medical cannabis. This is issued for an undefined time period ie, unlimited in time. To obtain this authorisation, the applicant should first have obtained a regular manufacturing authorisation. Wholesale distribution of any medicinal product, including medical cannabis, would also require a regular wholesale authorisation granted by the ChPhI. Specific wholesale distribution authorisation for narcotic drugs. The ChPhI is also responsible for issuing special licences required for the importation, exportation or intra-community supply of narcotic drugs. These licences should be obtained for each such specific import, export or supply, and should determine the volume and the term in which these can be performed eg, one-off licences. It should be noted that there are annual limits in force that determine the maximum volume of all medical cannabis imports into Poland. Estimated world requirements for determined narcotic drugs including medical cannabis and separately cannabis resin for all the countries are available on the International Narcotics Control Board website. These requirements are regularly updated, and in Poland they also set thresholds for annual imports of the narcotic drugs listed there. In general, ChPI will issue one-off import licences for the import of certain narcotic drugs in accordance with the application, provided however that the annual limit for Poland for this particular narcotic drug is not exceeded. The annual limit in for import of medical cannabis is 6,,g and 50g for cannabis resin. Cultivation and harvesting of medical cannabis require a special permit issued by the ChPhI. The Director of the National Support Centre for Agriculture maintains a register of poppy and hemp, in which producers cultivators of hemp and entities purchasing hemp from them should already be registered before cultivation begins. In other words, the producer must have all production contracted before they start cultivation. In Poland, there are no self-regulatory authorities, but there are a number of industry associations that promote use of cannabis for various purposes. One such organisation is Free Cannabis Wolne Konopie , which describes itself as an association acting for the reasonable and effective use of cannabis, established in The Polish Federation of Patients is an organisation that represents the interests of patients in Poland. CannabiMed Foundation is an organisation dedicated to promoting knowledge about the uses of medical cannabis in the treatment of various diseases and conditions. The Foundation is also working to change Polish law regarding the legalisation of medical cannabis. TRUSTT is one of two companies in Europe that have emerged to track the manufacturing processes of medical cannabis products and verify regulatory compliance. The company implements solutions based on advanced technology such as blockchain, ensuring the security and immutability of the data obtained. The solution proposed by TRUSTT can be an element of market self-regulation, but above all it can be a tool used by the regulator to control the market. The list of the organisations involved in the topic of hemp in Poland continues to grow, as interest in the subject has grown in recent years. Most such organisations are focused on spreading awareness of the use of medical cannabis and on providing access to it for those who need it. None of these organisations has a dominant position in the market, nor have they managed to develop and introduce any significant documents, rules or principles that would already significantly affect the market. Each of these players is trying to attain a significant position, but so far it is not possible to point to any entity considered to be shaping or significantly influencing market behaviour. The market is still in the early stages of development, where there is a high degree of discretion in the areas not strictly regulated by national law. This causes confidence in this market and its participants to remain quite low. A major legal change occurred in , when use of medical cannabis, including THC, became legally allowed for medical purposes under defined terms. In another recent significant legislative change, since May , cultivation and harvesting of non-fibrous cannabis with THC content over 0. However, this change should only be seen as a prelude to a true opening of the market for medical cannabis cultivation in Poland, since this option is available only to a limited number of State research institutes, which should meet numerous and extremely strict requirements. In practice, this significantly reduces, if not eliminates, any chance for domestic cultivation of medical cannabis. Therefore, in the coming months, and perhaps even in the longer term of one or two years, it is difficult to expect significant changes and the emergence of marketable volumes of medical cannabis from domestic cultivation. At the same time, the permitted concentration of THC in cannabis derivatives was increased from 0. As regards lifestyle products, including CBD from hemp, the regulations are very widespread and sometimes difficult to identify. It is widely discussed that with respect to lifestyle products, quality criteria and certification proceedings are missing, which can adversely affect their quality. For certain categories of popular lifestyle products, supervision by regulatory authorities is rather weak or ineffective. The Polish cannabis market is still in the early stages of development both in terms of legislation and market practices. Legal risks include the following. Certain derivatives of medical cannabis are considered narcotic drugs please see 1. In Polish law, sanctions — both criminal and administrative — are included in the Criminal Code and legal regulations regarding specific categories of products ie, narcotics, medicinal products and food. As referred to in 1. Polish law also penalises certain activities involving