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

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

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

In general, hemp herb other than fibre, containing more than 0.20% of the sum of delta-9-Tetrahydrocannabinol (THC) and Tetrahydrocannabinoleic acid (delta-9-THC-carboxylic acid) is not authorised in Poland. However, certain forms are authorised for specific purposes.

The Act of 29 July 2005 on Counteracting Drug Addiction (“Act on CDA”) addresses, among other things, psychotropic substances. The Regulation of the Minister of Health of 17 August 2018 on the list of psychotropic substances, narcotic drugs and new psychoactive substances (“Regulation”) divides psychotropic substances into groups, according to the risk of developing addiction when used for non-medical purposes and the extent of their medical use.

A group of tetrahydrocannabinols are listed in group I-P, which contains a list of psychotropic substances that have no medical use and high potential for abuse, and which are excluded from the pharmaceutical market and can only be used for scientific research. However, delta-9-THC is enumerated in group II-P, containing a list of psychotropic substances with low medical use and high potential for abuse that can be used for medical, scientific and industrial purposes. Also, some synthetic cannabinoids are to be found in group I-N, which contains a list of narcotics that are substances with high addictive potential that be used for medical, scientific and industrial purposes.

Medicinal Cannabis is regulated separately (see Medicinal Cannabis).

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

Cannabinoid Drugs fall under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e. the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych oraz Produktów Biobójczych – “URPL”), and – in the area of manufacturing, import, distribution, advertising and promotion of medicinal products, the Chief Pharmaceutical Inspector (“GIF”), as well as the Ministry of Health, which is generally responsible for public health-related matters (see Question 1, on Regulatory, Pricing and Reimbursement Overview).

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

General rules apply to the authorisation, pricing and reimbursement of Cannabinoid Drugs considered medicinal products, together with some specific rules regarding narcotic drugs and psychotropic substances set forth in the Act on CDA.

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

To date only one finished drug containing cannabinoids has received market approval by way of the mutual recognition procedure (MRP). It contains 27 mg of delta-9-tetrahydrocannabinolum and 25 mg of cannbidiolum per ml. It is used in the treatment of multiple sclerosis, specifically to treat symptoms related to muscular stiffness (spasticity).

5. Who can prescribe Cannabinoid Drugs?

Drugs containing cannabinoids can be prescribed by any medical doctor.

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

No.

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

Cannabinoid Drugs containing substances classified as narcotic substances can only be prescribed on an ‘Rpw’ prescription form, i.e. a prescription for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (a narcotic drug prescription).

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

Sale is only possible through pharmaceutical wholesalers and pharmacies. Organisations wanting to manufacture, process, transform, import or distribute narcotic drugs or psychotropic substances have to obtain a permit from the GIF. In order to obtain a permit, the applicant must have in place specific procedures and a control system covering its activity (in particular to ensure the continuity of activity), it must employ a qualified person responsible for supervision, it must have a system for securing the production and storage rooms of the substances against access by unauthorised persons, it must store the substances in a manner protecting them against theft or access by unauthorised persons, it must keep a record of revenue and expenses related to narcotic drugs or psychotropic substances, and, in the case of manufacturing, processing and transforming narcotic drugs or psychotropic substances, it must keep records of technically justified standards of consumption of precursors substances used in the process and standards of losses allowed at particular stages of production (par. 2 of the Regulation of the Minister of Health of 9 November 2015 on the authorisation of the manufacture, processing, transformation, import, distribution or use for scientific research of narcotic drugs, psychotropic substances or category 1 precursors).

Cannabinoid Drugs are authorised for retail sale in pharmacies.

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

There is no specific list of retailers/distributors authorised to sell Medicinal Drugs. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

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

Currently, there are no proposals for reform or significant change to the regulation of Cannabinoid Drugs.

11. When are they likely to come into force?

Not applicable.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medical Cannabis is authorised in Poland.

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

Medicinal Cannabis falls under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e. the URPL, and – in the area manufacturing, import, distribution, advertising and promotion of medicinal products, the GIF, as well as the Ministry of Health, which is generally responsible for public health-related matters. See Question 1, on Regulatory, Pricing and Reimbursement Overview).

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

The Act of 7 July 2017 amending the Act on Counteracting Drug Addiction and the Act on the Reimbursement of Medicines, Foodstuffs for Special Nutrition and Medical Devices (the “2017 Act”) introduced Medicinal Cannabis to the Act on CDA by stating that hemp herb other than fibre hemp and extracts, pharmaceutical tinctures and all other extracts of hemp other than fibre and hemp resin other than fibre may constitute pharmaceutical raw material, as defined under Article 2 point 40 of the Pharmaceutical Law, intended for the preparation of compounded medications referred to in Article 3 (4) point 1 of the Pharmaceutical Law, after obtaining a marketing authorisation issued by the URPL. The amending act entered into force on 1 November 2017.

A marketing authorisation for a pharmaceutical raw material intended for the preparation of compounded medications in the form of hemp herb other than fibre hemp and extracts, pharmaceutical tinctures and all other hemp extracts other than fibre and hemp resin other than fibre, issued by the URPL, is valid for five years. The issuance or refusal to issue the authorisation, the amendment of the data on which the authorisation was based or a change in the documentation on which the authorisation was based, the extension of its validity, the refusal to extend its validity, the shortening of its period of validity and its withdrawal is affected by a decision of the URPL.

