Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Wildgen / Luxembourg
Cannabinoid drugs, medicinal cannabis and opioid drugs in Luxembourg – a comprehensive legal overview. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
The use of recreational cannabis is prohibited according to the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.
The use of medicinal cannabis (cannabis used for pharmaceutical purposes) has recently been authorized by a law of 20 July 2018, introducing article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended. See Chapter 9 on this point.
According to the Grand-Ducal regulation of 26 March 1974 establishing the list of narcotic drugs, are not considered as narcotic drugs, under specific conditions related to their crop and their intended purposes, the varieties of hemp, provided that their concentration in delta-9-tetrahydrocannabinol (THC) is less than a specific rate.
Furthermore, according to the Grand-Ducal Regulation of the 4 March 1974 relating to certain toxic substances, delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinol (CBN) and their isomers are considered as toxic substances, provided that they are incorporated in a medicinal product delivered in accordance with the Community acquis. They are classified as category “S” medicinal products in the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, meaning that their deliverance is subject to a special medical prescription. As a consequence, their use is governed by the legislation applicable to medicinal products and the legislation applicable to toxic substances. For an easiest reading, such medicinal products will be referred as “Cannabinoid Drugs”.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Similarly to medicinal products, the regulatory authority in charge of Cannabinoid Drugs is the Ministry of Health (“Ministère de la Santé”), in particular the National Health Directorate (“Direction de la Santé”) and its department the Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”).
Moreover, because Cannabinoid Drugs are also subject to the provisions of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the following persons would be also competent:
- judicial police officers;
- officers of the gendarmerie, and police;
- the customs and excise administration; as well as
- the director, the deputy director, the medical inspectors and the pharmacist-inspectors of the National Health Directorate
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
i. Authorization of Cannabinoid drugs
Cannabinoid Drugs in themselves are subject to the same provisions as medicinal products in this respect, so that there is not a specific regulatory framework for the authorization of Cannabinoid Drugs
ii. Pricing, and reimbursement of Cannabinoid drugs
There is no specific regulatory framework for cannabinoid drugs but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund (“Caisse Nationale De Santé” or “CNS”) apply also to cannabinoid drugs.
4. Which are the cannabinoid drugs that have received market approval to date?
To our knowledge, the only Cannabinoid Drugs that has received a marketing authorization is Sativex®
5. Who can prescribe Cannabinoid Drugs?
All the doctors authorized to practice in Luxembourg can prescribe Cannabinoid Drugs.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No, there is no list of doctors authorized to prescribe Cannabinoid Drugs.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
No approvals or notifications are required to prescribe Cannabinoid Drugs.
However, according to article 5 of the Grand Regulation of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, all those who hold Cannabinoid Drugs shall keep a specific register indicating the quantities they possess of said Cannabinoid Drugs. They shall enter in this register on a daily basis the quantities they acquire, produce, manufacture or debit and those they use for preparations or manufacturing. This register, as well as invoices or other supporting documents, must be kept for 10 years at the disposal of the judicial authorities and law enforcement officials.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
According to article 2 of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, only those that have been subject to a prior authorization from the Minister of Health may deliver Cannabinoid Drugs, except the following category of persons and establishments:
- pharmacists holding a pharmacy which is open to the public;
- hospitals and specialized hospitals with a hospital pharmacy;
- doctors and veterinary doctors authorized to hold medicinal products within the limit of a provision for urgent care
Moreover, only pharmacists holding a pharmacy which is open to the public may sell or offer to sell Cannabinoid Drugs without the authorization of the Minister of Health.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
There is no list of retailers/distributors authorized to sell Cannabinoid Drugs.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
No, there is no proposals for reform or significant change to the regulation of Cannabinoid Drugs.
11. When are they likely to come into force?
The question is not applicable.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Yes, medicinal cannabis is authorized since a law of 20 July 2018, introducing article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The regulatory authority with jurisdiction over medicinal cannabis in Luxembourg is the National Health Directorate under the authority of the Ministry of Health.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
i. Authorization of medicinal cannabis
The authorization of medicinal cannabis is governed by article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.
ii. Pricing, and reimbursement of medicinal cannabis
There is no specific regulatory framework but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund (“Caisse Nationale De Santé” or “CNS”) apply also to medicinal cannabis.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
According to article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the cannabis produced shall be subject to an approval from the National Health Directorate attesting their medical use.
According to article 1 of Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended:
- medicinal cannabis can only be imported with a prior authorization of the Minister of Health;
- the import authorization is delivered following a written application, stating the nature, quantity of the substances to import, as well as the alkaloid content of the substances. The importer can only take possession of the imported products after verification by the pharmacist-inspector of the Ministry of Health that may take samples.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
A prior authorization of the Minister of Health is necessary to import medicinal cannabis and the import is subject to a prior authorization of the Minister of Health.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
The marketing and distribution of medicinal cannabis is governed by article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.
