Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Cuatrecasas / Portugal
All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
The placing in the Portuguese market of products or substances based on cannabinoid drugs for medicinal purposes is subject to a specific authorization from Infarmed – National Authority on Medicines and Health Products (“Infarmed”). Moreover, the activities of cultivation, import, export, manufacturing, distribution, direct sale of cannabinoid drugs for medical purposes are also subject to specific authorization procedure before Infarmed.
The recreational use of cannabinoid drugs is still a crime in Portugal; however, private consumption is not penalized, as long as authorities find that the possessor is an occasional consumer.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Infarmed is the regulatory authority with powers to license and supervise all operations related to Cannabinoid Drugs for medicinal purposes such as cultivation, distribution, import, export, manufacturing and marketing authorisations.
In some cases, the law mandates non-binding participation of other public entities such as the Office for the Intervention against Additive Behaviour (SICAD) and other ministries.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
In July 2018, Law 33/2018, of 18 July (“Law 33/2018”) was published, and subsequently came into effect, legalizing the sale and use of cannabis and cannabis products for medical purposes. Under Law 33/2018, cannabis will be available only from pharmacies with a medical practitioner’s prescription. The entering into force of the Law 33/2018 was pending on the publication of the respective regulation that occurred in January 2019, through Decree-Law no. 8/2019, of 15 January (“Decree Law 8/2019”). Additionally, Decree Law 8/2019 also foresaw the publication of a ministerial order regulating the content of the requests and procedures for the issuing of authorizations to pursue activities related to cannabis, such as cultivation, manufacture, wholesale distribution, transit, import and export of cannabis based medicinal products, preparations and substances, as well as the cultivation of cannabis for industrial purposes. Accordingly, Ministerial Order no. 83/2021, of 15 April (“Ministerial Order 83/2021”) was published and sets out the aforementioned measures to be adopted.
These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacture, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.
These products may be authorised and placed in the market only for the therapeutic indications that have been previously approved by Infarmed.
The pricing of products based on cannabis for medical purposes is regulated by Ministerial Order 44-A/2019, which established a free pricing regime, but subject to an authorization of the price by Infarmed.
4. Which are the cannabinoid drugs that have received market approval to date?
According to the new legal framework described above one product has been approved, Dry Flower with THC, . However, there was already a medicinal product approved, Sativex, a prescribed mouth spray to alleviate neuropathic pain, spasticity, and other symptoms of multiple sclerosis, that is already in the market as a medicinal product.
5. Who can prescribe Cannabinoid Drugs?
Any doctor through a specific prescription form. However, prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
The prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects.
Moreover, Cannabinoid Drugs may only be prescribed for the therapeutic indications pre-approved by Infarmed (Deliberation no. 11/CD/2019).
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Any entity duly authorized by Infarmed for the activities of wholesale sale distribution of medicinal products and of cannabis for medical purposes.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
There is a public database, managed by Infarmed, of whom is licensed and authorized for the manufacturing, wholesale distribution and direct sale, but it does not display which entities distribute and/or sell Cannabinoid Drugs.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
The legalization and regulation of medicinal cannabis is very recent. The legalization was approved in July 2018, through Law 33/2018 and came into effect in January 2019 through the publication of additional regulation. This is was the main reform in this sector, and now with the publication of Ministerial Order 83/2021 on the applicable procedure for authorization requests, we do not anticipate any other significant changes in a near future.
The legalizing for recreational use will be discussed during in June 2021, at the Parliament, but it does not seem to have the support to be approved yet.
11. When are they likely to come into force?
Law 33/2018 entered into force in January 2019.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
As mentioned above in 3., in January 2019 the legal framework that authorizes the commercialization in Portugal of cannabis and products based on cannabis for medical purposes came into force.
Since 1993, it was already possible, provided an authorization procedure before Infarmed was initiated, to cultivate, import and export cannabis for medical purposes, but only since January 2019 is it possible to market these products and distribute them in the Portuguese market.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
Infarmed is the competent authority to regulate and supervise the cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
As mentioned in 3. above, the regulatory framework for the authorization of medicinal cannabis is set forth in Law 33/2018, that legalized the sale and use of cannabis and cannabis products for medical purposes and in Decree Law 8/2019, that regulated Law 32/2018. These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes, their authorization procedure and conditions being regulated by Ministerial Order 83/2021.
