European Union: Cannabis For Medical Use: Cee Regulatory Update

Last Updated: 20 June 2019
Article by Tomáš Čihula

June 2019 – A growing number of countries around the world are gradually legalising the use of cannabis for medical purposes.

It can be said that governments are now generally taking a more liberal approach to this product, which could significantly benefit many patients suffering from serious illnesses. This trend is also opening up many interesting business opportunities. Below, we present a summary of recent changes related to the national regulation of cannabis for medical use in some Central and Eastern European countries:

Czech Republic

The use of cannabis for medical treatment has been allowed in the Czech Republic since April 2013, although it is strictly regulated. There are certain restrictions on the prescription of cannabis for medical use: (i) the strains of cannabis that can be prescribed, i.e. Cannabis indica and Cannabis sativa L.; (ii) the types of medical problems it can be used for (mainly chronic illnesses, interminable pain, oncological diseases and treatment of HIV symptoms); (iii) the amount that can be prescribed (180 grams of dried cannabis for medical use per person per month); and (iv) the areas of expertise required from physicians authorised to prescribe medical cannabis.

Growing medical cannabis is only possible on the basis of a licence granted by the State Institute for Drug Control (the "Institute"). That said, licence holders may only begin cultivation after they have been granted a permit to handle addictive substances. Once harvested, producers are obliged to sell the medical cannabis to the Institute, which further resells it to authorised operators of a pharmacy for the preparation of medicinal products. There is only one company in the Czech Republic authorised to grow cannabis for medical use – Elkoplast Sluaovice, which won a tender for the licence. Their first delivery of cannabis to the Institute took place in March 2016. Medical cannabis is also imported into the Czech Republic, mainly from the Netherlands.

Although medicinal products containing cannabis are not reimbursed by the public health insurance in the Czech Republic, this is currently being reconsidered. In early 2019 the Ministry of Health proposed allowing public health insurance to cover 90 per cent of the cost of an individually prepared medicinal product containing medical cannabis. The proposal is currently being discussed in Parliament and seems to have wide support by the main political parties. However, there is an ongoing discussion whether certain restrictions should be imposed on the reimbursement in order to control the overall cost of reimbursement from the budgets of health insurers.

Recently there have also been attempts to further soften the current regulation of cannabis use in general. Some MPs have suggested allowing private cultivation of a certain number of cannabis plants, the possibility of holding or donating up to 30 grams of cannabis to another person and having one and a quarter kilograms of dry matter at home. However, the proposal was rejected by the government.

It is likely that similar proposals will continue to emerge, and it will be interesting to see whether the current government will change its position in the future.


Cannabis is classified in Bulgaria as a plant constituting a high risk to public health due to the harmful effect of its abuse, and it is prohibited for use in human and veterinary medicine.

More specifically, the Act on Narcotic Substances and Their Precursors has also banned the cultivation, production, processing, trade, storage, import, export, re-export, transit, transfer, transport, supply, acquisition, use and possession of cannabis. However, this is subject to two notable exceptions. In particular, the above prohibition does not apply when:

(i) the cultivation of cannabis is intended for fibre, seeds for animal feed and sowing, provided the plants contain less than 0.2 per cent of THC; or

(ii) limited quantities of cannabis are used for medical, scientific or laboratory research, for educational purposes, as well as for maintaining the ability of dogs uncovering narcotic substances.

The activities under (i) and (ii) above are subject to separate licences, which are issued by the Minister of Agriculture, Food and Forests and the Minister of Health, respectively. The maximum cannabis quantity allowed for the purposes under item (ii) is 30,000 grams.

Otherwise, interest is increasing in Bulgaria in industrial cannabis. At the end of 2018 it was reported that the Canada-based International Cannabis Corp (ICC) entered into a partnership agreement with Balkan Cannabis Corp (which claims to have operations in both Bulgaria and Macedonia) for a large cannabis-related project in Bulgaria, although there has been no official confirmation of this project.


Hungary only allows processing of industrial cannabis for CBD oil, subject to notification and license requirements.

There have recently been some discussions and proposals related to the regulation of cannabis for medical purposes. However, no specific steps have been taken yet. In any event, interest is growing for industrial cannabis in Hungary.


