Five companies have obtained authorisation from Portugal’s National Medicines Authority (Infarmed) to grow, import and export cannabis for medicinal purposes, over a total cultivation area of 120 hectares, according to data released to Lusa.
Several requests for authorisation to carry out various activities, such as growing, manufacturing, import, export and wholesale distribution, have been received Infarmed said in a report on the first year of legalisation of cannabis use for medicinal purposes, which was published in the country’s state journal on 15 January 2019 and came into effect on
One of the companies, “Tilray Portugal”, has a certificate of Good Manufacturing Practice, in addition to the authorisation for cultivation, import and export in the area of Cantanhede and Reguengos de Monsaraz.
The other companies with authorisation for growing, import and export are ‘Terra Verde’ in Alcochete, ‘RPK Biopharma’ in Sintra and Aljustrel, ‘Sabores Purpura’ in Tavira and ‘VF 1883 Pharmaceuticals’ in Benavente.
Regarding applications for authorisation to place cannabis plant preparations on the market for medicinal purposes, Infarmed said that two applications have been received, which are under evaluation.
In April last year, the drug authority created the Office of Cannabis for Medicinal Purposes, with members from various areas (licensing, inspection, evaluation, communication and legal advice), which has been working constructively with companies, patient associations, specialised press and various public entities.
Communication on this matter has been a concern, which has also led to the creation of an area on its website that gathers all relevant information (www.infarmed.pt/web/infarmed/canabis-medicinal).
This theme has been the object of much interest, especially of the companies and entities that intend to dedicate themselves to this activity. Thus, in the year 2019, 1,304 requests for information on cannabis were answered (14 percent of the answers given by the Infarmed Information Centre), Infarmed said.
In July 2018, the parliament passed the law establishing the legal framework for the use of medicines, preparations and substances based on the cannabis plant for medicinal purposes, namely the prescription and dispensing in a pharmacy.
The entire production chain, from the cultivation of the plant to its preparation and distribution, is known and controlled, and it is possible to ensure that products are produced in accordance with all applicable good practices and requirements.
In this way, it is guaranteed that patients have access to products with quality and safety, not being exposed to unnecessary and avoidable risks, preventing their misuse and limiting their use to cases where conventional treatments have not produced the expected effects or have caused relevant adverse effects, Infarmed said.
The use of these products depends on the medical assessment and their dispensing can only be carried out in 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, appetite stimulation in the palliative care of patients undergoing oncologic treatment or with AIDS.