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Legal alert no. 84

 

Decree-Law no. 8/2019, dated from January 15th, which regulates the use of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes 

On the past January 15th, it was published, in the Official Gazette of the Portuguese Republic, Decree-Law no. 8/2019, which regulates Law no. 33/2018, dated from July 18th, which settles the legal regime for the use of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes.


Additionally, Decree-Law no. 8/2019, dated from January 15th, amended for the fourth time Regulatory-Decree no. 61/94, dated from October 12th (previously amended by Regulatory-Decrees no.s 23/99, dated from October 22nd, 19/2004, dated from April 30th, and 28/2009, dated from October 12th), which settles the rules regarding the control of the legal market of narcotics and psychotropic substances.


Decree-Law no. 8/2019, dated from January 15th, foresees that the activities of growing, manufacturing, wholesale trade, import, export and transit of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes require to be authorized. Furthermore, the maintenance of the provided authorization requires to be annually requested or, otherwise, the authorization may terminate. Notwithstanding the above, the Military Laboratory of Chemical and Pharmaceutical Products – legally authorized to produce medicinal products, preparations and substances based on the cannabis plant – is exempt from the referred requests of authorization and relevant maintenance.


The requests for authorization and maintenance above referred require to be submitted at the site of INFARMED – Authority of Medicinal and Health Products (hereinafter INFARMED). It is also noted that an authorization for “own use” shall not be granted.


In accordance with this Decree-Law, the marketing of both, medicinal products based on the cannabis plant for medicinal purposes and preparations or substances based on the cannabis plant for medicinal purposes are subject to specific authorizations: “autorização de introdução no Mercado” (AIM) and “autorização de colocação no Mercado” (ACM), respectively.


Decree-Law no. 8/2019, from January 15th also regulates the prescription and supply of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes.


In this regard the referred prescription – to be electronically performed – is solely allowed if it is determined that the conventional treatments with authorized medicinal products are not producing the intended effects or are causing relevant adverse effects.


INFARMED shall provide a list of the therapeutic indications considered to be suitable for the prescription of preparations and substances based on the cannabis plant for medicinal purposes, which shall be periodically reviewed, pursuant to the evolution of the technical and scientific knowledge.


In what regards to the supply, this Decree-Law clarifies that the medicinal products, preparations and substances based on the cannabis plant prescribed for medicinal purposes are supplied in pharmacies, on presentation of the relevant medical prescription and validation of the purchaser’s identity.


Decree-Law no. 8/2019, dated from January 15th, enters into force on February 1st of 2019.


To access to the full version of this Decree-Law, please click here.

 

 
 
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