fibrous hemp. Penalties for individual offences vary depending on the type of offence and the amounts of narcotic drug involved, as follows. There is a separate offence specifically concerning non-fibrous hemp and certain other plants , as follows. It should be noted that according to the general provisions of the Polish Criminal Code, a fine can always be inflicted by the court upon a perpetrator condemned to imprisonment, where this perpetrator committed the offence to obtain financial advantage, or where they obtained financial advantage. An individual who does not have a medical cannabis treatment certificate commits a criminal offence. When determining a case for an offence against safety in communication committed under the influence of an intoxicant, the court must determine in each case whether the drug had a real effect on the psychomotor performance of the driver of the vehicle to a degree similar to that of being under the influence of alcohol. The Act also provides for fines for non-compliance with the labelling requirements applicable to foodstuffs, including presentation, advertising and promotion. Bringing danger to the life or health of many people by manufacturing or marketing substances, foodstuffs or pharmaceuticals that are harmful to health and that do not meet the applicable quality conditions is a crime listed in the Polish Criminal Code. Such an act is punishable by the basic penalty of imprisonment for six months to eight years. In enforcing criminal law provisions, the key role is played by the authorities conducting criminal proceedings — ie, the police, public prosecutors and common courts. The police and public prosecutors conduct criminal investigations, which may result in bringing charges to a common criminal court, which conducts judicial proceedings that may result in conviction and determined penalties. The Pharmaceutical Law applies to narcotic drugs within the meaning of the provisions on preventing narcotics addiction and which are considered medicinal products. Importantly, in the event of violation of the conditions for the manufacturing or importation of medicinal products, which are very restrictive in relation to drugs containing cannabinoids, the Chief Pharmaceutical Inspector may issue a decision prohibiting the placing of a medicinal product on the market or on withdrawing a medicinal product from the market. Medicinal products containing narcotic substances may be dispensed only upon a medical prescription. Conducting wholesale trade in narcotic drugs requires an additional permit, whereas brokering in narcotic drugs is prohibited. In addition, it is prohibited to advertise medicinal products containing narcotic drugs to the public. In accordance with the Pharmaceutical Law, breaking this prohibition is punishable by a fine ie, it is a criminal offence. The State Sanitary Inspection is the Polish authority responsible for supervision over the health conditions of food. The investigation procedure is aimed at clarifying whether the product covered by the notification is a foodstuff in accordance with the qualification proposed by the food business operator and whether it meets the requirements for a given type of foodstuff eg, for a food supplement. In addition, the procedure determines whether or not the food meets the requirements of a product of another category eg, a medicinal product. In the event of suspicion that a food product not meeting the specified requirements is on the market, the regional sanitary inspector may decide to temporarily suspend the marketing of this food product or to withdraw it from the market until the end of the procedure. Given the lack of uniform regulation of hemp and medical cannabis at the level of EU legislation, players in the European market must take into account and analyse national regulations. The problem is even more significant in the case of cross-border trade with non-EU countries. Although there is a common trend across the EU towards liberalisation of THC levels in cannabis products and availability of medical cannabis, differences remain. Therefore, any market player which intends to engage in cross-border transactions must carefully examine the legal environment of the country in question before entering into such transactions. There is a lack of organisations, platforms or other initiatives at the international level that would transparently present the differences in regulations from one country to another. This is even more important given the fact that national laws are constantly being amended, and although they are usually aimed at liberalising regulations, these constant changes make it difficult to operate across borders. Use of medical cannabis for medical purposes is allowed, under strictly defined terms. At present, access to medical cannabis requires a special medical prescription for narcotic substances. This can be issued by any physician; however, many do not have appropriate training and expertise for treating patients with medical cannabis. There are no official guidelines on indications in which medical cannabis may be used, and in which dosages. Each physician should decide individually on whether to prescribe medical cannabis in given circumstances, bearing personal liability. Notwithstanding, at least several dozen thousands of prescriptions are issued in Poland for medical cannabis, what makes Poland a country where the medical cannabis market grows quickly. During the COVID pandemic, medical consultations and online prescriptions were permitted on a large scale. As a result, internet portals specialising in medical consultations related to medical cannabis treatment were established. This resulted in a certain market pathology, in which a prescription for medical cannabis could have been obtained online literally within minutes. The problem has already been recognised by the MoH and in consequence, a regulation was adopted, which