The use of cannabis for medical purposes is legal in Romania. The cultivation of cannabis for medical use is possible with a permit issued by the Ministry of Agriculture, Forests and Rural Development. In addition, the Ministry of Health issues authorisations for the purchase, distribution and use of cannabis products. However, these authorisations are limited to specific needs. As regards imports of cannabis to Romania, every individual import activity has to be authorised by the Romanian Ministry of Health. In practice, these authorities have been reluctant to issue the respective authorisations.

In March 2019, the Romanian Finance Minister publicly stated that Romania might take further steps towards liberalisation of cannabis use in the near future. According to available information, the Romanian Ministry of Health has created a special action group to consider the next steps in the process. However, we will have to see what results this activity will bring, and how far the liberalisation of the use of cannabis for medical purposes will go.


The use of cannabis for medical purposes is currently not possible in Serbia. In 2014, several patient organisations initiated a campaign to legalise the use of cannabis and cannabis oil in patient treatments, with a special emphasis on cancer patients. In response to the campaign, the Ministry of Health announced that it would analyse possible uses of cannabis for medical purposes. However, the respective working group ultimately concluded that cannabis had no medical indications. Nevertheless, there are some synthetic cannabis-based medicines that may be prescribed, such as Dronabinol (for the treatment of HIV patients), Nabilone (for the treatment of cancer patients) and Sativex (for the treatment of patients with multiple-sclerosis).

In 2018, a petition was submitted to the Constitutional Court asking it to declare unconstitutional the provisions of the Act on Psychoactive Substances that prohibit the use of cannabis, but the court rejected this petition. Currently, there is a persistent effort by some patients as well as cannabis-promoting organisations to put more effort towards the legalisation of cannabis in Serbia. In particular, Cannabis-promoting organisations in Belgrade and other cities in Serbia have organised occasional rallies of cannabis legalisation supporters as well as seminars on the curative effects of using cannabis for certain medical conditions. In addition, their representatives appear from time to time in Serbian media, advocating cannabis legalisation. However, these activities seem to have not produced any wider effect so far.


Medical treatment involving cannabis is generally not allowed in Slovakia. Cannabinoids – the chemical compounds that give cannabis its medical and psychoactive properties – including cannabidiol are treated as controlled substances. Some medicinal products may contain certain controlled substances that are cannabis compounds. However, these products are only available through prescription and have additional prescription restrictions (e.g. prescribed number of packages cannot exceed quantity required for 30 days of treatment).

Possession of registered medicinal products containing certain cannabis substances (Delta 9-THC or cannabidiol) is allowed only in dosages intended for personal use.


Cannabis treatment is not allowed in Ukraine. Free use and cultivation of cannabis is forbidden. Cannabis is only permitted for (i) analysis by experts; (ii) operational investigations in connection with criminal intelligence and surveillance operations; (iii) academic research and educational purposes (if such purpose is sanctioned by law); and for (iv) licensed cultivation and use of cannabis plants (only low THC-yielding plants (0.08 per cent) for industrial purposes, not medical treatment). This rule does not apply to cannabis resin, cannabis tincture or extract of cannabis.

Ukraine's Strategy of the State Drug Policy, With Regard to Narcotic Drugs up to 2020, includes among its priorities the research of possibilities for the medical use of cannabis. The respective draft law was submitted to lawmakers in April 2016, but it has never advanced further.

In March 2019 a petition for the legalisation of cannabis for medical purposes gained more than 25,000 signatures, which is enough for it to be considered by Parliament. A number of non-governmental organisations signed the petition, which also has support from the current Healthcare Minister Ulana Suprun. On 20 March 2019, the Parliament's Committee on Human Rights expressed its support for the petition. The Committee decided to create a working group responsible for preparing a draft law legalising cannabis for medical use. On 21 May 2019, this draft law was registered at the Ukrainian Parliament. It is widely expected that the proposal will be approved.


There have recently been some positive developments as regards the use of medical cannabis in CEE. The Czech Republic has enabled both its use and cultivation, though it is strictly regulated. Some other countries, such as Bulgaria and Romania, have taken first steps. We have seen some initial transactions and increased cooperation in the sector and this promises to pave the way for others.

Nevertheless, some countries still have a negative view of the use of this product. This applies in particular to Slovakia, Hungary and Serbia, where cannabis cannot be used for medical purposes at all. Ukraine seems to be taking some steps towards enacting relevant legalisation, although there are still many obstacles in the way.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions