Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Carey / Chile
The legal framework for cannabinoid drugs, medical cannabis and opioids in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
So far, only pharmaceutical products containing an extract of flowers and leafs of cannabis sativa (Sativex solución para pulverización bucal) have been approved for sanitary registration (marketing authorization) by the Public Health Institute (ISP). We are also aware of an Import Authorization without sanitary registration granted to a company to import certain products containing cannabis.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
- Ministry of Health and ISP: regulate importation, registration, distribution, marketing and clinical studies for pharmaceutical products containing cannabis.
- Ministry of Agricultural and Agricultural and Livestock Service (SAG): Authorization of sowing, planting, cultivating or harvesting plant species of the genus cannabis.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Our local health regulations set the provisions for the authorization for the import, registration, distribution, marketing and clinical studies of Cannabinoid Drugs by the Ministry of Health and ISP. No regulations about pricing and reimbursement are included in the local health regulations.
4. Which are the cannabinoid drugs that have received market approval to date?
Please refer to question No. 1.
5. Who can prescribe Cannabinoid Drugs?
A physician duly authorized to prescribe.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No, there is no specific list in this regard.
Any physician duly authorized for the issuance of medical prescriptions may prescribe Cannabinoid Drugs.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
The Cannabinoid Drug must have an approved sanitary registration (marketing authorization) granted by the Chilean Public Health Institute (“ISP”) in order to be commercialized in the country.
Cannabinoid Drug recognized in S.D. 404/85 may only be prescribed under retained prescription (receta retenida) with stock control.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
In general, all entities which are authorized to sell/distribute controlled pharmaceutical products (authorized, pharmacies, wholesalers, among others)
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
No, there is no specific list in this regard.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Currently there are no bills or proposals to change regulations in this matter.
11. When are they likely to come into force?
Not applicable. See answer to question 10.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
No. Chilean Law does not explicitly authorize the use of medicinal cannabis. Notwithstanding the above, there is a growing jurisprudence of the superior courts of justice, which has understood that if the cannabis is cultivated for medicinal use, the amount can be considered as “personal consumption” (which is authorized in some circumstances) and not for drug trafficking purposes (which can be criminally prosecuted).
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?
There is no applicable regulation for Medicinal Cannabis in this regard.
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?
There is currently a bill in congress which intends to amend Law No. 20,000 with sanctions the illicit traffic of narcotics and stupefacient. Pursuant to this bill, medical prescription of cannabis will be deemed as an authorization to produce some products derived from cannabis, for medical treatment purposes. This bill provides that the use of medicinal cannabis under medical prescription cannot include “combustion”.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Yes.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
- Ministry of Health and ISP: regulate importation, registration, distribution, marketing and clinical studies of opioid drugs.
- Ministry of Agricultural and Agricultural and Livestock Service (SAG): Authorization of sowing, planting, cultivating or harvesting plant species.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Our local health regulations contemplate the authorization for the importation, registration, distribution, marketing and clinical studies of Opioid Drugs by the Ministry of Health and ISP.
Pricing is not regulated.
Reimbursement will depend on the private insurances of each patient.
28. Which are the Opioid drugs that have received market approval to date?
There are several Opiod drugs that have a sanitary registration (marketing authorization) in Chile containing the following active ingredients:
- Morphine
- Apomorphine
- Fentanyl
- Remifentanil
- Sufentanil
- Pethidine
- Oxycodone
- Hydrocodone
- Codeine
29. Who can prescribe Opioid Drugs?
A physician duly authorized for the issuance of medical prescriptions.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
No, there is no specific list in this regard.
Any physician duly authorized for the issuance of medical prescriptions may prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The Opioid Drug must have an approved sanitary registration (marketing authorization) by ISP in order to be commercialized in the country. Opioids pertaining to Lists I or II as recognized in S.D. 404/85 may only be prescribed under official prescription (receta cheque) or retained prescription (receta retenida)
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
In general, all entities which are authorized to sell/distribute controlled pharmaceutical products (authorized, pharmacies, wholesalers, among others)
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
No, there is no specific list in this regard.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Currently there are no bills or proposals to change regulations in this matter.
35. When are they likely to come into force?
Not applicable. Please refer to question No 34.