became binding in August The regulation introduced an obligation on each doctor prescribing medical cannabis to a patient to verify the number and kinds of other medicines which were prescribed to this patient, and to examine the patient, on an on-site or on-line consultation, if the time since the last examination exceeded three months. In , more than 4. This is a huge increase compared to previous years. Compared to , pharmacists dispensed as much as 3. This indicates a growing interest in medical cannabis in Poland. The above-mentioned amendment to the LPNA has established a framework for the cultivation, production and distribution of medical cannabis in Poland. Some key aspects of this amendment include the following. As a result of current unavailability of domestic cultivation of medical cannabis, all the requirements for it have so far been met by imports from other countries mostly the EU. This certainly affects access to it, since imported medical cannabis is expensive. Considering that medical cannabis is not reimbursed in Poland, patients wishing to purchase it must pay for it with their own resources. Where dosages prescribed by treating physicians are high, the monthly costs of treatment which may be close to the minimum monthly salary in Poland may be unaffordable for some patients. There have been discussions about expanding the list of medical conditions for which medical cannabis can be used, but no significant changes have yet been made. The Polish government has been generally cautious about cannabis legalisation, so any changes to the legal elements affecting access to medical cannabis may take time. However, with the growing awareness of the potential benefits of medical cannabis, it is possible that the legal landscape may evolve in the future. This Regulation is applied directly in Poland. No such authorisation has yet been granted for non-controlled cannabinoids; therefore, they cannot be used in food. An important issue should be emphasised in this context. Some cannabis sativa L products such as seeds, seed oil, hemp seed flour and defatted hemp seeds are widely used in the EU, have a long history of use and are not considered novel foods. In contrast, extracts from cannabis sativa L that contain cannabinoids such as cannabidiol CBD , and foods enriched with extracts from cannabis sativa L or with cannabinoids such as CBD eg, hemp seed oil with CBD or dietary supplements with CBD are considered novel foods, as history of consumption has not been demonstrated. This applies to both the extracts themselves and to any products to which they are added as an ingredient such as hemp seed oil. This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are also considered novel foods. According to the official information provided by EFSA, its scientists cannot currently establish the safety of cannabidiol CBD as a novel food due to data gaps and uncertainties about potential hazards related to CBD intake. Therefore, as long as the scientific assessment of CBD in terms of its safety remains incomplete, and foodstuffs containing CBD remain not authorised by the European Commission, products containing CBD cannot be placed on the Polish market as food. In one of the more interesting court cases concerning cannabis sativa L in the context of novel foods, the Voivodeship Administrative Court in Warsaw held that only the following are novel foods:. The court explained that the cannabis sativa L herb is not a novel food, because it has a long history of use and does not constitute a novel food according to catalogues published by the EU. In the opinion of the court, the EU list of novel foods does not by definition list all food products and ingredients that can be used in food production. The fact that a food or ingredient is not explicitly mentioned does not automatically mean that it is a novel food. The list of novel foods includes only those products and ingredients for which the European Commission has received a request for an opinion on whether a given product or ingredient should undergo the authorisation procedure. On this basis, the court concluded that cannabis sativa L the herb is not a novel food. The position on the use of hemp in food was also analysed by the sanitary authorities. Nevertheless, when placing food containing the above-mentioned raw materials on the market in Poland, the supplier should have current and reliable results of the analysis of the finished food, confirming the absence of psychotropic substances ie, tetrahydrocannabinol THC above acceptable levels. Issues related to hemp are also within the scope of the Polish tax authorities. Although the decisions of these authorities are not generally applicable law and do not determine whether a given commodity can be legally traded as food, they indirectly by reference to the circumstances of a given case show the industry practice and the variety of problems and issues related to the marketing of the products in question. For example, in one of the decisions clarifying the combined nomenclature CN classification for the purpose of taxation, dried hemp inflorescences were presented to the tax authorities as a product not intended for human consumption, and such classification was accepted Director of the National Tax Information KDST Despite the aforementioned, products containing CBD are available on the market in Poland. However, they are not promoted as food, and their labels do not contain information suggesting that the products are edible. Such information can sometimes be obtained from the sellers. Interestingly, manufacturers or sellers provide information on the characteristics of a product, without stating explicitly that the described effects require its consumption as food. Some CBD-containing products are also presented as food supplements; however, due to the lack of authorisation under novel food regulations, this is not legally allowed. Such