Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Olaniwun Ajayi LP / Nigeria
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Nigeria. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
Generally, in Nigeria, it is an offence to manufacture, sell, possess, import, export or otherwise deal in cannabinoid drugs without an appropriate license. Cannabinoid drugs may however be used only for medicinal or scientific purposes subject to certain conditions.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
In Nigeria, the regulatory authorities with jurisdiction over cannabinoid drugs are: (i) the National Drug Law Enforcement Agency; and (ii) the National Agency for Food and Drug Administration and Control; (iii) the Federal Ministry of Health; and (iv) the Federal High Court.
The importation, possession, supply, distribution and use of cannabinoid drugs is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.
Also, cases of wanton or illegal possession and distribution of cannabinoid drugs in Nigeria are dealt with by the National Drug Law Enforcement Agency (NDLEA).
The National Agency for Food and Drug Administration and Control Agency (NAFDAC) in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of Medical Cannabis in Nigeria and as such, no cannabinoid drugs can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
While there are no specific guidelines for pricing and reimbursement of cannabinoid drugs, authorization of cannabinoid drugs is regulated by the following statutes: Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.
The license to supply, procure, offer to supply or procure, import, export, manufacture or advertise cannabinoid drugs for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, it is important to note that cannabinoid drugs must be registered with NAFDAC prior to their manufacturing, importation, advertisement, sale or distribution in Nigeria.
4. Which are the cannabinoid drugs that have received market approval to date?
In Nigeria, there is no list of approved cannabinoid drugs. However, given that Indian Hemp, a common cannabinoid drug is legal under Nigerian law for medicinal purposes, it can be inferred that that Indian Hemp is an approved cannabinoid drug for medicinal questions subject to the license granted by Minister of Health.
5. Who can prescribe Cannabinoid Drugs?
Cannabinoid drugs can only be prescribed by medical and dental practitioners and veterinary surgeons.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
There are no list specifying the names or cadre of doctors that can prescribe Cannabinoid drugs in Nigeria. As such, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe cannabinoids drugs.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
There are essentially no express provisions for approvals to be sought or notifications to be made to any agency or body, whether prior or subsequent to the prescription of the drugs save for the fact that such prescription must be made by a registered, licensed or qualified Medical and Dental Practitioner, or veterinary surgeon.
In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual signature and address, and shall (x) specify the name and address of the person for whose use the prescription is given; and (y) the total amount of the drug to be supplied on the prescription.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
The Regulations streamlines the category of persons that can distribute this drug. Consequently, only person or organizations licensed by the Minister of Health to either manufacture, import, export or distribute cannabinoid drugs can sell or distribute these drugs.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute Cannabinoid drugs. There are no known or published lists of these authorized persons.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Though there are quite a number of pending Bills in the National Assembly on narcotics, from our review of these pending Bills there are no significant change in the licensing or operation of the Cannabinoid drugs regime.
11. When are they likely to come into force?
Given that the bills are still at the preliminary stages, we are unable ascertain with any exactitude when these Bills will come into force.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
The Indian Hemp Act defines Indian Hemp to include “any plant or part of a plant of the genus cannabis”; the Act goes further to prohibit the planting, cultivation, importation, exportation and use of Indian Hemp in Nigeria. The above provisions and prohibition is however expressed to be subject to the provisions of the Dangerous Drugs Act. The Dangerous Drugs Act authorizes Medicinal Cannabis in Nigeria. This authorization is subject to certain laid down conditions in Nigeria.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The importation, possession, supply, distribution and use of Medicinal Cannabis is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.
Also, cases of wanton or illegal possession and distribution of Cannabis in Nigeria are dealt with by the National Drug Law Enforcement Agency (NDLEA).
The National Agency for Food and Drug Administration and Control Agency (NAFDAC) in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of Medical Cannabis in Nigeria and as such, no medicinal cannabis can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
While there are no specific guidelines for pricing and reimbursement of medical cannabis in Nigeria, authorization of medical cannabis is regulated by the following statues: Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.
The license to supply, procure, offer to supply or procure, import, export, manufacture or advertise medical cannabis for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, medical cannabis must be registered with NAFDAC prior to its manufacturing, importation, advertisement, sale or distribution in Nigeria.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Only persons authorized by the Minister of Health are able to produce and import medical cannabis in Nigeria. In the case of imports, an import authorization is required which is granted by the Minister of Health and should specify that medical cannabis can be imported.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The authorization or license to supply, procure, offer to supply or procure, import, export, manufacture or advertise medical cannabis for sale is granted by the Minister of Health of Nigeria.
It is also important to note that such Medical cannabis would be required to be registered with NAFDAC prior to its manufacture or importation in Nigeria.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Medical Cannabis is regulated by the Indian Hemp Act; Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.
Its marketing and distribution is subject to the license granted by the Minister of Health.