These products may be authorised and placed in the market only for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).
The pricing of these products is regulated by Ministerial Order 44-A/2019, which established a free pricing regime for all products based on cannabis for medical purposes, but subject to an authorization of the price by Infarmed.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Manufacturing and import activities are regulated and licensed by Infarmed.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The production of medicinal cannabis is subject to the following approvals:
- License for the cultivation, import and export of medicinal products to be provided by Infarmed and
- License for the manufacturing of medicinal cannabis products to be provided by Infarmed
- Certificate proving the prior authorization for each operation of import of plants, substances and preparations of cannabis to be provided by Infarmed
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
For the import of medicinal cannabis it is necessary to obtain a license from Infarmed for the undertaking of such activity and also an additional and specific authorization from Infarmed for each import transaction.
As mentioned in 3. above, the regulatory framework for the authorization of medicinal cannabis is set forth in Law 33/2018, that legalized the sale and use of cannabis and cannabis products for medical purposes and in Decree Law 8/2019, that regulated Law 32/2018. These new laws are now the main legal framework for the activities in Portugal of cultivation, manufacturer, distribution, import, export and placing in the market of medicinal products, preparations and substances based on cannabis for medical purposes.
18. How can patients obtain Medicinal Cannabis?
The cannabis and products based on cannabis for medicinal purposes may be obtained by the patients in pharmacies and with a specific prescription form issued by a doctor for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).
19. Who can prescribe Medicinal Cannabis?
Any doctor through a specific prescription form. However, prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
No, all doctors can prescribe.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
The prescription of cannabis by doctors is only allowed for the situations where conventional treatments with authorized medicinal products are not producing the expected effects or cause relevant adverse effects and only for the therapeutic indications that have been previously approved by Infarmed (currently Deliberation no. 11/CD/2019 is in force).
22. Where is Medicinal Cannabis available?
Medicinal Cannabis products will be available only in pharmacies.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
The only retailers authorized are the pharmacies, and no specific or additional authorization or communication is necessary to be undertaken by the pharmacies. There is list at Infarmed’s website of all the pharmacies.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
The legalization and regulation of medicinal cannabis is very recent. The legalization was approved in July 2018, through Law 33/2018 and came into effect in January 2019 through the publication of additional regulation. This was the main reform in this sector, and now with the publication of Ministerial Order 83/2021 on the applicable procedure for authorization requests, we do not anticipate any other significant changes in the near future.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Recreational use of Opioid Drugs is a crime in Portugal. However, private consumption has no penalty for occasional consumers, as long they possess a residual dose.
Moreover, medicinal products may, and some do, contain opioids and follow the authorization procedure for medicinal products, being subject to a special prescription form from a doctor.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Infarmed is the regulatory authority and competent body to license all operations related to the cultivation, import, export and distribution of Opioid Drugs for medical purposes.
In some cases, the law mandates non-binding participation of other public entities such as the Office for the Intervention against Additive Behaviour (SICAD) and other ministries.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Licenses and authorizations are regulated under Drug Fight Law and its regulation. On pricing and reimbursement of Opioid Drugs there are no specific regulations regarding pricing or reimbursement.
28. Which are the Opioid drugs that have received market approval to date?
There is a public database accessible by the public listing all opioid drugs. There is a public database in which all approved medicinal products are listed.
29. Who can prescribe Opioid Drugs?
Doctors, through a specific prescription form.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
All doctors can prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
A specific prescription form is required.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
The medicinal products containing opioids shall be distributed and sold in the same terms and conditions of medicinal products, which is by authorized distributors of medicinal products.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is a public database, managed by Infarmed, of whom is licensed and authorized for the manufacturing, wholesale distribution and direct sale.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No. Ever since major legislative reforms in the 90s, Portugal has significantly diminished additive consume not linked to a therapeutic end. There has been no public debate in Portugal about drugs regulations other than Cannabis.
35. When are they likely to come into force?
NA.