controversial practices are partly a result of inefficient market supervision. The Polish supervisory authorities for compliance with food law and that are responsible for performance of official food inspections are the State Sanitary Inspection and the Chief Sanitary Inspector, which is the relevant central government administration authority. Each food business operator is obliged to make a notification regarding the first placement on the market of a food supplement, and the Chief Sanitary Inspector may conduct explanatory proceedings regarding the product to clarify it is a foodstuff in accordance with the qualification proposed by the food business operator, and whether it meets the requirements for a given type of foodstuff. In addition, the procedure may aim to determine whether the food is not in fact a different category of a product eg, a medicinal product. Despite the broad competences of the Sanitary Inspection, the great number of notifications roughly 25, in makes it difficult to control the market. In Poland, until , possession for personal use of small amounts of substances covered by the regime of the LPNA was not punishable. The situation changed when the provisions of Article 62 were adopted, stipulating that possession of any type of drug is punishable, regardless of the quantity and purpose of possession. The rationale behind this step was to increase the effectiveness of police operations. Among other things, the idea was that a dealer arrested with a prohibited substance should not escape responsibility by declaring possession for personal use. The amendment caused the number of detected drug possession offences to rapidly increase — from nearly 1, in to over 31, in data from the Polish Drug Policy Network. Prosecutors have the option to discontinue prosecution for possession of insignificant amounts of psychoactive substances. Today, one in three cases for possession is dropped. In recent years, a growing number of countries around the world have begun to liberalise their cannabis policies, which has led to increasingly more debate about legalising recreational cannabis in Poland. In Poland, a parliamentary panel on the legalisation of recreational cannabis was established in Chambers and Partners website Toggle navigation. Last Updated May 30, Law and Practice. Expand All. Regulatory Framework. Classification The LPNA splits the cannabis genus cannabis L into two categories: hemp literally, fibrous cannabis ; and non-fibrous cannabis. The LPNA refers to the following: herb — defined as any terrestrial part of a cannabis plant alone or in a mixture of non-fibrous cannabis, excluding seeds, containing over 0. Possession According to the LPNA, possession of any narcotic drugs is authorised only for entities or individuals who are allowed to possess them under binding statutory provisions. The LPNA authorises the following entities to possess narcotic drugs: pharmacies; healthcare institutions and physicians, provided they obtained a special permit issued by the regional pharmaceutical inspector; and certain other entities. Permitted use According to the LPNA, all narcotic drugs I-N and II-N — including, therefore, herbs and extracts, pharmaceutical tinctures and all other extracts of medical cannabis, as well as cannabis resin, as defined in the LPNA — may be used only for medical, industrial or research purposes upon meeting other applicable requirements. Marketing medical cannabis Most of the terms applicable for marketing medical cannabis are included in the LPNA. Manufacturing The LPNA regulates two basic stages of manufacturing of medicines, including narcotic substances, such as the derivatives from medical cannabis. Cultivation and harvest Cultivation of hemp fibrous cannabis is allowed only for explicitly listed purposes; however, their scope is quite large and covers numerous industrial purposes. Distribution Wholesale of medical cannabis is also strictly regulated by the LPNA and requires special authorisation for details, please see 1. The Pharmaceutical Law The second major legal act applying to medical cannabis only is the Pharmaceutical Law Ustawa prawo farmaceutyczne , which establishes legal requirements for the manufacturing, importation, wholesale and retail distribution of medicinal products in general. The following provisions of the Pharmaceutical Law apply to medicinal products containing derivatives of medical cannabis: on the marketing authorisation, including those on special proceedings concerning market approvals for raw pharmaceutical materials; on the manufacturing and importation of medicinal products, and Good Manufacturing Practice; on the manufacturing of active pharmaceutical ingredients, including Good Manufacturing Practice of active pharmaceutical ingredients; on wholesale distribution of medicines; on retail sale of medicines; and on prescriptions. Other Regulations Reimbursement In Poland, medicinal products containing medical cannabis are not currently reimbursed; therefore, a person wishing to buy such product and holding a medical prescription will have to bear its entire cost. Lifestyle products Various products other than medicinal products containing cannabinoids especially CBD are available on the Polish market. These products may be divided into the following categories among others : cosmetic products; food; and smoking accessories. There are numerous authorities responsible for enforcing laws regarding cannabis in Poland. Regular manufacturing authorisation The ChPhI issues regular manufacturing authorisation required to manufacture any medicinal product, including medical cannabis, as the raw pharmaceutical material. Specific manufacturing authorisation for narcotic drugs The ChPhI is also responsible for issuing specific authorisation required to manufacture, process, import or distribute narcotic drugs, such as medical cannabis. Regular wholesale distribution authorisation