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

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No, cannabinoid drugs can be prescribed by any physician according to answer to question 5 above.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

No approvals or notifications are required. Authorized physicians can prescribe cannabinoid drugs to their patients in their own discretion, on regular prescription.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

According to national regulations, all drugs (i.e. including cannabinoid drugs) are only dispensed to patients through hospital pharmacies or private community pharmacies (see answer to question 14 of “Regulatory, Pricing, and Reimbursement Overview”).

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

No, all hospital pharmacies (public/private) and private community pharmacies are authorized.

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

There is a new Decree underway that aims to lay down the procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including cannabinoid drugs) as introduced by Article 245 of Health Law No 18-11. The main objective of the ongoing reform is to insure traceability of these drugs from the reception of the raw materials until the dispensation at pharmacy level.

According to the draft of the aforementioned Decree, prescription of drugs with psychotropic properties will be limited to three (03) months, and must be written on a special prescription in three copies of different colors (white, yellow and pink):

• White and yellow color copies are given to the patient;
• The pink copy must be kept by the prescribing physician for a period of two years;
• The yellow copy is saved by the pharmacist after dispensing the drugs;
• The white copy is returned to the patient after dispensation or directly sent to the payer.

Every prescribing physician must record his prescriptions in a register opened for this purpose, marked and initialed by the Provential Health and Population Directorate (“DSPW” – “Direction de la Santé et de la Population de Wilaya”) for those practicing in the private sector, and by the health structure director for those in the public sector. The register must be kept for five years.

The prescription of psychotropic drugs for hospital use with a restricted prescription must be made by a specialized physician at the exercise hospital. The maximum duration of prescription will be limited to one (01) month. The dispensing of these drugs is reserved for hospital pharmacies, and the list of these psychotropic drugs will be fixed through Ministerial Decree.

11. When are they likely to come into force?

The aforementioned Decree is expected to be published in the Official Gazette by Q1 2020.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal cannabis can be authorised in Algeria in accordance with provisions of Decree No 07-228 dated 30 July 2007 and published in the Official Gazette, laying down the procedures for granting authorization to use narcotic and psychotropic substances for medical or scientific purposes.

According to Article 3, the authorization provided for by this Decree No 07-228 may be granted only if the use of the plants, substances and preparations is intended for medical or scientific purposes.

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

The Ministry of Health is the national regulatory authority with jurisdiction over medicinal cannabis.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

The Decree No 07-228 dated 30 July 2007 and published in the Official Gazette, laying down the procedures for granting authorization to use narcotic and psychotropic substances for medical or scientific purposes, alongside with the Law No 04-18 dated of 25 December 2004 and published in the Official Gazette, on the prevention and repression of the illicit use and trafficking of narcotic and psychotropic substances, form together the regulatory framework for medicinal cannabis.

Plants, substances and preparations intended for “compassionate use” under the regimen of temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) are regulated under provisions of Article 233 within the Health Law No 18-11, when prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production, manufacturing, holding, offer, sale, offer for sale, acquisition, purchase for sale, storage, extraction, preparation, distribution, delivery, brokerage, shipping, transit, transport, export or import of narcotics and/or psychotropic substances and their precursors, as well as cultivation of opium poppy, coca and cannabis plants, are subject to the issuance of an authorization granted by the Minister of Health according to provisions of the Decree No 07-228.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The application for authorization is to be addressed to the Minister of health and must mention:

• The identification and the quality of the applicant;
• The nature of the proposed transaction;
• The name of the product/substance;
• The quantity in figures and letters of the product;
• The mode of transport envisaged;
• The use that will be made of the product;
• The applicant’s signature;
• An extract from the applicant’s criminal record.

The authorization is issued after a social inquiry into the moral and professional qualities of the applicant, carried out by the services authorized for that purpose, at the request of the Ministry of Health. The applicant must enjoy his civil rights and not have been convicted for the offenses provided for by the Law No 04-18 on the prevention and repression of the illicit use and trafficking of narcotic and psychotropic substances. The validity of the export or import authorization for each operation is three (03) months from the date of delivery.

The pharmaceutical, health or scientific establishments authorized to import substances or preparations classified as narcotic or psychotropic have to report quarterly to the Minister of Health. Their declaration must specify, for each substance/product:

• The quantities of imported products;
• Dosage per unit of setting;
• The form and presentation;
• The name and address of the supplier.

Holders of production authorization are required to draw up an annual report indicating for each narcotic drug or psychotropic substance:

• The quantity received;
• The quantities used for manufacturing or processing, specifying the nature and quantity of the products obtained;
• The quantity sold and its destinations;
• The end-of-year stocks, including those under processing.

This report covering the past year is sent to the Minister of Health no later than February 15th.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

There is not yet a specific regulatory framework for the marketing and distribution.

18. How can patients obtain Medicinal Cannabis?

The dispensing of medicinal cannabis is reserved for hospital pharmacies.

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis can be prescribed by any specialized physician providing healthcare services at the exercise hospital where the patient will receive the substance/preparation. The conditions for the prescribing physicians are that they have to be registered on official list of the Doctors Order National Council, not being involved in substances procurement, and not being under prescription ban.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No, they can be prescribed by any authorized physician according to answer to question 19 above.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

No approvals or notifications are required. Authorized physicians can prescribe medicinal cannabis to their patients in their own discretion.

22. Where is Medicinal Cannabis available?

Medicinal cannabis can be only available at hospital pharmacies.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

No.

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

There is a new Decree under way that aims to lay down the procedures for specific, administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including medicinal cannabis) as introduced by Article 245 of Health Law No 18-11 (see answer to question 10 above).

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opioid drugs, i.e. drug products as defined in Article 208 of Health Law No 18-11, dated of 2 July 2018, where the active substance is derived from opium, are authorised in Algeria in accordance with the Health Law No 18-11 provisions related to drugs.

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

The National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institu- tion newly created under Article 223 of Health Law No 18-11, dated of 2 July 2018, and placed under the administrative authority of the Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national regulatory authority with jurisdiction over opioid drugs for human use in Algeria.

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

According to Article 245 of the Health Law No 18-11, opioid drugs are subject to a specific administrative, technical and security control that encompasses:

• The production, manufacture, packaging, processing, importing, exporting, offering, distribution, disposal, acquisition, holding of substances, drugs with narcotic and/or psychotropic properties;
• The use of plants or parts of plants with narcotic and/or psychotropic properties.

The overall regulatory framework for the authorization, pricing, and reimbursement remains the same as for the other drugs (see answer to question 2 of “Regulatory, Pricing, and Reimbursement Overview”).

The Prescription and dispensation of opioid drugs is regulated by Ministerial Decree, dated of 29 June 2013 and published in the Official Gazette, fixing conditions for prescribing and dispensing of prescription related to drugs containing substances classified as narcotics.

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

According to the national database of drugs for human published in August 2019 by the Ministry of Health, there are several opioid drugs that are already authorized for marketing in Algeria, including morphine (both oral and injectable), fentanyl (injectable), sufentanil (injectable), oxycodone (oral), codeine (oral), and buprenorphine (injectable).

29. Who can prescribe Opioid Drugs?

Authorized opioid drugs can be prescribed by any physician providing healthcare services and registered on official list of the Doctors Order National Council, excepting those involved in drugs procurement and those under prescription ban (punished by Article 419 of the Health Law No 18-11).

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

No, they can be prescribed by any authorized physician according to answer to question 29 above.

31. What approvals or notifications are required to prescribe Opioid Drugs?

No approvals or notifications are required. Authorized physicians can prescribe opioid drugs to their patients in their own discretion. Prescribing of opioid drugs is limited to seven (07) days for injectables and to twenty-eight (28) days for oral preparations, and must be written on special prescription extracted from a notebook with stumps: one part must be kept by the prescribing physician, and the second is saved by the pharmacist after dispensing the drugs.

The prescribing physician of opioid drugs must mention in readable plain text the following:

• The identification of the public or private health facility to which the physician belongs;
• The identification of the prescriber: title, function, registration at the doctors ordinal section;
• The precise identification of the patient: name, sex, age, if any, height and weight;
• The identification of the opioid drug(s);
• The detailed formula, the number of units or the volume if it is a compounding preparation;
• The strength or concentrations of substances in case of pharmaceutical specialties.
• The pharmaceutical form, dosage, duration of treatment and route of administration;
• The number of therapeutic units per dose;
• The number of doses.

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

According to national regulations, authorized opioid drugs are only imported by public institutions and dispensed to patients through hospital pharmacies or authorized private community pharmacies (see answer to question 14 of “Regulatory, Pricing, and Reimbursement Overview”).

According to the Ministerial Decree dated of 29 June 2013, a prescription related to opioid drugs may be dispensed in its entirety or for the entire fraction of the treatment, only if it is presented to the pharmacist in forty-eight (48) hours from the date of its establishment, or after the end of the previous fraction. If it is submitted after this period, it can only be executed for the duration of the prescription, or the fraction of treatment remaining to be covered.

In addition, it is forbidden to prescribe and to deliver substances classified as narcotics when they are not contained in a pharmaceutical specialty or a compounding preparation.

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

All hospital pharmacies are authorized, and any private community pharmacy is eligible for authorization.

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

No, there is no plan for reform in relation with opioid drugs regulation.

35. When are they likely to come into force?

Not applicable.