Portugal sets new rules for growing industrial hemp

portugal hemp

The amendment seeks to address the regulatory insufficiency

Portugal has updated its rules for growing cannabis by adding new guidelines for the hemp industry. Ministerial decree 14/2022, publié January 5 sets out the requirements and procedures for granting permits for activities related to the cultivation, manufacture, wholesale, transport, circulation, import and export of medicines, preparations and substances made from the plant of cannabis.

Last week, a ministerial decree was issued detailing the rules for growing cannabis and industrial hemp, after it emerged that existing legislation was not clear enough.

The decree constitutes the first amendment to Ordinance 83/2021, which defines the requirements and procedures for the authorization of cultivation, manufacture, wholesale, transport, circulation, import and the export of medicines, preparations and substances made from the cannabis plant.

Thanks to this modification, the cultivation of hemp for industrial purposes is differentiated from the cultivation of the cannabis plant for other reasons.

The new decree only authorizes the cultivation of hemp in the open air, and prohibits the cultivation of plants in greenhouses or their transplantation. The transport of flowers, whether or not they contain seeds, is also not permitted.

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The minimum production area has been set at half a hectare (5 square meters), which excludes some small farmers. Some rules for the production of medical cannabis have also been changed.

Lawyer Ricardo Rocha, of the Portuguese law firm PLMJ, explains that for activities concerning the production of medical cannabis, the ordinance requires that the technical director be a pharmacist with a specific qualification in the field of cannabis but only within the framework of the manufacture of drugs of substances and preparations.

“The requirement for this specialization will be lifted in cases where only active substances intended for the pharmaceutical industry are manufactured. "

The amendment also specifies the regulation of the wholesale trade of the plant, the flower and the active substances of therapeutic cannabis, adds Master Rocha.

Meanwhile, legalization efforts in Portugal have stalled.

A pair of adult cannabis bills introduced last summer expired with the December parliamentary session, according to CannaReporter. The bills will have to be reintroduced during the next legislative session.

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This is not the first attempt to legalize cannabis in Portugal. A proposal to fully legalize cannabis in 2013 was rejected, although it has been medically legal since 2018.

And while medical cannabis is legal, it is not readily available.

“Although the regulatory framework is established, the truth is that the use of medical cannabis products is still residual. On the one hand, the market does not have a large number of alternatives. In the case of medicines, at present only Sativex is sold in the Portuguese market at a relatively high price, although it is subject to the co-payment of the state, ”Mr Rocha said in November.

Finally, in the inspection of facilities for medical, medico-veterinary or scientific research activities, it is no longer necessary to present proof of industrial license at the time of the inspection request. This applies in cases where the operations to be carried out are exclusively the first processing, cutting and drying, carried out in accordance with good manufacturing practice for active substances for medicinal products for human use approved by the Delegated Regulation (EU) of Commission 1252/2014 of May 28, 2014.

Tags : LawPortugal

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