What is the most appropiate way to structure a cultivation licence?

As te Technical Manager at Kannabeira, I would like to share that the licensing process for medical cannabis cultivation activities was truly comprehensive and challenging. Our licensing journey with INFARMED, the regulatory authority in Portugal, was not only a legal and regulatory requirement, but also an enriching opportunity for growth and participation in building a young and disruptive sector in the pharmaceutical industry. Navigating in the ecosystem implies not only the observation of national and international regulation, but also the adherence to essential and transversal guiding standards and guidelines.

Quality Assurance and Quality Management Systems (QMS) play a critical role in our operation. We follow GACP-EMA (Good Agricultural and Harvesting Practices -European Medicines Agency) guidelines. This ensures that our products meet the highest quality standards, promoting safe and effective therapies for patients. We work in close collaboration with the various industry players, maintaining high standards of quality and compliance, which is reflected in a Qualification process and Technical Quality Agreements for the products and services promoted.

A thorough record keeping and documentation system is the blackbone of traceability of batches placed on the market. This is essential to ensure that each product can be monitored at all stages along the value chain and is a crucial tool for Pharmacovigilance. In addition, we have implemented a Facility Security System, including physical measures and constant monitoring of perimeters and areas, with access control for every human resource, visitors and suppliers and central alarm system. This ensures the protection of our operations and the safety of our products.

The experience of being at the forefront of the Medical Cannabis industry has been challenging, but incredibly rewarding. The commitment to quality, compliance and, above all, the mission to promote safe and effective therapies to patients continues to guide us on this disruptive journey in the health and wellness sector.

Francisco Amaral, CPO and Technical Manager at Kannabeira