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Infarmed authorizes 5 companies for medical cannabis purposes

Parliament approved the legalization of cannabis in Portugal for medical purposes. Since then, Infarmed – the National Authority for Medicines and Health Products – has authorized five companies to cultivate the plant for medical purposes. One of the companies is Tilray Portugal – the first medical cannabis producer to successfully import cannabis products into the European Union.

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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.

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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)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

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First published in PAISAOMINUTO, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Anne Kings is a reporter for the financial sector, often tackling Wall Street and shareholders' interests. She also covers the intersection of media and technology, and delves into interesting topics on entertainment. Sometimes she also writes about the cannabis industry, in particular CBD and hemp. She is currently based in New York.