INFARMED has tightened the criteria for those intending to import or export medicinal cannabis within the national territory. The recently published changes introduce new requirements in the certification processes for these two activities, making them more stringent and detailed.

‍

The main requirements are the obligation to submit additional documentation and to provide evidence of the qualification of the entities involved in each operation. The documentation required for each authorisation is subdivided according to the type of entity involved — manufacturers, distributors of active medicinal cannabis substances, and cultivation entities (clones and seeds).

‍

Such requirements help safeguard the rigorous standards expected in the handling of medicinal cannabis. This product, being classified as a psychotropic substance, demands rigorous safety and quality standards at every stage of its handling. These new rules help reinforce confidence in the Portuguese pharmaceutical sector, ensuring the country remains an international reference in the control and commercialisation of this product.

‍

Updated documentation related to the export and import authorisation requests can be found on the official INFARMED’s website at: https://www.infarmed.pt/web/infarmed/substancias-controladas .

‍

Owlpharma is available to help in the preparation and submission of these authorizations’ requests to the regulatory authority INFARMED, ensuring your organisation meets all the new requirements. For more information, please contact us at owlpharma@owlpharma.pt. Our team stands ready to assist with any questions or requirements.

‍