The rules on the manufacturing, import and distribution and marketing of medicinal products apply to Medicinal Cannabis. See Question 2, on Regulatory, Pricing and Reimbursement Overview).

Under Article 5a of the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use, and Medical Devices (the “Reimbursement Act”), Medicinal Cannabis, being a compounded medication prepared from pharmaceutical raw materials which obtained a marketing authorisation pursuant to Article 33 of the Act on CDA, is not refundable.

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

The general rules for the production and import of medicinal products set out in Chapters 3, 3a and 5 of the Pharmaceutical Law apply to Medicinal Cannabis. The competent authorities are the URPL and the GIF (see Question 13 above).

Under the Act on CDA, the cultivation of Medicinal Cannabis is not permitted in Poland. The pharmaceutical raw material, e.g. dried hemp, can thus only be imported. The URPL issues the authorisation to market the pharmaceutical raw material. The GIF issues the authorisation to import the pharmaceutical raw material. The pharmaceutical raw material is then used to prepare the compounded medication in pharmacies, on the basis of a medical prescription.

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

The commencement of economic activity consisting in the manufacturing or importing of Medicinal Cannabis is subject to authorisation to manufacture or import Medicinal Cannabis (Article 38 of the Pharmaceutical Law). The GIF is the competent authority to issue the authorisation. A copy of such authorisation must be filed as an attachment to and together with the request to grant the marketing authorisation, which is then issued by the URPL.

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

Medicinal Cannabis, as a pharmaceutical raw material, may be marketed upon the URPL’s authorisation, which is valid for five years (Article 33a of the Act on CDA). It may be extended upon the request of the marketing authorisation holder according to the general rules set out in the Pharmaceutical Law (see Question 5, point A), on Regulatory, Pricing and Reimbursement Overview).

18. How can patients obtain Medicinal Cannabis?

Patients can obtain Medicinal Cannabis by receiving a narcotic prescription (an ‘Rpw’ prescription) from a medical doctor, upon which they can purchase Medicinal Cannabis in a pharmacy.

19. Who can prescribe Medicinal Cannabis?

In theory, any medical doctor, with the exception of veterinarians, can prescribe Medicinal Cannabis. In practice, not every doctor, due to their specialisation, issues prescriptions falling under the category of prescriptions for medicinal products ‘containing narcotic drugs or psychotropic substances as defined in separate legislation’ (‘Rpw’), i.e. a narcotic drug prescription. In most cases, it will be oncologists, psychiatrists and palliative care specialists who issue such prescriptions.

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

There is no specific list of doctors authorized to prescribe Medicinal Cannabis.

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

No approvals or notifications are required to prescribe Medicinal Cannabis. However, the prescription for Medicinal Cannabis falls under the category of prescriptions for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (‘Rpw’), i.e. a narcotic drug prescription.

Medical treatment with Medicinal Cannabis is not treated as first choice therapy. The doctor decides whether to prescribe Medicinal Cannabis while taking into account the history of the patient’s treatment, and considering the effects of previous treatment methods. Being a pharmaceutical raw material, there is no summary of product characteristics for Medicinal Cannabis, i.e. there is no document regulating what diseases it can be prescribed for.

22. Where is Medicinal Cannabis available?

Medicinal Cannabis is available for retail purchase in pharmacies.

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

There is no specific list of retailers authorised to sell Medicinal Cannabis. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

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

At this point, there are no proposals for reform or significant change to the regulation of Medicinal Cannabis.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Certain Opioid Drugs used for medical purposes are authorised in Poland. Opioids are classified in groups I-N, II-N, III-N and IV-N as defined in the Regulation, i.e. narcotics which are treated as either highly addictive substances (I-N), moderately addictive substances that can be used for medical, scientific and industrial purposes (II-N), mildly addictive and subject to milder control and being non-prescription drugs (III-N, being a sub-group of I-N and II-N), and drugs subject to stricter control which can only be used for research purposes and for animal treatments (IV-N, being a subgroup of I-N).

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

Opioid Drugs fall under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e. the URPL, and – in the area of manufacturing, import, distribution, advertising and promotion of medicinal products, the GIF, as well as the Ministry of Health, which is generally responsible for public health-related matters. See Question 1, on Regulatory, Pricing and Reimbursement Overview).

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

Generally, the same rules for the authorisation, pricing, and reimbursement of medicinal products apply to opioids.

However, some stricter rules also apply. In order to manufacture, process, alter, import or distribute narcotic drugs or psychotropic substances, an authorisation from the GIF is required.

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

Opioids that have received market approval are, among others, those containing: codeine, dihydrocodine, tramadol, morphine, fentanyl, methadone, tapentadol, oxycodone, oxycodone with naloxone, buprenorphine, pethidine, pentazocine, and diphenoxylate.

29. Who can prescribe Opioid Drugs?

Any medical doctor can prescribe Opioid Drugs. In practice, due to their specialisations, not every doctor issues such prescriptions.

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

No.

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

No approvals or notifications are required to prescribe Opioid Drugs. However, Opioid Drugs require a special kind of prescription for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (“Rpw”), i.e. a narcotic drug prescription.

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

Sale is only possible through pharmaceutical wholesalers and pharmacies. See Question 8.

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

There is no specific list of retailers authorised to sell Opioid Drugs. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

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

There are currently no proposals for reform or significant change to the regulation of Opioid Drugs.

35. When are they likely to come into force?

Not applicable.