Legal & Regulatory > Slovakia > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Slovakia. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes. In our understanding, Cannabinoid Drugs are medicinal drugs containing active compounds of cannabis (such as THC and CBD) as opposed to psychoactive cannabis per se intended for recreational use.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authority with jurisdiction over Cannabinoid Drugs in the Slovak Republic is the State Institute for Drug Control which is directly controlled by the Ministry of Health.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

No. Authorization and pricing and reimbursement of cannabinoid drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview).

4. Which are the cannabinoid drugs that have received market approval to date?

The only cannabinoid drug that has received market approval in the Slovak republic to date is Sativex oral spray (registration No. 63/0251/12-S, registration holder: GW Pharma (International) B.V., the Netherlands, type of registration procedure: mutual recognition procedure).

Sativex contains extracts from cannabis – cannabinoids (THC and CBD; each 100 microliters of spray contain 2.7 mg of THC and 2.5 mg of CBD). Sativex is used in treatment of multiple sclerosis, specifically for betterment of symptoms related to muscular stiffness (spasticity). Sativex can be prescribed only after other medicine for muscular stiffness proved ineffective.

Treatment by Sativex can be initiated by a physician with specialization in respective medical field (specialist). Before initiation of treatment, specialist must first assess the patient’s medical state (specialist mainly assesses gravity of patient’s muscular stiffness and reactions to previous treatments). After the initial assessment, patient undergoes a 4-weeks testing of Sativex after which the specialist performs additional assessment to determine whether treatment shown intended effects. Treatment by Sativex can continue only after the 4-weeks testing shown significant betterment of spasticity symptoms.

5. Who can prescribe Cannabinoid Drugs?

Under the Act on Medicinal Products, cannabinoid drugs can be prescribed by a physician. However, if their prescription is linked to a specialization of the physician in respective medical field (specialist), they can be prescribed only by such specialist. The specialist is required to have a specific numeral code assigned by the Health Care Surveillance Authority and an agreement on provision of healthcare with the health insurance company in which respective patient is insured in place.

Cannabinoid drugs can be also prescribed by a general physician (GP) based on recommendation of a specialist listed in patient’s medical record.

Cannabinoid drugs can only be prescribed on the specific form of prescription labelled by diagonal blue stripe. These forms must be registered. In addition, the physician is obliged to create so-called “prescription record” signed with the qualified electronic signature into the electronic patient’s medical record.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No. Cannabinoid drugs can be prescribed by any doctor who fulfils the conditions outlined in Answer No. 5 to this article.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

No approvals or notifications are required. Authorized doctors can prescribe cannabinoid drugs to their patients in their own discretion after thorough assessment of medical state of an individual patient. Please also refer to Answers No. 4 and 5 to this article.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

There are few specific rules which must be fulfilled by subjects handling with the cannabinoid drugs. Under the respective legislation, handling with cannabinoid drugs means (inter alia) wholesale distribution of cannabinoid drugs and provision of apothecary care by pharmacies.

Handling with cannabinoid drugs is regulated by the Act on Medicinal Products and the Act on Narcotic and Psychotropic Substances.

Cannabinoid drugs are broadly categorized as drugs containing narcotic and psychotropic substances. Subject can be handling with drugs containing narcotic and psychotropic substances (i.e. also with cannabinoid drugs) solely based on two different authorizations granted by the State Institute for Drug Control (general authorization granted pursuant to the Act on Medicinal Products and special authorization granted pursuant to the Act on Narcotic and Psychotropic Substances):

1. General authorization is necessary for handling with any kind of drugs (not just cannabinoid drugs). Applicant for a general authorization must meet the conditions set out in the Act on Medicinal Products.
2. Special authorization is required when handling with drugs containing narcotic and psychotropic substances – i.e. also with cannabinoid
   drugs. Applicant must fulfil requirements set out in the Act on Narcotic and Psychotropic Substances.

The only organizations authorized to sell cannabinoid drugs to public are the pharmacies which fulfil conditions set out by respective legislation described above. Pharmacies can sell these drugs directly to patients upon presentation of an official medical prescription and verification of the identity of the patient.

Wholesale distribution of cannabinoid drugs can be performed by subjects who fulfil conditions set out by respective legislation described above. Under the Act on Medicinal Products, these subjects can distribute cannabinoid drugs mostly (but not exclusively) to pharmacies and healthcare facilities.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

No. Any pharmacy/wholesale distributor fulfilling conditions outlined in answer No. 8 to this “Chapter 8: Cannabinoid Drugs” is authorized to sell/distribute cannabinoid drugs.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Yes. Currently, there is a proposal subject to discussions of the Slovak Parliament to amend the Act on Narcotic and Psychotropic Substances. It is being proposed to exclude “Cannabidiol (CBD)” from the list of psychotropic substances since it is neither in the list of psychotropic substances under the Convention on Psychotropic Substances of 1971 nor in the list of narcotics under the Convention on Narcotic Drugs of 1961. As a result, medicinal products containing such substance would be considered as “regular” medicinal products and no special authorisation regarding them would be required. On the other hand, it is being proposed to add certain syntetic cannabinoids to the list of psychotropic substances.

11. When are they likely to come into force?

The proposed date of the effectiveness of this amendment is 1 May 2021.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No. Under Medical Cannabis we understand psychoactive cannabis used for medicinal purposes.

