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What do you need for the cultivation of medicinal cannabis in Europe?

What steps should be taken to grow cannabis for medicinal use in Spain? And for the manufacture of active substances derived from cannabis? Can I grow cannabis in Spain and sell it to my customer in Germany? What do I need? These and other questions are common among companies who want to start their business in the world of medical cannabis.

In recent months it has been observed a growing interest in the pharmaceutical industry worldwide in the use of cannabis for medicinal purposes. its cultivation for medicinal purposes is subject to a number of peculiarities.

A project to open a facility for the processing and manufacture of cannabis derivatives requires thorough planning based on the various applicable regulatory requirements, in order to ensure the success of the project on schedule. In addition, a dual GACP/GXP approach must be incorporated, considering the requirements at the level of safety and those related to the handling of narcotic substances, and having a global vision of the project and a holistic perspective of the existing needs.

In Europe, the cultivation, manufacture, marketing, import and export of preparations and substances based on the cannabis plant for medicinal, medical-veterinary and research purposes are subject to the control of the competent local Health Authorities.

Cannabis cultivation

In relation to the cultivation, collection and primary processing of plants for medicinal use, the applicant must have a Quality Management System that incorporates multiple requirements. In the case of cannabis, in addition, all its particularities and specific connotations must be taken into account, as well as the specific requirements for narcotic substances.

Cultivation authorisation

In order to obtain authorization to manufacture medicinal products for human use and/or investigational medicinal products and/or herbal preparations of cannabis for medicinal purposes, compliance with the requirements set out in Part I and II of the guide to Good Manufacturing Practice for medicinal products, relating to



Author: Marta Rodríguez Velez, Industry Area Director.


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