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

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Ukrainian legislation, namely Resolution No.770 of the Cabinet of Ministers of Ukraine (the ‘CMU’) dated 6 May 2000, establishes the ‘List of Narcotic Drugs, Psychotropic Substances and Precursors’ (hereinafter – the ‘List of Narcotic Drugs’), which provides a list of narcotic substances, psychotropic substances and precursors, separated into 4 categories:

• Prohibited narcotic substances and psychotropic substances (Table I);

• Especially dangerous narcotic substances which turnover is prohibited (Schedule 1);
• Especially dangerous psychotropic substances which turnover is prohibited (Schedule 2);
• Plants, containing narcotic and psychotropic substances, which
  turnover is allowed for manufacturing purposes (Schedule 3);

• Narcotic substances and psychotropic substances with limited turnover (Table II):

• Narcotic substances with limited turnover (Schedule 1);
• Psychotropic substances with limited turnover (Schedule 2);

• Narcotic substances and psychotropic substances with limited turnover and exclusion of certain control measures (Table III):

• Narcotic substances with limited turnover and exclusion from certain control measures (Schedule 1);
• Psychotropic substances with limited turnover and exclusion from certain control measures (Schedule 2);

• Precursors (Table IV):

• Precursors with limited turnover subject to control measures (Schedule 1);
• Precursors subject to control measures (Schedule 2).

The notion of ‘turnover’ includes development, production, growing of plants, manufacturing, storage, transportation, sending, sale, purchase, importation, exportation, transit, use and utilization.

Turnover of narcotic and psychotropic substances listed in Table I of the List of Narcotic Drugs is prohibited (except for expert, investigation or training activity), which means that such substances can’t be used for production of medicinal products. Analogues of narcotic and psychotropic substances, i.e. substances which are not included in the List of Narcotic Drugs but which possess chemical structure and characteristics resembling those of narcotic and psychotropic sub- stances, are also prohibited in Ukraine. Substances, included in Tables II, III and IV may be used for medical purposes under certain conditions.

Cannabinoids (e.g. tetrahydrocannabinol including its isomers and their stereochemical variants) are defined as ‘especially dangerous psychotropic substances, which turnover is prohibited’ and are enlisted in Schedule 2, Table I, which means that turnover of such substances is prohibited in Ukraine.

Notably, Dronabinol ((-) – trans delta-9-tetrahydrocannabinol) is the cannabinoid substance which is currently included in Schedule 2 Table II of the List of Narcotic Drugs, which means that it can be used for production of medicinal products in Ukraine. Therefore, Dronabinol is the substance which may be used in Cannabinoid Drugs in Ukraine. The List of Narcotic Drugs may be subject to amendments, therefore the current status of each particular substance shall be checked separately.

Ukrainian law differentiates between narcotic and psychotropic substances and precursors as such, and medicinal products produced from such sub- stances. According to Ukrainian legislation, medicinal products can be placed on the market only after state registration. For instance, Dronabinol or medicinal products containing Dronabinol have not yet been registered in Ukraine and therefore cannot be placed on the Ukrainian market.

Dronabinol was added to Schedule 2, Table II of the List of Narcotic Drugs by the CMU Resolution of 2011. However, the effectiveness of this CMU Resolution (by means of which dronabinol was added to ‘psychotropic substances, the turnover of which is restricted’, listed in Schedule 2, Table II of the List of Narcotic Drugs) has been suspended numerous times (for the last time until 1 June 2012).

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

The State Service of Ukraine on Medicinal Products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors, and combating its illegal trafficking. The SSM is responsible for the licensing of commercial activities connected with the production and import of medicinal products, wholesale and retail of medicinal products, and the turnover of narcotic drugs, psychotropic substances and precursors.

Registration of medicinal products in Ukraine is carried out by the Ministry of Health of Ukraine.

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

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

As indicated above, the only cannabinoid psychotropic substance which can be used for production of medicinal products in Ukraine is dronabinol. Since dronabinol is considered a psychotropic drug, the general regulatory framework for medicinal products and the specific one for narcotic drugs, psychotropic substances and precursors shall apply to dronabinol and medicinal products containing it.

Medicinal products containing cannabinoid substances allowed for use in Ukraine (for instance, dronabinol), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market in Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until their expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration the medicinal products may be placed on the market for an unlimited period.

