Licensing for the cultivation of the cannabis plant in Portugal

A possible investment could go through innovative sectors such as the cultivation, manufacturing and trade of the cannabis plant for medicinal purposes.

Through the ”Cannabis Law” for Medicinal Purposes, Decree-Law No. 8/2019, of January 15, the government regulated the use of cannabis plant-based medicines and preparation of substances for medicinal purposes, namely their prescription and marketing in pharmacies.

Given the multiple aspects of this plant, it was imperative to regulate the cultivation, production, extraction and manufacturing, wholesale trade, import, export, transit, acquisition, sale and delivery of cannabis plant medicines.

As for medicines, the human use implies that a multiplicity of existing legislation for medicines is applicable, it would be appropriate to address the specific matters that the production and treatment of the cannabis plant entails.

A special office was created with INFARMED – National Authority of Medicines and Health Products, I. P., for the treatment and licensing of this matter.

Decree-Law No. 8/2019, of January 15, established the legal framework for the use of cannabis plant-based medicines, preparations and substances for medicinal purposes.

This law establishes the legal basis for an economic agent to legally carry out the cultivation, manufacturing, wholesale trade, import, export and transit of the plant/and cannabis plant-based products.

Thus, in accordance with the applicable legal terms, the exercise of these activities requires a special authorization.

This authorization request is made online, exclusively on the website of INFARMED – National Authority of Medicines and Health Products.

The authorization for the cultivation of hemp for industrial purposes must be requested from the Directorate-General for Food and Veterinary.

For the cultivation of the cannabis plant for medicinal purposes, the applicant must demonstrate that it complies with the  , published by the European Medicines Agency, an assessment that is carried out in regular inspections of cultivation facilities.

As for the manufacturing of cannabis plant-based medicines for human use, and/or investigational medicines, and/or preparations and substances for medicinal purposes, the applicant must demonstrate that it complies with the good manufacturing practices for medicines for human use (Good Manufacturing Practices (GMP) Guidelines), and/or with the requirements of good manufacturing practices for active substances (Commission’s Delegated Regulation (EU) No. 1252/2014, of May 28, 2014), an assessment that is carried out based on regular inspections of the manufacturing facilities and Decree-Law No. 176/2006, of the August 30.

Validity: The authorization is valid for one year and must be renewed annually.

However, there is a limitation that planting is not authorized for own use and the same applies to other activities.

The marketing is subject to a Marketing Authorisation (AIM).

The placing on the market of cannabis plant-based preparations or substances for medicinal purposes is subject to a placing on the market authorization (PMA).

These requests are also addressed to INFARMED, and several elements must be included, such as name or company, domicile or head office, taxpayer identification number, proposed name for the preparation or substance to be used.

cannabis plant base, proof of payment of fees.

The validity of the PMA is 5 years, subject to renewal, after which it is considered valid for an indefinite period.

Renewal of the PMA must be requested at least 9 months in advance of the expiration.

Finnaly, the prescription of cannabis plant-based medicinal products, preparations and substances for medicinal purposes is only allowed in cases where it is determined that conventional treatments with authorized drugs are not producing the expected effects or cause relevant adverse effects.

There will be a public listing of authorized prescription medicines and only electronic prescription is authorized.

These cannabis plant-based medicines are dispensed in pharmacies, of course, upon presentation of the medical prescription and verification of the identity of the prescriber/patient.

Thus we come to the conclusion that the goal of the legislation in force is that the entire production chain, from the cultivation of the plant to its preparation and distribution, is known and controlled, thus making it possible to ensure that the products are produced according to all applicable good practices and requirements.

Fees to be paid in 2020 for the Placing on the Market Authorization (PMA):

1. Request of PMA € 1,800.00;
2. Request for renewal of PMA € 1,000.00;
3. Request for amendment of PMA € 500.00.

Fee to be paid in 2021 for Industrial Production is € 3,000.00, plus the amount of € 50.00 for laboratory analysis.

The remaining fees should be checked on a case-by-case basis.

As for the procedure for planting and production, it can be extensive and requires several documents, namely:

1. a) Application signed by the members of the corporate body that bind the entity, according to the draft provided;
2. b) Criminal records of all members of the Board of Directors or of the manager(s) of the company, where it is stated at the end for which it is intended for the LICITY MARKET OF NARCOTICS/PSYCHOTROPIC SUBSTANCES;
3. c) Location and geographical location plan by coordinates of the place where the cultivation activity will be carried out;
4. d) Document attesting to the absence of restrictions on the cultivation of the cannabis plant issued by the City Council where the land or facilities where the activity will be carried out are located;
5. f) Brief description of the project to be developed;

(among others).

We can see that, as would be expected, there is a heavy bureaucratic burden and an extensive need to prove that the business to be licensed is legal and that INFARMED requires it.

Finally, we share the deliberation taken by INFARMED on January 31, 2019, which contains the list of therapeutic indications considered appropriate for cannabis plant-based preparations and substances:

1. Spasticity associated with multiple sclerosis or spinal cord injury;
2. Nausea, vomiting (resulting from chemotherapy, radiotherapy and combination therapy of HIV and medication for hepatitis
3. Appetite stimulation in palliative care in patients undergoing cancer or AIDS treatment;
4. Chronic pain (associated with oncological diseases or the nervous system, such as neuropathic pain caused by nerve damage, phantom limb pain, trigeminal neuralgia or after herpes zoster);
5. Gilles de la Tourette syndrome;
6. Epilepsy and treatment of severe convulsive disorders in childhood, such as Dravet and Lennox-Gastaut syndromes;
7. Therapy-resistant Glaucoma.

This summary has no binding character, it was written as an analysis and opinion article and does not exempt the consultation of the law, as well as the advice regarding the existing obligations. We recommend counseling and appropriate legal advice for this purpose.