One year after the first substance based on the cannabis plant began to be marketed in pharmacies, the National Authority for Medicines and Health Products (Infarmed) is analysing two applications for authorization to place on the market (ACM).

“Currently, there is an authorised cannabis plant-based preparation and two applications for the placing on the market authorisation (MCA) of cannabis plant-based preparations and substances are in progress, one concerning dried flower for inhalation by vaporisation and another related to an oral solution”, says Infarmed in a written response to Lusa agency.

According to the medicine authority, “both requests are awaiting responses from the requesting entities”.

Regarding licensing requests for the activities of growing, manufacturing, importing and exporting the cannabis plant, Infarmed said that it received 99 requests “for the territory”, of which nine are under analysis.

Infarmed is awaiting the request for inspection of the facilities of 80 companies by the requesting entities.

There are 10 requests in which Infarmed is awaiting a response to requests for elements from the requesting entities.

Parliament approved in July 2018 the law that established 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.

Accessible use

This legal framework, regulated by decree-law on 15 January 2019, aimed to “make treatment with medicines, preparations and substances based on the cannabis plant accessible”, ensuring that the preparations made available meet all the necessary requirements in terms of quality and safety, “thus contributing to the safeguarding and protection of public health and the prevention of misuse” of these products.

The entire production chain, from the cultivation of the plant to its preparation and distribution, is known and controlled, making it possible to guarantee that the products are produced in accordance with good practices.

The use of these products depends on the medical evaluation and their dispensation can only be carried out at the pharmacy with a doctor's prescription.

Among the indications for the use of these products are chronic pain associated with oncological diseases, epilepsy and treatment of severe convulsive disorders in childhood, multiple sclerosis, nausea and vomiting caused by chemotherapy, appetite stimulation in palliative care of patients undergoing cancer treatment or with AIDS.