Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Danijel Pribanić / Croatia
All legal aspects surrounding cannabinoid drugs, medical cannabis and opioids in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
Cannabinoid Drugs are authorized only in the form of Medicinal Cannabis.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Office for Suppression of Drug Abuse has jurisdiction over Cannabinoid Drugs.
Agency for Medicinal products and Medical devices of Croatia is the regulatory authority with jurisdiction over medicinal products containing tetrahydrocanabinol (hereinafter: THC).
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
The authorization, pricing, and reimbursement of Medicinal Cannabis is regulated by Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products (Official Gazette Nos. 86/2013, 90/2013, 102/2014, 107/2015, 72/2016) and also all other regulations that concern authorization, pricing, and reimbursement of medicines in Croatia. This Ordinance has been issued by the Minister of Health.
4. Which are the cannabinoid drugs that have received market approval to date?
Cannabinoid drugs have received market approval only in the form of medicinal products containing THC.
5. Who can prescribe Cannabinoid Drugs?
Medicinal products containing THC dronabinol or nabilon are prescribed by the selected medical doctor in the activity of general/family medicine, health care of preschool children and health care of women at the recommendation of a medical doctor of the specialisations neurology, internal medicine in oncology, oncology and radiology, infectology and paediatrics with a subspecialisation in neuropaediatrics on a non-repeatable prescription.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
There is no list of doctors authorized to prescribe Medicinal Cannabis.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Regulations only specify the selected medical doctor that can prescribe medicinal products containing THC and illnesses for which the medicinal product containing THC can be prescribed.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Medicinal Cannabis can only be given in pharmacies with presentation of the prescriptions. The medicinal products containing THC are not on the list of approved Croatian Health Insurance Fund medicinal products, which means that patients pay the medicines full price.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
Medicinal product containing THC are only available in pharmacies with the presentation of a doctor’s prescription.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
The only prospect changes concern the usage of the entire plant for industrial purposes, whereas the cultivation of plant for production of medicinal cannabis remains unchanged, thus legally impossible. The reason for this is a lack of inter-sectoral cooperation and actual local investors.
Draft on Bill of Amendments of the Drug Prevention Act predicts that the freedom of movement of goods is allowed within EU member states to abolish the obligation to issue drug transit permits and psychotropic substances through the territory of a Member State and third countries.
11. When are they likely to come into force?
Bill of Amendments of the Drug Prevention Act is drafted. The moment when it comes into force depends on the legislative procedure.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Medicinal Cannabis is authorized in Croatia.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The Agency for Medicinal products and Medical devices of Croatia has regulatory authority over medicinal products containing THC.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The authorization, pricing, and reimbursement of Medicinal Cannabis is regulated by Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products (Official Gazette Nos. 86/2013, 90/2013, 102/2014, 107/2015, 72/2016) and also all other regulations that concern authorization, pricing, and reimbursement of medicinal products in Croatia. This Ordinance has been issued by the Minister of Health.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
The import of Medicinal Cannabis is regulated by Drug Abuse Prevention Act (Official Gazette Nos. 107/2001, 87/2002, 163/2003, 141/2004, 40/2007, 149/2009, 84/2011, 80/2013). Provisions of this Act regulate the obligation of the Minister of Health to issue a license for import, export, transport and transit of drugs, drug-containing drugs and parts of plants from which the drug is manufactured at the request of a legal entities that carry out wholesale of medicinal products, if the conditions laid down by Drug Abuse Prevention Act, other regulations and international treaties the Republic of Croatia is party to.
The Agency for Medicinal products and Medical devices of Croatia gives authorization for wholesale of medicinal products according to the provisions of Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13). This Ordinance has been issued by the Minister of Health.
Production of Indian-based drug remedies is not possible in Croatia for now.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
A license for import issued by the Minister of Health to legal entities that carry out wholesale of medicinal products. Authorization for wholesale of medicinal products given by the Agency for Medicines and Medical Products is required to carry out wholesale of medicinal products.
Production of Medicinal Cannabis in the Republic of Croatia is currently not possible.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
The import of herbal preparations from Indian hemp to the Republic of Croatia is regulated by Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products and Ordinance on Amendments to the Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products. These ordinances have been issued by the Minister of Heath.
18. How can patients obtain Medicinal Cannabis?
Medicinal products containing THC, dronabinol and nabilon may be prescribed to alleviate the symptoms of multiple sclerosis, carcinoma, epilepsy and AIDS.
Medical doctors are obliged to stipulate the following on a prescription for a magistral preparation:
- the quantity of THC per individual dose,
- the type of herbal drug and herbal preparation from which the magistral preparation is made,
- number of individual doses,
- medicinal form,
- dosage and instructions for use.
Medicinal products containing THC may be prescribed on a prescription in the quantity necessary for treatment for up to 30 days. The total quantity of prescribed THC for 30 days of treatment may not exceed 7.5 g.
19. Who can prescribe Medicinal Cannabis?
Medicinal products containing THC, dronabinol or nabilon are prescribed by the selected medical doctor in the activity of general/family medicine, health care of preschool children and health care of women at the recommendation of a medical doctor of the specialisations neurology, internal medicine in oncology, oncology and radiology, infectology and paediatrics with a subspecialisation in neuropaediatrics on a non-repeatable prescription.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There is no list of doctors authorized to prescribe Medicinal Cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Regulations only specify the selected medical doctor that can prescribe medicinal products containing THC and illnesses for which the medicinal product containing THC can be prescribed.
22. Where is Medicinal Cannabis available?
Medicinal products can only be given in pharmacies with presentation of the prescriptions. The medicinal products that containing THC are not on the list of approved Croatian Health Insurance Fund medicinal products, which means that patients pay the medicines full price.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
The medicinal product that containing THC is provided for only in pharmacies with presentation of doctor’s prescription.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
The only prospect changes concern the usage of the entire plant for industrial purposes, whereas the cultivation of plant for production of medicinal cannabis remains unchanged, thus legally impossible. The reason for this is a lack of inter-sectoral cooperation and actual local investors.
Draft on Bill of Amendments of the Drug Prevention Act predicts that the freedom of movement of goods is allowed within EU member states to abolish the obligation to issue drug transit permits and psychotropic substances through the territory of a Member State and third countries.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Opioid Drugs are not authorized in Croatia.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The Office for Suppression of Drug Abuse has jurisdiction over Opioid Drugs.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Opioid Drugs are not authorized in Croatia.
28. Which are the Opioid drugs that have received market approval to date?
No Opioid drugs have received market approval to date.
29. Who can prescribe Opioid Drugs?
No one can prescribe Opioid Drugs.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There is no list of doctors authorized to prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Prescription of Opioid Drugs is not possible.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
No organizations are authorized to sell/distribute Opioid Drugs.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is no list of retailers/distributors authorized to sell Opioid Drugs.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Bill of Amendments of the Drug Prevention Act is drafted but does not provide any significant change to the regulation of Opioid Drugs.
35. When are they likely to come into force?
The moment when Bill of Amendments of the Drug Prevention Act comes into force depends on the legislative procedure.
