Law 33/2018 of 18th July established the legal context for the utilization of medicines, preparations and substances derived from the cannabis plant, for medicinal purposes, namely for its prescription and distribution in pharmacies.
All medicine, preparations and substances placed in the medicine market, that contain in their composition cannabis plant, using the leaves and the fruit tips of the plant, the oil and other extracts, are subject to an authorization issued by INFARMED.
The prescription of medicines, preparations and substances derive from the cannabis plant, will occur through a special prescription, in a format that will be approved by the Ministry of Health. This prescription shall only be provided if the traditional treatments, with the authorized medicines, do not produce the expected effects, or if they are causing relevant adverse effects, as long as they contained the therapeutic indications considered as appropriate by INFARMED (National Pharmaceutical Authority).
These medicines, preparations and substances will be dispensed at pharmacies, against presentation of a special prescription, as mentioned above, and after the confirmation of the identity of the acquirer, which, in case of being minor, disabled or incapable, must have a legal representative to pick up the prescription. It is possible for the holder to possess these medicines, as long as they are for personal consumption and the amounts correspond to those that are mentioned in the prescription.
INFARMED will be the authority responsible for the regulation and supervision of the cultivation activities, the production, extraction, manufacturing, wholesale trade, distribution to the pharmacies, importation and exportation, transport, acquisition for sale and delivery of these types of medicines.
The regulation of this Law will occur in the coming months.