Law nº 33/2018 of 18 July enters into force today

The legislation regulating the use of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes, Law No. 33/2018, of July 18, entered today, August 1, 2018, into force.

As of today, it is legal to prescribe and use cannabis for medicinal purposes in Portugal, although the regulation by Infarmed is not complete.

Infarmed has a period of 60 days to regulate the medical cannabis market in Portugal, but has already warned, in a DN report, that this process may take “a few years”.

The full text of Law 33/2018 of 18 July, which enters into force today, is transcribed below.

Law No. 33/2018 of July 18

Regulates the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes

The Assembly of the Republic decrees, under the terms of paragraph c) of article 161 of the Constitution, the following:

Article 1

Object

This law establishes the legal framework for the use of medicinal products, preparations and substances based on the cannabis plant for medicinal purposes, namely their prescription and dispensing in a pharmacy.

Article 2

Authorization

Medicines, preparations and substances based on the cannabis plant are always subject to authorization issued by INFARMED – National Authority for Medicines and Health Products, IP (INFARMED, IP).

Article 3

Settings

For the purposes of this law, it is understood as:

a) 'Medicines, preparations and substances based on the cannabis plant' means the leaves and flowering or fruiting tops of the plant, the oil and other standardized or prepared extracts extracted or obtained from the cannabis plant;

b) «Use for medical purposes» the use of medicines, preparations and substances based on the cannabis plant, when prescribed by a doctor, by means of a special medical prescription, with the aim of exploiting its medicinal properties.

Article 4

Production

The Military Chemicals and Pharmaceuticals Laboratory can contribute to the production of medicines, preparations and substances based on the cannabis plant.

Article 5

Prescription

1 – The prescription of medicines, preparations and substances based on the cannabis plant is made by means of a special medical prescription, according to the model to be approved by decree of the member of the Government responsible for the health area, and adapted to the electronic form.

2 – The prescription must mention the identification of the user and the doctor, the identification of the drug, preparation and substance based on the cannabis plant to be dispensed, the amount and dosage, as well as the route and method of administration.

3 – The prescription referred to in no. of article 1

Article 6

pharmacy dispensing

1 – Medicines, preparations and substances based on the cannabis plant prescribed for medicinal purposes are dispensed at a pharmacy, upon presentation of the prescription and after verifying the identity of the purchaser.

2 – In case the revenue is intended for a minor or a disabled or prohibited person, it must be granted only to those who hold and prove the respective legal protection.

3 – Only the pharmacist, or whoever replaces him in his absence or impediment, can fill the prescriptions referred to in paragraph 1 of article 5.

4 – Recipes that have already been filled cannot be filled again.

Article 7

detention and transport

A person who holds a medical prescription under the terms of Article 1(5) may hold and transport medicinal products, preparations and substances based on the cannabis plant, provided that they are for personal consumption, in accordance with the prescription and within the the amount prescribed by the doctor and contained in the special medical prescription.

Article 8

Scientific investigation

The State should encourage and support scientific research on the cannabis plant, its properties and therapeutic applications, carried out by state laboratories, associated laboratories or higher education research units.

Article 9

INFARMED, IP

1 – It is incumbent upon INFARMED, IP, to regulate and supervise the activities of cultivation, production, extraction and manufacture, wholesale trade, distribution to pharmacies, import and export, transit, acquisition, sale and delivery of medicines, preparations and substances based on cannabis plant intended for human use for medicinal purposes.

2 – The placing on the market of medicines, substances and preparations based on the cannabis plant intended for human use for medicinal purposes requires a Marketing Authorization to be issued by INFARMED, IP

3 – It is also up to INFARMED, IP, to approve the therapeutic indications considered appropriate for medicines, preparations and substances based on the cannabis plant intended for human use for medicinal purposes, provided that the provisions of paragraph 3 of article 5 are verified. .º

4 – In order to carry out the regulatory and supervisory functions referred to in paragraph 1, a specific office on medical cannabis may be created within INFARMED, IP.

Article 10

Information for health professionals

The Government, through the services and bodies integrated in the direct and indirect administration of the State within the scope of the Ministry of Health, and the entities of the public business sector, in the health area, promotes, among doctors and other health professionals, information on the medicines, preparations and substances based on the cannabis plant for medicinal purposes.

Article 11

transitional provision

INFARMED, IP, after the publication of this law, determines which drugs, preparations and substances based on the cannabis plant, currently in existence, are able to be used for therapeutic and medicinal purposes.

Article 12

Regulation

The Government approves, within a maximum period of 60 days after the publication of this law, the respective regulations.

Article 13

Implementation

This law enters into force on the first day of the month following the date of its publication.

Approved on June 15, 2018.

The Vice-President of the Assembly of the Republic, replacing the President of the Assembly of the Republic, Jorge Lacão.

Enacted on July 10, 2018.

Publish yourself.

The President of the Republic, Marcelo Rebelo de Sousa.

Countersigned on July 11, 2018.

For the Prime Minister, Maria Manuel de Lemos Leitão Marques, Minister of the Presidency and Administrative Modernization.

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