18. How can patients obtain Medicinal Cannabis?
In Nigeria, further to a prescription by Medical and Dental Practitioners and Veterinary Surgeons, the medical cannabis may be obtained from licensed pharmacists or any other shop for retailing of drugs registered with the Pharmacists Council of Nigeria.
19. Who can prescribe Medicinal Cannabis?
Medical Cannabis can only be prescribed by medical and dental practitioners and veterinary surgeons.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There are no list specifying the names or cadre of doctors that can prescribe medical cannabis in Nigeria, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe medical cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
There are essentially no express provisions for approvals to be sought or notifications to be made to any agency or body, whether prior or subsequent to the prescription of the drugs save for the fact that such prescription must be made by a registered, licensed or qualified Medical and Dental Practitioner, or veterinary surgeon.
In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner registered or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual signature and address, and shall (x) specify the name and address of the person for whose use the prescription is given, (y) the total amount of the drug to be supplied on the prescription.
22. Where is Medicinal Cannabis available?
Medical cannabis is available at licensed pharmacists or any other shop for retailing of drugs registered with the Pharmacists Council of Nigeria.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute medical cannabis. There are no known or published lists of these authorized persons.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Though there are quite a number of pending Bills in the National Assembly on narcotics, from our review of these pending Bills there are no significant change in the licensing or operation of medical cannabis.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
In Nigeria, it is an offence to manufacture, sell, possess, import or export or otherwise deal in opioid drugs without an appropriate license. Opioid drugs may however be used for medicinal or scientific purposes subject to certain conditions.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
In Nigeria, the regulatory authorities with jurisdiction over opioid drugs are: (i) the National Drug Law Enforcement Agency (NDLEA); and (ii) the National Agency for Food and Drug Administration and Control (NAFDAC); (iii) the Federal Ministry of Health; and (iv) the Federal High Court.
The importation, possession, supply, distribution and use of opioid drugs is regulated by the Minister of Health under the Dangerous Drugs Act and the Regulations.
Also, cases of wanton or illegal possession and distribution of opioid drugs in Nigeria are dealt with by the NDLEA.
NAFDAC in its capacity as the apex regulatory agency for drug and drug products regulates the manufacture, import, export, advertisement, sale, distribution and use of opioid drugs in Nigeria and as such, no medicinal cannabis can be imported, manufactured, sold or used in Nigeria without the prior approval of NAFDAC.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
While there are no specific guidelines for pricing and reimbursement, authorization of opioid drugs is regulated by the following statues: Dangerous Drugs Act; NDLEA Act, Cap. N30, LFN, 2004; and the NAFDAC Act.
The license to supply, procure, offer to supply or procure, import, export, manufacture or advertisement of opioid drugs for sale is granted by the Minister of Health of Nigeria and such license must be used in accordance to the terms and conditions attached to it. Also, cannabinoid drugs must be registered with NAFDAC prior to their manufacturing, importation, advertisement, sale or distribution in Nigeria.
28. Which are the Opioid drugs that have received market approval to date?
An opioid drug that has received market approval in Nigeria is Tramadol. However, only 50mg and 100mg of Tramadol are approved for use in the country.
29. Who can prescribe Opioid Drugs?
Opioid drugs for medicinal purposes can only be prescribed by medical and dental practitioners and veterinary surgeons.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There are no list specifying the names or cadre of doctors that can prescribe opioid drugs in Nigeria, all registered or licensed medical practitioner, registered or licensed dental surgeon or qualified veterinary Surgeons can prescribe opioid drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
There are essentially no express provisions for approvals to be sought or notifications to be made to any agency or body, whether prior or subsequent to the prescription of the drugs save for the fact that such prescription must be made by a registered, licensed or qualified Medical and Dental Practitioner, or veterinary surgeon.
In addition to this, The Dangerous Drugs Regulations (“the Regulations”) provides that prescription of these drugs must be in writing, dated and signed by the registered or licensed Medical Practitioner registered or licensed dental surgeon or qualified veterinary surgeon as the case may be, with his usual sig- nature and address, and shall (x) specify the name and address of the person for whose use the prescription is given, (y) the total amount of the drug to be supplied on the prescription.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
The Dangerous Drugs Regulations streamline the category of persons that can distribute this drug. Consequently, only person or organizations licensed by the Minister of Health to either manufacture, import, export or distribute opioid drugs can sell or distribute these drugs.
33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?
No. As noted above, only persons authorized by the Minister of Health are able to sell or distribute opioid drugs. There are no known or published lists of these authorized persons.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Although there are quite a number of pending Bills in the National Assembly on narcotics, from our review of these pending Bills there are no significant change in the licensing or operation of medical cannabis.
35. When are they likely to come into force?
Given that the bills are still at the preliminary stages, we are unable to ascertain with any exactitude when these Bills will come into force.
