Portugal: Infarmed changes requirements for import and export of medicinal cannabis. Companies concerned about speed of processes

Infarmed – the National Authority for Medicines and Health Products (IP) has published new requirements for issuing import and export certificates for medicinal cannabis. The procedures are now more rigorous and require more information than before, so some licensing entities are concerned that the new rules will make the processes even more time-consuming. Portugal currently has 50 companies licensed to export and 49 to import substances and preparations based on the cannabis plant.

The exponential increase in requests and Infarmed's lack of response capacity are believed to have been the reason for the new requirements. Among the new rules, which imply greater collection of information, is the need to now present evidence of the qualifications of the entities involved in the import/export (except for the import of clones). This change aims to reinforce the controls already in place, which aim to ensure that cannabis for medicinal purposes is imported and exported from Portugal lawfully. It is also now mandatory to present the certificate of analysis when requesting import.

According to Infarmed, the information regarding the certificates contained in the draft application currently in force “has already been requested from applicants in part since March 2025”. In statements to CannaReporter®, the National Medicines Authority clarified that “this update aims to improve the management of the growing volume of requests for the issuance of import and export certificates that have been received since the beginning of 2025”.

Portuguese companies worried that there will be even more delays

The Canna.Biz facilities in Torres Vedras, Portugal. Photo: Laura Ramos | CannaReporter®

It is a fact that several Portuguese companies have been complaining over the last few years that certificates take a long time to be issued, sometimes damaging business and product quality after several weeks of waiting. With the new rules, the industry fears that this waiting time will increase even further and that this could lead to more serious consequences, such as the loss of customers or Portugal's position in the medicinal cannabis market.

Speaking to CannaReporter®, Gonçalo Real, from Canna.Biz, expressed concern about the increase in bureaucracy in the procedures and suggested possible alternatives. “We agree that strengthening control over import/export processes is important, but perhaps the focus should be more on inspection and less on increasing bureaucracy”. Real also said that the change seemed “disproportionate” to him and could “significantly increase the already long deadlines for issuing certificates, especially for perishable products”. Furthermore, he stressed, “relevant situations such as small imports for testing or standards are left out. It seems like a somewhat hasty and poorly thought-out change”, he confessed.

When asked about a possible alternative to the current model, Gonçalo Real stated: “our suggestion would be to, together with Infarmed, create a list of qualified international companies as suppliers and/or customers. If the company we want to import from or export to is not on that list, then it would be up to us to register it, sending the licenses from the competent authorities in the respective country so that Infarmed could validate its authenticity. Once created and validated, the entire process would be simpler and would be under the direct control of Infarmed, with full traceability”.

Speaking to CannaReporter® on the phone, Vera Broder from Medicane (MHI Cultivo Medicinal) said she agreed with a solution of this kind: “It makes perfect sense to create a list of companies that have already been verified and for these processes to be faster”. For Vera Broder, “rigour is good, as long as it does not affect the speed and effectiveness of our response”. The head of Medicane, which is based in Campo Maior, in the Alentejo, also states that “as a Portuguese industry, we enjoy a good reputation due to the quality criteria we apply in conjunction with the regulatory body, which is essential for establishing ourselves globally in this emerging and growing industry. If we lose speed, the reputation we have created will no longer be important, in favour of other countries with established industries and eager to capture our markets”, she warns.

Jorge Godinho, from Herdade das Barrocas, told CannaReporter® that the increased requirements for submitting export certificate applications “are positive for the industry if they mean greater rigour for all stakeholders” and that this “will protect the good image of the Portuguese industry”. However, “close attention will have to be paid to the total timeframes, to avoid them being extended and Portugal losing its competitive advantage in terms of speed in accessing the European market”, he stated. “In order not to worsen the application of the new procedures in the industry, the time chain cannot be made any longer. We believe that the authorities know what needs to be done and will defend the robustness of the Portuguese industry. The import of flower from third countries must be viewed and reformulated with discernment and caution, because it is not always possible to contribute to the creation of added value in Portugal”, he warned.

New rules for import and export certificates of cannabis for medicinal purposes

According to Infarmed website, the current application forms for export and import certificates for preparations and substances based on the cannabis plant are as follows:

• Import certificate for cannabis for medicinal purposes
• Certificate of export of cannabis for medicinal purposes
  

The above models must be submitted through the Lic+ portal, in searchable PDF format, and accompanied by the following documents, as applicable:

Import certificates

1. Manufacturing entities (import for processing in their facilities)
1.1. Certificate of analysis of the product to be imported;
1.2. Description of the stages of the manufacturing process to be carried out at the manufacturer's facilities, including the identification of the respective in-process control points:
1.3. Specifications of the final product into which the product to be imported will be incorporated;
1.4. Model of batch documentation approved by the entity, relating to the manufacture and/or packaging of the final product;
1.5. Model of the product analysis certificate after transformation at the manufacturer's facilities;
1.6. Indication of the destination of the final product: national market or country of export;
1.7. Proof of supplier qualification, issued by the requesting entity.

2. Distributors of active cannabis substances for medicinal purposes
2.1. Written confirmation issued by the competent authority of the country of origin;
2.2. Certificate of analysis of the active substance issued by the manufacturer;
2.3. Customer approval by the distributor.

3. Cultivation entities (cannabis clones for medicinal purposes)
3.1. Certificates of clones to be imported;
3.2. Indication of the final destination of the clones.

Export certificates

1. Manufacturing entities
1.1. Specifications and model of the certificate of analysis of the products to be exported.
1.2. Description of the stages of the manufacturing process, including the identification of the respective in-process control points.
1.3. Proof of the client’s qualification, issued by the requesting entity.
1.4. Where applicable, a copy of the technical addendum to the contract with the subcontracted entity (e.g. sterilization), whenever the product is intended for a manufacturing or processing operation carried out outside the manufacturer's facilities.

2. Distributors of active cannabis substances for medicinal purposes
2.1. Product analysis certificate, issued by the respective manufacturer.
2.2. Proof of customer qualification.

3. Cultivation entities (cannabis for medicinal purposes)
3.1. Proof of customer qualification.
3.2. Specifications and certificate of analysis of the product to be exported.

See the new certificate models here:

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Laura Ramos

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With a degree in Journalism from the University of Coimbra, Laura Ramos has a postgraduate degree in Photography and has been a Journalist since 1998. Winner of the Business of Cannabis Awards in the category "Journalist of the Year 2024", Laura was a correspondent for Jornal de Notícias in Rome, Italy, and Press Officer in the Office of the Minister of Education of the 21st Portuguese Government. She has an international certification in Permaculture (PDC) and created the street-art photography archive “Say What? Lisbon” @saywhatlisbon. Co-founder and Editor of CannaReporter® and coordinator of PTMC - Portugal Medical Cannabis, Laura directed the documentary “Pacientes” and was part of the steering group of the first Postgraduate Course in GxP's for Medicinal Cannabis in Portugal, in partnership with the Military Laboratory and the Faculty of Pharmacy of the University of Lisbon.

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