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

The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

No.

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

The National Unique Registry of Chemicals Operators. Meanwhile, they are competent as criminal investigation police authorities under the direction of the Public Ministry: The National Armed Forces, the Corps of Scientific, Criminal and Criminal Investigations and the Maritime Police. (Art. 121, 127, 128 and 129 Organic Law against Illicit Trafficking and Consumption of Narcotic and Psychotropic Substances.)

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

There are no formal proposals on this issue. It does not seem that any significant change is approaching in the short term.

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

No.

Medicinal Cannabis

5. Is Medicinal Cannabis authorized in the country?

No.

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

The National Unique Registry of Chemicals Operators. Meanwhile, they are competent as criminal investigation police authorities under the direction of the Public Ministry: The National Armed Forces, the Corps of Scientific, Criminal and Criminal Investigations and the Maritime Police.

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

We do not advance any significant progress, regarding the regulation of Medicinal Cannabis.

Opioid Drugs

8. Are Opioid Drugs authorized in your country?

Yes, they are allowed for medicinal use and in a controlled manner.

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

The Ministry of Health, National Drug Council (CONMED), Pharmaceutical Products Review Board and the National Registry of Chemicals Operators.

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

We do not have a specific regulatory framework for opioid drugs. These are regulated through the Drug Law, the Official Drug List and the Fair Price Law.

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

Opioid anaesthetics

• 1-02-0307-02-10-03 Fentanyl, 0.05mg / ml, vial or vial, 10ml, I.V. VEN-M: V.

Opioid analgesics

Natural Opium Alkaloids

• 01-01-0840-31-10-3E Morphine sulphate, 15mg, capsules or tablets, V.O. (Narcotics Control). * VEN

M: V, Restricted use: Oncology, Hematology, Orthopedics, and Pain Clinic.

• 1-02-0668-01-10-03 Morphine hydrochloride or sulphate, 10mg / ml, ampoule, calibrated syringe or vial, 1ml, S.C.; I.M.; I.V. (Narcotics Control).

(Official Drug List No. 25787 Official Digital Gazette, Wednesday, May 9, 2007.)

12. Who can prescribe Opioid Drugs?

“Medicines with an optional prescription will only be prescribed by medical professionals, dentists and veterinary doctors. Those must be qualified for the exercise of the profession and duly registered before the respective Ministry.”

(Article 35. Medication Law). In the case of some opioids, they can only be prescribed by: Oncology, Hematology, Orthopedics, and Pain Clinic.

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

There is a list of doctors and specialists in the country. However, we do not have an independent record of which of these doctors are authorized to prescribe opioids.

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

Pharmaceutical Laboratories, drug stores, representative houses and pharmacies; These have different functions.

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

No.

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

We are not aware of upcoming reforms or changes in the regulation of this substance.