Wholesale distribution of any medicinal product, including medical cannabis, would also require a regular wholesale authorisation granted by the ChPhI. Specific wholesale distribution authorisation for narcotic drugs A separate authorisation is also necessary for wholesale distribution of narcotic drugs. Import and export licences The ChPhI is also responsible for issuing special licences required for the importation, exportation or intra-community supply of narcotic drugs. Permits for cultivation and harvesting of non-fibrous cannabis Cultivation and harvesting of medical cannabis require a special permit issued by the ChPhI. Examples of other organisations active in the market include the following. Key market challenges include the following. The lack of quality standards for cannabidiol products. The vast majority of the market operates without any certification or quality monitoring. The market for cannabidiol products is growing rapidly, which causes many operators to try to achieve the best possible sales results at a low cost. Hence, for most products, there is no certainty that the product complies with the declared composition. The attitude of the State administration is still highly distrustful, and lack of education of forces responsible for law enforcement police, customs, etc causes cannabis to continue being associated mainly with narcotics. This means that the cultivation of hemp with an acceptable THC content ie, below 0. The lack of uniform nationwide laboratory methods for determining THC levels to exclude the risk of erroneous or contradictory results, which can have serious consequences, including the risk of criminal liability. There are no standards and scopes for laboratory testing. There is no practice of testing for more cannabinoids, for terpenes or for contaminants such as heavy metals. Of course, standards are in place with pharmaceutical standard laboratories taking into account EU Good Manufacturing Practice, but unfortunately most testing is done in non-standardised units. This also and perhaps especially applies to forensic laboratories and customs. Due to the wide disparity in standards and testing methods used, there is large discrepancy with final laboratory results. This creates a great deal of problems and controversy, given the limited number of entities that can cultivate 13 State research institutes , which do not have adequate funds or ways to obtain them from the market, and which do not have the knowledge or competence regarding how to put into practice the provisions of the law and to start growing medical cannabis, not for research but for commercial purposes, and on an appropriate scale. In spite of this fact, the situation with regard to liberalisation of law in respect of not only medical but also recreational cannabis appears to be much better than under the previous conservative government. Moreover, according to one recent public survey, Therefore, future changes of the law seem to have only one direction — liberalisation. Of course, the frequently changing regulations are a challenge for those planning to operate in this market. The need for improving knowledge of medical cannabis therapy, especially among doctors. Numerous doctors complain about unavailability of adequate training on how and in which indications to prescribe medical cannabis. The absence of medical cannabis on the list of reimbursed medicines. Therapy with medical cannabis should be financed entirely by patients; due to relatively high costs of medical cannabis, certainly many patients who could benefit from using it cannot afford it. Restrictions on agricultural land trading constitute a barrier for entities that would like to enter the market of industrial hemp cultivation and that do not have the status of a farmer in the understanding of Polish law. Numerous laws no single act comprehensively regulating the cannabis market — ie, for medical cannabis, cannabinoids and industrial hemp — makes it difficult for start-ups to know all their rights and obligations; and It should be remembered that hemp and cannabis are still widely and strongly perceived as narcotics in Poland, which is why the cannabis business still faces a certain amount of suspicion and mistrust, especially towards newcomers to the business. However, the awareness of state authorities is increasing and medical cannabis is already seen as a drug used in many therapies. Recently, the Polish Police, when queried by the Ombudsman, confirmed that persons with a prescription for the use of medical cannabis are treated like any other patient in the event of an inspection. Of course, this does not apply to the situation of driving under the influence of medical cannabis. Polish authorities are significantly focusing on even small discrepancies of the legalised THC percentage, which has resulted in bans on product importation, penalties for businesses and delays in delivery, and even exposure to criminal liability. The lack of standards and methods for determining THC that are uniform for all domestic laboratories may mean an increased risk of violating norms regarding permissible THC levels. Compliance procedures can be quite complicated and time-consuming, and differences in the interpretation of the law between State control services police, customs, pharmaceutical inspectors, etc sometimes extend the procedures or cause previously unforeseen legal complications. Changing legislation, which is still in the early stages of development, and annual limits on medical cannabis imports introduced at the national level in the context of estimated domestic demand , make long-term business development planning difficult. There is also limited access to the agricultural land enabling the cultivation of hemp, due to the restrictions of Polish law on agricultural land trading and leasing. Placing narcotic drugs on the market or taking part in such activities: imprisonment