Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
AFRA / Panama
The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
Cannabinoids are substances subject to national control for medical or scientific use.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The regulatory authority is the Pharmaceutical and Drug Department from the Ministry of Health.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Yes, the Law No. 14 of May 19, 2016, Executive Decree No. 183 of June 8, 2018 and Resolution No. 410 of July 12, 2018 whereby is regulated the authorization, distribution, manufacture, storage, export and import.
4. Which are the cannabinoid drugs that have received market approval to date?
To the best of our knowledge up to date the Panamanian Authority has not received an application for approval of any the cannabinoid drug.
5. Who can prescribe Cannabinoid Drugs?
- Doctors
- Veterinarians
- Dentist
- Nurses
- Pharmacy
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
To the best of our knowledge up to date there is no special list.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
It must be done through the authorized prescription book or vouchers.
Voucher for Controlled Substances are specifically for distribution. These vouchers must be compiled by the distribution agencies, laboratories, drugstores and filed it before the Pharmaceutical and Drug Department for evaluation and authorization according to the establish format.
Specifically, for National and Regional Hospitals Pharmacies that purchase directly from distribution agencies, laboratories, drugstores are required to be previously authorized by the Pharmaceutical and Drug Department.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
It is necessary to have a special License of operations for marketing the Cannabinoid Drugs Pharmaceutical Regent.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
To the best of our knowledge to date there is no special list.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
No, because the regulations (Executive Decree No. 183 of June 8, 2018 and Resolution No. 410 of July 12, 2018) were recently approved.
11. When are they likely to come into force?
The Law No. 14, came into force since May 24, 2016.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
No. However, there is a Project of new Law No. 153 pending approval by the Senate for Medicinal Cannabis.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
N/A
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
N/A
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
N/A
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
N/A
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
N/A
18. How can patients obtain Medicinal Cannabis?
N/A
19. Who can prescribe Medicinal Cannabis?
N/A
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
N/A
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
N/A
22. Where is Medicinal Cannabis available?
N/A
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
N/A
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Please refer to Question 10.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Yes, opioid drugs are authorized but only for medical or scientific use.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The regulatory authority is the Pharmaceutical and Drug Department from the Ministry of Health.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Please refer to Question 3.
28. Which are the Opioid drugs that have received market approval to date?
This is not public information.
29. Who can prescribe Opioid Drugs?
Please refer to Question 5.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
Please refer to Question 6.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Please refer to Question 7.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Please refer to Question 8.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
Please refer to Question 9.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No to the best of our knowledge.
35. When are they likely to come into force?
Please refer to Question 11.