Moreover, general licensing requirements applicable to medicinal products and special licensing requirements for the development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of the List of Narcotic Drugs are applicable to Cannabinoid Drugs.

Pricing or reimbursement for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state.

Dronabinol (as well as other narcotic drugs, psychotropic substances and precursors) is not enlisted in the Register of medicinal products, the price of which is subject to reimbursement. Therefore, dronabinol or any medicinal product containing it cannot be placed on the market or be reimbursed to retail sellers of medicinal products.

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

No Cannabinoid Drugs have received market approval (registration) to date.

5. Who can prescribe Cannabinoid Drugs?

In general, all narcotic or psychotropic medicinal products can be prescribed by doctors licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice). Prescription of narcotic or psychotropic medicinal products is via specially designed prescription form 3.

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic or psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment.

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic or psychotropic medicinal products unless the respective business entity has a license for the production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

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

There is a register of entities (including medical establishments, pharmaceutical stores, etc.) entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products. A license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medical product).

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

Any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of psychotropic substances included in Schedules 2, Table II of the List of Narcotic Drugs can prescribe narcotic or psychotropic medicinal products.

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

Since no medicinal products containing cannabinoids have been registered in Ukraine to date, there are no organizations authorized to sell/distribute them.

However, any medicinal product (narcotic or psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be conducted exclusively through pharmaceutical establishments and shall not be conducted through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

Narcotic or psychotropic medicinal products like any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

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

There is no special list of retailer/distributors authorized to sell Cannabinoid Drugs.

There is a register of entities, including pharmacies and their branches, authorized to sell narcotic or psychotropic medicinal products that have received special license for this purpose. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic or psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

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

There have been numerous discussions and petitions to the parliament, although no legislative proposals for reform or significant change to the regulation of Cannabinoid Drugs has been introduced to date.

The Strategy of State Policy on Narcotics for the period up to 2020 (approved by Ruling of the Cabinet of Ministers of Ukraine (hereinafter – the ‘CMU’) No. 735-p dated 28 August 2013) includes certain provisions on scientific research of medical usage prospective of Cannabinoid Drugs as pain killers and other medical drugs.

11. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Cannabinoid Drugs, it is impossible to predict whether they will occur in the nearest future.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No, Medical Cannabis is not authorized in Ukraine.

Cannabis, cannabis resins, cannabis extracts and cannabis tinctures are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in Schedule 1, Table I of the List of Narcotic Drugs.

Cultivation of cannabis plants for industrial purposes is not prohibited provided that contents of tetrahydrocannabinol in the dried straw of cannabis plants, originating cannabis seeds for such cultivation, does not exceed 0.08 percent. The cultivation of cannabis plants requires a special license according to the licensing terms, approved by the CMU Resolution No. 282 dated 6 April 2016. Cultivation of cannabis is subject to a number of requirements applicable to such activity.

Under Ukrainian law, the illegal production, purchase, storage, transportation, transmission or turnover of narcotic drugs, psychotropic substances and their analogies as well as illegal cultivation of cannabis plants may entail administrative or criminal liability.

Ukraine also fulfills its international obligation in the field of control over narcotic and psychotropic drugs turnover. Notably, Ukraine is a participant of the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which together set the framework for international drug control regulation.

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

Since Medical Cannabis is not authorized in Ukraine, there are no regulatory authorities over it.

Combating the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

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

Since Medicinal Cannabis is not authorized in Ukraine, there is no specific regulatory framework for authorization, pricing, and reimbursement.

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

The production and import of Medicinal Cannabis are prohibited in Ukraine.

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

The production and import of Medicinal Cannabis are prohibited in Ukraine.

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

Since Medicinal Cannabis is prohibited in Ukraine, there is no regulatory framework for the marketing and distribution of Medicinal Cannabis.

18. How can patients obtain Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, patients cannot obtain Medicinal Cannabis.

19. Who can prescribe Medicinal Cannabis?

Since Medicinal Cannabis is prohibited in Ukraine, there are no persons authorized to prescribe Medicinal Cannabis.

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

Since Medicinal Cannabis is prohibited in Ukraine, there are no doctors authorized to prescribe Medicinal Cannabis.

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

Since Medicinal Cannabis is prohibited in Ukraine, there are no specific requirements for approvals or notifications to prescribe Medicinal Cannabis.