for six months to eight years. In the case of significant amounts: imprisonment for two to 12 years, and a fine. Importation, exportation, transportation, intra-community acquisition or intra-community supply of drugs: imprisonment of up to five years, and a fine. In the case of significant amounts, or where the perpetrator acts for their own financial or personal advantage: imprisonment from three years to 20 years, and a fine. Manufacturing and reprocessing of narcotic drugs: imprisonment for up to three years. In the case of significant amounts, or where the perpetrator acts for their own financial or personal advantage: imprisonment from three years to 20 years. Unauthorised possession of a narcotic drug: imprisonment for up to three years. In the case of significant amounts: imprisonment for one to ten years. Advertising or promoting narcotics drugs: a fine, restriction of liberty or imprisonment for up to one year. Cultivation and harvesting of non-fibrous hemp unauthorised : imprisonment for up to three years. Where the crops may produce significant amounts of non-fibrous hemp: imprisonment for six months to eight years. Certain practical aspects concerning possession of medical cannabis are presented below. Responsibilities of a person in possession of medical cannabis A person in possession of medical cannabis should: keep it in its original packaging unless a smaller amount has been measured at the pharmacy, in which case in an airtight package from the pharmacy ; carry a medical cannabis treatment certificate; carry an identity card; and carry documents that confirm the purchase of medical cannabis in accordance with the law — eg, a scan of a prescription from a pharmacy with a receipt. Driving after consuming medical cannabis When determining a case for an offence against safety in communication committed under the influence of an intoxicant, the court must determine in each case whether the drug had a real effect on the psychomotor performance of the driver of the vehicle to a degree similar to that of being under the influence of alcohol. The LPNA also penalises: manufacturing, storing, purchasing, selling or adapting equipment which may be used for the unauthorised manufacturing or reprocessing of narcotic drugs; preparations to commit offences penalised by the LPNA; inducing other persons to use narcotic drugs, and providing them with, or making it possible or easier to use, such drugs; and certain other activities regarding use of narcotic drugs. The law also penalises the following activities in relation to fibrous hemp: illegal cultivation or buying of hemp — punishable with a fine; and providing inaccurate information about the surface of crops — also punishable with a fine. The Polish Criminal Code Bringing danger to the life or health of many people by manufacturing or marketing substances, foodstuffs or pharmaceuticals that are harmful to health and that do not meet the applicable quality conditions is a crime listed in the Polish Criminal Code. Enforcement authorities In enforcing criminal law provisions, the key role is played by the authorities conducting criminal proceedings — ie, the police, public prosecutors and common courts. Enforcement by Administrative Authorities The Pharmaceutical Law The Pharmaceutical Law applies to narcotic drugs within the meaning of the provisions on preventing narcotics addiction and which are considered medicinal products. Pharmaceutical inspectors may issue decisions: on suspension or withdrawal from the market or of use of medicinal products in the event of suspicion or finding that a given product is not authorised in Poland; prohibiting placing on the market, or on the withdrawal of an active substance from the market; or on suspension or withdrawal of prohibited products from public pharmacies and pharmaceutical wholesalers. Under the Food Law The State Sanitary Inspection is the Polish authority responsible for supervision over the health conditions of food. Cross-Jurisdictional Matters. Legal and Regulatory Developments. The values of medical cannabis dispensed in Poland between and are as follows: — 33,g; — 94,g; — ,g; — 1,,g; and — 4,,g. The amendment requires entities that want to cultivate medical cannabis to obtain a licence from the Polish Pharmaceutical Inspectorate. The licence is granted for a period of five years and is subject to renewal. The amendment sets out quality control standards for medical cannabis, including testing for contaminants and ensuring consistency of the active ingredients. The amendment regulates the supply chain for medical cannabis, from cultivation to distribution for patients. It requires that all entities involved in the supply chain be licensed and comply with relevant regulations. The amendment aims to improve patient access to medical cannabis by allowing licensed entities to produce and distribute medical cannabis products. Patients will still need a valid prescription from a licensed physician to obtain medical cannabis, but the amendment may help to ensure a more reliable and consistent supply of medical cannabis products. Jurisprudence of Courts and Positions of State Authorities In one of the more interesting court cases concerning cannabis sativa L in the context of novel foods, the Voivodeship Administrative Court in Warsaw held that only the following are novel foods: cannabis sativa L plant extracts containing cannabinoids; products derived from these extracts — ie, any products to which these extracts have been added such as seed oil ; extracts from plants, other than cannabis sativa L, containing cannabinoids; and synthetically obtained cannabinoids. Market practice Despite the aforementioned, products containing CBD are available on the market in Poland. Law and Practice Authors. Select Topic s. Please select at least one chapter and one topic to use the compare functionality. 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