Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Mușat & Asociații / Romania
All about cannabinoid drugs, medicinal cannabis and opioid drugs in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
According to the national catalogue of medicines in Romania published by NAMMD, currently there are no cannabinoid medicinal products authorized for marketing in the country.
By law, certain psychotropic substances extracted from cannabis, namely the substance having the international nonproprietary name Dronabinol (specifically, trans-delta-9-tetrahidrocanabinol) are considered “useful for medicine”, and can be used under a strict control.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The competent regulatory authorities dealing with psychotropic and narcotic medicinal products, including cannabinoid medicines, are the Ministry of Health and NAMMD. The authorization for growing cannabis plants for medical purposes is granted by the Ministry of Agriculture.
Thus, as a rule, it is permitted to cultivate plants containing substances under national control (such as tetrahydrocannabinol (THC) – which can be found not only in Cannabis indica, but also in Cannabis sativa), based on an authorization from the Ministry of Agriculture and/or the local departments in its subordination, on condition that (1) the crop is processed for technical purposes, to produce stalk, fiber, seed and oils, or for medical and scientific purposes; and (2) the THC level on the entire surface of the cultivated hemp shall not exceed 0.2%.
3. Is there a specific regulatory framework for the authorization, pricing and reimbursement of Cannabinoid Drugs?
In order to be authorized for marketing, a cannabinoid medicine should have an active substance relevant for medicinal purposes. The Romanian legislation provides for the list of cannabinoid substances which are relevant for such purposes, as well as for the list of prohibited substances.
There are no specific legal requirements for the pricing and reimbursement of such products, meaning that they should follow the normal procedures applicable for all medicinal products.
4. Which are the cannabinoid drugs that have received market approval to date?
Based on the publicly available information it appears that no cannabinoid medicine was authorized for marketing in Romania.
5. Who can prescribe Cannabinoid Drugs?
Currently, there are no special provisions for the prescription of cannabinoid medicines.
However, since the law provides that certain cannabinoid substances are qualified as psychotropic substances relevant for medical purposes, please note that the psychotropic substances should be prescribed by physicians using special, secured forms, within the medical units duly authorized by the Ministry of Health (hospitals, ambulatory care units or treatment centers).
In principle, cannabinoid medicines could be subject to additional prescription restrictions, in accordance with the terms of the marketing authorization and the therapeutic guidelines which shall be issued by the Ministry of Health. Since these products should be used under a strict control, we anticipate that the authorities will issue specific guidelines for ensuring such control.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No, there is no such list.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
The in force legislation does not provide special prescription procedures in respect of medicinal products with cannabinoid composition. Thus, they should observe the prescription rules applicable to psychotropic substances (as mentioned at Section 5 above), as well as any other rules which may be laid down in their marketing authorization.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
This is not expressly provided by the law.
However, please be advised that in order to distribute psychotropic substances it is required to have an authorization from NAMMD and the Ministry of Health. During the authorization process, the regulatory authorities shall verify, amongst others, the procedures implemented by the distributors for ensuring the safety and the security of the supply chain, and the storage and handling conditions.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
No, there is no such list.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
There is no ongoing procedure for reforming or changing the legal framework applicable to such products.
11. When are they likely to come into force?
While cannabinoid medicinal products are authorized for marketing in other EU member states, it is advisable for the companies acting in this field to closely monitor the legal developments in Romania.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Medicinal Cannabis is currently not authorized by the national legislation.
While the law on psychotropic and narcotic substances stipulates that, under certain conditions, cannabis can be grown for medical and scientific purposes based on the authorization of the Ministry of Agriculture, the terms and conditions for using medicinal cannabis in Romania have not been regulated to date. Unauthorized distribution and/or use of cannabis products can fall under the umbrella of the criminal legislation.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The competent regulatory authorities in the medicine field are the Ministry of Health and NAMMD.
Assuming that the medicinal cannabis will be authorized in Romania, it is likely that these authorities will be competent also for this type of products.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Not provided by the in force legislation.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Not provided by the in force legislation.
The competent authority authorizing the import and/or export of narcotic and/or psychotropic plants, substances and compounds, including but without limitation to plants, substances and/or compounds containing THC, is the Ministry of Health. However, even if medicinal cannabis could fall under these categories, currently the legislation does not regulate a procedure for authorizing the production, import or export of medicinal cannabis.
The Agricultural Payments and Interventions Agency (APIA) grants the import and/or export licenses for the following products:
a) seeds of varieties of hemp for sowing, falling within CN code 1207 99 20;
b) true hemp, raw or retted, falling within CN code 5302 10 00; and
c) hempseeds other than for sowing, falling within CN code 1207 99 91.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Not provided by the in force legislation.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Not provided by the in force legislation.
18. How can patients obtain Medicinal Cannabis?
Not provided by the in force legislation.
19. Who can prescribe Medicinal Cannabis?
Not provided by the in force legislation.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There is no such list.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Not provided by the in force legislation.
22. Where is Medicinal Cannabis available?
Not provided by the in force legislation.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
There is no such list.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
There is no ongoing procedure concerning the legal framework applicable to such products. However, it is advisable for the companies acting in this field to closely monitor the legal developments in Romania.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
By law, medicinal products having an opioid composition can be authorized for marketing in Romania. Opium and certain other active substances fall under the category of narcotic substances relevant for medical purposes, under a strict control.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The main regulatory authorities are the Ministry of Health, NAMMD and the National Health Insurance House.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
There are no specific legal requirements for the authorization, pricing and reimbursement of such products, meaning that they should follow the normal procedures applicable for all medicinal products.
Thus, these products should be authorized for marketing (by NAMMD or by the European Medicines Agency), should have the price approved by the Ministry of Health, and could be approved for reimbursement by the Romanian Government and the reimbursement authorities (i.e., the Ministry of Health and the National Health Insurance House).
28. Which are the Opioid drugs that have received market approval to date?
Numerous opioid medicinal products have been granted marketing authorization in Romania, including codeine, oxycodone, fentanyl, remifentanil, morphine, pethidine and methadone.
29. Who can prescribe Opioid Drugs?
As a response to rising rates of opioid misuse, the opioid-prescribing practice has been subject to certain national regulatory restrictions. Hence, opioid medicinal products can be prescribed by physicians only within authorized medical units (hospitals, ambulatory care units) or within drug addiction treatment centers, duly authorized by Ministry of Health.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There is no such list.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The medical units and the treatment center where opioid medicines are prescribed should be authorized to carry out such activities by the Ministry of Health.
The physicians who prescribe such medicines (e.g., in hospital or in ambulatory care) do not require a special license. However, the law provides for various obligations and rules which should be observed by the attending physicians, when prescribing narcotic substances.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
In order to distribute psychotropic or narcotic substances it is required to have an authorization from NAMMD and the Ministry of Health. During the authorization process, the regulatory authorities shall verify, amongst others, the procedures implemented by the distributor for ensuring the safety and the security of the supply chain, and the storage and handling conditions.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is no such list.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
There is no ongoing procedure for reforming or changing the legal framework applicable to such products.
35. When are they likely to come into force?
N/A.