22. Where is Medicinal Cannabis available?

Since Medicinal Cannabis is prohibited in Ukraine, it not available.

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

Since Medicinal Cannabis is prohibited in Ukraine, there is no list of retailers authorized to sell Medicinal Cannabis.

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

The Draft Law No. 4533 dated 27.04.2016 ‘On amending the Law of Ukraine ‘On Narcotic Drugs, Psychotropic Substances and Precursors’ (On the Turnover Procedure of Substances under Control)’ (hereinafter – the ‘Draft Law No.4533’) has been introduced to the Verkhovna Rada (Ukrainian Parliament).

The Draft Law No.4533 offers to allow cultivation of cannabis for the purposes of scientific research and medical usage.

It suggests to displace Schedule 3 (Plants, containing narcotic and psychotropic substances, which turnover is allowed for manufacturing purposes) from Table I (Prohibited narcotic substances and psychotropic substances) to Table II (Narcotic substances and psychotropic substances with limited turnover), thus allowing the restricted cultivation of cannabis plants.

Notably, Draft Law No. 4533 has not been through a first hearing in parliament yet. The parliamentary procedure provides that a draft law shall pass two to three hearings before adoption by parliament.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Ukrainian legislation has no definition and special regulatory framework for Opioid Drugs. Ukrainian law differentiates between narcotic and psychotropic substances and precursors (including opioids) as such, and medicinal products, produced from such substances. Medicinal products authorized for medical use shall be duly registered before their market placement.

Opioid substances are considered within the general legislative framework applied to narcotic and psychotropic substances and precursors and fall under one of the categories indicated in Chapter 8 above (according to the tables and schedules indicated in the List of Narcotic Drugs).

There are different regimes for different kinds of opioid substances in Ukraine. The turnover of opioid substances indicated in Table I of the List of Narcotic Drugs is prohibited in Ukraine. Such substances cannot be used for the production of medicinal products. The turnover of opioid substances indicated in Tables II and III of the List of Narcotic Drugs is restricted.

For instance, some opioids like acetorphine, etorphine, heroin, and opium are considered ‘especially dangerous narcotic drugs, the turnover of which is prohibited’, enlisted in the Schedule 1, Table I of the List of Narcotic Drugs, which turnover is prohibited in Ukraine. Such substances cannot be used for production of medicinal products.

In turn, certain Opioid Drugs, for instance morphine, codeine, tramadol are considered as ‘narcotic drugs, the turnover of which is restricted’, enlisted in Schedule 1, Table II of the List of Narcotic Drugs, which turnover in Ukraine is restricted, but which can be used for the production of medicinal products.

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

The State Service of Ukraine on Medicinal products and Drugs Control (hereinafter – the ‘SSM’) is a state body controlling the turnover of narcotic drugs, psychotropic substances and precursors and combating illegal trafficking. The SSM is also responsible for the licensing of commercial activities connected with production and import of medicinal products, wholesale and retail of medicinal products, and turnover of narcotic drugs, psychotropic substances and precursors.

Registration of medicinal products in Ukraine is exercised by the Ministry of Health of Ukraine.

Combatting the illegal turnover of narcotic drugs, psychotropic substances and precursors is the responsibility of the National Police, the Security Service of Ukraine, the General Prosecutor’s Office, the State Fiscal Service, the State Border Service, and other bodies within their authority.

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

There is no specific framework for authorization of Opioid Drugs.

The general regulatory framework for medicinal products and the specific framework for narcotic drugs, psychotropic substances and precursors shall be applicable to medicinal products containing opioids.
Medicinal products containing opioids allowed for use in Ukraine (Tables II-III of List of Narcotic Drugs), like any other medicinal product in Ukraine, must be registered with the Ministry of Health of Ukraine in order to be placed on the market of Ukraine. Upon completion of registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicinal products which are placed on the market during the five-year validity period are allowed for use until the expiry term indicated on the packaging. After expiry of the five-year initial registration term, medicinal products shall be re-registered. After re-registration, medicinal products may be placed on market for an unlimited period.

Moreover, special licenses are required for development, manufacture, production, storage, transportation, purchase, sale, import into Ukraine, export from Ukraine, usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the Tables II-IV of List of Narcotic Drugs.

Medicinal products containing narcotic drugs, psychotropic substances and precursors are subject to control measures (e.g. import quotas, reporting, etc.). Medicinal products with small amounts of narcotic drugs, psychotropic substances and precursors, which cannot be easily extracted therefrom, can be exempted from certain control measures.