In fact, under the Criminal Code, it is illegal to possess, manufacture, import, export, purchase, sell, exchange or procure cannabis under the threat of imprisonment up to 25 years or life imprisonment, depending on amount of cannabis in question and other specific details of particular case. This also includes cannabis intended for medicinal use as the Slovak law does not differentiate between medicinal cannabis and cannabis for recreational use.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

There are no regulatory authorities with jurisdiction over medicinal cannabis. Please refer to answer No. 12.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

There is no regulatory framework. Please refer to answer No. 12.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

It is forbidden to produce and import cannabis intended for medicinal use in the Slovak republic.

Under the Act on Narcotic and Psychotropic Substances it is however permitted to produce and import cannabis intended for industrial or research purposes based on special authorization granted by the Ministry of Health.

It is also permitted (without any special authorization) to import/export seeds of certain cannabis types listed in Common Catalogue of Varieties of Agricultural Plant Species (published in accordance with Council Directive No. 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species).

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

No approval or notifications are necessary. Please refer to answer No. 12.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

There is no regulatory framework. Please refer to answers No. 12.

18. How can patients obtain Medicinal Cannabis?

Patients cannot legally obtain medicinal cannabis in the Slovak Republic.

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis cannot be prescribed in the Slovak Republic.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No. Please refer to answers No. 1 et seq. to this article.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

No approval or notifications are required.

22. Where is Medicinal Cannabis available?

Medicinal cannabis is not legally available in the Slovak Republic.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

No.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

No.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Yes.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Regulatory authorities with jurisdiction over opioid drugs are the State Institute for Drug Control and the Ministry of Health.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

No. Authorization, pricing and reimbursement of opioid drugs are regulated by the same legislation as the authorization, pricing and reimbursement of other drugs (please refer to Answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview).

28. Which are the Opioid drugs that have received market approval to date?

Act on Narcotic and Psychotropic Substances establishes a list of narcotic and psychotropic substances which are contained as a medicament in the drug (annex No. 1 to the Act on Narcotic and Psychotropic Substances).

Act on Narcotic and Psychotropic Substances also distinguishes so-called excluded preparations which contain narcotic and psychotropic substances listed in annex No. 1 to the Act on Narcotic and Psychotropic Substances in quantity and concentration further stated in annex No. 2 to the Act on Narcotic and Psychotropic Substances. This includes opioid drugs containing certain narcotic and psychotropic substances in such small quantity and concentration that represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse. Such opioid drugs are excluded from scope of the Act on Narcotic and Psychotropic Substances.

Any drug containing narcotics listed in annex No. 1 to the Act on Narcotic and Psychotropic Substances (whether or not they fall under the scope of the Act on Narcotic and Psychotropic Substances) can receive market approval provided that the conditions set out by respective legislation are met. In this regard please refer to answer No. 27 in connection with answer No. 2 to Chapter 1: Regulatory, Pricing, and Reimbursement Overview.

29. Who can prescribe Opioid Drugs?

Under the Act on Medicinal Products, opioid drugs can be prescribed by a physician. However, if their prescription is linked to a specialization of the physician in respective medical field (specialist), they can be prescribed only by such specialist. The specialist is required to have a specific numeral code assigned by the Health Care Surveillance Authority and an agreement on provision of healthcare with the health insurance company in which respective patient is insured in place.

Opioid drugs can be also prescribed by a general physician (GP) based on recommendation of a specialist listed in patient’s medical record.

Opioid drugs can be prescribed on the specific form of prescription labelled by diagonal blue stripe. These forms must be registered. In addition, the physician is obliged to create so-called “prescription record” signed with the qualified electronic signature into the electronic patient’s medical record.

Opioid drugs containing narcotics and psychotropic substances in only small quantity and concentration which represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse can also be prescribed on general form of description.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No. Opioid drugs can be prescribed by any doctor who fulfils the conditions outlined in answer No. 29 to this article.

31. What approvals or notifications are required to prescribe Opioid Drugs?

No approvals or notifications are required. Authorized doctors can prescribe opioid drugs to their patients in their own discretion after thorough assessment of medical state of an individual patient.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Only organizations authorized to sell opioid drugs to public are the pharmacies which fulfil conditions set out by respective legislation (described in answer No. 8).

Pharmacies can sell these drugs directly to patients upon presentation of an official medical prescription and verification of the identity of the patient.

Wholesale distribution of opioid drugs can be performed by subjects who fulfil conditions set out by respective legislation (described in answer No. 8”). Under the Act on Medicinal Products, these subjects can distribute opioid drugs mostly (but not exclusively) to pharmacies and health care facilities.

Opioid drugs containing narcotics and psychotropic substances in only small quantity and concentration which represent a negligible risk for health and from which it is not possible to extract a sufficient amount of narcotics necessary for their abuse can also be sold/distributed based on general authorization by the State Institute for Drug Control only (no second – special authorization for handling with opioid drugs containing narcotic and psychotropic substances is necessary).

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

No. Any pharmacy/wholesale distributor fulfilling conditions outlined in answer No. 32 to this article (in connection with answer No. 8) is authorized to sell/distribute opioid drugs.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

Yes. Currently, there is a proposal subject to discussions of the Slovak Parliament to amend the Act on Narcotic and Psychotropic Substances. It is being proposed to include further substances to the list of narcotics or the list of psychotropic substances based on the decision adopted on the 63rd Session of the United Nations Commission on Narcotic Drugs, including the synthetic opioid crotonyl fentanyl.

35. When are they likely to come into force?

The proposed date of the effectiveness of this amendment is 1 May 2021.