Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

April 27, 2021

Cannabinoid Drugs

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.

What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Infarmed is the regulatory authority 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.

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”). 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.
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.

 

Continuar a ler o artigo de Joana Silveira Botelho e Luís Ribeiro Telles no site da Pharma Boardroom.


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