Pricing for narcotic drugs, psychotropic substances and precursors, included in the Tables II-IV of the List of Narcotic Drugs, as well as medicinal products containing such substances, is not regulated by the state. Medicinal products containing opioids are not enlisted in the Register of medicinal products, price of which is subject to reimbursement (regularly reviewed), thus, they cannot be reimbursed to retail sellers of medicinal products.

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

Medicinal products containing opioids that have received market approval and have been duly registered can be found in the Register of medicinal products.

29. Who can prescribe Opioid Drugs?

In general, all narcotic and psychotropic medicinal products can be prescribed by doctors in specially designed prescription form 3, licensed for medical practice according to their medical specialties and working at business entities (medical establishments, hospitals, individual entrepreneurs or other entities authorized for medical practice).

In order to prescribe this category of medicinal products, medical establishments or other entities authorized for medical practice are additionally required to receive a special license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs.

Feldshers (Physician Assistant or Nurse Practitioners) working at medical establishments are entitled to prescribe narcotic and psychotropic medicinal products for patients with protracted and chronic diseases for the purpose of continuing the treatment provided by the doctor by stating their position, placing their signature and the stamp of the medical establishment.

Medical practitioners (doctors or feldshers) are not authorized to prescribe narcotic and psychotropic medicinal products unless the respective business entity has a license for production, storage, purchase or sale (release), usage and utilization of restricted narcotic drugs, psychotropic substances and precursors.

Please note that certain narcotic and psychotropic medicinal products can be prescribed by any doctor according to simplified prescription form 1 (regardless of whether they work at the respective entity being licensed for the particular schedule of the particular table of the List of Narcotic Drugs or not) unless they contain more than the marginal quantity of narcotic drugs, psychotropic substances or precursors established by the CMU. In regard to opioids, the CMU establishes marginal quantity for codeine, dextropropoxyphene and tramadol. Medicinal products which contain more than the marginal quantity of narcotic drugs, psychotropic substances and precursors shall be prescribed according to prescription form 3 generally applicable for all narcotic and psychotropic medicinal products.

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

There is a register of entities (including medical establishments, pharmaceutical stores, etc.), entitled to conduct economic activity related to the production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic drugs and precursors included in the List of Narcotic Drugs according to special Licensing terms.

As a general rule, any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV of the List of Narcotic Drugs can prescribe narcotic and psychotropic medicinal products. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective Schedule (not a single medicinal product).

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

Any doctor working at a medical establishment or other entity authorized for medical practice and licensed for production, storage, purchase or sale (release), usage and utilization of narcotic drugs, psychotropic substances and precursors included in Tables II-IV the List of Narcotic Drugs can prescribe medicinal products containing opioids.

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

As a general rule, any medicinal product (including narcotic and psychotropic medicinal products) shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

Moreover, pharmaceutical warehouses, pharmacies and their branches shall receive a special license for production, storage, transportation, purchase, sale, import, export, usage and utilization of narcotic drugs, psychotropic substances and precursors included in the List of Narcotic Drugs.

Narcotic or psychotropic medicinal products as any other medicinal product subject to state procurement procedure can be provided to patients in the course of treatment in state medical establishments which have received a special license for this purpose.

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

There is no special list of retailer/distributors authorized to sell Opioid Drugs. There is a register of entities including pharmacies and their branches authorized to sell narcotic and psychotropic medicinal products that have received a special license for this purpose. The license is issued to a particular entity for the particular schedule of the particular table of the List of Narcotic Drugs, including all substances of the respective schedule and table (not a single medical product).

Please note that medicinal products (including narcotic and psychotropic medicinal products), shall only be sold for wholesale in pharmaceutical warehouses and for retail in pharmacies or their branches. Trade in medicinal products can be made exclusively through pharmaceutical establishments and shall not be made through any electronic commercial means, by post or by establishments other than pharmaceutical ones (some exclusions are envisaged for rural areas where medicinal products may be sold by certain healthcare institutions).

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

There have been no proposals for reform or significant change to the regulation of Opioid Drugs.

35. When are they likely to come into force?

Since there were no proposals for reform or significant change to the regulation of Opioid Drugs, it is impossible to predict whether they will occur in the near future.