18. How can patients obtain Medicinal Cannabis?
According to article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the patient having the following symptoms can obtain medicinal cannabis from a doctor authorized to practice in Luxembourg who had a previous special training about medicinal cannabis before:
- a serious illness, late stage or terminal illness, or
- a disease whose symptoms have a significant and lasting negative impact on its quality of life and which can be mitigated by the administration of medicinal cannabis.
19. Who can prescribe Medicinal Cannabis?
Doctors with a previously special training on the pharmacology of medicinal cannabis product, its presentation forms, therapeutic indications and side effects, as well as on the modalities and scientific bases of its prescription can prescribe medicinal cannabis, in accordance with article 30-2 of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There is no list of doctors authorized to prescribe medicinal cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
No approvals or notifications are required to prescribe medicinal cannabis.
22. Where is Medicinal Cannabis available?
Medicinal cannabis can only be delivered in hospital pharmacies, in accordance with the above-mentioned article.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
There is no list of retailers authorized to sell medicinal cannabis.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
There is no proposals for reform or significant change to the regulation of medicinal cannabis, but the legalization of medicinal cannabis in Luxembourg has been done recently by the law of 20 July 2018 amending the amended law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Opium and most opioid substances, such as fentanyl, oxycodone and piritramide are considered as narcotics according to the Grand-Ducal regulation of 26 March 1974 establishing the list of narcotic drugs and their recreational use is prohibited in accordance with the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended.
Other opioid substances, such as Buprenorphine, are considered as toxic substances in accordance with the Grand-Ducal regulation of 4 March 1974 concerning certain toxic substances as amended.
Opioid substances for medical use and medicinal products containing opioid substances are classified as category “S” medicinal products in the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, meaning that their deliverance is subject to a special medical prescription. As a consequence, their use is governed by the legislation applicable to medicinal products and the legislation applicable to narcotics or toxic substances. For an easiest reading, such medicinal products will be referred as “Opioid Drugs”.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Similarly to medicinal products, the regulatory authority in charge of Opinoid Drugs is the Ministry of Health (“Ministère de la Santé”), in particular the National Health Directorate (“Direction de la Santé”) and its department the Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”).
Moreover, because Opioid Drugs are also subject to the provisions of the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, the following persons would be also competent:
- judicial police officers;
- officers of the gendarmerie, and police;
- the customs and excise administration; as well as
- the director, the deputy director, the medical inspectors and the pharmacist-inspectors of the National Health Directorate
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
i. Authorization of opioid drugs
Opioid Drugs in themselves are subject to the same provisions as medicinal products in this respect, so that there is not a specific regulatory framework for the authorization of Opioid Drugs.
ii. Pricing, and reimbursement of opioid drugs
There is no specific regulatory framework for opioid drugs but the general regulatory framework for medicinal products including the Social Security Code and the statutes of the National Health Fund apply also to Opioid Drugs.
28. Which are the Opioid drugs that have received market approval to date?
Based on the list of medicinal products marketed in Luxembourg (“Liste des médicaments commercialisés”), the Opioid Drugs which have received market approval to date include (without being exhaustive):
- Fentanyl (such Durogesic®)
- Piritramide (such as Dipidolor®)
- Buprenorphine (such as Temgesic® and Transtec®)
29. Who can prescribe Opioid Drugs?
All the doctors authorized to practice in Luxembourg can prescribe opioid drugs.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There is no list of doctors authorized to prescribe opioid drugs in Luxembourg.
31. What approvals or notifications are required to prescribe Opioid Drugs?
No approvals or notifications are required to prescribe Opioid Drugs.
However, according to article 5 of the Grand Regulation of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, all those who hold Opioid Drugs shall keep a specific register indicating the quantities they possess of said Opioid Drugs. They shall enter in this register on a daily basis the quantities they acquire, produce, manufacture or debit and those they use for preparations or manufacturing. This register, as well as invoices or other supporting documents, must be kept for 10 years at the disposal of the judicial authorities and law enforcement officials.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
According to article 2 of the Grand-Ducal regulation of 19 February 1974 implementing the law of 19 February 1973 concerning the sale of medicinal substances and the fight against drug addiction as amended, only those that have been subject to a prior authorization from the Minister of Health may deliver Opioid Drugs, except the following category of persons and establishments:
- pharmacists holding a pharmacy which is open to the public;
- hospitals and specialized hospitals with a hospital pharmacy;
- doctors and veterinary doctors authorized to hold medicinal products within the limit of a provision for urgent care
Moreover, only pharmacists holding a pharmacy which is open to the public may sell or offer to sell Opioid Drugs without the authorization of the Minister of Health.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is no list of retailers/distributors authorized to sell opioid drugs.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No, there is no such reform or significant change related to the regulation of opioid drugs.
35. When are they likely to come into force?
The question is not applicable.
