Regulator has 99 licensing requests for cultivating medicinal cannabis

Infarmed, Portugal’s medicines regulator, has received to date 99 licensing applications for cultivation, manufacture, import and export of cannabis for medicinal purposes, but has only two applications to put substances based on this plant for sale in pharmacies.

As for the companies already licensed, Infarmed said there are currently 18 in Portugal.

A year after the beginning of marketing in pharmacies of the first substance based on the cannabis plant, the national authority of medicines and health products (Infarmed) is reviewing two applications for marketing authorization (MCA).

“Currently there is one authorised cannabis plant-based preparation and two applications for marketing authorisation (MA) of cannabis plant-based preparations and substances are in progress, one relating to dried flower for inhalation by vaporisation and another relating to an oral solution,” Infarmed said in a written response to Lusa news agency.

According to the medicine authority, “both applications are awaiting replies from the applicant entities”.

In relation to licensing applications for the cultivation, manufacture, import and export of cannabis plants, Infarmed said it had received 99 applications “for the country”, nine of which are currently being analysed.

Infarmed is waiting for the request for inspection of the facilities of 80 companies by the applicant entities.

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

Parliament approved in July 2018 the law that established the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes, namely their prescription and dispensing in pharmacies.

This legal framework, regulated by decree-law on January 15, 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 safeguarding and protecting public health and preventing the misuse” of these products.

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

The use of these products depends on medical assessment and can only be dispensed 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, stimulation of appetite in palliative care of patients undergoing cancer or AIDS treatment.