Infarmed authorizes 5 companies for medical cannabis purposes

Five companies have already obtained authorization from the National Medicines Authority (Infarmed) to cultivate, import, and export cannabis for medical purposes. This is still in progress, in several phases, “requests for authorization for various activities such as cultivation, manufacturing, import, export and wholesale distribution,” Infarmed stated in a balance of the first year of cannabis legalization for medical purposes.

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Five entities for cannabis cultivation

Taking stock of the licensing of entities and products under the new legislation, the National Authority of Medicines and Health Products said that “currently there are five entities authorized to cultivate, import and export cannabis plants for medical purposes, with a total authorized area of 120 hectares”.

One of the companies, “Tilray Portugal”, has a certificate of Good Manufacturing Practice, besides the authorization for cultivation, import, and export in the area of Cantanhede and Reguengos de Monsaraz. The other companies with authorization for cultivation, import, and export are “Terra Verde” in Alcochete, “RPK Biopharma” in Sintra and Aljustrel, “Sabores Purpura” in Tavira and “VF 1883 Pharmaceuticals” in Benavente.

Medical cannabis on the market

As regards applications for authorization to place cannabis preparations on the market for medical purposes, Infarmed reported that two applications have been received, which are “under evaluation”.

Cannabis products can be used in cases of chronic pain associated with oncologic diseases, epilepsy, and treatment of severe seizure disorders in childhood, multiple sclerosis, nausea and vomiting caused by chemotherapy, appetite stimulation in palliative care of patients undergoing oncologic treatment or AIDS.

In April last year, the drug authority created the Office of Cannabis for Medical Purposes, with elements from various areas (licensing, inspection, evaluation, communication, and legal advice). It has been working “in a constructive way with companies, patient associations, specialized press, and various public entities.”

Cannabis law

This theme has been the object of much interest, mainly of the companies and entities that intend to dedicate themselves to this activity. In July 2018, Parliament passed a law establishing the legal framework for the use of medicines, preparations, and substances based on the cannabis plant for medical purposes, including its prescription and dispensing in pharmacies.

The entire production chain, from the cultivation of cannabis to its preparation and distribution, is known and controlled. It is possible to ensure that the products are produced in accordance with all applicable good practices and requirements.

Access to quality cannabis products

This ensures that patients have access to quality and safe products. They are not exposed to unnecessary and avoidable risks, that their misuse is prevented and that their use is limited to cases where conventional treatments have not produced the expected effects or have caused relevant adverse effects, Infarmed stressed.

The use of these products depends on the medical assessment and they can only be dispensed at the pharmacy on prescription. Among the indications for the use of these products are chronic pain associated with oncologic diseases, epilepsy and treatment of severe seizure disorders in childhood, multiple sclerosis, nausea and vomiting caused by chemotherapy, stimulation of appetite in the palliative care of patients undergoing oncologic treatment or with AIDS.

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(Featured image by Mateo Paganelli via Unsplash)

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